PhRMA Senses Wood Is Close To FDA Nomination; Sundwall Interviewed
This article was originally published in The Tan Sheet
Executive Summary
The Pharmaceutical Research & Manufacturers of America is advising its members to look carefully at the background and published positions of Vanderbilt's Alastair Wood, MD, as the White House moves closer to a nomination for the post of FDA commissioner
|
The Pharmaceutical Research & Manufacturers of America is advising its members to look carefully at the background and published positions of Vanderbilt's Alastair Wood, MD, as the White House moves closer to a nomination for the post of FDA commissioner. The trade association e-mailed D.C.-based representatives of pharmaceutical companies on Feb. 11, warning that a White House decision appears imminent on the candidacy of Wood, who is a member of FDA's Nonprescription Drugs Advisory Committee. PhRMA highlighted three of Wood's own writings as markers of his previous positions: a May 12, 1999 Journal of the American Medical Association article on direct-to-consumer advertising and drug safety, and two New England Journal of Medicine editorials on the same topics (Oct. 19, 2000 and Dec. 17, 1998). The trade group also included a package of three recent editorials expressing concern about Wood: a Jan. 11 National Review article by Manhattan Institute senior fellow Robert Goldberg ("Cloning Kessler: A Bad Choice for the FDA"); a Jan. 17 Wall Street Journal editorial ("It's Not Ted's FDA"); and a Jan. 21 Washington Times editorial by Hoover Institution fellow Henry Miller ("The Right Cure for the FDA?: Ailing Agency Urgently Needs Reform"). As Wood continues to be one of the candidates with staying power in the protracted selection process, PhRMA is treading carefully. While the association is clearly uncomfortable with the prospect of Wood as the nominee, it does not want to come out too forcefully or openly against the Vanderbilt vice chancellor. Wood's name has been discussed publicly since the beginning of January when the Los Angeles Times suggested that his selection was being considered (1 (Also see "FDA Commissioner Logjam Broken?: NDAC’s Wood May Be Nominee" - Pink Sheet, 14 Jan, 2002.), p. 6). The industry refrain against Wood is that he would be another David Kessler, MD, the commissioner selected by the first President Bush. Kessler, who made his mark early by cracking down on drug promotional campaigns, stayed on into the Clinton Administration and carved out an independent agenda focusing on hot-button topics like tobacco, RU-486 and breast implants. While the FDA commissioner is undeniably an important and high visibility position for the regulated industries, the Bush Administration has implemented a number of organizational changes that will limit the eventual nominee's freedom to maneuver. The chief counsel, public affairs and legislative offices of FDA have been aligned more closely with HHS department level staff, creating another level of oversight and checks on the prerogative of the FDA commissioner (2 (Also see "HHS Public, Legislative Affairs Centralization Will Shift 80 FTEs From FDA" - Pink Sheet, 11 Feb, 2002.), p. 9). Wood has strong supporters within the academic medical community (some with good GOP bona fides) that are providing him with ballast against the concerns raised by the regulated industries. The leading candidate from last fall, former Center for Veterinary Medicine Director Lester Crawford, PhD, shows a reverse pattern of support. Industry groups have been more openly receptive of Crawford. His work in food safety makes him an appealing choice for the agricultural state members of the GOP caucus. Academic and physician groups, however, believe the FDA job should be a medical position. Two other candidates are understood to remain under consideration for the post: American Clinical Labs Association President David Sundwall, MD, and Health Directions CEO Jonathan Javitt, MD. White House staff interviewed Sundwall on Feb. 4. He is understood to have been offered the Surgeon General post, but declined. Sundwall, an MD with government and Hill experience, remains a strong compromise candidate. Deputy Chief of Staff and Assistant to the President for Presidential Personnel Clay Johnson is understood to have conducted the most recent FDA interviews. It is increasingly clear that the Prescription Drug User Fee Act reauthorization process will be completed before a commissioner is in place. A realistic timeline suggests the next FDA commissioner might not take office until 2003. Once the White House finalizes its choice, the FBI background check is likely to consume most of 2002. |