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Statement by Kirsten Moore on Creating a New Class of Behind-the-Counter Drugs

Thursday, November 15, 2007 General News J E 4
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WASHINGTON, Nov. 14 Kirsten Moore, President and CEO,Reproductive Health Technologies Project, who is presenting at today's U.S.Food and Drug Administration (FDA) public meeting regarding behind-the-counter(BTC) availability of drugs, issued the following statement:

"Creating a new class of behind-the-counter drugs may be one way toincrease access and convenience to needed medication for many Americans.However, the FDA should carefully consider whether having a learnedintermediary such as a pharmacist would advance quality health care or createan unnecessary barrier. It will be more useful to identify criteria for thekinds of products to which easier access with a learned intermediary wouldimprove health outcomes.

"The current de facto behind-the-counter status of Plan B emergencycontraception provides a good example of the potential benefits and drawbacksof creating a new class of drugs. Because of its dual label status, Plan B iskept behind the counter so that someone has to check for proof of age. BTCstatus has increased access to Plan B for many Americans but has kept it fromothers despite ample evidence that the drug is safe and effective for allwomen of reproductive age. This requirement unnecessarily delays access tothis time-sensitive treatment potentially increasing the risk of unintendedpregnancy.

"Plan B is a cautionary tale for the agency. We urge the FDA to prioritizeimproved health outcomes as it considers a new class of behind-the-counterdrugs."

Contact: Natalia Barolin

202-261-0405 / Natalia.Barolin@ddbissues.com

SOURCE Reproductive Health Technologies Project
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