Pharmacy & Therapeutics Journal, July 2008
CDER Director Wins “Wows” Amid Agency Woes
Representative John Dingell (D-Mich.), the irascible, octogenarian Democratic chairman of the House Energy and Commerce Committee, normally sinks his teeth into Bush administration officials like a lion falling on a springbok. At a very contentious hearing on April 29, he tore into
FDA Commissioner Andrew von Eschenbach, MD, for spouting “hooey.” Mr. Dingell ranted, “Let’s come down to the nutcutting stage. I don’t want to weasel words.” But here John Dingell was two weeks later, listening to Dr. von Eschenbach’s deputy, Janet Woodcock, MD, and purring like a kitten.
“Again, I want it known that I appreciate Dr. Woodcock’s candor,” intoned Mr. Dingell,
whose committee has jurisdiction over the FDA. “To her credit, she has stepped forth in
the midst of a public health crisis to deal honestly with Congress. How I wish others in the
administration showed the same vigor, responsiveness, and leadership.”
Why was John Dingell stroking a Bush administration official? A few days before, at a different hearing, Dr. Woodcock, an internist and rheumatologist, had supplied what Dr. von Eschenbach had refused to furnish: an estimate that the FDA would need another $225 million per year to
inspect foreign drug-manufacturing firms such as the ones in China—the source of the contaminated active ingredient in heparin that has caused 81 deaths in the U.S. so far.
Heparin is just the most recent FDA drug disaster in a string of misadventures that started with Merck’s rofecoxib (Vioxx) and moved on to other public relations fiascos involving the
selective serotonin reuptake inhibitor (SSRI) class of anti - depressants, GlaxoSmithKline’s rosiglitazone (Avandia), and too many others to mention. In all those instances, including
heparin recently, FDA regulatory oversight has been, if not quite blind, then fuzzy enough to defy even the most talented optometrist. Never has the FDA’s regulation of drugs been
held in lower regard by Congress and the public.
But in a seeming paradox, amid the agency’s woes, its top drug regulator has been getting “wows.” In her roomy sixth floor office in the FDA’s new office building just outside the
Beltway off New Hampshire Avenue in suburban Maryland, Dr. Woodcock, who has worked at the FDA in one position or another since 1986—including an earlier stint as director of the
Center for Drug Evaluation and Research (CDER) from 1994to 2005—agrees that this has been the most contentious period for the FDA since she has been at the agency. She points to a
generic drug scandal in the late 1980s but calls that event more of “a tempest in a teapot,” compared with what is going on now.
“I regard the heparin problem as a landmark type of event,” she adds. “It demonstrated that an essential drug used everyday all over the health care system can be contaminated. That
is pretty bad.”
It is not often that one hears a top federal official admit to a serious mistake. Democrats
and Republicans on Capitol Hill appreciate Dr. Woodcock’s attempts to push candor to the
limits. Referring to her colloquy with Representative Dingell on May 1, Bill Hubbard, longtime
(now retired) Associate Commissioner at the FDA, who was also testifying at that hearing
and who worked with her at the FDA, says: “Janet was willing to speak her mind, which
is refreshing and also somewhat unusual. Usually, administration witnesses have to spout the
party line. She is very popular now on Capitol Hill, but she may have ticked off people in the
Pressed as to whether anyone in the White House has come down on her for making nice
with John Dingell, she demurs. “The chips will fall where they may,” she adds.
Director Woodcock is also apparently willing to take more than just rhetorical risks. Although she is well regarded by the drug industry, a few noses there might have gotten out of
joint when the FDA decided on April 28 not to approve Cordaptive, Merck’s new cholesterol-lowering medication. Analysts who had been predicting that the drug could easily top $1 billion
in sales were surprised by the news that the FDA sent a “Not Approved” letter to Merck. Dr. Woodcock refuses to discuss the case but explains, “Every year we learn more, and we
apply it moving forward.”
Ron Rodgers, a spokesman for Merck, says, “The question we sometimes get is whether the FDA is changing the standard for approval. We believe the rejection had to do with the ‘science’
and we hope to get an understanding of the agency’s reasoning in an upcoming meeting.”
Asked whether the black eyes the agency has earned in the past few years over Vioxx, SSRIs, and other drugs led the FDA to make a statement to the public by canning Cordaptive,
Dr. Woodcock laughs and says, “We don’t make decisions that pander to public approval.”
Heparin is the latest, if not the most disturbing, drug dis aster she has had to live through at the FDA. After taking over as Director of CDER in 1994, she was kicked upstairs in 2005 and
given the title of deputy commissioner and chief medicalofficer. Dr. von Eschenbach brought her back to the CDER, first as the acting director in October 2007, because then current
direct or, Rear Admiral Steven Galston, MD, MPH, was named acting surgeon general. With the Bush administration nearing the end of its line, not too many people were lobbying for the CDER director’s job, especially since its domain new drug approval and postmarketing surveillance—
was in serious dis repair as a result of successive political earthquakes. Dr. Woodcock’s “acting” designation was removed in March 2008.
