FDA to decide Avandia’s fate on the market

TEXT OF STORY

Bill Radke: The Food and Drug Administration meets tomorrow to decide whether a blockbuster diabetes drug is so dangerous it needs to be pulled from shelves. Marketplace’s Gregory Warner looks at what’s at stake for the drug’s maker and for the FDA.

Gregory Warner: The FDA slapped a warning label on the drug called Avandia in 2007, when scientists said it was linked to heart attacks and strokes. GlaxoSmithKline, the maker of the drug, responded with counter-studies saying it was safe, but sales plummeted. Glaxo was accused of knowing about the safety risks and concealing them from the FDA.

Bob Goldberg: This is like Vioxx redux.

Bob Goldberg is with the Center for Medicine in the Public Interest. He says that just like with Merck’s controversial painkiller, the FDA is trying to keep the discussion about science, but it keeps becoming about politics. At tomorrow’s hearing, FDA researchers will testify that senior officials underplayed their concerns about the drug’s safety.

Goldberg: If they decide to keep it on the market, they’ll be slammed as tools of the industry. If they pull it off the markets, the commissioner and the agency’s senior leadership will give veto power to all drugs on the market to two or three unelected individuals.

And that has the pharmaceutical industry watching very carefully.

I’m Gregory Warner for Marketplace.