Over 30 years of reporting on Congress, federal agencies and the White House for corporate America as well as national trade and professional associations.

Lowering the Ozone Standard

Aftermarket Business, May 2008

The Environmental Protection Agency's new lower ozone standard will force many states to reassess their automobile inspection and maintenance (I&M) plans. The plans, which vary from state to state, require motorists to get periodic safety and emission checks for designated model-year autos. Each state specifies how onboard diagnostic (OBD) systems should be checked and when defective parts need to be replaced. In California, for example, higher quality aftermarket catalytic converters will be required in some instances starting in 2009.

The EPA announced on March 12 that it was lowering its ozone standard from .084 parts per million (ppm) to .075 ppm. Ozone is formed in the atmosphere as the result of a chemical reaction between nitrogen oxide and volatile organic compounds, both of which are emitted from auto exhaust systems. States will have approximately three years to determine which of their counties are out of compliance with the new standard and to submit a plan to the EPA laying out how they will bring those counties into attainment with the new standard. From that point, nonattainment counties will have between three and 20 years — depending how severe their air pollution is — to meet the .075 ppm standard.

Many newspapers serving those counties have carried stories quoting local air control officials on the immense task in front of them. In Jefferson County, Ky., which includes Louisville, for example, officials say cars, trucks and other motor vehicles are responsible for about 31 percent of the area's nitrogen oxide and volatile organic compound emissions, while industrial plants are responsible for 40 percent. Kentucky and Indiana officials produced maps showing 19 Kentucky counties and 25 Indiana counties that would violate the new .075 ppm standard based on the current three years of air monitoring.

The regulatory impact analysis (RIA) accompanying the EPA rule suggests that one way nonattainment counties could reduce ozone levels would be through adoption of continuous inspection and maintenance (I&M), which involves equipping vehicles with a transmitter that attaches to the OBD port. The device transmits the status of the OBD system to receivers distributed around the I&M area. Transmission may be through radio frequency, cellular or Wi-Fi means.

Aaron Lowe, vice president of government affairs for the Automotive Aftermarket Industry Association (AAIA), says that upgraded I&M programs would be good for the aftermarket as long as auto owners are allowed to bring their cars to independent service stations.

Damage to the aftermarket auto parts industry from warranty work may also come into play if the lower ozone standards encourage states to adopt a California-style program, which mandates that a certain percentage of autos sold in the state be low-emission vehicles. A contingent part of that California requirement is that the manufacturers of those cars must give extended warranties for the emission systems to the buyer. In California, the requirement is 15 years and 150,000 miles.

Changes in state I&M programs and higher low-emission vehicle thresholds will be even more radical if Congress decides to lower the EPA's new .075 ppm standard further. However, President Bush would likely veto any law setting the standard lower — but a President McCain, Clinton or Obama might well applaud a further reduction.

Stephen Barlas has been a full-time freelance Washington editor since 1981, reporting for trade, professional magazines and newspapers on regulatory agency, congressional and White House actions and issues. He also writes a column forAutomotive Engineering,the monthly publication from the Society of Automotive Engineers.

The Perils of Physician Profiling

EyeNet magazine, May 2008

When the letter from BlueCross and BlueShield of Texas landed on his desk last October, oculoplastic surgeon John W. Shore, M.D. couldn’t believe his eyes. The insurance company was creating a new network of “low-cost” physicians who follow evidence-based practices. BlueChoice Solutions was to be an all-star team. Shore had not made the cut. The Austin-based ophthalmologist who co-founded Texas Oculoplastic Consultants in 1997 sees patients from all the other BCBS plans—even the low cost plans offered by BCBS that have unattractive rates. He thought for sure he would have made the Solutions team.

“We were rankled,” remembers Shore. “It wasn’t that we were going to lose that much money. It is more from the patient’s perspective. They were going to have to pay out-of-network prices to see us since we would not be a part of that plan” After all, many patients needing oculoplastic surgery in Austin are probably going to Texas Oculoplastic Consultants (TOC). It is the only practice in town limited to oculoplastic surgery. But suddenly, patients were walking through the doors of TOC and being confronted by potential roadblocks and significant financial barriers to care. “We knew some patients would not seek needed care because of significant out-of-network charges since we were excluded from the Solutions network,” Shore states. “We try to be proactive with our patients and make sure they understand the situation before they get here. We were sure we would get constant haggling about bills because of co-pays approaching 30 percent. For some people the difference between a $50 co-pay and a $210 co-pay is a major stumbling block.”

Ted Haynes, vice president of health care delivery, BlueCross and BlueShield of Texas, acknowledges that an individual choosing Solutions or an employee whose company only offers Solutions—and not the broader BlueChoice network, of which Solutions is a subset--does face some conflict over cost of the health plan versus access to physicians.

Angry patients, angry docs. Their ranks are growing as insurance companies across the country introduce new, exclusive networks like BlueChoice Solutions catering to cost-conscious companies and consumers. The networks offer lower premiums and co-pays in exchange for restricted networks which ostensibly—and that is the key word, ostensibly—feature physicians whose per episode treatment costs are lower, and who have shown they are “quality” providers. BlueChoice Solutions is far from the only network of this kind. In January, UnitedHealthcare introduced an affordable health plan called EDGE which United’s CEO described as offering “an affordable alternative to consumers who receive care from specialists recognized for high-quality, cost-efficient care.” In Massachusetts two years ago, the head of the Group Insurance Commission, a quasi-state agency, ordered all insurance companies offering health plans to all state and many municipal employees to group all physicians in two tiers. All the health plans, be they Tufts, Harvard Pilgrim, Unicare or the others, do their tiering a little differently. But in all cases, the plans try to steer members to purportedly less expensive Tier 1 physicians, visits with whom call for lower co-pays. Bill Rich, M.D., medical director for health policy for the AAO, says similar plans are starting to crop up in states such as Georgia and Alabama.

Everyone agrees, emphasizes Rich, that a health plan which carefully and transparently evaluates physician costs and uses established, respected quality measures ought to be able to establish networks based on those clear, clean facts. But so far, none of these new networks advertised as “low-cost, high-quality” are fully transparent, nor are their cost and quality measures carefully developed. This past February, Linda Lacewell, who heads New York Attorney General Andrew Cuomo’s health-care industry task force, characterized the Ingenix database owned by UnitedHealthcare, which is the major health claims data base, as “garbage in, garbage out,” according to a story in the Wall Street Journal.

Most health plans use that Ingenix database and run the claims information through what is called “grouper” software, where the claims are grouped into episodes of care and each physician is then given a total cost for an episode. The three grouper products out there are Ingenix’s Episode Treatment Group (ETG), MedStat Episode Groups (MEGs) and Cave Consulting Grouper (CCG). Of these illness classification systems using groupers, the ETG methodology has 90 percent of the market. For ophthalmologists, a typical episode of care might be chronic open angle glaucoma. Bill Rich explains that when grouper software looks at chronic open angle glaucoma, for example, it tosses in an ophthalmologist’s charges to the insurance company for imaging of the nerve, diagnostic testing, surgery, drugs, facility fees for surgery and more. Those charges, of course, are probably greater in the practice of a glaucoma subspecialist where where many end-stage patients are seen, as opposed to a general ophthalmologist such as Bill Rich, for whom glaucoma patients may only be 20 percent of his patient load, with many in the early stage of the disease. Yet the grouper software compares Rich’s costs for treating chronic open angle glaucoma to the costs of the academic physician, and designates the latter as a “high cost” provider.

Haynes of BCBS of Texas says BlueChoice Solutions does not use the Ingenix data and uses MEGs as its grouper software. “We look at episodes, and case mix adjust them, meaning we account for more serious versus less serious cases, take into account co-morbidities and any other complicating factors.” In fact, Solutions puts a considerable amount of information on its Web site (http://www.bcbstx.com/provider/bluechoice_solutions/tool_raci.htm) explaining how its risk adjustment process works. However, they are unable to risk adjust diseases like glaucoma with no co-morbidities and only one ICD9 code for both early and advanced disease. Nonetheless, Solutions is one of the better networks out there, a fact recognized by the Medicare Payment Advisory Committee, which advises Congress. In an October 2007 report, MedPac wrote: “Health plans included in the study were generally in the early stages of using resource measures to assess provider efficiency, with fairly limited applications to benefit design, payment, or provider
selection. However, BCBS of Texas was well ahead of the other plans.”

