FDA Scrutiny of J&J Plants Should Be Widened: Congress

Lawmakers are calling for the FDA to widen a probe into Johnson & Johnson drug manufacturing problems to include some of its third-party suppliers after the drug maker disclosed that a recent Rolaids recall involved drugs that it outsourced to another company. 

U.S. House Rep Darrell Issa, ranking Republican on the House Oversight and Government Reform Committee, has called for FDA Commissioner Margaret Hamburg to investigate BestSweet, a candy and chewable drugs manufacturer in North Carolina, as part of its ongoing investigation into a number of recalls that have plagued Johnson & Johnson this year.

Johnson & Johnson has recalled tens of millions of bottles of drugs over the last year and was forced to shutdown one of its major production plants for most of the year due to a variety of problems, including pesticide contamination and poor quality control of its ingredients.

The most recent J&J drug problems came earlier this month, when the company’s McNeil Consumer Healthcare division announced a recall of Rolaids that affected about 13 million packages of Rolaids Softchews. The recall came after consumers complained of finding metal and wood fragments in the chewable drugs.

The recalled Rolaids Softchews were actually not manufactured at a Johnson & Johnson facility, but instead were made by BestSweet. Rep. Issa said that the FDA should take a close look at the company and all of its other products as a result of the revelation.

BestSweet officials have responded by saying that they are working with all parties involved and claim to have an excellent safety record. They say that the factory was inspected in October 2009 and given a clean bill of health by the FDA.

Johnson & Johnson has faced scathing criticism from both Issa and from committee Chair Edolphus Towns since an April recall of Tylenol, Benadryl and Motrin, which affected affected 136 million bottles of children’s medications. That recall resulted in the shutdown of the company’s Ft. Washington, Pennsylvania, plant and the suspension of the production of all children medications manufactured by their McNeil subsidiary.

Last week, the FDA released inspection reports from the Ft. Washington plant. Inspections as recent as this month identified problems that included poor quality control measures and inadequate tracking and responses to consumer complaints.

The report on the Fort Washington plant follows a similar inspection report on Johnson & Johnson’s Puerto Rico facility, the only plant the company has left for the manufacture of over-the-counter drugs. Inspectors who investigated that facility found similar quality control deficiencies.

The ongoing problems with Johnson & Johnson,  have resulted in Congressional hearings and have increased the likelihood that the FDA will receive increased powers to regulate drug makers. Both Issa and Towns have railed against the company’s policies and have urged the FDA to scrutinize the company closely.