01 The FDA's cozy little relationship
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AAA’s treasu the Food and cturers and s ng firms, ass , are quite si eneration of nities.” Halpe was appointe velopment. irman of the at in looking ss, among ot o not.” Perha s and may no stry they reg urrent on ma of the FDA . edge during c mni stay in to n through exp rman of the f Institute (FD medicines . . nd others.” In se of the FDA iscussion of merly vice pre ard of directo board of dire act research is appointme regulatory aff presents mo formation sys sary even and Drug es:
Transcript of 01 The FDA's cozy little relationship
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A and y loyees of
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ent and mprise rms, ng to its tral forum ulatory artis) and ccelerate
l Device ndustry,” formerly hich he al on 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