Solutions may be risk adjusting better than other similar “low cost” plans, but even its methodology is not fully transparent, nor is it without significant shortcomings. For example, Solutions averages episode costs among similar physicians in each of Texas’s 23 regions. That means that John Shore’s average costs are compared to the average costs for other eye surgeons—not oculoplastic surgeons—in an area that includes Austin and perhaps other nearby counties.

“The data they use is totally flawed in my opinion,” Shore explains. He asked for, and was given by BlueChoice Solutions, bar graphs comparing his per episode costs to those of other eye physicians, all of whom presumably were eye surgeons of some type. “We were being compared to practices whose patients did not need the same services our patients require.” For instance, as an oculoplastic specialist Shore is called upon to repair complex lacerations, fractures, infections and major head and neck trauma. Patients with these injuries require intensive services such as CAT scans, hospitalization for intravenous antibiotics, or intensive nursing care. ”Ours is an intense surgical practice,” he explains. “Therefore our use of hospital resources is more and our costs are correspondingly higher.”

Moreover, in Shore’s case, he may treat an episode of orbital inflammatory syndrome (pseudotumor) requiring a four or five day stay in the hospital as the result of a referral from an optometrist to a comprehensive ophthalmologist who then refers the patient to Shore. The “episode” costs for the patient’s office visits reported by the first two physicians may be thrown into Shore’s episode costs. That is because some insurance companies typically assign responsibility for each episode’s actual and expected costs to a physician based on an attribution rule such as: “responsibility is assigned to the physician who accounts for 30% or more of professional and prescribing costs included in the episode.” For BlueChoice Solutions, an episode is billed to the physician or professional provider who bills the greatest total Relative Value Units (RVUs) in that episode (excluding those billed by anesthesiologists, pathologists, and radiologists).

Another problem is that an ophthalmologist may only have a couple of episodes, and so it would be statistically invalid to assign him an “average” cost.

Not only are there some imperfections in the way episode costs are calculated and analyzed for these new “low cost” or “tiered” networks, but health plan claims that the networks contain “high quality” physicians are also open to question. Haynes of BlueChoice Solutions says that network doesn’t make a “high quality” claim, only that the physicians included follow evidence-based measures (EBMs), the identity of which is published on the BCBS Texas web site. For ophthalmologists, the EBM is an annual visual field test for patients with primary open angle glaucoma. Any physician who is more than two standard deviations from the mean is excluded from Solutions. Haynes says this EBM comes from the AAO. But Flora Lum, MD, AAO policy director for quality of care and knowledge based development, says that is not a performance measure developed for CMS’ PQRI, but is based on a recommended frequency in the Academy’s Preferred Practice Patterns.

In Massachusetts, according to Cynthia Mattox, MD, vice chair and director, glaucoma and cataract service at the New England Eye Center, Tufts University School of Medicine, and a member of AAO's Health Policy Committee, health plans use as their quality determination whether a diabetic patient had a dilated exam in the past year. That is it. What made it worse, at least initially, was that the companies were only counting exams billed by an ophthalmologist using evaluation and management CPT codes. The Bay State Group Insurance Commission was not recognizing diabetic dilated exams when the claim listed a "V" code, which is used for documenting "routine eye exams" billed to vision care plans. Michael Price, M.D., uncovered that discrepancy and brought it to the attention of the GIC which corrected the oversight. Overnight, the percentage of ophthalmologists rating in the highest quality tier went from 65% to 98%.

No private insurance plan has come close to the quality determination effort made by the Centers for Medicare and Medicaid Services (CMS). It developed a Medicare Physician Quality Reporting Initiative (PQRI) in 2007, which is being continued in 2008, where physicians are offered a 1.5 percent bonus based on their reporting of stated quality measures, four of which were designed in 2007 exclusively for ophthalmologists, and which were developed by a workgroup co-chaired by the American Academy of Ophthalmology.

For primary open-angle glaucoma, an ophthalmologist has to dilate the pupil and evaluate the optic nerve in 80 percent of the patients he or she sees. For age-related macular degeneration, the quality standard is a dilated macular examination with documentation of presence or absence of macular thickening or hemorrhage, and the level of macular degeneration severity. For diabetic retinopathy, there are two indicators. For one, the physician has to document the presence or absence of macular edema and the level of severity of retinopathy. The other requires communication with the primary care physician managing the on-going diabetes care. The fifth indicator, new in 2008, is a diabetic eye exam annually, or every two years if there was a negative exam performed the year before. There are also two structural measures available for all physicians also: whether a physician has and uses electronic health records and whether he or she uses electronic prescribing.

Typically, ophthalmologists have to bill the “quality” codes for 80 percent of their patients, and for three of the four indicators, unless they do not see patients for whom those indicators come into play. In some instances, an ophthalmologist may only show 80 percent for one indicator. The maximum annual Medicare bonus amount available is approximately $4,400. Rich says that is very simple for ophthalmologists to document those quality measures, and points to the fact that ophthalmologists, at 60 percent, have the highest participation rate of any specialty in the PQRI.

The private “low cost, high quality” networks now cropping up around the U.S. are neither as credible nor as transparent as the PQRI. At least BlueChoice Solutions offers physicians an appeals process if they feel they have been unfairly excluded. Haynes says a peer review committee composed of physicians hears appeals, one of which was made by John Shore. “We stood up to them,” he says. “As soon as someone looked at data, they said ‘We’ll let you guys in.’” But the reason he really won his reprieve, probably, was that his practice is the only one in Austin that does ocuoplastic surgery.

That would be less likely to happen in Boston, for example, where there is a larger supply of eye surgeons, including those like Cynthia Mattox at the New England Eye Center. She says, as Shore does, it is the patients, not the physicians, who are ultimately hurt by these poorly-designed networks, which shift higher costs onto patients, and save the insurance company money. “Patients are going to be penalized for seeking subspecialty care, even if that is the most cost-efficient way for them to get their care,"Mattox says.

Corporate Pay Under New Scrutiny

Financial Executive, April 2008

By Stephen Barlas

The economic malaise and the huge woes at financial firms have triggered hearings on top executive – mostly CEO – pay packages. Congressional Democrats see a hot political issue, and the SEC and IRS are also taking action on compensation topics.


Tom Lehner, the director of public policy for the Business Roundtable, relates a conversation he had recently with the CEO of a Fortune 500 company, who he declines to name. The CEO’s company, like 350 others, received a letter from the U.S. Securities and Exchange Commission (SEC) during the second half of 2007 voicing unhappiness with the company’s disclosure in its 2007 proxy about how the pay levels of top executives are determined.

This company, like all public companies filing proxies, was required for the first time in 2007 to comply with rules the SEC published in 2006 requiring companies to spell out in the Compensation Discussion and Analysis (CD&A) the “metrics”— a somewhat vague term, admittedly — used in determining the pay of the CEO, CFO and next three most highly compensated executives.

The SEC’s Division of Corporation Finance had looked at this company’s 2007 proxy, seen a significant disparity between the pay for two vice presidents and complained to the company that it had not spelled out why one compensation package was heavyweight and the other lightweight.

“One of them is doing a much better job,” explained the CEO to Lehner, with a touch of exasperation, “but we can’t put that in the proxy.”

Exasperation is, in fact, the principal reaction these days among corporate executives whose pockets Washington players, and not just the SEC, are — if not exactly picking — pulling out and examining with all the fervor of a CSI technician looking for evidence of crimes.

Even before the disclosures about the severance packages given to former Merrill Lynch & Co. CEO Stan O’Neal and Countrywide Financial founder Angelo Mozilo (which led to a congressional committee hearing on February 28) and the bonuses paid to top executives at Bear, Stearns & Co. and Morgan Stanley — seen as big rewards for floundering performances — at least two congressmen had been on the warpath against lavish pay packages. Even the Internal Revenue Service (IRS) is getting in on the action.

