Two years ago this month, a federal court in New York issued a ruling that was a stinging rebuke to Bush-era policies regarding accessible birth control.
The ruling came in response to a 2005 lawsuit filed against the U.S. Food and Drug Administration by the Center for Reproductive Rights on behalf of a coalition of women’s health groups over the FDA’s handling of emergency contraception.
Specifically, the plaintiffs hoped to force the FDA to ease restrictions on who could access the drug, and how. Those restrictions, critics charged, could present time-consuming, even insurmountable, barriers to women who need the drug, which must be taken within a narrow time frame to be effective.
In 2009, Judge Edward R. Korman of New York’s Eastern District Court issued a ruling that addressed many women’s advocates’ concerns—and that, in the process, slammed the Bush administration for bowing to conservative political pressure in its handling of the drug. Korman threw out the 2006 FDA rule that restricted the over-the-counter sale of Plan B to women aged 18 or older, ordering that the age for OTC sales be dropped to 17. In addition, the judge called on the FDA to reconsider the controversial restrictions it had put in place for the drug’s sale.
But two years and one presidential administration later, the FDA has yet to budge on those issues. Late last year, the Center for Reproductive Rights filed yet another lawsuit, this time attempting to force the Obama administration to remove the restrictions placed on the drug, which are stricter than those placed on most over-the-counter medications.
Meanwhile, the pharmaceutical company that makes the best-known emergency contraceptive, Plan B, has once again applied to the FDA to allow its drug to be sold over the counter without age restrictions. That move might finally force the Obama FDA to take a stand on the controversial issue it’s so far failed to deal with.
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Emergency contraception—sometimes known as the “morning-after pill”—contains a high dose of the hormone progestin, typically found in regular daily birth control pills. If taken within a brief window of time after unprotected sex—a scenario that can involve anything from a broken condom to a sexual assault to simple forgetfulness—EC can prevent pregnancy from taking place. But time is of the essence: to be effective, the pill must be taken within 72 hours.
The FDA first approved the drug in 1999, but only with a doctor’s prescription. Pointing to the short period of time in which the drug must be taken to be effective, women’s health advocates argued that the prescription requirement was an undue and unfair burden.
In 2004, Barr Pharmaceuticals, the company that manufactured Plan B at the time (the company was subsequently acquired by a rival company, Teva Pharmaceutical Industries), applied to the FDA to allow the drug to be sold over the counter. The FDA rejected that application, despite the fact that the agency’s own advisory committee strongly recommended its approval.
According to the agency, its decision came from a desire to protect young girls who might not know how to use the drug properly; critics responded that the FDA had improperly taken into consideration behavioral issues—including whether, as conservatives argue, young women would become more promiscuous if they had easy access to Plan B—rather than the scientific and medical data on which its decisions are supposed to be based.
The following year, the Center for Reproductive Rights, a national nonprofit headquartered in New York, sued the FDA for not approving the drug for over-the-counter sales and for its age restrictions. That same year, Susan Wood, then head of the FDA’s Office of Women’s Health, was so frustrated by the agency’s handling of the drug that she resigned in protest. “I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled,” Wood wrote at the time.
In 2007, the FDA decided to make the drug available without a prescription, but with a set of restrictions not typical for over-the-counter medications: the drug would be kept behind the counter, so a woman who wanted it would have to ask a pharmacist to get it for her. And, because the FDA had only approved it for women aged 18 or over, a woman would have to show an ID, with proof of age, to buy it.
Arguing that those requirements were too restrictive, the CRR pressed forward with its lawsuit. In 2009, Korman, the federal judge in New York, issued his ruling lowering the age requirement to buy Plan B from 18 to 17, and ordering the FDA to reconsider—but not necessarily to change—its restrictions on over-the-counter purchases.
Perhaps the most striking thing about the ruling was its strong condemnation of the FDA’s handling of Plan B. “The FDA repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons,” Korman wrote, noting that the agency had refused to act on Barr’s application until Sen. Patty Murray (D-Wash.) and then-Sen. Hillary Rodham Clinton of New York threatened to hold up confirmation hearings for a new FDA commissioner. Korman also made note of the agency’s decision to ignore positive reports about Plan B from its advisory panel and to appoint anti-choice members to a panel reviewing the drug.
Korman found that the FDA “acted in bad faith and in response to political pressure.” The agency, he continued, “departed in significant ways from [its] normal procedures,” engaging in “repeated and unreasonable delays” in the drug’s approval process.
The political pressure Korman referred to came from conservative groups that the Bush administration was eager to please. Those groups include the Family Research Council, a Christian think tank that contends that allowing teenage girls to independently access emergency contraception “jeopardizes [their] health and the ability of parents to care for their daughters’ physical and emotional well-being.” The federal court ruling, the FRC said at the time, amounted to “promoting sexual license for teens.”
In addition, the FRC warned, “There is a real danger that Plan B may be given to women, especially sexually abused women and minors, under coercion or without their consent.”
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Korman’s 2009 ruling came at a time when women’s rights advocates were cheering signs that the hostile attitude toward reproductive rights held by the Bush administration was coming to an end.
Shortly after taking office that January, Barack Obama lifted a ban on U.S. funding to international health organizations that performed abortions or offered abortion counseling. The same month Korman handed down his ruling, Obama overturned a ban on using federal money to fund embryonic stem-cell research.
In announcing the end of the stem-cell ban, the new president vowed—in a pointed jab at his predecessor—that his administration would bring “scientific integrity to government decision-making.”
“Promoting science isn’t just about providing resources, it is also about protecting free and open inquiry,” Obama said. “It is about letting scientists & do their jobs, free from manipulation or coercion, and listening to what they tell us, even when it’s inconvenient, especially when it’s inconvenient. It is about ensuring that scientific data is never distorted or concealed to serve a political agenda and that we make scientific decisions based on facts, not ideology.”
But as the months have passed, the Center for Reproductive Rights, for one, has been unimpressed by the new administration’s response to the lingering, unresolved battle. “[T]he FDA and the Obama Administration has ignored a court order to reconsider its refusal to make emergency contraception available over the counter to women of all ages,” the CRR said in a recent statement. “The Center has given the FDA ample time to end its baseless restrictions, but as of today it has not taken any steps to comply with the court order.”
So last November, the CRR took the FDA back to court, asking that the agency be held in contempt for ignoring the 2009 ruling to reconsider its conditions on access to Plan B.
“These intrusive restrictions, unprecedented for drugs with over-the-counter status, make it harder and more stigmatizing for consumers to get the contraception during its most effective window,” the organization contends.
Then, last month, Teva Pharmaceuticals—now the maker of Plan B—submitted a new petition to the FDA, asking that the drug be approved for over-the-counter sale with no age restrictions. In support of its application, Teva has submitted research data on its use by girls aged 11 to 16. The FDA is expected to rule on that application by year’s end—in the process, signaling where the current administration falls on the controversial issue of emergency contraception.
