Posted by Ryan Morgan on September 19, 2013 at 12:17 PM
Another question that’s come up in our #SCECOTC scavenger hunt is, “Why is Plan B One-Step available over the counter and not all emergency contraceptives?” Charleston County Teen Pregnancy Prevention Council explains why in this excerpt from their “History of Emergency Contraception in the US.”
The fight to make EC universally available has been going on for more than a decade, with lawsuits and petitions being filed for EC to be made available over the counter without a prescription or age restrictions. Ease of access to EC is crucial, given the time-sensitive nature of its effectiveness. In 2006, the FDA approved non-prescription behind-the-counter access to EC for women ages 18 and older. In 2009, a US judge ordered the FDA to allow 17-year-olds to have non-prescription behind-the-counter access to EC.
In 2011, the FDA announced that there would no longer be age restrictions or limits on over-the-counter sales of EC because the FDA’s own studies had found that EC was safe and effective. But in an unprecedented move, the Obama administration’s Health and Human Services Secretary Kathleen Sebelius unilaterally overruled the FDA, making EC available without a prescription only to those ages 17 and older, and keeping EC behind pharmacy counters, with identification and proof of age required to purchase it. Sebelius said that she had based her decision on science because studies had failed to demonstrate that the drug was safe for girls as young as 11. This was the first time that the FDA was publicly overruled by a cabinet secretary.
On April 5, 2013, New York Federal Judge Edward R. Korman ordered that all levonorgestrel-based emergency contraceptives be available over the counter without a prescription to women of all ages, and gave the government 30 days to comply. Judge Korman stated that the Obama administration had put politics before science in restricting access to EC, and called the 2011 decision to prevent EC from becoming more widely available “arbitrary, capricious, and unreasonable.” He ordered an end to all age restrictions for EC by May 5. Judge Korman also stated that Ms. Sebelius’ decision to overrule the FDA was “politically motivated, scientifically unjustified, and contrary to agency precedent.” He also accused the federal government of “bad faith” in dealing with the requests over more than a decade to make the EC universally available.
On April 30, rather than removing all EC restrictions as Judge Korman had ordered, the FDA announced its approval of the sale of one type of EC (Plan B One-Step, the most widely known EC pill), lowering the minimum purchasing age without a prescription from 17 to 15. The FDA also required that purchasers show proof of age in order to purchase Plan B-One Step. Plan B One-Step would now be available on shelves next to other family planning products such as condoms and feminine hygiene products, so that it would be available not only in pharmacies, but also in retail stores that have pharmacies onsite, even if the pharmacy is closed at the time of purchase. This decision did not affect the other forms of EC marketed in the US – the Plan B two-dose version or the generic two-dose formulations, which still required a prescription for women under the age of 17, or Ella, which required a prescription irrespective of age. These other types of EC would remain behind pharmacy counters.
The FDA stated that this decision was not a response to Judge Korman’s April 5 court ruling to make all EC available over the counter without a prescription to women of all ages. The FDA stated that this action was in response to an application submitted in 2011 by the manufacturer of Plan B One-Step, Teva Pharmaceutical Industries. This decision applied only to Plan B One-Step because the FDA said that there were not enough data to show that the other versions of EC could be used responsibly by younger teenagers without the intervention of a health provider. The approval of Plan B One-Step for use without a prescription by women 15 years of age and older is based on data submitted to the FDA by Teva Pharmaceutical Industries, showing that women ages 15 and older understood that the product was not for routine use and would not protect them against sexually transmitted diseases. These data also established that Plan B One-Step could be used properly within this age group without the intervention of a healthcare provider.
Also on April 30, the US attorney’s office filed an appeal of Judge Korman’s order. Judge Korman refused to alter his order, however, and the government responded by stating that it would approve Plan B One-Step and drop its appeal. In accepting that offer, Judge Korman voiced concern that the FDA might grant “marketing exclusivity” to Teva Pharmaceutical Industries, essentially giving the drug manufacturer a monopoly on the sale of non-prescription EC. Federal law permits the FDA to grant such exclusive agreements to drug companies that fund and conduct clinical trials which are deemed essential to the drug’s approval. Judge Korman wrote that such exclusivity would “only result in making a one-pill emergency contraceptive more expensive and thus less accessible to many poor women.”
In this June 10 announcement, the FDA also stated that it did not intend to change the approval status of two-pill Plan B or its generic equivalents, which meant that the two-pill products would remain prescription-only and behind the pharmacy counter for those younger than 17.
On June 20, the FDA approved unrestricted sales of Plan B One-Step, removing all age limits to purchase the product, in compliance with the April 5 court order of Judge Korman, who the week before had approved a proposal from the FDA and the Department of Health and Human Services to approve Plan B One-Step for over-the-counter sales, but not other versions of EC. Teva Pharmaceutical’s two-pill version of the drug was not included in the FDA’s approval, nor were the other brands of EC. The FDA formally approved the application for Plan B One-Step from Teva Pharmaceutical Industries, and these other forms of EC will have to be submitted to the FDA for approval. Actavis Inc. markets a generic version of Plan B One-Step called Next Choice. Actavis will apply to the FDA for approval to sell Next Choice without restrictions, as will Watson Pharmaceuticals, Inc., the manufacturer of Ella.
Check out CCTPPC's full history of EC here
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