Congressional Democrats, certainly, sense a political opportunity in an anti-corporate executive comp campaign, especially given a looming recession and middle-class economic angst. When he released his economic plan on February 13, Sen. Barack Obama (D-Ill.) criticized executives who “are making more in a day than the average worker makes in a year,” according to The Wall Street Journal.

Not that Sen. John McCain (R-Ariz.) evidently feels much differently. When he discusses his health plan, he disdains any federal program as a solution and instead opts for a nationwide private insurance market that ensures broad and vigorous competition — which, he adds, “will wring out excess costs, overhead and bloated executive compensation.”

Waxman Questions Consultant Usage

While the rhetoric is flowing on the campaign trail, Rep. Henry Waxman (D-Calif.), the leading House hit man on executive compensation, sent a letter to Fortune 250 companies on January 31 asking them to provide information about how executive compensation consultants are utilized in determining senior executives’ pay packages. Waxman has held a year’s worth of hearings and issued a report last December that exposed alleged conflicts of interest when compensation consultants do salary advising and other consulting, be it tax, human resources or auditing, for the same company.

Waxman’s House Oversight & Investigations Committee, which he chairs, has no legislative authority. So, even if Waxman were to propose some type of Sarbanes-Oxley anti-conflict-of-interest legislation aimed at corporate use of compensation consultants, it would have to go through the Financial Services Committee chaired by Rep. Barney Frank (D-Mass.). Waxman has not declared his intentions.

Brent Longnecker, a compensation consultant who represented Enron plaintiffs and today works with seven large corporations, says having consultants sign an affidavit attesting to the lack of pressure from management would be a good idea. Longnecker says that very occasionally a board may ask him after he makes salary recommendations to give them any ideas for improvements in that process, and his comments may go into the board’s minutes, which may or may not be public. But that appears to be as far as the corporate internal policing of compensation consultants goes today.

Ira Millstein, senior partner at Weil, Gotshal & Manges LLP and dean of the National Association of Corporate Directors (NACD) Corporate Directors Institute, says, “Waxman has raised the right question. It should be clear to boards that this is a hot enough issue that if they don’t do something, they are risking legislation.”

One piece of legislation aimed at making boards think twice about questionable pay packages has already passed the House. That would be “The Shareholder Vote on Executive Compensation Act” (H.R. 1257), sponsored by Rep. Frank. The bill would require that public companies ensure that shareholders have: 1) an annual nonbinding advisory vote on their company’s executive compensation plans; and 2) an additional nonbinding advisory vote if the company awards a new golden parachute package while simultaneously negotiating the purchase or sale of the company.

A number of companies have already adopted this proposal voluntarily, so it isn’t the most radical notion to come down the pike. Nonetheless, the Business Roundtable and other business groups oppose it.

Despite that opposition, the House passed it by a vote of 269-134 on April 20, 2007. That is about 20 votes short of a veto-proof majority, which is important since the Bush Administration opposes the bill. That could lead to a veto if the legislation is passed by Congress. At the moment, however, there appears to be little chance of that.

After it came over from the House, the bill sat in the Senate Banking, Housing and Urban Affairs Committee for the rest of 2007 as Sen. Chris Dodd (D-Conn.), the chairman there, ran for the Democratic presidential nomination. Some would say Dodd was too busy to take up the Frank bill, which is sponsored in the Senate by Sen. Obama.

But one lobbyist for a shareholders’ group says the rumor is that Dodd declined to take it up last year because he was loathe to give a legislative gift to Obama while Dodd was competing with him for the Democratic nomination. Dodd has continued to sit on the bill now that he is off the campaign trail.

Voluntary Advisory Votes Seen

“In a legislative year shortened by the elections, the prospects for moving the Frank/Obama bill are unclear,” says Lehner of the Business Roundtable. Moreover, he doesn’t think the bill is necessary because nearly 100 companies have already said they would voluntarily allow an advisory shareholder vote on pay, so the Fortune 500 is moving on its own in that direction.

Companies already are disclosing more information about how they come up with the pay packages for their top five executives as a result of the 2006 SEC rules, which came into play for the first time for 2007 proxies. But John White, director of Corporation Finance for the SEC, made it clear in speeches during the second half of 2007 that companies made good-faith efforts to comply with the rules but needed to do better on manner of presentation and analysis.

As it happens, the SEC took no action against any of the 350 companies whose disclosures it examined in 2007. But as companies prepare their 2008 proxies, there is palpable fear that the SEC will not be so understanding this year. SEC spokesman John Nester says the agency will have “the full range” of enforcement options on the table in 2008, including forcing companies to restate their proxies or taking enforcement action if companies balk at that request.

With regard to Lehner’s anecdote about the exasperated CEO, Nester says that if a metric a company uses to determine pay is “material,” then it must be disclosed. “If performance is one of those metrics the board looks at when approving pay, most observers would consider it material,” he states.

The SEC isn’t the only federal burr under the corporate salary saddle. The IRS issued a letter ruling last September — which became public and controversial on February 8 — reversing its long-standing position on the effect of standard severance arrangements on the deductibility of performance-based compensation under Section 162(m) of the IRS Code. That part of the code explains when companies can take more than a $1 million deduction for the pay of any of its top five executives.

Performance Linkage at Issue

This $1 million cap does not apply to qualified performance-based compensation. But, there is a raft of considerations that go into determining whether the $1 million-plus exception is available to any company. For example, the pay is still considered “performance-based” even if the plan allows the compensation to be payable on death, disability or a change of control or ownership.

In 1999 and 2006, the IRS issued private-letter rulings stating that the safe harbor from the regulations governing death, disability or change of ownership or control would also extend to compensation paid on an involuntary termination of employment or termination for good reason. This was welcomed by business groups. Then came the September 2007 ruling, which applied to one company — so it is not IRS policy, at least not yet — and the publication of that letter on February 8, which set off a firestorm.

During a February 14 webcast on CompensationStandards.com, Ken Griffin, associate chief counsel, executive compensation branch at the IRS, acknowledged the uproar caused by publication of the September private-letter ruling. “Much of the thunder that we’re hearing is focused on the financial accounting ramifications from this ruling, and it’s from every direction we’re getting it. We hear it more and more,” he said.

“It appears pretty likely that some further guidance will be out soon from the IRS, at least regarding the possible retroactive application of the private-letter ruling’s conclusion,“ said Broc Romanek, editor of CompensationStandards.com, “since otherwise, the position could cause thousands of companies to adjust their tax reserves significantly.”

Any IRS guidance will probably relieve some corporate indigestion and be welcome. But it may not reverse the underlying change in IRS policy on compensation deductibility. That IRS clarification, as is the case with all the executive compensation initiatives in Washington (though no agency or politician will say so openly), is being driven by unfavorable public — and therefore political — perceptions about corporate pay gluttony. That scrutiny is likely to intensify no matter who becomes President in 2009.

Stephen Barlas (sbarlas@verizon.net) is a freelance writer in Washington, D.C., who covers finance, accounting and other business topics.

FDA Embroiled in New Controversies

Contract Pharma, March 2008

Last Year's Big Bill a Bust?

By Stephen Barlas

The year 2008 was suppose to be the start of a New Era for the Food and Drug Administration given congressional passage last September of the biggest FDA reform bill in decades. The Food and Drug Administration Amendments Act (FDAAA) of 2007 was suppose to correct some of the regulatory shortcomings which hamstrung the FDA in responding convincingly to allegations about the safety of drugs such as Vioxx, Ketek, Avandia and many others. When the FDAAA passed the House and Senate in September 2007 by overwhelming margins, key sponsor Sen. Edward Kennedy (D-Mass.) called it a “strong and comprehensive measure.”

But in at least a couple important instances, that bill is turning out to be a bust. Democrats have already stymied implementation of some important provisions, including the Reagan-Udall Foundation, which was suppose to funnel private sector funding to contractors who would speed up the development of scientific methodologies the FDA could use to accelerate drug approvals and more accurately determine the safety of new drugs. For companies looking for pharmaceutical contracting opportunities, the RUF would be a gold mine; it is suppose to raise and spend only private money so that the 76 Critical Path Initiative projects the FDA has identified as needing funding can be begun. Only four have gotten off the ground since 2004, when the CPI was established, because of lack of FDA funding. “Our bill recognizes that innovation is the key to medical progress by establishing a new center, the Reagan-Udall Foundation, to develop new research methods to accelerate the search for medical breakthroughs,” Kennedy had said last September.

