LAWMAKER CRITICIZES OTC PLAN B SINCE REGULAR BIRTH CONTROL IS RX
A senator with a background in women's health says Plan B should not be distributed OTC because the drug is a much stronger version of regular birth control, which requires a prescription.
The FDA Aug. 24 approved Barr Laboratories' Plan B (levonorgestrel) to be sold OTC, ending a lengthy process many said was drawn out for political reasons. Sen. Tom Coburn (R-Okla.), who is also an obstetrician, blasted the decision, saying "never before has the FDA approved a medicine for over-the-counter sales when a lower dose of the same drug requires a prescription. Exposing women to the high-dose hormones in Plan B without the guidance of a physician will put them at risk."
But CDER Director Steven Galson, in his letter notifying Barr subsidiary Duramed that the FDA had approved the OTC version of its drug, said the agency allows a prescription-to-OTC switch only when it "finds that Rx dispensing is not necessary for the protection of the public health" due to potentially harmful effects, and that "the drug is safe and effective for use in self-medication as directed in proposed labeling."
Galson also pointed out that it is inappropriate to use Plan B for routine contraception since that high of a dose of levonorgestrel has not been determined to be safe for that use.
The agency approved OTC sales of Plan B after Barr's subsidiary Duramed Pharmaceuticals submitted an amended drug application Aug. 17, roughly a week after the company and the FDA met to discuss conditions under which the agency would approve OTC use. Those conditions include changing the minimum age for OTC use from 16 to 18 and ensuring that the drug will be kept behind the counter at pharmacies and dispensed only with production of valid photo identification verifying the buyer's age. Barr first sought OTC status for Plan B with a lower minimum age in 2003, but the FDA rejected the request, saying the application lacked scientific data on the product's OTC use among adolescents younger than 16.
Coburn believes the new restriction will not help, saying teens "will likely discover obtaining morning-after pills over the counter is as easy as obtaining alcohol." In fact, when the agency decided to extend the Plan B OTC review in August 2005, it said it was not clear: how the age restriction could be enforced; whether Plan B could be marketed as an Rx and OTC drug based solely on age of the person using the drug; and whether the Rx and OTC versions should be identically packaged.