Pharmacy & Therapeutics- July 2008 - (Page 397) PROFILE: Janet Woodcock, MD officer. Dr. von Eschenbach brought her back to the CDER, first as the acting director in October 2007, because thencurrent director, 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 disrepair 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 infrastructure. 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 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. I Vol. 33 No. 7 • July 2008 • P&T® 397
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