ABC News is reporting this morning on a decision, announced yesterday by the United States Food and Drug Administration, to approve the sale of Plan B One Step emergency contraceptive pills to young women ages 15 and over without a prescription.
Until now, the drug could only be sold to those aged 17 and older. The action is based upon the review of an amended application submitted by Teva Womens’ Health, Inc., the drug’s manufacturer.
According to the FDA, the pill will not be sold to anyone who is unable to provide verification of age and the packaging will be equipped with an anti-theft tag. Packaging will also have a product code that requires the cashier to verify the age of the purchaser. The pill will be available in female health and family planning sections and will carry a label that reads, “Not for sale to those under 15 years of age. Proof of age required. Not for sale where age cannot be verified.”
The drug is a synthetic hormone, preventing pregnancy by both impeding sperm and blocking the ovulation process. Their effectiveness in preventing pregnancy is best when taken immediately after sexual intercourse, but can be effective from between 24 to 72 hours after. In women already pregnant, the drug causes no harm to a fetus that is developing, nor does it cause an abortion.
In response to a lawsuit brought by the Center for Reproductive Rights, New York’s United States District Judge Edward Korman ruled that all contraceptives that are levonorgestral-based, like the Plan B One Step, be made available to all ages with no prescription within 30 days. The lawsuit complaint was that federal regulators were unfairly limiting access to a safe drug and criticized government regulators for how they handled the drug’s approval process, stating that their actions were, ‘politically motivated and scientifically unjustified.’.
After the FDA approval yesterday, Nancy Northup, president of the reproductive rights organization said in a statement, ” The FDA is under a federal court order that makes it crystal clear that emergency contraception must be made available over the counter, without restriction, to women of all ages by next Monday.
Lowering the age restriction to 15 for over-the-counter access to Plan B One Step may reduce delays for some young women, but it does not address the significant barriers that far too many women of all ages will still find if they arrive at the drug store without identification or after the pharmacy gates have been closed for the night or weekend.”
FDA Commissioner Margaret Hamburg said, “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 sexually transmitted diseases.”