Plan B

Yesterday, FDA announced that it has approved Teva Women's Health, Inc.'s application to market its Plan B One-Step emergency contraceptive for women ages 15 and up. The press release notes that this application was pending before a federal judge ordered the agency to make Plan B available without any age restrictions; the 15-and-up change is "independent of that litigation and this decision is not intended to address the judge’s ruling." (A quick refresher: In December 2011, HHS Secretary Kathleen Sebelius overruled FDA Commissioner Margaret Hamburg's decision that Plan B should be available…

Last week, Judge Edward Korman of the District Court of Eastern New York overturned the Obama administration's restrictions on the over-the-counter sale of the emergency contraceptive Plan B to young women under age 17. This is good news for public health, and I hope it will be the end of a long and disturbing episode in the history of US contraceptives. Emergency contraceptives like Plan B can dramatically reduce the risk of an unintended pregnancy if taken within 72 hours after unprotected intercourse, but their efficacy wanes the longer a woman has to wait to take the drug. Making Plan B…

In the New York Times last week, Gardiner Harris reported on tensions between FDA and the White House over FDA decisions that White House officials fear will be politically problematic for President Obama. Harris reminds readers that "The Bush administration repeatedly stopped the agency from issuing rules to prevent contamination of eggs, produce and other foods ... Much of the agency's staff assumed that the Obama administration would restore the agency's independence." This assumption of the Obama administration restoring agency independence wasn't unfounded -- less than two months after…

By Susan Wood, cross-posted from RH Reality Check On Friday, January 6th, 2012, several public health experts addressed the President's Council of Advisors on Science and Technology on the issue of Plan B One-Step® and the Obama administration's refusal to let the Food and Drug Administration lift the age restriction from over-the-counter deliver of emergency contraception. Dr. Susan Wood gave the following testimony: Good afternoon Dr. Holdren and members of the Council. I would like discuss the recent misuse of science and data as part of the decision by the Secretary of HHS to overrule…

My colleague Susan F. Wood had an excellent op-ed in the Washington Post over the weekend about the Obama administration's overruling of the scientifically grounded FDA decision to approve emergency contraceptive Plan B for over-the-counter sale without age restrictions. She begins by going back in time to a much more promising moment: President Obama's signing of a Presidential Memorandum on scientific integrity: It was a proud moment, in the East Room of the White House, on a beautiful spring day in March 2009. In the room were leading scientists, Nobel laureates, the president's science…

During the George W. Bush Administration, one of the prime examples of politics trumping science was the FDA's refusal to approve the emergency contraceptive Plan B (levonorgestrel) for over-the-counter sale without age restrictions. Now, during the Barack Obama Administration, history seems to be repeating itself. Emergency contraceptives like Plan B can dramatically reduce the risk of an unintended pregnancy if taken within 72 hours after unprotected intercourse, but their efficacy wanes the longer a woman has to wait to take the drug. If a woman has to wait to see a doctor to get a…