Insight: Big Pharma braces for retirement of favorite regulator

By Toni Clarke WASHINGTON (Reuters) - The retirement of Dr. Janet Woodcock as head of the Food and Drug Administration's pharmaceutical division is at least a year away, but already the industry she regulates is worrying about who will replace her. Over the past 20 years Woodcock, who is 65, has reshaped the drug approval process, relaxing the criteria needed for certain drugs to reach the market - especially those that represent scientific breakthroughs. Last year, the agency approved 39 new drugs, the most since 1996. That is good news for drug companies who depend on product approvals to fuel profit growth, and some fear that once Woodcock leaves the pace of drug approvals will slow. She also appears to have done little to develop a bench of potential successors - a challenge Woodcock acknowledges. "No-one is seeing that luminous, next-generation leadership," said Dr. Robert Meyer, a former top medical reviewer at the FDA who subsequently joined drug maker Merck & Co as a vice president and in March took an academic position at the University of Virginia. According to interviews with some two dozen people inside and outside the agency who have worked with her, Woodcock is a force of nature. She moves from meeting to meeting - sometimes as many as 16 a day - with crisp efficiency, dealing one minute with a complex cancer drug and the next with an angry lawmaker. The learning curve for her successor will be steep. "The thought of bringing someone in and expecting them to take over from Janet Woodcock any time soon is the ultimate absurdity," said one former senior FDA official who asked not to be identified because he now works for a company that deals with the regulator. Woodcock's boss, FDA Commissioner Margaret Hamburg, acknowledges the difficulty. "It's very hard to parachute into these jobs," she said in an interview, noting that a wide variety of skills - management, scientific and regulatory - are needed for the role. INSTITUTIONAL MEMORY Woodcock's influence at the FDA, and by extension the global pharmaceutical industry which takes its lead from the United States, is hard to overstate. While the commissioner may be the agency's public face, Woodcock is its institutional memory and drives pharmaceutical policy. The office she runs, the Center for Drug Evaluation and Research, is by far the agency's biggest, with a budget of more than $1 billion and a staff of 3,450. Her actions are scrutinized by companies, regulators, physicians, patients and investors around the world. Yet she is struggling to come up with a deep pool of potential successors. "We get people in, they almost take the ring, they're at the altar, and then they realize they have to divest everything," Woodcock said in an interview. Employees must eschew stocks and other investments in FDA-regulated companies because they are privy to market moving information. In February, Woodcock hired Dr. Richard Moscicki, former head of clinical development at the biotechnology company Genzyme Corp as one of her top deputies. Moscicki said he would "welcome the chance, as daunting as it is to watch Janet," to take over if the opportunity arose. But installing any former pharmaceutical executive would almost certainly prompt criticism from drug safety watchdogs who already claim the FDA is too cozy with the drug industry - a charge Woodcock has heard many times and rejects. "If industry wasn't around, patients would be in deep trouble, many of them," she said. Woodcock, who trained as a rheumatologist, is a career civil servant. Petite, with short brown hair and eyebrows that rise in quizzical fashion, she does not tolerate fools gladly; and she can be weak at delegating, former colleagues say. That may have limited the number of people able to advance into more senior roles, though possible candidates do exist, the former colleagues said. For a list of potential successors, click here. Woodcock says her goal is to "put the right people in charge," not micromanage, but she says finding those people is difficult. "I know some of my senior office directors have tried to recruit in and they have gotten repeated turndowns from people who would be fabulous," she said. "It's mainly the money." Government salaries can be at least 10 times lower than the $1 million plus packages on offer at drug companies. Woodcock said she has begun giving certain people within the FDA more responsibility but some say it is has been hard for talent to rise easily to the top. For example, a 2006 report by the Institute of Medicine described a work environment at the Center for Drug Evaluation and Research "that is not sufficiently supportive of staff." Even Woodcock's most ardent admirers concede she can be intimidating. "One thing every chief executive has to worry about is whether they scare the hell out of people," said Dr. Robert Temple, one of Woodcock's closest colleagues. She tries not to be frightening, he added, but is by nature "formidable." DRUG DEVELOPMENT PRIORITY Woodcock has used her influence in part to bend the agency's agenda to her own. She believes more new drugs mean greater choice and better patient outcomes, and has made drug development a central part of the FDA's mission in a way that was not historically the case and that not everyone agrees with. Some colleagues felt the agency should focus principally on drug safety and law enforcement. "People who had been there a long time had a more old-school view, that our job when we got drug applications was just to look for safety and efficacy, and have that high bar," said Meyer. "I never heard Janet articulate anything about lowering the bar, but there was a bit of a philosophical shift and I think she was ahead of the curve on that." Woodcock insists that the agency has not relaxed its safety standards, but there is some evidence to suggest it is more reluctant than other countries to withdraw or restrict potentially dangerous products. A study published last year in the journal Innovations in Pharmacy found that of roughly 150 drugs that the United Nations lists as banned around the globe, 17 percent are available in the United States. Only 9 percent of drugs banned by the United States are available internationally. "It shows that the U.S. may no longer be leader in observing, reporting and removing dangerous drugs from the market," Albert Wertheimer, the study's author, concluded. Wertheimer is a professor in the school of pharmacy at Temple University in Philadelphia. Woodcock declined to comment on the report. The FDA's focus on new drug development has also angered generic drug companies, who face significant delays getting their products reviewed. The office that handles generic drugs is understaffed and overwhelmed by the number of new applications, which have risen from a couple of hundred a year to more than 1,000. "To me, a good manager would divert some resources to an office that is struggling," a former senior official in the division said. "The fact that 80 percent of drugs prescribed in the United States are generic doesn't seem important to the center director." Woodcock says the generic drug office has not received the same kind of funding as the office in charge of novel drugs because until recently the FDA did not receive fees from generic drug makers, as it does from branded companies, to review applications within a set time period. She expects that to change. As Woodcock moves towards the end of her career, she has one more major initiative up her sleeve: a plan to help the drug industry improve quality control by introducing, among other things, techniques to identify and remove the cause of defects during the manufacturing process. "People are moving now to continuous manufacturing and really much more high tech modern ways and it doesn't fit the way good manufacturing practice has been thought about over the years," Woodcock said. "We have to forcibly make sure we allow the better to come about." (Editing by Edward Tobin, Martin Howell and Grant McCool)