Plan B One-Step to Be Made Available OTC With No Age Restrictions

Daniel Weiss, Senior Editor

A federal district judge has grudgingly accepted a proposal from the Obama administration to make the single-pill emergency contraceptive Plan B One-Step (levonorgestrel) available over-the-counter with no age restrictions. In April, US District Court Judge Edward Korman had ordered that all versions of levonorgestrel-based emergency contraceptives be made available without restriction , but the proposal will maintain restrictions for the time being on generic single-pill versions as well as all 2-pill versions.In a letter to the court sent on June 10, 2013, a Justice Department representative said that the FDA will approve “without delay” a request from Teva Pharmaceuticals, the manufacturer of Plan B One-Step, for removal of age and sales restrictions. Once this occurs, generic manufacturers of the single-pill version are expected to file for removal of restrictions as well, but the Justice Department indicated that the FDA might reject these requests, granting Teva a period of market exclusivity as the only emergency contraceptive available without restrictions. In addition, the Justice Department indicated that there are no plans to remove restrictions on branded or generic 2-pill versions of Plan B due to concerns that young girls would have trouble timing the doses. (Accordingly, those under 17 would continue to require a prescription for the 2-pill versions.)In a memorandum released on June 12, 2013, Judge Korman urged the Obama administration not to grant Teva market exclusivity, which would give the company “a near-monopoly that will only result in making a one-pill emergency contraceptive more expensive and thus less accessible to many poor women.” Judge Korman also pointed out that Teva had submitted an actual use study along with its supplemental new drug application, but that the study was not necessary to determine that the medication should be available without restriction. (In fact, he pointed out that in 2003 an FDA advisory committee voted overwhelmingly to approve over-the-counter availability of levonorgestrel-based emergency contraceptives without having the study at hand.)Once the new rules for Plan B One-Step go into effect, individual pharmacies will be able to decide whether to make the medication available in the aisles or to keep it locked behind the counter. Given its price, which can run up to $60, many pharmacies may choose to keep Plan B One-Step behind the counter to reduce theft. The impending lack of restrictions on Plan B One-Step also poses a dilemma for pharmacies regarding whether to allow all employees to exercise a right not to sell it based on their beliefs. (Currently, pharmacists may refuse to sell emergency contraceptives based on conscience as long as they refer customers to another pharmacist or nearby pharmacy.) Representatives of Walmart, Rite Aid, and Walgreens queried by CNN Money said they were still working out how to proceed, while a CVS spokesman said any employee opposed to selling emergency contraceptives would be accommodated.The agreement is just the latest step in a struggle that has now lasted more than a decade and pitted both the Bush and Obama administrations against reproductive rights advocates who have argued that the “morning-after” pill, which is most effective when taken within 72 hours of unprotected sex, should be available to all women and girls without a prescription. The drug required a prescription when it was introduced in 1999, was made available without a prescription to women 18 and older in 2006, and to those 17 and older in 2009. In 2011, the FDA recommended approval of a request from Teva Pharmaceuticals to make Plan B One-Step available over-the-counter with no age restrictions, but was overruled by Health and Human Services Secretary Kathleen Sebelius.On April 5, 2013, Judge Korman ordered that all levonorgestrel-based emergency contraceptives be made available over-the-counter without age restrictions. On April 30, 2013, the FDA announced that Plan B One-Step would be made available without a prescription to girls 15 and older . The next day, the Justice Department appealed Judge Korman’s order. Last week, a federal appeals court panel refused in part to delay Judge Korman’s order, indicating that the government had little hope of succeeding in its appeal.Advocates of increased availability of emergency contraceptives were pleased with the decision, but vowed to continue fighting for all restrictions to be dropped. "Now that the appeals court has forced the federal government's hand, the FDA is finally taking a significant step forward by making Plan B One-Step available over-the-counter for women of all ages,” Nancy Northup, president and chief executive of the Center for Reproductive Rights, said in a statement. “But the Obama administration continues to unjustifiably deny the same wide availability for generic, more affordable brands of emergency contraception.”