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The FDA's Cozy Little Relationship

Relationships between the FDA and the pharmaceutical industry have led to a “revolving door,” in which pharmaceutical executives go to work for the FDA, making regulatory decisions on matters affecting their industry and sometimes even their own former companies. When their time at the FDA is over, they go back to higher-paying jobs in the industry.

A web search for “FDA revolving door” turns up numerous examples, but it’s no longer necessary even to go to the trouble. The revolving door was formalized in 2001, with the creation of the Food and Drug Administration Alumni Association (FDAAA).

The FDAAA’s web site says the group is “a non-profit, non-lobbying organization dedicated to serving those who have supported the consumer protection mission of the U.S. FDA.” Oddly, however, pharmaceutical industry lobbyists and p.r. people are well represented on its board of directors.

Among the FDAAA's goals are to “enable former colleagues to stay current on major scientific and regulatory issues facing FDA, educate the public about the vital work of the FDA ...,” and “assist FDA in recruiting alumni with specialized expertise and institutional knowledge during critical situations.” The web site also says that the FDAAA’s “core mission is to help alumni stay in touch with the issues of the day facing FDA and support the Agency’s public health mission through expertise-sharing, training and outreach opportunities.”

The FDAAA’s revenue “is primarily derived from member dues and outside contributions.” As far as outside contributions go, “support from other persons and institutions is welcome.” To facilitate recruiting alumni, the home page has industry job postings—and the site can be accessed from a link on the FDA’s site. The FDAAA’s logo incorporates the FDA’s logo. In fact, the FDAAA’s office is in the same building as FDA headquarters in Maryland. Its motto is “Serving Those Who Have Served.”

The chairman of the FDAAA, John C. Villforth, writes in the organization’s first newsletter (November 2002) that in looking into the idea of an alumni group, “we discovered that NIH, SSA, HCFA and Congress, among others, have active alumni associations; other agencies such as NRC, EPA and OSHA do not.” Perhaps it didn’t occur to them that the latter three, like the FDA, are regulatory agencies and may not have thought it appropriate for their officials to be fraternizing with employees of the industry they regulate.

Villforth is on the board of directors of Vasogen, which makes heart drugs, and EduNeering, which provides regulatory compliance “learning solutions.” He has also been on the boards of other medical companies.

A few other examples:

The FDAAA’s treasurer and chairman of the finance committee, Jerome A. Halperin, is president and CEO of the Food and Drug Law Institute (FDLI). FDLI’s web site says its “500+ members comprise manufacturers and suppliers of medicines ... medical devices, food and cosmetics ... law firms, consulting firms, associations, and others.” Interestingly, the stated goals of the FDLI, according to its web site, are quite similar to those of the FDAAA: “providing high quality education and a neutral forum for the generation of ideas and discussion of law and public policy for its legal, policy and regulatory communities.” Halperin was formerly vice president of technology for CIBA-GEIGY (now Novartis) and in 2001 was appointed to the board of directors of PharmQuest, which provides software to accelerate drug development.

James S. Benson, a member of the FDAAA board of directors, is also on the board of Medical Device Consultants, “a leading consulting and contract research organization for the medical device industry,” according to the press release announcing his appointment to that company’s board. He was formerly executive vice president for technology and regulatory affairs at AdvaMed (formerly HIMA), which he has described as “a trade association that represents more than 800 manufacturers of medical devices, diagnostic products, and medical information systems.” The press release said Benson was the “lead strategist for the association’s regulatory agenda.” FDAAA board member Elizabeth Jacobson is executive vice president of AdvaMed.

Wayne L. Pines, another FDAAA board member and chairman of the activities committee, is “president of regulatory services and health care” for APCO, a “global communication consultancy” — a p.r. firm. Pines “provides strategic counsel to clients facing crises or media, legislative, regulatory or marketing problems.” Board member Gerald F. Meyer is a senior consultant at AAC Consulting Group, which, its web site says, “provides a full range of support and compliance assistance. ... offers a team of former high-level FDA officials and industry experts.”

For those who might be suspicious of all this togetherness between the FDA and employees and board members of the industries it ostensibly regulates, the FDAAA has a code of ethics. Unfortunately, its lofty-sounding but carefully worded constructions do not inspire confidence. It says, for example, that members aren’t allowed to “influence FDA policy or action in a manner other than that which [sic] any member of the general public is legally entitled.”

Of course, if you have personal access in a social setting to FDA regulatory officials who approve your product or could hire you or whom you might hire, you’re already in a more favorable position than “any member of the general public” — especially the small alternative businesses the FDA feels it has a mandate to persecute.

Members aren’t allowed to lobby, either — but they don’t need to lobby. They represent a community of interests. All they need to do is network — for example, at a wine tasting at the Bretton Woods Conference Center in October 2004 — and they’re already way ahead. Whatever happened to the idea of avoiding even the appearance of impropriety?

Violations of the ethical code are reviewed by ... the board of directors. If a violation is corroborated, the executive committee “may” impose sanctions, including warning, suspension, and expulsion. So the worst that can happen for an attempt to influence an FDA employee that’s so flagrant it can’t be ignored is expulsion from the organization.