In a move that could make contraception more accessible and cheaper for many women, the U.S. Food and Drug Administration (FDA) has allowed the generic versions of the morning-after pill to be sold over the counter and without age requirement.
Generic versions of the morning after pill, a popular form of emergency contraceptive taken within 72 hours after an unprotected sex, were available only to women who are at least 17-years old but the FDA has now lifted the restriction making the pill accessible to women of all age.
In July, the FDA removed the age restriction on the sale of Plan B One-Step manufactured by Teva Pharmaceuticals. In doing so, however, the agency also gave the drug's maker the exclusive right to sell the morning-after pill over the counter and without age restrictions as it was responsible for the pill's actual use study in teenage women.
As a result of the exclusivity agreement, Teva Pharmaceuticals was granted permission to be the only pharmaceuticals company to sell the drug over the counter and without age restriction. Pills manufactured by Teva's rivals had been restricted for sale to 17-year olds and over.
FDA, however, has apparently reconsidered its decision. In an 11-page letter sent to Teva's, competitors, the agency said that its rules were "too broad". "In FDA's view, however, this characterization of the exclusivity is too broad and Teva's proposal for conditions on ANDA labeling and marketing is too restrictive," Kathleen Uhl of the FDA's Office of Generic Drugs, said.
The agency has now also allowed the generic forms of the drug to be sold without ID requirement. Nonetheless, the packaging must still contain label that says the pills are intended for women who are at least 17 years of age albeit they can now be sold without age restrictions.
The decision will likely bring down the cost of over the counter morning-after pill as Plan B One-Step is more expensive than its competitors. Plan B costs around $50 while its generic versions are way less expensive. My Way and Next Choice One Dose, for instance, sell for only $20 to $35.
Women's health groups, however, pointed out that the labeling may cause some issues. "It's still going to be confusing for the public," a doctor who once worked for the FDA, said. "But it's another step in the right direction."