Bush administration officials won’t say whether Dr. Woodcock returned to the CDER willingly or whether her arm had to be twisted. Bill Hubbard thinks she was frustrated with a
lack of discipline in the Commissioner’s office and is “probably glad to be back at CDER.” But now that she is back and has some political capital from Democrats to spend, expect her to keep speaking her mind, which she does politely but not pointedly. She laughs frequently throughout an hour-long interview, and smiles, two devices that seem to be used to make her refusal to get too colorful or too specific more palatable. Looking back over the past decade and a half, she can see where the seeds of many of the FDA’s current problems were planted. And in many of the cases, the Johnny Appleseeds were congressmen like John Dingell.
Throughout the 1990s, Congress piled new drug regulatory programs on the FDA: the Best Pharmaceuticals for Children program, the FDA Modernization Act of 1997, and others.
Dr. Woodcock cites former FDA official Peter Barton Hutt, who estimated that Congress had given the FDA 125 additional mandates over the past 15 years. However, even though those
laws heaped new responsibilities on the FDA’s shoulders, Congress did not provide increased appropriations to run those new programs. The CDER staff was stretched thinner than a
piece of Saran Wrap. The pharmaceutical industry kept paying higher user fees, of course, but those funds can be used only for restricted purposes.
Steadily increasing responsibilities and a lagging congressional appropriation eroded by inflation has led to a hollowing out of the CDER’s capabilities in terms of staff and infra -
structure. So it should have been no surprise when an FDA scientific advisory subcommittee published a report called FDA Science and Mission at Risk in November 2007. Garret
FitzGerald, MD, Professor of Medicine and Chair of Pharmacology at the University of Pennsylvania and one of the report’s authors, referred in testimony on January 29 to “a disturbingly systemic set of problems in the agency.”
Dr. Woodcock agrees with the conclusions of that report. “Our infrastructure is in very disturbing shape,” she concedes. But she sees the glass as being only half empty. “Our
level of scientific sophistication is unparalleled; there is no comparison to 20 years ago. While we are finding problems more frequently, our ability to identify them is at a higher level than ever before.” Nonetheless, she agrees that higher appropriations over the past decade, for example, would have allowed the agency to bolster its information technology resources, which are not
exactly state of the art. However, Dr. Woodcock does not commit political suicide by blaming the Bush (or Clinton) administration, whatever her private feelings might be. She won’t criticize criticize Congress directly, either, although it is fairly easy to read her unspoken thoughts. She notes:
“When I was at a hearing this winter in Ms. [Rosa] DeLauro’s subcommittee, she said that was the first drug hearing the subcommittee had held in 25 years.” Representative DeLauro (D-Conn.) is chairman of the House FDA appropriations subcommittee, which holds the pursestrings for the FDA.
Bill Hubbard is more direct. “DeLauro is inconsistent,” he states. “She won’t give more money until the FDA does a better job.”
Dr. Woodcock continues, “The FDA has gotten a lot of blame, but we’re not in charge of setting the federal budget. Period.”
Last year, Representative DeLauro declined to appropriate money for the new Reagan–Udall Foundation, which is intended to be a nonprofit group dedicated to getting Dr. Woodcock’s
“baby”—the Critical Path Initiative (CPI)—further off the ground. Dr. Woodcock established the CPI in 2004 as a funding source for new science advances that might help the
FDA assess new drugs more quickly and accurately. Money goes to universities and to private researchers, but the CPI never received much in the way of congressional appropriations,
she concedes. “If you consider that the hallmark of success, that is not happening,”
she says. “But there is a tremendous amount going on in Critical Path.”
Nonetheless, the Reagan–Udall Foundation is supposed to raise private funds that would dwarf what the FDA has been able to spend on CPI projects. Dr. Woodcock is circumspect when she explains why the Foundation has taken so long to get off the ground. She does
not blame Rosa DeLauro for not providing funds in 2008, as the FDA Amendments Act allowed her to do. Instead, she explains that it is the “elaborate procedures” specified in the FDA Amendments Act that have stymied the Foundation, although she argues that it takes a year to get many nonprofit organizations off the ground. But even though the FDA appointed a board of directors last October, headed by former FDA Commissioner Mark McClellan, MD, PhD, Dr. Woodcock says that the board has not even written the Reagan–Udall Foundation’s by-laws yet. That has to happen before the Foundation can begin its work. She estimates it will be up and running by the end of 2008.
But don’t ask her to offer any opinion on the Bush administration’s handling of problems with drug safety or to compare it with the Clinton administration’s approach. “Here we go,” she mugs when the question is asked. She clearly expects any self-respecting journalist to test her
tongue—and she is ready with the parry.
“How smart would that be,” she sniffs, feigning being insulted that she could be baited, as if she just fell off the hay wagon in Washington.
Just the opposite, actually; Janet Woodcock is riding high.