This spurred political conflict over wether the drug should be easily accessible to minors. They argue the FDA is holding Plan B to stricter standards compared to other drugs and not embracing evidence.
But a few months later, the federal agency gives the OK for Plan B to be sold without a prescription to women ages 18 years and older. Minors still need a prescription. District Judge Edward Korman in Brooklyn rules that FDA acted without good faith in denying the petition, and orders morning-after drugs to be made available to women 17 and older.
Korman says the FDA should think about lowering the age and access restrictions. Next Choice is also available over-the-counter for women ages 17 and older and with a prescription for anyone younger.
Drum roll please The history of emergency contraception includes significant victories and some defeats. In the end, the availability of this important contraceptive serves as one more tool in the prevention of unplanned pregnancies and abortions. Sign up for our Health Tip of the Day newsletter, and receive daily tips that will help you live your healthiest life. The American College of Obstetricians and Gynecologists. Emergency contraception. Updated September Wertheimer RE. Emergency postcoidal contraception.
Am Fam Physician. Kaneshiro B, Aeby T. Long-term safety, efficacy, and patient acceptability of the intrauterine Copper TA contraceptive device. Int J Womens Health. Federal Registrar. Prescription drug products; Certain combined oral contraceptives for use as postcoital emergency contraception. Updated February 25, Updated September 1, Planned Parenthood.
Emergency contraception history and access. Updated August FDA: Plan B sales rejected against advice. Updated May 8, Weismiller DG. Updated April 30, Tummino v. Updated March 23, Center for Reproductive Rights. Federal judge orders FDA to broaden access to emergency contraception. Office of Population Research at Princeton University. Types of emergency contraception. Once this occurs, generic manufacturers of the single-pill version are expected to file for removal of restrictions as well, but the Justice Department indicated that the FDA might reject these requests, granting Teva a period of market exclusivity as the only emergency contraceptive available without restrictions.
In addition, the Justice Department indicated that there are no plans to remove restrictions on branded or generic 2-pill versions of Plan B due to concerns that young girls would have trouble timing the doses. Accordingly, those under 17 would continue to require a prescription for the 2-pill versions. In fact, he pointed out that in an FDA advisory committee voted overwhelmingly to approve over-the-counter availability of levonorgestrel-based emergency contraceptives without having the study at hand.
Once the new rules for Plan B One-Step go into effect, individual pharmacies will be able to decide whether to make the medication available in the aisles or to keep it locked behind the counter.
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