FDA expands Plan B over-the-counter access to those 15 and up

The U.S. Food and Drug Administration announced on Tuesday that Plan B one-step emergency contraception will now be available to women ages 15 and up without a prescription. According the FDA website, the company Teva Women’s Health, Inc.’s application to market Plan B One-Step for over-the-counter sales has been approved.

Teva applied in 2011 to make Plan B available to all females of reproductive age without a prescription, but was not approved. Labeling for the product will now read, “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” The product, said the FDA, will be sold in stores’ family planning and female health aisles.

The agency kept the age limit in place in spite of an order from a federal judge to drop it.

Medications like Plan B prevent pregnancy by not allowing a fertilized egg to implant in the uterine wall. Therefore women who have had unprotected sex can use the drug to stop fertilization from progressing into a pregnancy. Plan B cannot terminate an existing pregnancy and has not been found to harm an existing fetus.

FDA Commissioner Margaret A. Hamburg, M.D. said in a statement, “Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States. The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease.”

Studies have shown that greater access to contraception leads to fewer unintended pregnancies, which leads in turn to a reduction in the number of abortions.

Southern Poverty Law Center-designated hate group the Family Research Council warned darkly where it believes the FDA’s decision could lead.

“There is a real danger that Plan B may be given to young girls, under coercion or without their consent. The involvement of parents and medical professionals act as a safeguard for these young girls. However, today’s ruling removes these common-sense protections,” said spokesperson Anna Higgins of the FRC’s Center for Human Dignity.

Planned Parenthood of America President Cecile Richards said in a statement, “While there are still practical questions to resolve, this is an important step forward to expand access to emergency contraception and for preventing unintended pregnancy. Emergency contraception is a safe and effective form of birth control that can prevent pregnancy if taken within five days of unprotected sex. This decision will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception when they need it, which means many more women will be able to prevent unintended pregnancy.”

Marcia D. Greenberger, Co-President of the National Women’s Law Center released a statement that said, “While an improvement over current policy, today’s announcement is still disappointing because by retaining an age restriction that the FDA had previously determined was unnecessary, women of all ages must surmount barriers to getting the morning-after pill. Because all women will be required to show an ID to establish their age, those without IDs could be denied access. Further, there is no medical justification for young women under the age-cutoff to have to secure a prescription at all. As a court found recently, the Department of Health & Human Services had in an arbitrary way failed to follow FDA’s original determination and the merit of the ruling still stands.”

[image via Shutterstock.com]

via The Raw Story http://www.rawstory.com/rs/2013/05/01/fda-expands-plan-b-over-the-counter-access-to-those-15-and-up/