In a completely unexpected turn of events, the US Food and Drug Administration announced today that it was not going to permit the emergency contraception pill, Plan B, to be sold over the counter without any age restriction. The agency’s commissioner said it had planned to lift the age restrictions but was overruled by Health and Human Services Secretary Kathleen Sebelius.
In dueling press statements, the two Obama administration appointees said they came to opposite conclusions about the safety of making Plan B available to girls under age 17. FDA Commissioner Dr. Margaret Hamburg said that she agreed “that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”
Sebelius, who has authority over the FDA, said in her statement that “the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately” and that she doesn’t believe that the manufacturer’s application to make Plan B available over the counter “met that standard.” She said the studies submitted “did not contain data for all ages for which this product would be available for use.”
She directed the FDA to tell the manufacturer, Teva Pharmaceuticals, that the product would remain as is: stocked behind the pharmacist’s counter and available without a prescription only to women aged 17 and over.
‘‘We commend the FDA for making the recommendation ... and we are disappointed that at this late date, the Department of Health and Human Services has come to a different conclusion,’’ Teva said in a statement, which added that the company would have to review the decision before determining its next steps.
The product, which contains a high dose of the female hormone progestin, has mild side effects including nausea, abdominal pain, and breast tenderness, and needs to be taken within 72 hours of unprotected sex to be most effective at preventing pregnancy. The newer One-Step product contains just one pill, rather than two pills to be taken 12 hours apart.
That means the one-pill product is even easier to use than the older version that was available when the FDA’s advisory committee voted in 2003 to recommend that Plan B go over-the-counter without any age restrictions. In an unusual move, the FDA decided not to follow the advice of its advisory committee, in a decision that many blamed on the politics of the Bush administration.
Many, no doubt, will question the role that politics played in today’s decision as well, given that an FDA spokesperson told me that the Health and Human Services department has never before, to their knowledge, overturned an FDA decision on drug approvals.
Women’s health groups were angered by the administration’s decision.
‘‘We are outraged that this administration has let politics trump science,’’ Kirsten Moore of the Reproductive Health Technologies Project, an advocacy group, told the Associated Press. ‘‘There is no rationale for this move.’’