"FDA Keeps ‘Sweetheart Arrangement’ With Big Pharma That Limits Access To Cheaper Morning After Pill"
Late Monday night, the Food and Drug Administration (FDA) finalized its decision to give pharmaceutical giant Teva Pharmaceuticals three years of exclusive rights to sell its brand name Plan B One-Step emergency contraception pill over-the-counter to women of all ages. The agency will also allow less expensive generic versions of the morning after pill to be sold without a prescription — but those will only be available to women aged 17 years and older for the next three years, after which the restrictions will lapse.
Under the new regulations, generic versions of single pill emergency contraception may be stocked on drug store shelves, but will require women to present identification proving that they’re at least 17 to buy it. That means that women under 17 seeking emergency contraception will only have the brand name option available to them while Teva still has its market exclusivity. Generic versions of the morning after pill cost about $20 or $30 less than the $60 Plan B.
In April, U.S. District Judge Edward Korman ordered the FDA to remove restrictions on Plan B, which until then required a prescription for all women under 17. The Obama administration tried to lower the acceptable age for OTC Plan B to 15 and asked Korman to delay his order. In a fiery ruling, Korman denied the government’s request and called the administration’s age cutoff “an insult to the intelligence of women.” He also criticized the fact that only Teva would be authorized to sell its products over-the-counter under the proposal, calling it a “sweetheart arrangement” between the pharmaceutical giant and the FDA that would disproportionately affect the poor and hike prices for young women seeking emergency contraception.
The FDA finally relented in June, when it officially brought Plan B out from behind the counter. But the agency still had to decide what to do about generic versions of the pill — and it ultimately chose to keep the one-pill generics out of young Americans’ reach for the next three years. The government is permitted to give exclusive marketing rights “to drug firms that fund and conduct clinical trials that are deemed essential to the drug’s approval,” according to the Los Angeles Times.
The decision won’t just affect younger women who are less likely to have disposable income to spend on expensive brand name drugs. Undocumented women who are over age 17 but lack a government-issued ID won’t be able to get the cheaper generic pills, either. Teva has promised not to hike Plan B’s costs despite its market exclusivity.