But Rep. Rosa DeLauro (D-Conn.), chairman of the House Appropriations subcommittee with responsibility for the FDA budget, refused to allow federal funding in 2008 for the RUF’s start up—things like paper clips, envelopes and a modest staff-- which the FDAAA authorized. Steven Walker, co-founder and chief advisor to the Abigail Alliance, a patient advocacy group, says, “The Reagan Udall Foundation, given the lack of congressional funding, is a foundation with a mission and nowhere to go. It is obviously crippled.” Mark McClellan, the chairman of the RUF and a former FDA commissioner, did not respond to numerous voice and e-mail messages asking for a progress report on the RUF. Nor would any of the board members contacted individually, via phone and e-mail, agree to be interviewed.

At the same time FDAAA provisions such as the RUF seem to be limping out of the starting gate, it is becoming clearer that the bill—lauded in September by Kennedy and others—may not even have addressed some major drug safety problems. That was evident when two members of the FDA Science Board, an advisory group composed of outside academics and industry scientists, appeared before the House Energy & Commerce Committee on January 29. They were part of the subcommittee formed in early 2007 when FDA Commissioner Andrew von Eschenbach asked for a report on whether FDA’s current science and technology can support the agency’s statutory mandate to protect the nation’s food and drug supply. The report, “FDA Science and Mission at Risk,” was published in November 2007. On January 29, 2008, before the House committee, Gail H. Cassell, vice president for scientific affairs at Eli Lilly, and chair of the Science Board subcommittee which wrote the report, said, “It became rapidly apparent that the FDA suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.”

Of course, the FDAAA had a regulatory focus, not a scientific one, except for the Reagan-Udall Foundation. But even the big bill’s regulatory reforms seem thin now measured against such 2008 controversies such as the ruckus over Vytorin, marketed by Schering-Plough Corp. and Merck & Co. There, allegations are rife that the two co-marketers of Vytorin voluntarily conducted a clinical trial of the drug after it was approved by the FDA but first fudged the results, then failed to report them when they showed Vytorin was no more effective in than Zocor, a generic, in lowering the risk of heart disease and stroke. Here, it was Vytorin’s efficacy, not its safety, which is at issue.

The FDAAA does give the FDA new authority with regard to clinical trials, but only with regard to reporting the pre-approval results when a drug is first approved, and with regard to ordering post-approval trials (which Merck and Schering did voluntarily). The new law says nothing about how those studies—pre-approval or post-approval-- should be conducted or when the post-approval results should be reported. Again, the FDAAA addresses reporting of clinical trials at the time a drug is first approved. So, for example, it requires companies to post, for the first time, the results of Stage II, III and IV clinical trials once the drug is approved. In addition, that post-approval information must include links to FDA reviews of the clinical trials and to medical journal articles in which the trials are discussed. That must be done within 90 days of the FDA approving a new drug. The bill allows the FDA to levy those $250,000/$ 1 million civil penalties against recalcitrant companies.

As important as those clinical trial reporting requirements were for many patient advocacy groups, the provisions were not among those billed as major drug safety advances; ones that, for example, would give the agency more leverage to force companies to change the labeling of a drug when adverse reaction data became available. That was the issue with Vioxx, whose labeling Merck balked at changing, and which the FDA was powerless to force the company to do. Previously, all the agency could do if a company refused to make a label change was pull the drug off the market, which could have widespread and deleterious ramifications for the people taking it. The FDAAA sets up a new expedited pathway for making label changes, where the company and the FDA move quickly through a process of proposals and counterproposals and, if there is no agreement, there is a time certain for ending the company’s appeals and forcing it to make FDA-dictated changes. Normally, these negotiations will last no longer than 120 days and maybe substantially less.

But the ink on that provision was barely dry before congressional Democrats began charging the FDA with perverting the intent of those labeling changes. On January 23 Democrats in the House and Senate, including Ted Kennedy, sent an angry letter to FDA Commissioner Andrew von Eschenbach complaining a proposed rule the FDA issued on January 15 makes “a glaring omission in its description of congressional intent with respect to FDAAA’s labeling change authority.”

One of the signatories to that January 23 letter was DeLauro, the Reagan-Udall Foundation villain. She also has had a hand in neutering another FDAAA provision; one which allowed the FDA to charge drug companies user fees which would be used for FDA review of direct-to-consumer (DTC) television advertisements. The FDA reviews TV ads now, but very slowly. The fees would have allowed the FDA to hire additional ad review staffers and give companies quick feedback so they promptly received some assurance that marketing campaigns would not be derailed at some later date by slow-developing FDA objections. The program was to have been funded at $11.25 million in 2008; some of that coming from the FDA budget, some of it from user fees. But DeLauro only allocated $4 million and, to make matters worse, refused to allow the agency to even raise additional funds via user fees. DeLauro’s press secretary failed to return both phone calls and e-mails asking for DeLauro’s rational with regard to both the RUF and the user fees for TV ad review.

Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson says, “The DTC user fee program was an important component of the drug safety enhancements that Congress passed through FDAAA. We urge Congress to act quickly and to provide the appropriate authority for the FDA to operate this vital program.”

None of these problems were foreseen, of course, when both the House and Senate passed FDAAA by overwhelming votes last September. The House passed the bill by a vote of 405-7 on September 19. The Senate followed the next day by unanimous consent. The FDAAA weighed in at over 400 pages of very technical verbiage and contains, according to the FDA’s von Eschenbach, at least 200 specific provisions, many of which have implementation timelines. There were essentially two parts to the bill: the drug safety provisions and the increase in user fees paid by the pharmaceutical companies, the revenue from which would pay the salaries of additional FDA staffers who would implement the drug safety provisions.

In fiscal 2008, according to Alan Goldhammer, deputy vice president, regulatory affairs, PhRMA, companies will pay a total of $459 million in drug approval user fees. Those fees will account for 62 percent of the budget of the FDA’s Center for Drug Evaluation and Research. The $459 million is an increase of nearly 50 percent over the $305 million the companies paid in 2007. That $459 million will increase in each of the next four years over the five year term of the reauthorization. Most of that money has been, and will continue to be, used for the review of new drugs. But the bill sets aside $54 million for drug safety activities in fiscal 2008, most of that in the area of post-marketing. That figure will also increase steadily over the next five years. Much of that $54 million will be used to hire staff in the area of post marketing surveillance.

But even the huge increase in user fees required under FDAAA turns out to be far short of what is actually needed. On January 29, members of the FDA Science Board described a report first issued last November which scathingly described the FDA’s scientific shortcomings, many of them the result of insufficient resources. In their appearances before the House committee on January 29, Cassell and Garret FitzGerald, a second member of the subcommittee and professor of medicine, chair of pharmacology at the University of Pennsylvania, decried the systematic funding shortfalls at the FDA and other bureaucratic problems.

“These include the politicization and instability of leadership, attrition of manpower, poor morale, structural and organizational inadequacies, depleted infrastructure and – most importantly- critical gaps in scientific expertise and technology as emphasized in our Science Board report,” said FitzGerald. “These factors – many, but not all reflecting a serious erosion of necessary resource - compound to undermine seriously the science base of the Agency and its ability to fulfill its mandate.”

After those hearings, Democratic leaders on FDA issues, instead of committing to increased FDA funding in the 2009 appropriations bill, did what politicians do when they try to avoid making tough decisions: call for a report. Rep. Henry Waxman (D-Calif.), a senior member of the House Energy & Commerce Committee, and Sen. Kennedy, sent a joint letter to the Government Accountability Office requesting an examination of the staffing, information technology, and other resources necessary for the FDA to successfully carry out its oversight of foods, drugs, biologics, and medical devices.

