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FDA Seeks to Modernize OTC Drug Reviews

Forty-year-old system needs overhaul (February 21)

The FDA is proposing major changes to its 40-year-old system for approving over-the-counter (OTC) medications to make the system more adaptable to scientific advances.

In a document filed with the Federal Register, the agency said it is interested in “exploring ways to re-engineer the process of regulating OTC drugs that are currently regulated under the OTC Monograph process to, among other things, create a process that is more efficient and more responsive to newly emerging information and evolving science, and to allow for more rapid product innovation where appropriate.”

When the OTC drug review process was established four decades ago, the agency said, “it was generally thought that safety and effectiveness evaluations for the various active ingredients would be fairly straightforward and would not necessarily need continuous reexamination over time.”

That is no longer the case, the agency said. Now it is interested in hearing ideas for changes to the process “or ideas for its replacement with an entirely new regulatory or statutory framework.”

The FDA has scheduled hearings for public comments on March 25 and March 26.

The agency’s monograph process describes the standards and conditions for marketing certain classes of OTC drugs that are generally recognized as safe and effective.

The FDA said several OTC products are on the market pending the finalization of monographs, meaning that there may not be enough data for the FDA to determine whether the products are safe or effective. In addition, the agency said, there are limitations on its ability to require new warnings or other labeling changes in a timely manner.

Sources: Reuters; February 21, 2014, and Federal Register; February 21, 2014.

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