Who might replace Janet Woodcock when she retires as head of the FDA’s all-important Center for Drug Evaluation and Research? Some may wonder, in fact, if anyone can replace Woodcock, a forceful and high-energy bureaucrat with a 20-year institutional memory and controversial profile that sometimes riles consumer advocates while placating pharmaceutical executives.
Although Woodcock, a formidable personality known for maintaining a frantic pace and offering blunt statements, is not scheduled to retire for a year or more, speculation is already mounting about a successor. But as Reuters notes, no one has been groomed for the job, the pay does not approach private sector levels and tapping someone from industry is certain to draw criticism from watchdogs.
“No one is seeing that luminous, next-generation leadership,” says Robert Meyer, a former FDA medical reviewer who later worked for Merck (MRK) and now heads the Center for Translational and Regulatory Sciences at the University of Virginia. “The thought of bringing someone in and expecting them to take over from Janet Woodcock any time soon is the ultimate absurdity,” the former FDA official tells Reuters.
[NEWS FLASH: Woodcock has issued a memo saying her retirement is not imminent. "I want to assure you that I am not planning to retire as erroneously reported in the media today. In fact, quite the opposite is true. I am becoming more deeply involved in many of the Center’s issues, including the proposed reorganizations of the Office of Pharmaceutical Quality and the Office of Generic Drugs. The inaccuracy of the media has unnecessarily raised concerns among Center staff, and even among my own family. My daughter emailed me this morning to ask if I’m retiring! I continue to be fully committed to the important work CDER does and to its staff who work so diligently to protect the health of the American public."]
The succession issue is of extreme importance to public safety and the pharmaceutical industry, since CDER has a budget of more than $1 billion and a staff of 3,450. Moreover, CDER decisions are taken as cues from other regulators around the world and, as Reuters adds, are scrutinized by countless physicians, investors and patients.
“We get people in, they almost take the ring, they’re at the altar and then they realize they have to divest everything,” Woodcock tells Reuters. Why? FDA staffers are privy to market-moving decisions. “…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. It’s mainly the money.”
Her eventual departure worries the pharmaceutical industry, where many executives privately consider her to be an ally in their quest to accelerate the pace and number of drug approvals despite repeated safety scandals that, in recent years, prompted withering scrutiny of industry practices. Last year, the FDA cleared 39 new pharmaceuticals, which was the highest number since 2004 (more here).
By the same token, consumer advocates privately carp that Woodcock appears too sympathetic to industry concerns. For her part, Woodcock insists to Reuters that CDER has not relaxed safety standards, but a study published last year in Innovations in Pharmacy found that of 151 drugs that the United Nations lists as banned around the world, 17 percent are available in the US. And only 9 percent of drugs banned by the US are available internationally (here is the study).
“It shows that the US may no longer be a leader in observing, reporting and removing dangerous drugs from the market,” Albert Wertheimer, a study co-author and a professor at the School of Pharmacy at Temple University, tells Reuters.
Of course, no one can please everyone all the time, especially a bureaucrat. As Reuters also points out, the latest complaints about Woodcock come from generic drugmakers, which grumble that the agency has not moved fast enough to accelerate approvals even after obtaining authority from Congress to collect fees (see this). But someone will have to succeed her. Who do you think it should be?
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