Pharma Skeptical of US FDA Plan for OTC Indications of Prescription Drugs

December 1, 2022

A group of pharma industry organizations have banded together and leveled their complaints and concerns at the US Food and Drug Administration’s recent plans to make a pathway for prescription drugs to receive over-the-counter (OTC) status for certain indications. A key sticking point was that insurers are likely to end coverage of prescriptions of these medications, complicating patient access and drugmakers’ earnings.

According to Zachary Brennan, “The AAM noted at the outset of its comment published last week that the FDA ‘does not address the likelihood that if a drug switches to nonprescription status with an ACNU, insurance companies may just stop paying for the prescription drug, effectively eliminating generic competition in the prescription drug market.’”

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(Source: Endpoints News, November 28th, 2022)

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