|
FDA RULING AGAINST OVER-THE-COUNTER PLAN B®
Statement by Kirsten Moore, President of Reproductive Health Technologies Project WASHINGTON, DC – The FDA’s refusal to make the emergency contraceptive product, Plan B® available without a prescription is a shocking, unprecedented triumph of politics over science. This decision blatantly disregards the overwhelming scientific evidence that supports over-the-counter Plan B and ignores the health-based verdict of the FDA’s own experts. Worst of all, the Bush Administration has denied American women timely access to a safe, proven second chance to prevent pregnancy. We are deeply concerned that the FDA violated its legal and public health mandate, which requires the agency to judge medications using an independent medical and scientific review process. We can only assume that the FDA bowed to political pressure in this case, allowing Presidential appointees to overrule medical authorities. The FDA’s decision today is part of a troubling pattern in the Bush Administration to discount, distort, and censor scientific data when it does not conform to its political agenda. Plan B is an FDA-approved, back-up birth control method that prevents pregnancy in the first few days after sex. Containing a concentrated dose of the progestin hormone found in daily birth control pills, Plan B reduces the risk of pregnancy by up to 89 percent when taken within 72 hours. (And the sooner a woman takes it, the better it works.) Emergency contraception could prevent up to half of the 3 million unintended pregnancies that occur each year in the U.S. But to make a real difference, women need to be able to get it quickly. Requiring a prescription is not only medically unjustified, it is also a known barrier to getting emergency contraception in time. Over-the-counter Plan B™ would help more women prevent unintended pregnancy and reduce the need for abortion. Last December, two FDA expert advisory committees
voted overwhelmingly to recommend that Plan B be made available
over the counter. These independent medical experts were also unanimous
in finding that Plan B has been proven safe for use without a prescription.
More than 70 of the nation’s leading medical and public health
organizations – including the American Academy of Pediatrics,
American College of Obstetricians and Gynecologists, and the American
Public Health Association – all agree that Plan B should be
available over the counter.
- 33 - |