Plan B’s Complicated History

As of Monday, pharmaceutical companies can start marketing generic versions of Teva Pharmacueticals' Plan B to women over 17, but what that means for women's access to the drug is less than clear. Emergency contraception (EC) is in the midst of many big changes: from brand name to generic, from two pills to one and, some advocates hope, from age-restricted to over the counter.

Today, access to EC is governed by an elaborate maze of rules, complicated by the introduction of new products onto the market. There are currently three options available: Plan B (a two-pill product), Plan B One-Step (a new one-pill product from the manufacturers of Plan B), and Next Choice (a generic version of Plan B, approved by the FDA in June for prescription use among women 17 and younger). Access to these three drugs depends on a woman's age. Here's the basic landscape: A 16-year-old needs a prescription to buy any EC. A 17-year-old needs a prescription for Next Choice, but not for either version of Plan B. And an 18-year-old has access to either Plan B over the counter but cannot get the generic Next Choice. (For more information about emergency contraceptives, see our recent explanation of how Plan B works.

Sound confusing? It is. "You have all these things in the mix at once, which makes it hard to predict [emergency contraception's] future," says Susan Wood, the FDA's former assistant commissioner for women's health, who left the agency in 2005 after being frustrated with delays to Plan B's over-the-counter approval. "Hopefully there will be more products available, the age restrictions gone, and more generics." While she looks forward with cautious optimism, others—the FDA included—advise against too much speculation. The over-17 generic hasn't even hit shelves yet, and the FDA has not taken any steps toward a reversal of age-restrictions. "There are so many things we're not sure of," says James Trussell, who directs Princeton University's Office of Population Research and runs Not-2-Late, a Web site and hotline devoted to emergency contraception. "Everything is in a very confused period."

FDA approval of medications is, generally, a relatively straightforward process: a drug company develops a drug and tests its safety and effectiveness. The FDA evaluates the drug and, if approved, decides what it should treat and how it should be made available. After approving a new drug, the FDA grants the manufacturer market exclusivity, a competition-free period where other pharmaceuticals cannot market a generic version. Market exclusivity periods vary depending on the drug but are generally between three and five years.

The story of emergency contraceptives, however, has more twists and turns than a season of Gossip Girl. Here's the Cliff's Notes version: in 1999 the FDA approved Plan B as a prescription emergency contraception. Four years later, Barr Laboratories (the maker of Plan B, which has since changed its name to Teva Pharmaceuticals) submitted an application to switch Plan B from prescription to over-the-counter status. The FDA rejected the application, citing a lack of data on women under 16 (a move Trussell and other EC advocates viewed as political, since contraceptive access is a charged political topic). Two FDA officials, Wood and Frank Davidoff, resigned in 2005 after the FDA announced it was postponing the approval of OTC Plan B indefinitely. Meanwhile, Barr repeatedly reworked its FDA proposal to address the agency's concerns. After several rejections, the FDA in 2006 decided that Plan B could be sold OTC for women over 18 only. This put the drug into a very small category of medications with a two-tiered, age-based system. Others include Sudafed, which can be made into methamphetamine, and aids to quit smoking, like Nicorette, since it's illegal for those under 18 to buy nicotine products .