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FDA Rethinks OTC

February 25, 2014

The system isn't working, says Woodcock

The Food and Drug Administration plans to overhaul the way it approves over-the-counter medical products, a move that will change how tens of thousands of medicines and personal care items reach US store shelves. OTC products include pain relievers, sunscreens, antifungal medicines and oral care formulas.

"The current system isn't working well for the public or for us," Dr. Janet Woodcock, director of the FDA's center for drug evaluation, said in an interview with The Wall Street Journal. "We would like monograph drugs to have the same safety framework as prescription drugs."

Revamping the approval path would have big implications for the over-the-counter medical products industry, which in 2012 recorded $29.3 billion in annual U.S. sales, according to the Consumer Healthcare Products Association. The industry could introduce new forms of products more quickly as researchers discover better ingredients.

The current approval framework was created in 1972 and now needs a complete revision to become a more agile and responsive process, the agency said. The FDA plans to hold a public hearing March 25 and 26 to consider ideas from the public.

"We want to get the word out that we're looking for creative ideas about how to improve the process," Dr. Woodcock said.


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