Recent Children’s Drug Recall May Lead to Increased FDA Recall Powers

Congress may use the recent Johnson & Johnson children’s medication recall as a reason to give FDA the power to force drug companies to issue recalls, instead of only being able to suggest or recommend them.  

At a hearing on Thursday before the House Committee on Oversight and Government Reform, Chairman Edolphus Towns said he intends to introduce legislation that would significantly increase FDA’s authority over the drug industry. Currently, the FDA can only suggest or recommend that manufacturers make drug recalls, but the new legislation would give the agency the power to force recalls when drugs are found to be dangerous.

Towns’ announcement (pdf) came during his closing statements for the hearing, during which he admonished Johnson and Johnson officials for not being completely honest with the U.S. public regarding the scope of its recent recall of children’s Tylenol, Motrin and other medications, manufactured by the company’s McNeil Consumer Healthcare subsidiary.

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The recall affected 136 million bottles of children’s medications, according to the FDA, and quality control problems the agency uncovered at the company’s Ft. Washington, Pennsylvania, plant have resulted in FDA warning letters, that plant being shut down, and all of the McNeil’s children medications production has been suspended.

Following reports of particulate matter found floating in liquid children’s drugs, FDA inspectors found raw ingredients contaminated with bacteria, as well as “super potent” doses of Tylenol and other problems at the factory. While the FDA and Johnson & Johnson officials say that the risk of injury, illness or death from the problems were remote, the FDA has received nearly 800 complaints about problems with the medications, including at least seven reports of deaths.

FDA officials say that so far none of the complaints or the deaths have shown a link between the recalled medications and adverse medical events, but some are still under investigation.

At the hearing, lawmakers introduced an FDA document that suggested McNeil knew about problems with Motrin as early as 2008, but instead of alerting FDA and issuing a recall, the company sent contractors out to stores to buy the products back and then asked stores not to mention that there had been a recall. The FDA later confronted the company about the incident and the company then issued a recall.

“Frankly, what we have heard today is not reassuring. I was hoping that J&J would be completely forthcoming today, but I think there are still unanswered questions,” Towns said in his statement. “One thing we know now is that the FDA needs mandatory recall authority. They shouldn’t have to persuade a company to recall suspect products.”

The statement echoes sentiments in a recent letter to the FDA by Senator Tom Harkin, who chairs the powerful Senate Committee on Health, Education, Labor and Pensions. Harkin told FDA Commissioner Margaret Hamburg that he was concerned that FDA did not have enough authority when dealing with drug company recalls. The letter could be a sign that Harkin intends to introduce legislation similar to Towns’ bill in the Senate.


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