On July 28, 2006, Congressman Ron Paul’s office sent a seven-point letter to the Food and Drug Administration (FDA), asking it to explain its actions in merging its activities with its counterparts in Canada and Mexico under a document signed in 2004 called the Trilateral Cooperation Charter.  (See http://www.thenhf.com/fda_62.htm)  The brainchild of the National Health Federation and the International Alliance for Health Freedom (IAHF), this letter asked the FDA to tell Ron Paul – and its four other Congressional signatories – among other things, what legal basis the FDA had for signing the Trilateral Cooperation Charter, what was being done to protect American citizens’ privacy from the record-sharing requirements of the Charter, whether the FDA intends to harmonize its rules and regulations with those of Canada and Mexico, and what internal controls had been implemented by the FDA to avoid breaking the law.

Months later, on November 24, 2006, David W. Boyer, FDA Assistant Commissioner for Legislation, finally responded in a point-by-point letter that made it clear that the FDA has a sense of humor after all.  Denying everything, Mr. Boyer admits everything.  He says that much of the Charter’s work has been incorporated into the President’s Security and Prosperity Partnership and that the “FDA does, however, intend to continue in various ongoing harmonization efforts under other currently existing mechanisms [including Codex Alimentarius].”

Boyer also continues FDA’s silly attempt to justify its sharing of private information on American citizens with foreign governments by trotting out Title 21 Code of Federal Regulations Section 20.89 as the legal basis for its lawbreaking actions.  Unfortunately for the FDA, though, Part 20 of this Title 21 (of which Section 20.89 is a subsection) only governs the disclosure of public information – and arguably, but not certainly, confidential commercial information submitted to the FDA – to such officials.  So, any sharing of private, personal information by the FDA with foreign agents has no legal justification.

Yet in its letter to Ron Paul and elsewhere, the FDA admits that it is sharing private information with foreign government agencies.  Boyer himself writes that “FDA can share non-public information with its foreign counterpart agencies under the Trilateral Cooperation Charter in reliance on the Trilateral Confidentiality Commitment” and “FDA would be diligent in limiting the sharing of personal information to the minimum necessary required to permit joint enforcement.”  Knowing government agencies as we do, it is a certainty that the FDA is exceeding its bounds.

The Federation is researching further the legal ramifications of the FDA’s actions here; and, along with our Lobbyist Lee Bechtel and others such as IAHF, the Federation will be taking further action.  You can rest assured that the FDA’s responsive letter is not the last word here.