This question of inadequate resources also raises questions about the viability and completion of another important initiative authorized by the FDAAA: the new “active post-market risk identification” network. Here the FDA will create a master database of sorts linking databases currently established by the Department of Veterans Affairs, the Centers for Medicare and Medicaid Services and those of private health insurers. This new network will supersede MedWatch, the current adverse reaction reporting system, which is close to useless. MedWatch depends on reports from health care providers and individuals, and frequently duplicate reports are filed.

The idea behind this new surveillance network is that as soon as information on adverse effects of a new drug becomes available, at the point-of-care as a result of a physician visit, it comes to the FDA immediately as the physician enters the data on a patient’s electronic medical record. There is no need for anyone to fill out a separate report. Plus, the FDA can then do retrospective searches of this master data base when it gets an inkling that there may be a problem with a new drug, i.e. inputting that drug’s name into the master file and seeing if there are adverse event reports in the system. The bill gives the agency two years to develop the data sources for this new risk identification system. But by July 1, 2010 there have to be at least 25 million patients in the data base. That number must increase to 100 million two years after that.

Getting this gigantic surveillance network up and running should result, as with the Reagan-Udall Foundation, in the letting of numerous contracts to private sector entities. Barbara Rudolph, director of leaps and measures at the Leapfrog Group, a group of large companies concerned about health care quality, spoke at a meeting at the FDA in March 2007 which was held to help the FDA get insights into what a new surveillance network might look like. That meeting helped seed the provision in the FDAAA. Rudolph says she has not heard a peep out of the FDA on the surveillance network since the FDAAA’s passage.

Tightening the Parachute Strings

Human Resource Executive Online, March 11, 2008

The IRS recently acted to tighten the rules affecting executive severance of more than $1 million, requiring companies to review their agreements. And more changes may be in the winds as well, as Congress continues to look into executive comp.

By Stephen Barlas

Companies have some new tax considerations that will force them to rethink many of the performance-based severance packages they have developed for top executives in the past.

It's possible the Internal Revenue Service was responding to prevailing political winds when it tightened its rules dealing with when executive compensation of more than $1 million can be deducted from corporate taxes.

The IRS > action on Feb. 21 may deflate some lucrative exit packages -- known as golden parachutes -- and may be the harbinger of upcoming congressional moves to eliminate the pay deduction entirely.

Steve Seelig, executive compensation counsel at Washington-based Watson Wyatt, says it is not clear whether the < IRS > was primarily motivated by what it learned in recent corporate audits or by the current political climate.

For example, had the new < IRS > ruling been in effect prior to Stan O'Neal's forced resignation from Merrill Lynch in October -- just a week after the investment bank reported its largest-ever quarterly loss of $2.24 billion -- Merrill would have qualified for a much smaller tax deduction.

O'Neal appeared before the House Oversight and Government Reform Committee on March 7, as part of chairman Rep. Henry Waxman's continuing investigation into the "compensation of executives who preside over billion-dollar losses."

Waxman, D-Calif., noted in his opening statement that the hearing was not about "illegality or even ethical breaches. It's a hearing to ... help us understand whether this situation is good for the companies, the shareholders and for America."

O'Neal -- who left Merrill Lynch with a $161 million retirement package -- was joined at the Waxman hearing by other CEOs who had been extremely well compensated by their floundering companies: Angelo R. Mozilo of Countrywide Financial Corporation -- who received more than $120 million in compensation and sales of stock as the company lost $1.6 billion in 2007 and its stock lost 80 percent of its value -- and Charles Prince of Citigroup -- who was awarded a $10 million bonus, $28 million in unvested stock options and $1.5 million in perks when he left the company.

It is congressional dissatisfaction with those kinds of pay packages that has led to talk about further curtailing exceptions to the $1 million pay cap.

A spokesman for Sen. Max Baucus, D-Mont., chairman of the Senate Finance Committee, says Baucus "is reviewing proposals that would affect deferred compensation, as he has been since last January. He remains committed to working with his colleagues, including Sen. [Chuck] Grassley, on this issue."

Grassley, from Iowa, is the top Republican on the committee.

With regard to the new < IRS > policy, Seelig says companies now need to examine severance and retirement packages to make sure they don't simply pay out at target levels.

This raises a couple of possibilities of how companies will seek to amend existing agreements. For example, a plan that pays out at target for a termination one year into a three-year performance might make the executive wait until the actual results come in at the three-year mark before paying out.

Or the company could substitute a severance agreement that entitles an executive to a specific dollar amount if he or she leaves prior to the end of the performance period.

Section 162(m) of the < IRS > Code explains when companies can take more than a $1 million deduction for the pay of any of its top five executives, excepting the chief financial officer. That $1 million cap does not apply to qualified performance-based compensation.

Based on rulings the < IRS > issued in 1999 and 2006, companies could pay, and top executives could receive, a pro-rated share of a performance-based award even if they left the company before the performance period ended, and before it was clear those performance goals had been met, as long as the executive left the company as a result of being terminated without "cause" or if he or she voluntarily terminated his or her employment for "good reason."

In its revenue ruling issued on Feb. 21, the < IRS explained that an employee could leave for "good reason" or be terminated without "cause" simply because that employee missed interim performance targets. Therefore, he or she was not eligible for performance-based pay, nor could the company deduct that pay of more than $1 million.

Seelig says that although 162 (m) explicitly deals with the five highest-paid corporate employees (not including the CFO), companies typically look at pay packages for lower-ranking employees outside the top five.

That is because, if a company, for example, sets a three-year performance period for its top 10 executives, it won't be clear at the start of the period which of those 10 will be in the "top five" three years later.

Infrastructure, cost blunt E85 adoption

Automotive Engineering, March 2008

Alexander Karsner, an assistant secretary at the Department of Energy, was obviously ticked at what he perceives as the slow introduction of E85-fueled vehicles when he appeared before the Senate Energy Committee on February 7. Sen. Jeff Bingaman (D-N.M.) had called the hearing because of growing fears that the renewable fuels mandate included in last year’s energy bill is unworkable.

Both Bingaman and Sen. Pete Domenici (R-N.M.), the ranking Republican, indicated that the committee may write a “technical corrections” bill which would revise the renewable fuel provision in the Energy Independence and Security Act (EISA) of 2007, which President Bush signed on December 19. That provision mandated the use of 9 billion gallons of renewable fuel in U.S. autos by 2008 and 36 billion by 2022. That is quite an increase from the 2005 energy bill, which set a goal of 5.4 billion gallons in 2008. The EISA provision did not establish any numerical goals for the production of flexible fuel vehicles, which ostensibly will be needed to use the corn- and cellulose-based ethanol fuel that will be produced in large amounts. But there is certainly de facto political pressure on Detroit to step up its FFV production, and fast, a fact reflected in Karsner’s testimony.

But reaching 9 billion gallons in 2008 depends on a heck of a lot more than the appearance of new FFV models from Detroit. Numerous witnesses at the Bingaman hearings—none of them from the auto industry—testified that the near term ethanol production/use goals were probably unrealistic and that for the goals to be reached many things will have to fall into place, including a fueling infrastructure and certification by EPA of fuels somewhere between E10 and E85 for use in conventional engines, actions which have nothing to do with the production rate of E85 vehicles.

Karsner noted the infrastructure problems, the shortage of fueling stations and the difficulty of getting ethanol to the East Coast. But he seemed to come down particularly hard on the auto industry on a day after GM North America President Troy Clarke told the Chicago Auto Show that GM will have 11 ethanol-capable vehicles on the market this year, and 15 in 2009.

Karsner wasn’t impressed, apparently. Speaking to Bingaman and Domenici, he read from his prepared testimony and said, “Both the Secretary (Samuel Bodman) and I have been calling on automakers to make flex-fuel and hybrid vehicles ubiquitous across the fleet, for every make and model, for every manufacturer who services the U.S. market.” He then picked up his head from the paper he was reading and emphasized, departing from his prepared testimony, “They need to be made available not in the hundreds, not in the thousands, but in the millions,” implying that U.S. automakers are dragging their feet.

Going back to his prepared testimony, he read, “We do not see any technical reasons that at least the option of flex-fuel vehicles could not be offered to all consumers at a relatively low price.” And again, add-libbing, he added, “And in short order.”

