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

Nov 14, 2007, 00:00 ET from Reproductive Health Technologies Project

    WASHINGTON, Nov. 14 /PRNewswire/ -- 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
     "Creating a new class of behind-the-counter drugs may be one way to
 increase access and convenience to needed medication for many Americans.
 However, the FDA should carefully consider whether having a learned
 intermediary such as a pharmacist would advance quality health care or
 create an unnecessary barrier. It will be more useful to identify criteria
 for the kinds of products to which easier access with a learned
 intermediary would improve health outcomes.
     "The current de facto behind-the-counter status of Plan B emergency
 contraception provides a good example of the potential benefits and
 drawbacks of creating a new class of drugs. Because of its dual label
 status, Plan B is kept behind the counter so that someone has to check for
 proof of age. BTC status has increased access to Plan B for many Americans
 but has kept it from others despite ample evidence that the drug is safe
 and effective for all women of reproductive age. This requirement
 unnecessarily delays access to this time-sensitive treatment potentially
 increasing the risk of unintended pregnancy.
     "Plan B is a cautionary tale for the agency. We urge the FDA to
 prioritize improved health outcomes as it considers a new class of
 behind-the-counter drugs."
     Contact: Natalia Barolin
     202-261-0405 /

SOURCE Reproductive Health Technologies Project