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Regulatory Focus™ > News Articles > Public Citizen Sues FDA Over OTC Drug Risks

Public Citizen Sues FDA Over OTC Drug Risks

Posted 21 September 2017 | By Michael Mezher 

Public Citizen Sues FDA Over OTC Drug Risks

Nonprofit Public Citizen on Thursday sued the US Food and Drug Administration (FDA) alleging that the agency has failed to act on safety issues related to the over-the-counter (OTC) drug benzocaine.

The lawsuit, filed on the grounds that FDA is in violation of the Administrative Procedures Act for "withholding or unreasonably delaying action" on a citizen petition filed by Public Citizen in 2014 that calls on the agency to add a warning that benzocaine can cause methemoglobinemia, a rare and potentially fatal blood disorder, and remove infant teething pain as an indication for the drug.

FDA has yet to decide on the citizen petition, but in its 2016 interim response, Center for Drug Evaluation and Research Director Janet Woodcock wrote that the agency had not reached a decision as the petition "raises significant/complex issues requiring extensive review and analysis by agency officials."

"FDA has been aware of these problems and has put out a variety of alerts regarding them on several occasions," Michael Carome, director of Public Citizen's Health Research Group, told Focus.

A quick search of FDA's website turns up an archived page on benzocaine listing numerous safety advisories dating back to 2003, and a page titled "Benzocaine and Babies: Not a Good Mix," first posted in 2012 and updated last week saying that children two and under have a higher risk for developing methemoglobinemia from benzocaine.

Part of the issue, Carome said, is that benzocaine products are currently marketed in the US under a tentative final OTC monograph.

"The over-the-counter monograph process is very cumbersome and, in fact, there are many monographs where the process has never been completed," he said.

So despite acknowledging the risks, FDA has not required new warnings or labeling for benzocaine, though in 2014 the agency said that companies could voluntarily add a warning for methemoglobinemia to their labels.

"FDA basically said that it would not object to companies that want to include a warning about methemoglobinemia in the labeling, even though that's something that's not allowed under the monograph," Carome said, adding that he doesn't know how many companies have voluntarily added the warning.

While FDA and Congress are currently looking to reform the OTC monograph process by creating a new user fee program and making changes that would help FDA respond more quickly to safety issues, Carome said the program's current shortcomings are no excuse for inaction.

"FDA bears responsibility for—and should be held accountable for—failing to address some of these safety concerns that have arisen over various drugs including benzocaine … even though the scheme is cumbersome," Carome said.

He also said he supports the efforts in Congress to reform the OTC monograph process.

"I have seen both the Senate and the House version of bills that are being considered and both would amend the over-the-counter regulatory scheme in a way that would allow FDA to act more expeditiously," he said.

Public Citizen, Complaint


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