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Pharmaceuticals / Regulatory Affairs

Congress Considers New FDA User Fees for Over-the-Counter Products

Sept. 18, 2017
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Congress is considering giving the FDA authority to regulate over-the-counter products through user fees and administrative action, similar to how it regulates prescription drugs.

The FDA’s current system for reviewing OTC monographs uses multistep notice-and-comment rulemaking procedures, which can take years, and the process has not been updated since 1972.

Woodcock described the FDA’s OTC regulatory program — one of the agency’s largest and most complex — as slow, antiquated and largely understaffed: only 30 full-time employees, with a budget of $8 million, currently oversee a $32 billion industry involving over 300,000 products.

To get safety warnings onto product labels faster, the FDA has relied on voluntary industry compliance, although not all drugmakers follow through.

Woodcock pointed to certain, smaller OTC acetaminophen manufacturers that may not include certain warnings on their products, even after the agency publically identified allergy risks involving potentially fatal skin reactions in 2013, and issued final guidance on the topic in January.

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