Three months ago, the US Department of Health & Human Services took the unprecedented step of overruling the FDA and thwarting a move to ease access to Plan B, which is also known as the morning after pill. The contraceptive is currently available only to women age 17 and older without a prescription, but behind counters. The FDA was willing to make the pill available in store aisles, which would have made it possible for younger teenage girls to purchase without assistance or a prescription.
The move, as you know, caused a fracas. The Obama administration was accused of playing politics with science and trying to appease conservative voters in a presidential election year, since some people believe that Plan B prevents a fertilized egg from implanting in the womb, and equate this with abortion. Since then, a coalition of reproductive rights advocates asked a federal judge to reopen a 2005 lawsuit that challenged FDA access restrictions but was effectively ended by the HHS decision.
Now, though, the data that the FDA reviewed use to guide its original decision has been published. And for those wondering what prompted the agency to reach its initial conclusion here are the results: There were 345 females enrolled in the study, and 279 were younger than 17. Of 340 participants who were included in the final analysis, 91.5 percent were able to appropriately determine when to use, or not use, the pill. Of the 298 who took the pill, 92.9 percent followed instructions correctly.
The bottom line: selection and correct usage were not associated with age. The authors also noted that 57 participants, or 18.8 percent, used additional emergency during the study period and seven participants, or 2.3 percent, who took the pill became pregnant. The pregnancy rate, by the way, was expected. The pill is not fool-proof, so to speak, and is known to reduce pregnancies by 89 percent, but some will occur.
"Restricting young females’ use of a single-tablet emergency contraceptive by prescription only is not warranted, because females younger than 17 years can use it in a manner consistent with over-the-counter access," the authors wrote. The study was supported, in part, by Teva Pharmaceuticals, which sought FDA approval to market a newer version of the pill called Plan B One Step that has a different dosing regimen, but with the same active ingredient and indication as Plan B (here is the study).
The HHS decision was "about social and political concerns. There are no medical concerns," says Cynthia Harper, who is one of the authors and an associate professor in the Dept of Obstetrics, Gynecology and Reproductive Sciences at the University of California, San Francisco. "But I shouldn't have been surprised. I’ve been doing research on emergency contraception from the begining with first OTC application. But I was very surprised, because this was done by the Obama administration."
Just the same, she says, the data is now on the record for all to see. "As policies are made and decisions are made, the data will be there now," she tells us. "I don’t know how it'll play out, but the data will be there for people to review if policy makers do look at it again."
Meanwhile, Washington state health officials asked an appeals court to reinstate a rule requiring that pharmacists dispense emergency contraceptives even when doing so violates their religious beliefs. Last month, a federal court judge blocked the regulation and ruled the state may not force pharmacies to sell the pill or other emergency contraceptives, because the purpose of the law was to suppress religious objections by pharmacists, not to promote access to those who may want or need the pill (back story).
The law was opposed by two pharmacists, who argued the state does not have the right to compel individuals to violate their religious beliefs. But the state Department of Health and Board of Pharmacy asked the Ninth Circuit Court of Appeals to overturn the ruling. "This isn't about religious objections," a department spokesman tells Reuters. "This rule is meant to ensure that people have access to time-sensitive medications."