FDA Drug Safety Worker Was Punished for Pushing Avandia Warnings

The FDA's handling of Avandia, the blockbuster diabetes drug retrospectively tagged as dangerous, and of drug safety in general will be the subject of a Congressional hearing today.

It sure doesn't look good for the agency, then, that an FDA drug safety official says she was punished last year for recommending stronger warnings for Avandia after becoming concerned about its cardiovascular safety (something that others at the agency had worried about five years ago, only to be overruled).

The supervisor, Dr. Rosemary Johann-Liang, said that in March 2006 she approved a recommendation from a safety reviewer at the agency that the drugs be required to carry the strongest warning, a so-called black box warning, because they posed a risk of unusual swelling that could lead to heart failure.

But after officials at the agency who dealt more closely with Glaxo complained, Dr. Johann-Liang said she was ordered to retract her approval of the warning, lost her power to approve such assessments and no longer supervised reviews of the safety of Avandia and Actos.

Diabetes Drug Still Has Heart Risks, Doctors Warn [New York Times]