The FDA rides again. Still afraid to act like a regulatory agency and still cowering under pressure from the nilly-willy neocons. The new acting commissioner is just as much a wuss as the old one, but then, what can you expect from a Bush appointee? That was probably part of the deal. Dubya made him sign a document that said, “Thou shalt not use good science when making decisions at the FDA. Thou shalt not think of the good of the public. And most important, thou shalt never permit Plan B to be allowed over the counter.
Why bother even having the FDA? Why waste money on such a corrupt agency who can’t be trusted to do its job?
So the point of this story is that Plan B, overwhelmingly approved for over the counter status by the FDA’s own advisory board, still hangs in limbo. If you can stomach it, here is yet another chapter in the long sad story of the FDA’s descent into loony-tunes.
Government Report on FDA’s Emergency Contraceptive Decision Is Made Public
Confirms “Unusual” Process
“FDA consults lobbyists, not scientists, when making decisions about our health,” says Rep. Maloney
WASHINGTON, DC – The Government Accountability Office has confirmed that the Food and Drug Administration undertook a “unusual” decision-making process when considering the application to make the Plan B emergency contraceptive available without a prescription. This confirms earlier allegations – including those from the FDA’s own scientists who were ignored – that science did not drive the FDA’s decision. The GAO’s much-anticipated report, which was made available this morning, said:
“The decision to not approve the Plan B OTC switch application was not typical of the other 67 prescription-to-OTC switch decisions made from 1994 through 2004. FDA’s joint advisory committee considered 23 OTC switch applications during this period; the Plan B OTC switch application was the only 1 of those 23 that was not approved after the joint committee voted to recommend approval of the application.”
Rep. Carolyn Maloney (NY-14), who has repeatedly pressured the FDA to use science as the basis for its decisions and who recently introduced the Plan B for Plan B Act (H.R. 4229), which would compel the FDA to make a quick decision on the most recent application for over-the-counter status, released the following statement:
“All the evidence lines up – the FDA let political interests, not health interests, drive its decision on the emergency contraceptive. The government’s investigation found a very ‘unusual’ decision-making process over at the FDA, just like the FDA’s own scientists have told us. The American people have every right to demand that decisions about their health be based on science, not politics.
“You don’t go to a lobbyist if you get sick, you go to a doctor. But for some reason, the FDA consults political interest groups, not scientists, when making decisions about our health. The FDA’s mission is to improve our health, not play to a political base, and right now it’s failing at its mission.”
