It just doesn’t look good for Johnson and Johnson and its subsidiary, McNeil Healthcare. Thursday afternoon, May 27, a House Committee on Oversight and Government Reform concluded that the Food and Drug Administration needs mandatory recall powers after a report found a series of secret maneuvers on the part of the company and a failure to notify regulators when the company received adverse reports. A document surfaced that shows when a problem was learned about Motrin in 2008, a subcontractor was called in to purchase Motrin from store shelves to determine whether a recall was needed. But the employees were told, “THERE MUST BE NO MENTION OF THIS BEING A RECALL OF THE PRODUCT” in the (note by the contractor). And this was just a “phantom recall.” Motrin was not formally recalled until July 2009.
The FDA is considering criminal penalties after four recalls in eight months by J & J. Appearing on behalf of the company, Colleen Goggins, insists that no children have been harmed by the latest production problems found at a Pennsylvania plant, including bacterial contamination, filthy conditions, and inconsistent formulations leaving some liquid medications “super potent.” That plant has been shut and so has production of about 70% of children’s cold and allergy medications including Tylenol, l, Motrin, Benadryl and Zyrtec. Six key quality control personnel have been changed and by July 15th, she promises the company will have a “master plan” in place to clean up all of the problems with production and product.
A number of lawmakers concluded that the FDA needs mandatory recall capability and they will work to introduce such legislation. Joshua Sharfstein, the deputy commissioner of the agency says they also need access to records in a timely manner. Otherwise it’s the tail wagging the dog and the FDA must follow the lead of pharmaceutical and medical device makers who get to decide when and if a recall takes place. If you or a family member has been harmed by a defective medication, you need to contact the manufacturer as well as the pharmacy that sold it to you. And a Florida drug injury attorney can advise you of the rights you retain. In the meantime, follow the advice of the FDA and ditch the J & J and McNeil brand and purchase generics.
