Pharmaceutical Industry Fights for an FDA Commissioner with Industry TiesDec 19, 2008 | Parker Waichman LLP
A group of some 34 big-name health interests got together and wrote a letter to Health and Human Services Secretary-designate Tom Daschle urging him to pick someone familiar with the industry for the soon-to-be-vacated U.S. Food and Drug Administration commissioner position, reports Pharmalot and the Wall Street Journal (WSJ). A number of the groups that make up the newly-created “FDA Commissioner Coalition” are backed by big Pharma and include patient and research organizations, many of which receive drug maker funding, said the WSJ.
Pharmalot reported that the letter to Daschle says that although the group did not suggest a new candidate, he/she should be in a position to make decisions that are not encumbered by “pressure from elected and appointed officials and from the news media.”
Pharmalot noted that recent reports have placed Cleveland Clinic cardiologist Steve Nissen and Baltimore health chief Joshua Sharfstein in the running for the new administration’s open post. Sharfstein leads President-elect Barack Obama’s team assessing the FDA, notes Pharmalot and both he and Nissen are known opponents of a variety of drug maker practices. Several consumer groups, including the National Research Center for Women & Families, are said to favor Nissen for the position. Nissen disclosed heart risks associated with the diabetes drug Avandia in a May 2007 study, and he has criticized the agency's handling of drug safety. If brought on, it is expected that Nissen would likely face strong opposition from the drug industry. Sharfstein is another favorite of consumer groups, gaining prominence last year after petitioning the FDA to ban marketing of over-the-counter cough and cold medicines to young children.
And, although House Democrat Bart Stupak (Michigan) has asked the president-elect to not name any standing FDA officials to the post, says the WSJ, the letter says industry ties should be viewed as a “positive qualification.” Stupak disagrees, adds the WSJ, stating that such ties place the candidate "too close with the industries they (sic) regulate."
The letter hinted at long-known flaws in the agency such as insufficient financial resources and a dearth of scientific professionals, both of which—say the group in its letter—“have put the FDA mission of promoting and protecting the public health at risk.” The group provided a detailed, bulleted list of what it felt would be necessary in the future commissioner that included credentials, skills, and a proven background in science, management, administration, consensus-building, impartiality, commitment to the future, and vision. The final bullet urged that. “Candidates for Commissioner should not be excluded due to relationships with industry during the course of his/her career. In fact, diverse experience, including that with an FDA-regulated industry, should be viewed as positive a qualification.”
Current FDA Commissioner Adrew von Eschenbach—who has been criticized as being too hands-off in his leadership—leaves the position in January, when the new administration takes its position. Meanwhile, over the past eight years, scandals involving drugs like Vioxx and Heparin; dangerous side effects from other medicines; plus recalls of peanut butter, spinach, and other foods, hurt the FDA’s reputation.