Asked after the hearings whether Karsner is annoyed with U.S. auto manufacturers, Julie Ruggiero, an Energy Department spokeswoman, said that isn’t the case. But she said Karsner believes, “We need to move beyond prototypes and concept cars and we need to do it with a sense of urgency.”

However, there is a real question about whether consumers would buy, in the short term, more flex fuel vehicles than Detroit is producing. Charles Drevna, president of the National Petrochemical & Refiners Association, noted that FFVs get about 20-30 percent fewer miles per gallon when fueled with E85. And if that were not bad enough—especially given the new CAFE mandates the industry faces—he pointed out that a gallon of E85 can cost upwards of $.80 a gallon more than a gallon of E10.

If mileage and price don’t discourage consumers, lack of fuel pumps certainly will. There are only 1,348 fueling stations in the U.S. offering E85.There is another 1,350 terminals where ethanol can potentially be blended.

Maybe a solution to those problems would justify more aggressive production of FFVs. So would the Environmental Protection Agency’s (EPA) certification of blends between E10-E85 in conventional auto engines. The DOE and the American Coalition for Ethanol co-sponsored an Optimal Ethanol Blend Level Investigation last year, and released the results in December 2007. “The investigation revealed unprecedented data that E20 and E30 blends can provide better fuel economy than regular gasoline in non-flex fuel vehicles with fewer harmful tailpipe emissions,” said Brian Jennings, executive vice president of the ACE.

FDA Bulks Up in 2008: Congress Injects Political Steroids; More Muscle for Drug Safety

Pharmacy & Therapeutics, December 2007

Avandia, the type-2 diabetes drug manufactured by Glaxo-SmithKline, is the most recent poster child for drug safety hysteria. A meta-analysis published last May by a noted cardiologist
fueled concern and headlines over possible cardiovascular side effects from the drug (rosiglitazone maleate), forcing the FDA to revisit Avandia’s labeling in the absence of any new, convincing clinical trials. The result: GSK’s agreement in mid-November to expand Avandia’s existing black-box warning with confusing language saying “a risk of an increase in myocardial
ischemic events was not confirmed or excluded in three long-term clinical trials.”

It is that kind of decision-making in the absence of facts that the Food and Drug Administration Amendments Act (FDAAA) of 2007 aims to help eliminate. The bill is a political steroid shot in the arm to the beleaguered FDA, long considered a 98-lb. weakling. As a result, its Center
for Drug Evaluation and Research (CDER) will flex new muscles in 2008. But don’t expect CDER to become Hulk Hogan overnight, if ever. In many ways, despite its size and provisions, the legislation is hardly radical. “It is not a rewrite of authority; [nor] is it a huge addition the
way the 1962 amendments were,” explains Bill Hubbard, who left the FDA in 2005 as Associate Commissioner. He now serves as senior advisor to the Coalition for a Stronger FDA.
“It is a tweaking, but a big tweaking,” he says.

The bill gives the FDA authority to impose restrictions on the distribution of new drugs that have significant benefits—like Avandia—but whose safety hasn’t quite been buttoned down at the time of approval (again, like Avandia). Those up-front agreements are called Risk Evaluation and Mitigation Strategies (REMS). The agency will be able to force companies to perform postapproval clinical trials to pin down unresolved safety problems. If those trials turn up troubling information, the FDA will be able to act quickly to force a label change. None of this had happened with Avandia.

Concerns about Avandia hit the headlines last spring when Steven Nissen, M.D., chairman of the Department of Cardiovascular Medicine at Cleveland Clinic and immediate past president
of the American College of Cardiology, dropped a bomb. The meta-analysis he published in the New England Journal of Medicine in May 2007 combined the results of 42 previously completed small studies to show that Avandia posed a 43% increased incidence of heart attacks. At the FDA’s insistence, GSK had added additional language about heart attacks to Avandia’s
warning label 15 months earlier. The Nissen meta-analysis, however, implied that the company
was soft-pedaling the risk—even though he conceded thathis meta-analysis was “less convincing” than a clinical trial, even though the New England Journal of Medicine itself had seconded the fuzziness of the doctor’s analysis in an accompanying editorial, and even though FDA Commissioner Andrew von Eschenbach, M.D., had noted “serious concerns.” He said that
patients taking Avandia and their health care providers were confused about the drug’s safety because of media reports surrounding the journal article.

Confusion and hysteria are what Congress hopes to eliminate in 2008 and beyond with the provisions of the FDAAA. A more accurate title for the bill might have been “The No More Vioxx, Ketek, Paxil, Avandia, et al., Act of 2007.” The legislation weighs in at more than 400 pages of technical verbiage and contains at least 200 provisions. Many of these provisions have deadlines for implementation and are identified within the bill itself. Although the bill’s drug safety provisions were the subject of numerous headline-producing congressional battles, they were actually an add-on to legislation reauthorizing the FDA to collect user fees from drug companies for the five years starting in fiscal year 2008, which began on October 1, 2007. Those user fees, althoug h controversial, are a critical component of the CDER’s budget.

In fiscal year 2008, according to Alan Goldhammer, Deputy Vice President of Regulatory Affairs of Pharmaceutical Research and Manufacturers of America (PhRMA), companies will pay a total of $459 million in user fees. These fees will accoun t for 62% of the CDER’s budget. The $459 million is an increase of nearly 50% over the $305 million the companies paid in 2007, and it will increase in each of the next four years over the five-year term of the reauthorization. Most of that money has been, and will continue to be, used for the review of new drugs. However, the bill sets aside $54 million for drug safety activities in fiscal year 2008; that figure will also increase steadily over the next five years, and much of the $54 million will be used to hire
staff in the area of postmarketing surveillance. By the end of 2008, the CDER’s staff will have grown by about 500 employees, a 20% increase. Congress expects to see a bigger, stronger, better-staffed CDER win more wrestling matches with pharmaceutical companies over drug safety, but the companies aren’t so sure that a larger CDER will necessarily mean fewer drug safety headlines.

Dolly A. Judge, Pfizer Vice President of Federal Government Relations, says: I think more interactions are better for drug safety management purposes. But I know the optics of the industry and agency meeting more frequently is not necessarily better politically. Senator Grassley and others have been critical of the relationship between industry and FDA, so more meetings could further enhance a false perception that the relationship is too close or somehow it is unholy, so to speak.

Certainly, the FDA has met with drug company representatives in the past, both before and after drug approvals, but the agency’s leverage has been limited. In the past, for example, the CDER’s negotiations with a company like GSK about adding or upgrading a warning about heart attacks to a drug like Avandia could go on for years, as happened with Merck and its pain relieve r rofecoxib(Vioxx), for example. It has been happening, apparently, with Avandia in the wake of the publicity around Dr. Nissen’s article and an FDA advisory com mittee meeting last summer.
In the past, the only power the FDA had in ordering a label change, after a drug went on the market, was to threaten to force a company to take the drug off the market. The FDA rarely used that authority, because such an action might have hurt patients already taking the drug. The FDAAA sets up a quicker pathway for making label changes. With the new step, the company and the FDA would move quickly through a process of proposals and counterproposals.
If there is no agreement, there is a time limit for ending the company’s appeals and
forcing it to make changes dictated by the FDA. Normally, these negotiations would last no longer than 120 days and might be substantially shorter. Why have these labeling discussions
taken so long? Part of the reason is the absence of clinical trial data; this lack has fostered
much uncertainty. Again, when the FDA approved Avandia in 1999, the drug was considered a real benefit for patients with type-2 diabetes. At that time, the FDA knew that adverse reactions might be a problem, but it had little leverage to force GSK to conduct a major postmarketing clinical trial directed at pinning down the risk of a heart attack. Because of the cost of clinical trials, GSK had little incentive to undertake such a trial on its own. Subsequently, many small studies were performed on Avandia, but heart attack was not an endpoint in any of them. This series of events led to Dr. Nissen’s hysteria-promoting article in May 2007.

