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
Contact: Natalia Barolin
202-261-0405 / Natalia.Barolin@ddbissues.com
SOURCE Reproductive Health Technologies Project