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"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.
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"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 / [email protected]
SOURCE Reproductive Health Technologies Project
