Senate Bill Would Allow FDA to Fine Companies for Not Completing Post-marketing Studies
The US Senate has now proposed legislation that would allow the FDA to fine pharmaceutical companies for failure to complete post-marketing studies that are agreed to when a drug is approved.
Key senators unveil bill to bolster drug safety
Currently, the FDA has no recourse except to remove a drug from the market, something which does damage by denying consumer drugs that may be vitally needed. This legislation would allow the FDA to fine companies not complying with the agreements. I should note that this is only in the Senate and I’m not aware of anything similar in the US House. I also have my doubts about whether or not such legislation would actually pass.
I have often wondered why the FDA has no power to fine when companies don’t comply with post-marketing agreements. I never really made sense to me but then politics rarely makes sense to me. I have always thought that the FDA should have the ability to fine for failure to follow through on agreements.
BTW, if you want a great book about how the FDA developed and issues they have dealt with read “Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation” (Philip J. Hilts)
Technorati Tags: drug safety
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