|Plan B Decision Made: Obama Administration Disregards FDA||| Print ||
There was a collective sigh of disappointment for those following the impending decision by the Obama administration last week that would have hopefully relaxed the age restrictions on over-the counter sales of Plan B emergency contraceptive; a change that was recommendation by the FDA. The administration decided against the changes, a direct 180 from a 2009 promise to restore and support scientific integrity regarding its decisions about public health and to base its scientific decisions in "facts, not ideology."
Scientific and public health communities, including doctors, health advocates, family-planning advocates, and lawyers, were shocked by the decision. Studies have shown Plan B to be a safe and effective method of birth control, appropriate for over-the-counter sales and public access.
FDA commissioner Margaret Hamburg agreed with the results of an internal study conducted by the Center for Drug Evaluation and Research that found that Plan B should be made available to females under 17 without a prescription. The study was the result of nearly 10 years worth of research on emergency contraception conducted by federal agencies as well as independent medical experts.
“I agree with the Center 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,” Hamburg said
However, this body of evidence was not enough for the Obama administration. Secretary of Health and Human Services, Kathleen Sebelius was responsible for overruling the FDA recommendation, and did so without consulting the President. This signaled the first time that a health secretary has publicly rejected a finding by the FDA. Her argument was a lack of evidence that Plan B users can “understand the label and use the product appropriately," and she didn't believe that Teva Pharmecueticals makers of the contraceptive, had successfully met this standard.
Although Obama acknowledged that the decision was made without his consultation, he supported it. “A 10-year-old or 11-year-old going to a drugstore would be able to, alongside bubble gum or batteries, be able to buy a medication that potentially if not used properly can have an adverse effect," he explained.
Unfortunately, this paternalistic stance undermines the integrity of his prior promise, and misses an opportunity to make a true commitment to the safety and health of women. It also makes a discriminating case for the potential misuse of one OTC while dismissing the consequences of a plethora of other "potentially" harmful products sold on shelves that might be "purchased alongside bubblegum," including Excedrin Migraine, Ibuprofen, laxatives, Benadryl, and high-fructose corn syrup candy.
What does the President find more likely to have an "adverse affect" on our nation's 10 and 11 year olds? The unfortunate and likely painful circumstances that may lead a 11-year-old to need Plan B? Or are we expected to see the very purchase of an over-the-counter hormone by a preteen as the greater tragedy?
"As the father of two daughters," Obama told reporters, "I think it is important for us to make sure we apply some common sense to various rules when it comes to over-the-counter medicine."
We think so too.