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Pharmaceuticals / Regulatory Affairs

FDA Official Calls OTC Monograph Reform an Agency Priority

May 29, 2019
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OTC monograph reform “remains a top priority” for the FDA, Lauren Silvis, chief of staff at the FDA’s Office of the Commissioner, said at a Consumer Healthcare Products Association meeting in Rockville, Md.

The agency is pushing for innovation to expand the amount of OTC drug products available to patients, she said. The agency views the reform efforts as important because the OTC monograph system enables the marketing of a large array of nonprescription drugs that are regulated differently than NDA meds.

“Each monograph can provide for the marketing of hundreds, or even thousands of products” and products meeting monograph specifications usually don’t require FDA review prior to marketing, she said.

Silvis said the agency is currently working with drugmakers and Congress to modernize the monograph system. Lawmakers are taking the lead on the issue, but the agency will fight to keep it in the public eye.

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