01 The FDA's cozy little relationship

Relationships betwee en the FDA and a the pharrmaceutical industry have e led to a “reevolving doorr,” in which ph harmaceutica al executives s go to work ffor the FDA, making regu ulatory decissions on mattters affecting g their industrry and sometimes even ttheir own form mer companies. When thheir time at th he FDA is over, tthey go backk to higher-pa aying jobs in the industry y.

A web se earch for “FD DA revolving door” turns up numerous examples, but it’s no loonger necess sary even to go to tthe trouble. The T revolving g door was fformalized in 2001, with the creation oof the Food and a Drug Administtration Alumn ni Associatio on (FDAAA).

The FDA AAA’s web siite says the group g is “a n non-profit, non-lobbying organization o ddedicated to serving those wh ho have supp ported the co onsumer prottection missiion of the U.S S. FDA.” Odddly, howeverr, pharmacceutical indusstry lobbyists s and p.r. pe ople are well represented d on its boarrd of directors. mer colleagu Among tthe FDAAA'ss goals are to o “enable form ues to stay current on maajor scientific c and regulatory issues faccing FDA, educate the pu ublic about th he vital work of the FDA . . . ,” and “as ssist FDA in recruitting alumni with w specializ zed expertise e and institutional knowle edge during ccritical situations.”

The web b site also sa ays that the FDAAA’s F “corre mission is s to help alum mni stay in toouch with the e issues of the da ay facing FDA A and suppo ort the Agenccy’s public he ealth mission n through exppertise-sharing, training a and outreach h opportunitie es.”

The FDA AAA’s revenu ue “is primarily derived frrom member dues and ou utside contribbutions.” As far as outside ccontributionss go, “supporrt from other persons and d institutions is welcome.”” To facilitate e recruiting g alumni, the e home page e has industryy job posting gs—and the site s can be aaccessed from a link on the FDA’s site. Th he FDAAA’s logo incorpo orates the FD DA’s logo. In fact, the FDA AAA’s office is in the same bu uilding as FD DA headquartters in Maryla and. Its mottto is “Serving g Those Whoo Have Serve ed.”

The chairman of the FDAAA, Joh hn C. Villforth h, writes in th he organization’s first new wsletter (Nov vember 2002) that in looking into the idea a of an alumn ni group, “we e discovered that NIH, SS SA, HCFA an nd Congresss, among others, have active a alumni associations s; other agen ncies such ass NRC, EPA A and OSHA do not.” Perha aps it didn’t occur o to them m that the lattter three, like e the FDA, aare regulatory y agenciess and may no ot have thought it approp priate for theiir officials to be fraternizinng with employees of the indusstry they regulate.

Villforth is on the boa ard of directo ors of Vasoge en, which ma akes heart drugs, and EdduNeering, which w providess regulatory compliance c “learning solu utions.” He has h also been n on the boa rds of other medical companiies.

A few other example es: The FDA AAA’s treasu urer and chairman of the ffinance committee, Jerom me A. Halperrin, is president and CEO of tthe Food and d Drug Law Institute I (FD LI). FDLI’s web w site says s its “500+ meembers com mprise manufaccturers and suppliers s of medicines m . . . medical de evices, food and a cosmeticcs . . . law firrms, consultin ng firms, associations, an nd others.” In nterestingly, the t stated go oals of the FD DLI, accordin ng to its web site, are quite siimilar to thos se of the FDA AAA: “providing high quality educationn and a neuttral forum for the generation of ideas and discussion of law and pub blic policy for its legal, pollicy and regu ulatory commun nities.” Halpe erin was form merly vice pre esident of tec chnology for CIBA-GEIGY Y (now Nova artis) and in 2001 w was appointe ed to the boa ard of directo ors of PharmQuest, which h provides sooftware to ac ccelerate drug devvelopment.

James S S. Benson, a member of the t FDAAA b board of directors, is also o on the boarrd of Medical Device Consulta ants, “a leadiing consulting and contra act research organization n for the meddical device in ndustry,” accordin ng to the presss release an nnouncing hiis appointme ent to that company’s boaard. He was formerly executivve vice presid dent for techn nology and rregulatory afffairs at AdvaMed (formerrly HIMA), wh hich he has desccribed as “a trade t association that rep presents more than 800 manufactureers of medica al devices, diagnostic products, p and d medical infformation sys stems.” The press releasse 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.

Izvor: http://www.goodhealthinfo.net/cancer/fda_cozy_relationship.htm