FDA Ordered to Make Plan B Pills Available

FDA Ordered to Make Plan B Pills Available

June 6th, 2013 // 12:33 pm @

Latest FDA and cGMP Compliance News

A federal court this week ruled that the older type of Plan B morning after pills is allowed to be sold to girls and women of all ages on an OTC basis. At the same time, the court state that FDA can also restrict access to the newer, one pill drug which is known as Plan B One Step. They can do so as FDA continue to appeal a ruling from a lower court.

This ruling, which FDA may appeal, makes FDA move closer to following a decision in made in 2011 to allow emergency contraception for girls and women with no prescription or proof of age. In that case, FDA was overruled by HHS that resulted in much criticism for the White House.

The National Women’s Liberation Plaintiffs states that the decision affirms that the restrictions that were imposed by FDA were not supported by science. This new decision makes it harder for the Obama administration to delay making the morning after pill an OTC product.

The ruling by the appeals court came after the agency appealed an April order from a US district court judge, Edward Korman. He directed the agency to make both kinds of Plan B available without any restrictions within one month. After that, FDA approved the new One Step drug, which is made by Teva Pharmaceuticals, for women 15 years and older on an OTC basis. Proof of age is required and the drug has to be bought from a pharmacy.

That approval enraged Korman who previously blasted the White House for pushing politics over science. The decision in 2011 made some say that the White House was attempting to mollify conservatives and was putting politics before science. Some think that Plan B stops a fertilized egg from implanting itself in the womb, which some say is similar to abortion.

Korman accused the administration of causing delays and acting in bad faith, and letting FDA create an agency filibuster.

FDA has argued that Korman exceeded his authority, because this issue should be decided by rulemaking at FDA. The White House says that the way to change distribution is for the manufacturer to provide the necessary paperwork to let up the restrictions.

A three judge panel in the second circuit of the US Court of Appeals suspended Korman’s order temporarily to provide the Obama administration until July 11 to file its appeal on Plan B One Step.

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