Regulatory Focus™ > News Articles > Full Information From FDA OTC Switch Meeting Released

Full Information From FDA OTC Switch Meeting Released

Posted 28 March 2012 | By Alexander Gaffney, RAC 

The complete information from the 23 March over-the-counter switch meeting between the US Food and Drug Administration (FDA) and industry and public stakeholders has been made public.

FDA is currently considering whether to create regulations that would make it easier for consumers to buy medications that are currently prescription-only. The so-called "over-the-counter (OTC) switch" would make some popular medications available OTC if they can be used safely with minimal supervision.

At the meeting, CDER Director Janet Woodcock told attendees any changes would require rulemaking, and FDA is "gathering information from stakeholders about potential impacts of changing OTC regulations."

Woodcock also illustrated how an OTC switch might function.

"For example, before getting a medication, you might have to talk with a pharmacist, or need to have a diagnostic test," said Woodock in a statement. "In other cases, you might have to visit a physician to obtain the original prescription, but not to get refills. FDA is also considering whether some drugs could be a prescription drug and a nonprescription drug with conditions of safe use."

Documents released 28 March provide a full list of attendees, FDA's meeting agenda, and testimony and comments prepared for the meeting by stakeholders.

The meeting was convened by FDA's Center for Drug Evaluation and Research (CDER) in response to concern about healthcare costs resulting from inadequate consumer access to medications.

For example, when primotine inhalers were taken off the market by FDA this year, there was concern some asthmatics would be unable to afford to go to the doctor to obtain a prescription for albuterol or other asthma medications. The proposals being considered might allow consumers to obtain such medication without needing a doctor's prescription.

Read more:

FDA/CDER - Testimony

FDA/CDER - Roster

FDA/CDER - Agenda

FDA Considers Expanding Definition of Nonprescription Drugs

FDA's Live-Tweeting of the Meeting on Twitter

Federal Register - Using Innovative Technologies and Other Conditions of Safe Use to Expand Drug Products Considered Nonprescription

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