Under the FDAAA, the FDA can force a study or a clinical trial in conjunction with a new drug approval if the scientific data are deemed appropriate. That authority has been absent in the past. A study can be ordered (1) to assess a known serious risk, (2) to evaluate signals of serious risks, and (3) to identify an unexpected serious risk when the available data indicate the potential for such a risk. If any of these three objectives can be achieved by the active
postmarketing risk-identification and analysis system, which this bill charges the FDA to set up, the agency cannot order a study. A clinical trial can be mandated only when a study cannot accomplis h the three objectives. The pharmaceutical company sets the timetable for completing the study or trial. If those deadlines are missed, the FDA can levy civil penalties.

The FDAAA allows the FDA to fine a company $250,000 for missing a deadline by 30 days; that fine is doubled every 30 days until it reaches $1 million. The FDA has this same authority to impose a penalty if a company fails to make post-approval label changes after the FDA mandates them. The FDA’s authority to order post-approval studies and clinicaltrials is constrained somewhat by the need to consider whether it can obtain the information it needs from the new active active postmarketing risk-identification network. With this new
network, the FDA would link up with databases currently established by the Department of Veterans Affairs, the Centers for Medicare and Medicaid Services, and by private health insurers. The new network will supersede MedWatch (the current system for reporting adverse reactions); however, this system is considered almost useless. MedWatch depends on reports from health care providers and individuals. Unfortunately, duplicate reports are often filed. Moreover, the FDA must then go back and interview those who sent in reports. All of this takes an enormous amount of time. Even after this step, the agency has no “denominator” (hard facts on how many other patient s had the same adverse reaction, much less how many people are taking the drug).

With the new postmarketing database, those data will no longer be available from MedWatch; the FDA will be able to go into the database and look for trends (e.g., cardiovascular
events tied to a particular drug). Setting this network up is going to take time, though. The FDA will have two years to develop the data sources. By July 1, 2010, at least 25 million patients must be in the database; by 2012, 100 million must be included. On its own, the FDA had already awarded contracts in this area. The new user fees for drug safety, flowing into the CDER budget starting in fiscal year 2008, will allow the FDA to accelerate its efforts to meet the
timelines in the FDAAA. Although FDA officials claim that they will be able to meet those deadlines, this new network might cost considerably more than what the FDA will have in user fees to pay for it.

Given the failure of Congress to appropriate adequate funds for drug safety, no one expects future FDA appropriations to add congressional money to the user fees that will be available for
the database. That is why the agency hopes to also supplement user fees with funding provided by the Reagan–Udall Foundation, also being established by the FDAAA. The fund has a
much broader purpose, however. It is a private foundation, modeled on the ones already used by the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health
(NIH). The fund will raise its own operating budget. That money will be spent on collaborative research in which drug companies, academic centers, and others join together for research that
would be dispersed broadly and whose results generally would not be patented. The kinds of research projects to be undertaken would be those on the FDA’s Critical Path Initiative (CPI) list.

The FDA established the CPI in March 2004. The CPI list includes 76 projects, but the FDA has funded only half a dozen or so. These projects cover biomarkers, animal models, inter-individual
variability in drug response, data analysis technology and methodology in drug development, and improvements in designing and conducting clinical trials. Some are concerned that because the Reagan–Udall Foundation will depend on private funding and because most (if not all)
of that funding will come from the drug companies, it will serve the interest of drug companies, even though its 14-person board of directors will have representatives from widely diverse
groups. Only four directors will be from the pharmaceutical, device , food, cosmetic, and biotechnology industries.

Steve Walker, co-founder of Abigail Alliance, a patient advocacygroup, says,
“The Reagan–Udall Foundation is the only provision of the bill with real potential to improve the FDA, but there is a real chance it won’t accomplish that goal.” He argues that the foundation has no authority to impose change on the FDA. It can fund only research, the results of
which the FDA can choose to accept or reject. “The FDA is a profoundly change-resistant agency and will likely reject or weaken any recommendations for real change from the institute,” he contends.

The Republican Senate staffer who worked on the FDAAA says that some of the concerns raised about the foundation are “misconstrued,” but she does acknowledge that the legislation allows drug companies to make “directed” donations based on bylaws to be developed by the board of directors; some of the research would be patentable, again based on board policies.

Just as there are skeptics of the Reagan–Udall Foundation, however, some are more optimistic. Mary Richards, Deputy Chief Executive Officer of the Parkinson’s Action Network (PAN), says that the development of a biomarker for Parkinson’s disease would be of “huge, huge importance” to the Parkinson’s community. It might not only hasten development of a drug that would be effective in the later stages of the disease—a drug that does not exist today—but might also allow for better diagnosis. Although this is the type of research we expect the foundation
to fund, two questions remain: • Can the foundation’s board of directors ensure that money
will come in from multiple sources? • Will the money be applied on the basis of strategic public
health needs? Ms. Richards states: “I think there will be a lot of scrutiny around
that.”

Patients with Parkinson’s disease and many other conditions are hopeful about another provision in the FDAAA that would require drug companies to post more complete information
about a clinical trial in progress on the NIH database (www. clinicaltrials.gov). Right now, that Web site has only limited information posted by the sponsor when the trial gets under way before the drug is approved. The FDAAA substantially increases that early information; mandates new search features for users; and, perhaps most importantly—and most controversially—forces companies to post, for the first time, the results of Stage II, III, and IV clinical trials after a drug is approved. The post-approval information must also include links to FDA reviews of the clinical trials and to medical journal articles in which the trials are discussed. This must be accomplished within 90 days of the FDA’s approval. The bill allows the FDA
to levy those $250,000 and $1 million civil penalties against recalcitrant companies.

The House bill had included a provision forcing companies to submit summaries of their clinical trials in “layman language.” PhRMA fought to have this provision kicked out of the bill because
of concerns it would expose drug companies to liability for making promotional claims and because it felt clinical trial results were useful only for medical professionals. Eventually, Congress eliminated the lay language provision. Instead, House and Senate members agreed to language requiring the FDA to finish making its rules in three years. They also debated
whether to require a summary of the clinical trial and its results, written in nontechnical, understandable language for patients , “if the Secretary determines that such types of summary
can be included without being misleading or promotional.”

Even patient activists have disagreed about whether it is good to add clinical trial results to the www.clinicaltrials.gov Web site. According to Mary Richards of PAN, the detailed additional clinical trial data that will become available will allow Parkinson’s patients to make better
decisions about new therapies. Many disease communities, including those involving
Parkinson’s disease, are experiencing low participation rates in new trials. She explains:
By providing greater data transparency and access to results information, we believe that will
enhance awareness and understanding of trials as well as secure greater trust in the clinical trial process. . . .

Ultimately, adequate enrollment in trials is essential for bringing newdrugs to the market, and this provision may have a positive impact on the current participation issues. However, Steve Walker believes that tossing huge masses of data from clinical trials into the public domain will give the Steve Nissens of the world more fodder for creating fiascos. He says:
I asked Congress to go back to the drawing board on posting clinical trial data and figure out how to make it available in a manner that would effectively limit irresponsible snipers from doing statistical drive-by hits on the integrity of our drug approval system. Obviously,
they didn’t do that, and I think that was a big mistake.

The FDAAA will give the FDA more money and authority in 2008 and beyond, but it doesn’t do everything that many inside and outside of Congress had hoped for. The bill gives the CDER
statutory authority to require REMS for the first time; however, in the past, the agency has demanded that drug companies produce Risk Minimization Action Plans (RiskMAPs) for some
drugs for which questions about safety rivaled their benefits. Those RiskMAPs required the companies to provide medication guides for the drugs, for example, as REMS will do. Many in
Congress wanted the FDA to require REMS for all drugs. The authority in the FDAAA pertains only to drugs for which REMS are needed to ensure that the drug’s benefits outweigh the
risks. Neither does the bill give the FDA new authority to restrict the advertising of new drugs, a power that many outside groups and many Democrats in Congress had favored. Of course, the
passage of any significant new legislation is subject to all kinds of compromises. In the case of the FDAAA, the finished product clearly improves the FDA’s bargaining position with drug
companies on matters of safety. In the end, having additionalleverage is one thing; using it effectively is another. 

