Tomorrow the House Committee on Oversight and Government Reform hears from FDA and Johnson & Johnson officials on the May 1 recall of more than 40 types of popular brand-name children's medicines by McNeil, a division of the drug giant.
The recall--which affected 70 percent of the kids' liquid meds market in the U.S., including common brands such as Tylenol, Motrin, and Benadryl--came after the company reported more than 40 consumer complaints about foreign materials in the medicines between June 2009 and April 2010, when an FDA inspection of the plant in Fort Washington, Pennsylvania turned up raw materials that were contaminated with gram-negative bacteria.
According to Reuters, a Committee document released yesterday said that the Food and Drug Administration does not consider the 775 reported adverse events a "spike" and there is no "clear pattern" indicating the problems were caused by the recalled products.
It’s still not clear what country the contaminated raw materials found in the Fort Washington plant came from, or whether that supplier was ever inspected by the FDA.
Committee members should find out how often inspections are done on plants that make over-the-counter meds, and whether there are plants that are skipped entirely. There was a big gap between the time the company reported receiving its first consumer complaints and the FDA inspection this April—Congress should find out why. And investigators should dig deeper on FDA's lack of recall authority: Can an agency charged with protecting the public's health really do so if it can't force a company to recall contaminated drugs?
Other members of Congress concerned with drug safety are getting in on the act, too. As we wrote here last week, Rep. Rosa DeLauro (D-CT) is looking into the recall, asking whether FDA inspections and recall authority match the demands and risks of the U.S. drug supply.
And this week, Senate HELP Committee chair Tom Harkin (D-IA) wrote to the FDA, asking for info on the company’s suppliers and quality controls. While neither DeLauro nor Harkin have announced hearings yet, the recall and these inquiries spurred FiercePharma to pose a question of its own:
This isn't the first time we've heard that question about FDA empowerment; could this highly public manufacturing mess-up lead to legislation?
--Kate Petersen, PostScript blogger