As expected, the Food and Drug Administration has granted an additional three years of protection from generic competition to the makers of the most popular form of the emergency contraceptive pill, Plan B One-Step.
The decision is one of the last formal pieces of business as the drug makes its way to retail shelves after a more than decade-long battle to make it more easily available to women who want to prevent pregnancy after unprotected sex. The government dropped its fight to keep the medication age-restricted last month after losing a series of court battles.
But as with almost everything involving this fight, even this last bit of policymaking is, well, complicated.
Here's a recap: As part of its original plan floated this spring, the FDA had granted Teva Pharmaceuticals, the maker of Plan B One Step, three additional years of exclusivity to sell its product on pharmacy shelves to 15- and 16-year-olds. Everyone would still have had to show ID to obtain it. Other generic emergency contraceptives containing the hormone levongestrel (there are older, two-pill versions as well as a generic version of the one-pill product) were to remain behind the pharmacy counter.
Then the FDA decided in June to remove all age restrictions from Plan B One Step. And that was followed by Wednesday's decision to grant another three years of exclusivity to the product's manufacturer, this time to sell to all ages. Those three year terms, however, will run concurrently. So generic competitors can apply to the FDA to sell to women of all ages without restriction beginning in 2016.
But there's a twist in the latest development. Because now there will be no prescription version of Plan B One Step any more – it will be fully over-the-counter with no age restrictions – its generic counterpart can no longer be prescription, either. But it also can't be sold to those under age 17, because of the new protections for the brand-name drug granted by the FDA.
The result is that Plan B One-Step, which costs around $50, will be available on pharmacy and other retail shelves without restriction. The generic one-pill product, which costs about $10 less, may also be available on retail shelves (if it gets the FDA's blessing), but only to those age 17 and older. Those younger won't be able to purchase it at all.
And the much cheaper, two-pill versions will remain behind the pharmacy counter, where it will have to be requested and proof-of-age shown, with prescriptions required for those under age 17.
It's a less than perfect result, say those who wanted the full array of products make fully available.
"We are disappointed by FDA's most recent decision to maintain age restrictions on generic brands of emergency contraception, which will leave more affordable alternatives of safe and simple emergency contraceptive products out of reach for many women," says Jessica Arons, president and CEO of the Reproductive Health Technologies Project, a group that advocated for the switch to over-the-counter status for the products. "This decision is not supported by the evidence to the Administration, will only lead to more confusion on the part of consumers and pharmacies, and will unnecessarily continue to feed the false assertion by some that emergency contraception is unsafe or risky."