Tougher FDA Approval Process for Opioids Sought by Congress

Posted 16 April 2015 | By Alexander Gaffney, RAC 

Tougher FDA Approval Process for Opioids Sought by Congress

New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA).


The bill, the FDA Accountability for Public Safety Act (FAPSA), is a response to FDA's regulation of opioid painkillers, and specifically one known as Zohydro. The drug was approved in October 2013 as a pure hydrocodone product lacking any physical characteristics which could make it more difficult to misuse or abuse. Zohydro's approval was considered somewhat unusual in that FDA bucked the advice of its advisory panel, which cited the drug's potential for abuse when recommending against its approval.

Zohydro's approval was an immediate source of controversy for FDA and the drug's manufacturer, Zogenix. In Massachusetts, officials sought to effectively prohibit the use of the drug. And in the US Congress, legislators introduced legislation which would have overruled FDA's approval of Zohydro and ban the drug.

That bill, the Act to Ban Zohydro, was supported by Sens. Joe Manchin (D-VA) and David Vitter (R-LA), two longtime critics of FDA's regulation of opioid painkillers.

New Legislation

But while the Act to Ban Zohydro ultimately died in committee, its sponsors are now taking another shot at reforming FDA to make it more difficult for additional painkillers to obtain approval.

The FDA Accountability for Public Safety Actwould require FDA to convene an Advisory Committee meeting or panel for each opioid drug submitted to the agency under Section 505 of the Federal Food, Drug and Cosmetic Act (FD&C Act). That would encompass all new drugs [505(b)], altered drugs [505(b)(2)] and generic drugs [505(j)].

The advisory committee would then be charged with evaluating each drug application and making a recommendation to either approve the drug or not approve it.

But the biggest change of all called for in the bill relates to how FDA would need to act on its advisory committees’ advice. At present, FDA is not required to act on its advisory committees’ recommendations, though it follows their advice in the majority of cases.

FAPSA would make the FDA commissioner personally accountable for the final approval of some opioids. The bill explains that if FDA's Center for Drug Evaluation and Research (CDER) decides to approve a drug after an advisory committee has determined a drug should not be approved, the FDA commissioner will need to make the "final decision" personally.

If such a decision is made, FDA will need to issue a report to Congress detailing the scientific reasoning behind the drug approval decision. An approved opioid could not be marketed until that report was submitted to Congress, the legislation states.


Press Release

Categories: Regulatory News

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