White House Overrules FDA On Access For Plan B

White House Overrules FDA On Access For Plan B

December 8th, 2011 // 3:12 pm @

In a move fraught with presidential politics, the US Department of Health & Human Services has overruled the FDA and thwarted a move to ease access to the Plan B pill, 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 unusual decision is likely to renew debate that yet another White House administration chose politics over science. The controversial pill was the subject of a fracas when George W. Bush was president, because some believe that Plan B prevents a fertilized egg from implanting in the womb, and some equate this with abortion. Many doctors and pharmacists still refuse to provide the pill.

As a result, President Barack Obama can be expected to face criticism that his administration made this decision in order to appeal to conservatives. And by extension, the move may also lead to a new line of skepticism into other FDA decisions if the episode convinces the public that the agency has become politicized.

In a statement explaining her decision, HHS Secretary Kathleen Sebelius said: “Today’s action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional.”

She contended that there are “significant cognitive and behavioral differences” between older adolescent girls and the youngest girls of reproductive age. And so she directed the FDA to issue a complete response letter denying the supplemental new drug application sought by Teva Women’s Health (read her letter to Hamburg and her statement).

The move is certain not to sit well with FDA commish Margaret Hamburg, who has attempted to carefully craft a progressive stewardship at the agency that balances safety and innovation. While she did not offer any insight into her thinking, Hamburg made a point of noting that there was disagreement, prompting speculation that she may consider resigning from the agency.

“This morning I received a memorandum from the (HHS Secretary) invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential” Hamburg says in this statement.

The Plan B pill has generated nothing but controversy in Washington. In 2005, Susan Wood, who was the top FDA official in charge of women’s health issues, resigned to protest against an agency decision to delay a final ruling on whether the Plan B pill should be more easily accessible (read here).

Today, Wood, who is now an associate professor of health policy and environmental and occupational health and executive director of the Jacobs Institute of Women’s Health at George Washington University, issued a statement saying: “This decision is stunning. I had come to believe that the FDA would be allowed to make decisions based on science and the public’s health. Sadly, once again, FDA has been over-ruled and not allowed to do its job. I cannot understand why Secretary Sebelius would reach in and overturn the FDA’s decision to allow timely access for all those who need safe and effective emergency contraception.”

And two years ago, US District Court Judge Edward Korman ordered the FDA to reconsider its 2006 decision that would allow only women ages 18 and older to buy the pill without a prescription. In his March 2009 ruling, Korman chastised the FDA for being “arbitrary and capricious,” making decisions in “bad faith” and being influenced by “impermissble political and ideological considerations” imposed by the Bush White House.

“The record is clear that the FDA’s course of conduct regarding Plan B departed in significant ways from the agency’s normal procedures regarding similar applications to switch a drug from prescription to non-prescription use,” Korman wrote. He then instructed the FDA to do make Plan B available to 17-year-olds within 30 days and review whether to make the emergency contraceptive available to all ages without a doctor’s order.

In April 2009, the FDA agreed to permit Plan B to be sold without a prescription to all women 17 and older, but would not allow the pill to become available to younger women unless a request was received from the manufacturer. That prompted the Teva Pharmaceuticals unit to file its supplemental new drug application with the agency.

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