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 .
In June, the FDA approved Watson Pharmaceuticals' application to market a generic version of Plan B called Next Choice. The new pill, however, would only be available by prescription for women 17 and under. Why? It comes back to market exclusivity: when the FDA approved an over-the-counter Plan B for the 18-and-up crowd, that reset the clock, giving the OTC product three years of market exclusivity beginning Aug. 24, 2006, and ending this week. Meanwhile, since the prescription-version of Plan B had been approved in 1999, the exclusivity had already expired—hence creation of a generic prescription product, which is only available to those 17 and under. The two-tier system leads to some bizarre situations: for example, if an 18-year-old got a prescription for generic Next Choice, because it was cheaper, would a pharmacy honor it? "I don't know," says Trussell. "My guess is that if you went into 10 different pharmacies, some would honor it and some wouldn't."
Now that the market is open, when can women over 17 expect a generic? It's difficult to tell. Watson Pharmaceuticals, which manufacturers the generic Next Choice for women 16 and under, says they have submitted an application to the FDA to market to women 17 and up, and are currently awaiting approval. When that will happen, says Watson spokesperson Patty Eisenhauer, is difficult to predict. "It could be any time after today, whenever the FDA is ready to act on it," she says. "We want to hope [it's] soon, but nothing is ever a guarantee."
Meanwhile, there was another development in the age-restrictions aspect of EC: in March, the U.S. District Court for the Eastern District of New York ruled that the FDA must lower the OTC cutoff to 17, and urged that age restrictions be ditched entirely. The decision called the FDA's decision making "arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making." The FDA responded with statement saying, "The government will not appeal this decision," allowing the rule to come into effect in April. "The [FDA] leadership clearly felt like this was in keeping with the scientific evaluation of the product," says FDA spokesperson Judy Leon.
This court case, as well as the FDA's reaction, pleased EC advocates like Wood. "I'm always surprised when I look back and say, 'My goodness, it got to the point where I had to quit my job over this,'" says Wood. "But over the next year and several years, I [became] much more optimistic." She sees the way FDA handled the court case as a signal of good things to come. "A traditional way for any federal agency to react would have been to challenge the court's ruling, say they don't like a court telling them what to do," she says. "But instead they made the first steps toward changing the status of emergency contraception." Another step forward is Plan B One-Step, which begins arriving in pharmacies this month and simplifies the process of taking EC. One-Step has the same active ingredients as its predecessor (1.5mg of levonrgestrel) but in one pill, rather than two pills spaced 12 hours apart.
Still, FDA spokesperson Leon warns against reading the court decision as tea leaves. "I would caution anybody from extrapolating out from this to anything else," she says. "Every single drug application is considered independently." Complying with the New York court's recommendations has nothing to do with eliminating age restrictions altogether. Moreover, the FDA won't drop the age restrictions without prompting; a pharmaceutical company needs to submit an application for an all-ages emergency contraceptive in order to start the process anew. And age restrictions still have their proponents, who see the constraints as a way to protect parents' rights. Some argue that EC should be treated just like birth control, which requires prescriptions for all users. Even advocates of EC access have hesitations about dropping the age limit altogether. Davidoff resigned from the FDA's Nonprescription Drug Advisory Committee in 2005 over Plan B delays. While he supports OTC access, he also sees the merit in age restrictions, which ensure that potentially pregnant teenagers speak with a doctor about their situation. With age restrictions, "a 16-year-old would have to come and talk with ob-gyn or family practitioner, and that would open the opportunity for some counseling or talk about using regular contraception," says Davidoff. "I can't argue with the merit of that."
And outside of the FDA, there are other hurdles in the way of increasing EC access. Plan B is still expensive, usually $35 to $60, according to Not-2-Late, and the generic is only slightly cheaper. It's priced to sell at 10 percent lower, meaning that a pharmacy selling Plan B for $45 sells Next Choice for $41. Another persistent problem is use: despite a decade of availability, not many women use emergency contraception. Multiple studies have failed to find evidence that EC access reduces pregnancy or abortion rates in a population. It's unclear why that is: perhaps the cost is prohibitive, or possibly it's doctors' reluctance to discuss the subject (a 2001 Kaiser Family Foundation Survey found only a quarter of ob-gyns routinely discuss EC with patients). Or, it could be fallout from the early 2000s. "There may be lurking moral doubts in people's minds, since there was all this controversy, that maybe there's something wrong with the drug, both morally and biologically," says Davidoff. Those fights still loom over the larger effort to make EC more available. As Wood explains, "Part of the complications today goes back to the unnecessary constraints and the blocking in the start. There's no magic wand to erase that and make things simple." While Wood and others hope these heated battles are a thing of the past, they know the controversy's legacy is very much part of emergency contraception's future.