Eagleionline

An interesting article in the nytimes this weekend by Gardiner Harris and Alex Berenson asks whether FDA approval may serve to pre-empt suits against drug companies. This could have significant ramifications for Federal regulatory organizations as the government assumes greater liability for its approval. While it is important to hold the FDA accountable for its decisions, one has to wonder if the FDA is willing and has the resources to assume such a role. The question arises out of the FDA’s approval of Johnson & Johnson’s Ortho Evra birth control patch in 2001. Even though a 1999 J &J study had shown that the patch could deliver more micrograms of estrogen than the FDA’s banned level,  the FDA approved the drug. Is the FDA really capable of providing such a degree of oversight that its approval should pre-empt suits against drug companies? At the least, there should be a few more jobs for graduating lawyers with the FDA.