FDA steps up enforcement against prescription drug manufacturers
In the first year of the Obama administration, enforcement letters from the Food and Drug Administration to drug manufacturers nearly doubled for improper marketing to healthcare professionals and patients. The FDA sent 41 enforcement letters in 2009 compared with 21 in 2008. The action shows the FDA under the Obama administration is going to be tougher on the drug manufacturers. It is about time.
The effects of these enforcement letters can be seen in some of the T.V. commercials for prescription drugs. Commercials for Pfizer's drug Chantix, marketed as a smoking cessation drug, now show one minute of safety warnings in comparison to its previous 14 seconds of safety warnings. The drug was linked to suicides in 2008. Plavix commercials now devote one-half of the commercial to safety warnings. Plavix, marketed by Bristol-Myers Squibb as protecting against future heart attacks and strokes, is linked to serious injuries including heart attacks, strokes, and internal bleeding.
When Margaret Hamburg was confirmed as FDA Commissioner in May 2009, she promised the FDA would more aggressively enforce existing guidelines and she has lived up to the promise, at least when it comes to drug marketing.
Source: Reuters, Bloomberg News
Reported by: Robert Kisselburgh, Mississippi Defective Prescription Drug Lawyer
