Members of new FDA board tied to industry.

T he Food and Drug Administration’s most recent steps toward modernizing the drug approval process have renewed some old questions about the FDA’s relationship with the industries it regulates. Several public advocacy groups affi liated with physicians and researchers have voiced their concern over the appointment of certain members to a newly formed agency board. The groups have warned that some members may have confl icts of interest due to past or current roles as board members of pharmaceutical and biotechnology fi rms. In September, Congress passed the latest version of the Prescription Drug User Fee Act — the law that established an accelerated new-drug application process funded through industry-paid fees. It included a provision requiring the FDA to establish a private – public partnership that would facilitate the Critical Path Initiative, the agency’s ongoing effort to streamline and modernize the drug approval process. The partnership, called the Reagan – Udall Foundation, will be responsible for setting goals and priorities for the Critical Path Initiative, as well as awarding grants and contracts to meet those goals, among other things. The foundation’s board of directors, appointed by the FDA commissioner, will be largely responsible for establishing bylaws, selecting an executive director to oversee day-to-day operations, and reporting to Congress on foundation activities and operations. The federal statute stipulates that of the 14 members named to the board, four members should come from industry, three from academia, two from consumer or patient advocacy organizations, and one from the health provider community. The remaining four spots are open to anyone with relevant expertise. The FDA has already chosen the members and is organizing the Reagan – Udall Foundation. However, some advocacy groups are concerned that several nonindustry members have strong ties to pharmaceutical and biotechnology companies, including one who is currently under investigation by the Senate Finance Committee. Tadataka “Tachi” Yamada, M.D., currently heads the Bill and Melinda Gates Foundation’s global health program but until 2006 worked as head of research for the pharmaceutical company GlaxoSmithKline. Senate investigators have uncovered evidence suggesting that, during his tenure with the company, he may have been involved in an effort to intimidate a scientist who was raising questions about the heart risks associated with the com pany’s blockbuster diabetes drug rosiglitazone maleate (Avandia). In a news article published in Nature late last year, Yamada said that he had not initiated any discussion of a lawsuit against the researcher, John Buse, M.D., of the University of North Carolina, and that he had contacted Buse’s boss to check the researcher’s credentials. In the Nature article, Buse confi rmed that although he felt others at the company had threatened him with a lawsuit, he never thought that any intimidation came from Yamada. Nonetheless, in a letter to FDA head Andrew von Eschenbach, M.D., Rep. Rosa DeLauro (D-Conn.) asked him to reconsider naming Yamada to the board. “I am sure you will agree that this conduct by Dr. Yamada should not be condoned ... I believe that these allegations of Dr. Yamada’s behavior as a research chief for a drug company raise serious questions about whether the industry will attempt to infl uence the so-called independent research mission of the foundation,” she wrote. According to an agency spokesperson, because the FDA does not have the authority to set confl ict-of-interest policies for the foundation, the board will have to do that. However, the FDA’s response to Rep. DeLauro does not fully address her concerns, said a representative from her offi ce. Yamada is not the only board member whose presence has generated concern. Several other members appear to have industry ties, said Roy Poses, M.D., president of the Foundation for Integrity and Responsibility in Medicine, a small nonprofi t that investigates problems in the health care system to inform policy makers and the public. In particular, Poses said he was concerned about the inclusion of William Brody, M.D., Ph.D., president of the Johns Hopkins University, and until August of last year, a director at the medical device company Medtronic;