Controlling The Drug Chain (Continued): FDA seeks flexibility in over-the-counter drug reviews

02/22/2014

WASHINGTON (AP) — The Food and Drug Administration is seeking to revamp its system for regulating hundreds of over-the-counter drugs, saying the decades-old process is not flexible enough to keep pace with modern medical developments.

In a federal posting Friday, the agency announced a two-­day meeting next month to discuss overhauling the system known as the over-the-counter monograph.

The system was put in place in 1972 as a way to set dosing, labeling and other standards for hundreds of nonprescription drug ingredients, everything from aspirin to anti-bacterial hand scrubs.

But regulators acknowledged that the process has proved extremely time-consuming, requiring multiple rounds of scientific review, public hearings and comments before a final monograph can be published.

As a result, many common pain relievers and cough medicines are still technically under review.

The monograph process was originally set in place by Congress in 1972 as a way for the FDA to review hundreds of nonprescription drugs that predated modern drug safety regulations.

The decade-spanning review process has increasingly come under fire from scientists, consumer groups and members of Congress.

Last year, the FDA said for the first time that there was no evidence that common anti-­bacterial soap cleansers, including triclosan, were more effective than regular soap. The agency issued that statement only after a three-year court battle with the Natural Resources Defense Council, an environmental group that sued the FDA to jumpstart its stalled review of the cleansers, which had been in regulatory limbo since 1978.

The leading industry group for nonprescription drugmakers says it supports the current monograph system.

“The system ensures consumers have access to a wide variety of safe and effective medicines, while at the same time providing FDA with access to important information on safety and quality,” said Elizabeth Funderburk, spokeswoman for the Consumer Healthcare Products Association.

The group represents companies such as Johnson & Johnson, Bayer, Procter & Gamble and others.

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