Controversy Flares over LNG Quality Standards

Pipeline & Gas Journal, December 2007

Spectra Energy’s Algonquin Gas Transmission, LLC is getting hit from all sides over the quality of the liquid natural gas (LNG) it expects to bring into the U.S. via the Northeast Gateway project in Massachusetts Bay. Greg McBride, vice president, rates and economic analysis, Spectra Energy, says, “As you would expect, the pipelines for the most part are in the middle in this. The LNG suppliers are on one side; they want gas quality specifications that are fairly broad. Customers want more narrow specs.”

The debate has also set LNG suppliers against local distribution companies, both of whom have engaged in some creative name calling. For example, Consolidated Edison, a major northeast distributor, sniffed that Statoil, the Norwegian company which apparently won’t even drop off LNG at Northeast, is taking a “cavalier” approach toward Con Ed’s peak-shaving facility, which Con Ed sniffs “is not a bakery.” Dominion Transmission Inc., another LNG supplier like Statoil and essentially its ally, says Algonquin is following the “Goldilocks Theory” arguing that because some say its proposed nitrogen limit is too high and others say it is too low it must be just right.

Rhetoric is definitely flowing fast and deep as FERC decides whether it should reconsider the gas quality standards it has already approved for Algonquin which has completed 13 miles of pipeline to connect its existing offshore terminal to a fleet of specially designed Energy Bridge™ Regasification Vessels (EBRVs) owned by Excelerate Energy L.L.C. The FERC’s reconsideration of such things as the Wobbe range, nitrogen level and hydrocarbon content of the LNG Algonquin expects to start selling in late November underlines what is likely to be the precedent-setting nature of FERC’s final decisions as new LNG delivery points coming on board, such as the Suez Neptune facility which will compete with Northeast in Boston, the Repsol Energy North America Corporation facility in Canada which will start delivering LNG through Spectra’s Maritimes to the U.S. in November 2008 and Weaver’s Cove, project slated for Fall River, Massachusetts.

Algonquin, the major natural gas supplier to the northeast U.S. along with Iroquis, already brings in about 7-8 percent of its 1.6 bcf/day of throughput from the Distrigas facility in Boston. Distrigas gets its LNG from Trinidad; there have been no issues about the quality of that gas. However, Algonquin could take as much as 800,000 mmcf/day from the Northeast Gateway project, which is suppose to start operating in late November.

Algonquin had tried for the past two years to hammer out a consensus agreement on gas standards with local distributors such as KeySpan, the largest firm customer on Algonquin, Con Ed and local New England LDCs. Owners of electric generating capacity such as FPL and gas suppliers such as BP have been involved in the discussions, too. But players in each of those three categories have big problems with the Algonguin gas standards the FERC has endorsed. The FERC is now taking a second look at those standards.

Some of the local distributors in New England and Con Ed are unhappy with the 2.5 percent nitrogen cap Algonquin has proposed. They want a 2 percent cap instead. Distributors store liquefied LNG in peak-shaving facilities during the summer for use during the winter. Too much nitrogen in the LNG leads to frozen liquid. Potential suppliers such as Statoil and BP want a higher nitrogen cap at around 4 percent because they often add nitrogen to the gas they bring in to the U.S. in order to drive down high Wobbe numbers. Wobbe is a measure of the interchangeability associated with different qualities of natural gas, and is expressed in a numerical range. Gas within a particular range will burn comparability.

The issues are so complex that some key parties take Algonguin’s side on one issue, but oppose it on another. So, for instance, KeySpan supports the 2.5 percent nitrogen cap. However, KeySpan is opposing Algonquin on a second issue: it wants a limit on hydrocarbon constituents for ethanes and heavier hydrocarbons of 10 percent. Algonquin, which has proposed a 4 percent level, calls a 10 percent level “unacceptable,” arguing it would cut off an additional six sources of LNG supply.

The New England LDCs are siding with KeySpan on the hydrocarbon constituent issues but part company on nitrogen, supporting a 2 percent nitrogen level; they cite Algonquin’s historical data which shows that nitrogen levels on the Algonquin

system are between 0.5 percent and 1.75 percent. Statoil and BP argue that even the 2.5 percent nitrogen level will cut off important supplies. It says LNG from places such as Qatar, Algeria and Nigeria will need nitrogen injection to reach the Wobbe numbers specified by Algonquin. Statoil wants a 4.0 percent nitrogen cap.

The Wobbe numbers themselves are a separate issue in dispute. The Wobbe number range comes into play for the utilities with dry low-Nox electric generators. Algonquin has proposed 1314-1400. Con Ed says while Algonguin’s range is reasonable, and may well be the right range long term, but in the short-term, while it is retooling its peak shaving facility in Astoria, Queens with what is called “auto-tuning” equipment, Con Ed wants an interim Wobbe range of 1314 and 1385. FPL Energy says 1314 to 1389 while Calpine supports 1314 and 1373.

Auto Manufacturing Fund a part of Senate Greenhouse Gas Bill

Automotive Engineering, December 2007

Higher fuel efficiency standards for autos are rearing their political head in a bi-partisan greenhouse gas bill heading for the Senate floor. The global warming bill which was likely to pass the Senate Environment and Public Works Committee in November includes a $232 billion “manufacturing incentive” fund for the auto industry which companies will only be able to access if their vehicle lineup averages 35 miles per gallon starting in 2012, the year those funds would start to flow. The money can be used for, among other things, engineering integration.

This CAFE provision in the America's Climate Security Act is different, of course, than the one the Senate passed as part of its omnibus energy bill. There the Senate mandated that fleets average 35 miles per gallon by 2020, no ifs, ands or buts. It was a mandate. The House didn’t have a CAFE increase in its energy bill, and it looks like the Senate and House are having trouble coming to an agreement on a compromise energy bill. So the increased CAFE standard in the Senate bill may never see the light of day.

The 35 mpg CAFE standard in the greenhouse gas bill—sponsored by Sens. Joe Lieberman (D-Conn.) and John Warner (R-Va)--only comes into play if a car company wants some of the manufacturing incentive money. So it is not a formal mandate. But what company won’t want to dip into the $232 billion? So the 35 mpg fleet-wide threshold is a de facto requirement, and kicks in four years earlier than the one in the Senate energy bill.

The Lieberman/Warner bill’s main objective is to reduce total U.S. greenhouse-gas emissions from electric power, transportation (large fleets, not consumer autos) and manufacturing (auto factories included) sources by as much as 19% below the 2005 level in 2020 and by as much as 63% below the 2005 level in 2050. Lieberman and Sen. John McCain (R-Ariz.) sponsored a very similar bill in the past which was rejected twice by the Senate. What is different this time around is the breadth of Republican support, for one thing. Of the seven co-sponsors of Lieberman/Warner, four voted against one or both of the earlier iterations. Now they are supporters.

In addition, greenhouse gas reductions have floated to the top of the presidential agenda, giving them added heat. On November 5, Sen. Hillary Clinton (D-N.Y.) gave a speech in Iowa in which she proposed a number of initiatives including $20 billion of “Green Vehicle Bonds” to help U.S. automakers retool their plants to meet greenhouse gas caps.

The Lieberman/Warner bill allows companies in all industries, including the electric utilities, who are a major target of the bill, to buy emission credits in an auction which allow them to emit more carbon than their industry “cap” would otherwise allow. The money from the auction goes to a Climate Change Credit Corporation. One of the things the auction proceeds will go for is a new advanced technology vehicles manufacturing incentive program. The Corporation would provide money to automobile manufacturers and component suppliers to pay up to 30 percent of the cost of reequipping or expanding an existing manufacturing facility to produce and/or engineer qualifying vehicles and qualifying components. In the original version of the Lieberman/Warner bill, vehicles eligible for funding were defined as those meeting Tier II Bin 5 emission standards, any new emission standard for fine particulate matter and at least 125 percent of the average base year combined fuel economy, calculated on an energy-equivalent basis, for vehicles of a substantially similar footprint.

When the bill came up for a vote in subcommittee, Sen. Bernie Sanders (D-Vt) offered an amendment changing the last requirement of the three to one where a company’s entire fleet would have to meet a standard of 35 miles per gallon. That amendment passed. Call that amendment CAFE 2, a more draconian proposal, given the start date, than CAFE 1 in the Senate energy bill. The auto industry hasn’t reacted to the Sanders’ amendment yet. But it will.