When the Food and Drug Administration decided last year that the brand name version of the morning-after pill, Plan B, could be sold to anyone of any age without a prescription, it granted the drug’s manufacturer three years of protection from generic competition. The FDA has now reconsidered that concession.
The FDA announced its decision to increase access to generic versions of emergency contraception pills to anyone of any age, off the shelf without a prescription, in an 11-page letter (PDF) to manufacturers of the generic products(via NPR).
Originally when the FDA decided to open up Plan B to all ages last year, it said it would let Teva be the only one on the market because it’d completed a study on the product’s use by teenagers.
But in reversing that decision now, the FDA took into account arguments from women’s health groups who wanted the product to be widely available. Plan B is often more expensive than generics, making it more affordable for many women.
The FDA’s acting director of its Office of Generic Drugs, Kathleen Uhl, writes that Teva’s stance that competitors should be barred from selling their products over the counter without age restrictions “is too broad.”
Instead, the FDA says the generic versions will have to indicate on package labels that the products are intended for “women 17 years of age or older,” but there will be no requirement to produce proof of age at the register.