FDA is considering a “new paradigm” for approving new drugs to facilitate making more Rx products available nonprescription, according to a notice for a March 22-23 public hearing.

One change under consideration would allow a prescription drug to be simultaneously available nonprescription with certain conditions of safe use. FDA is considering is allowing the same drug product to be simultaneously available as both a prescription and nonprescription product with conditions of safe use. “Dual availability could help ensure greater access to needed medications by making obtaining them more flexible,” the agency says in the notice prepared for the Feb. 28 Federal Register.

A list of questions included in the notice indicates the agency’s thinking on the topic has expanded well beyond simply saying that making more drugs available nonprescription would benefit public health, particularly in treating chronic conditions. FDA also is considering diagnostic technologies needed for consumers’ safe self-selection; the role of pharmacists and their compensation for increased interaction with consumers; and whether some drugs would be available only in pharmacies and not other retail venues that sell OTC drugs.

Stay tuned to "The Tan Sheet" for more coverage of this and other regulatory activities in the OTC drug and dietary supplement markets.

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FDA Considers “New Paradigm” To Switch More Rx Drugs

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