Drug Companies, Frist ‘Tussle’ over New FDA Commissioner
A "spirited tug-of-war" over the next FDA commissioner has "unfold[ed] behind the scenes" in the Bush administration, a "tussle" that may force President Bush to "choos[e] between his friends" -- the pharmaceutical industry and Sen. Bill Frist (R-Tenn.), the Los Angeles Times reports. According to the Times, the "$100 billion-a-year" pharmaceutical industry, which contributed $4.4 million to Bush and the Republican party during the 2000 election campaign, hopes to "maintain the FDA's fast-track approach to approving drugs" and has advocated for several candidates with "solid FDA credentials" to head the agency. Frist, however, has backed Dr. Raymond Woosley, an associate dean at Georgetown University Medical Center, who supports a "better system for tracking safety problems of FDA-approved drugs -- a stance that makes the industry nervous." According to one former top FDA official, "It looks like Bush will have to choose between friends. And during the political jockeying, you'll see people reading all sorts of motivations and positions (into) each of the candidates -- and not all of them will be accurate."
According to the Times, drug industry officials say they "are not looking for a puppet [to head the FDA] -- just someone who understands their needs, as well as those of consumers. The industry has recommended Dr. Michael Friedman, vice president for research and development at Pharmacia Corp.'s Searle division, who has served as FDA deputy commissioner for operations and as acting commissioner. The industry has also recommended Dr. Bruce Burlington of Wyeth-Ayerst Pharmaceuticals, the global pharmaceutical division of American Home Products Corp.. Burlington helped to "clea[n] up" the FDA's generics branch after a bribery scandal in the 1980s and ran the agency's medical devices center. In addition, drug companies have supported Dr. Ed Scolnick, president of Merck Research Laboratories. "Those are the people who could do the job who would be fair," Pharmaceutical Research and Manufacturers of America spokesperson Mark Grayson said. The Times also reports that industry officials "wouldn't mind if the White House takes its time" appointing a new FDA commissioner. One former top FDA official said that without a "permanent chief," the agency "is perceived as weaker," adding, "[I]ndustry likes that." According to the Times, the White House may not appoint a new commissioner for "months," and Bush has "given no indication of which way he is leaning."
Meanwhile, in a letter to HHS Secretary Tommy Thompson, Frist called Woosley "an outstanding candidate" for FDA commissioner, citing his "real world experience as a researcher, teacher and clinical practitioner." The Times reports that as FDA chief, Woosley would likely "push for rapid development of drugs -- but only if combined with a stronger safety review." Drug industry officials and experts refused to comment on Woosley or any other candidate, "fearing they would torpedo their candidates' prospects" or make comments that "could come back to haunt them." Other candidates for FDA commissioner include Dr. Lynn Drake, head of the department of dermatology at the University of Oklahoma's Health Sciences Center; Dr. Robert Califf, a cardiologist at Duke University Medical Center; Dr. David Feigal, head of the FDA's Center for Devices and Radiological Health; and Peter Barton Hutt, an attorney and former FDA general counsel. In addition, Bush may tap Dr. Murray Lumpkin, a senior medical advisor in the commissioner's office and former deputy director of the FDA's Center for Drug Evaluation and Research, to head the FDA, but the Times reports that Lumpkin has received "wide" criticism for "keeping the controversial diabetes drug Rezulin on the market" (Cimons, Los Angeles Times, 3/18).