Rep. Issa continues to attack FDA over 'phantom recall' of Motrin

The head of the House Oversight Committee on Friday continued to hammer the Obama administration over the 2009 recall of a defective pain medication. 

Rep. Darrell Issa (R-Calif.) said the Food and Drug Administration (FDA) hasn't followed through on vows to monitor a Puerto Rican drug plant — run by McNeil, a Johnson & Johnson subsidiary — at the center of a 2009 recall of Motrin, a popular pain killer.

Last September, then-FDA Deputy Commissioner Joshua Sharfstein told lawmakers on the oversight panel that FDA "intends to keep a close eye on these facilities until the company earns our confidence back."  

Since then, however, no FDA inspectors have visited the McNeil facility in San Juan, Issa said in a Friday letter to FDA Commissioner Margaret Hamburg. Issa had visited Puerto Rico earlier this week to meet with FDA leaders, including Maridalia Torres, FDA's Puerto Rico district director. He didn't like what he found.

"During our meeting, District Director Torres confirmed that neither she nor her staff had visited the McNeil plant in San Juan since September 2010," Issa wrote. "Moreover, Ms. Torres and her staff have not even reviewed the corrective actions undertaken by McNeil and have instead relied on a third-party compliance officer employed by McNeil to provide them with information."

The reason Torres gave for FDA's inaction, Issa said, was the agency's lack of resources. The California Republican called that response "deeply troubling" because McNeil had previously agreed to reimburse the agency "for the costs of all FDA inspections, investigations, supervision, analyses, examinations and reviews that FDA deems necessary to evaluate [McNeil's] compliance," according to the arrangement. 

Issa is seeking all records related to disciplinary actions the agency has taken against its employees related to the Motrin recall.

FDA did not immediately return requests for comment Friday.

The controversy swirls around the 2009 voluntary recall of defective Motrin tablets. To prevent the public from learning of the event, McNeil hired third-party contractors to buy up defective pills from retailer shelves, rather than launching a national recall, which would have alerted the public.

Not even the retailers stocking the defective pills were told of the plan.

"Run in, find the product, make your purchase and run out," the contractors were instructed. "There must be no mention of this being a recall of the product."

The tablets weren't suspected of posing a health risk, but they contained lesser amounts of active medicine — and were therefore less effective — than the label advertised.

The episode caught the eye of both Issa and Rep. Edolphus Towns (N.Y.), the senior Democratic on the oversight panel, which staged a series of hearings on the controversy last year. 

As part of the panel's wide-ranging investigation, lawmakers learned that J&J officials told the FDA about the defect as early as November 2008, but agency officials didn't press the company for a national recall until seven months later. In the meantime, J&J informed the agency that its contractors were visiting drug stores to "assess" the situation, but failed to mention that the contractors were buying up the medication.

Under current law, FDA does not have the authority to force a company to recall a product, regardless of the threat to public health. 

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