Physicians News Health news for doctors and patients.
By Brad Broker
Generic versions of emergency contraceptive drug Plan B One Step can now be sold over the counter – without restrictions – to women of all ages.
The Food and Drug Administration announced last week that generic manufacturers may sell their version of the morning-after pill so long as the packaging specifically states that the drug is intended for use only by women 17 and older. However, women will not be required to show ID in order to buy the generic version.
The generic label is a slight concession to Teva Pharmaceuticals, which last year was granted a three year exclusivity of Plan B One Step when they presented research showing the drug’s safety for girls below age 17. However, according to the FDA, “the exclusivity is too broad.” While the FDA agrees that Teva should retain some exclusivity regarding the labeling of the drug as safe for use in women of a certain age, they should not have exclusivity “for the regulatory consequences in terms of packaging or retail availability that may follow from these conclusions.”
“This is a significant leap forward in obtaining full over-the-counter status for emergency contraception and we commend the FDA for this decision,” said Jessica Arons, President & CEO of the Reproductive Health Technologies Project. “The sooner generic [emergency contraception] becomes available without point-of-sale restrictions, the sooner people will be able to purchase a more affordable, time-sensitive, back-up birth control option without delay.”
The only delay for the OTC generics will be changing the labels to read “17 and older.” That issue may lead to some initial confusion.
“I’m very puzzled over this labeling issue,” Martha Walz, president of the Planned Parenthood League of Massachusetts, told the Boston Globe. “I don’t know why the FDA would have any differences in labels for a generic” drug that is identical to Plan B One Step. Regardless of the label, the generics will be available to women of all ages “without point of sale restrictions,” according to the FDA.
Plan B One Step currently retails for about $50, which is anywhere from $15 to $30 more than the generic versions including My Way and Next Choice One Dose. Teva’s exclusivity on the labeling detail is set to expire in April 2016.