Legal/Regulatory

Regulatory

Waxman alleges Troy blocked Plan B decision

Before he left the FDA 18 months ago, former chief counsel Dan Troy failed to complete a necessary legal review of Barr Laboratories’ proposed under-16 sales restriction on over-the-counter Plan B, requested by FDA reviewers eight months earlier, according to a March 9 letter to the agency from Henry A. Waxman (D-CA).

As I see it

President Bush’s nomination of Andrew von Eschenbach in March to be the FDA’s permanent commissioner immediately ran into a brick wall.

WLF: leave ethics out of approvals

Calls by bioethicists and environmentalists for the FDA to consider other decidedly unscientific factors, including ethics and healthcare costs, when deciding a product approval decision are “absurd,” according to two senior officers of the American Council on Science and Health writing in a Washington Legal Foundation legal opinion letter.