Tuesday, April 29, 2008

The FDA blows it ... again.

Despite all of the recent, largely negative press that the US Food and Drug Administration has received, one of their biggest screw-ups has so far slipped under the radar.

In yesterday's Federal Register, the FDA published its amended rule for accepting for regulatory review data collected from in foreign clinical trials not performed under an IND.

I'm thrilled that the FDA wants all trials submitted to it for review to be conducted in accordance with Good Clinical Practice (GCP) guidelines, including review and approval by an independent ethics committee such as an IRB or a REC. In doing so, however, the FDA removed from its regulations all reference to the Declaration of Helsinki.

Many of us in the advocacy arena have been arguing against this proposed change for years, suggesting instead that the FDA should work towards harmonizing the substantive requirements of GCP with the ethical aspirations of the Declaration of Helsinki. But the Agency chose to ignore us, leaving many of us to wonder if this is just another example of the FDA kowtowing to corporate business interests ... particularly their oft-stated opposition to Paragraph 30 of the Declaration:

"At the conclusion of the study, every patient entered into the study should be assured of access to thebest proven prophylactic, diagnostic and therapeutic methods identified by the study

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