Drugs/Therapy
Feds Drop Appeal: The Journey in Making Plan B Available for All Women
The federal government's fight against the new measure allowing women of all ages to purchase emergency contraceptive pills, such as the Plan B One Step, over the counter has ended. Earlier this month, the U.S. 2nd Circuit Court of Appeals announced that the two-pill variants of the emergency contraceptive pills must be made available over the counter while the courts review the federal government's appeal over Judge Edward Korman's ruling stating that all morning-after pills must be sold over the counter without restrictions. Judge Korman, who is from the District Court of Eastern New York, has now successfully won a long battle for women.
Ever since the introduction of Plan B on the market in 1999, it has been subjected to debates regarding the availability of the drug. A decade ago, the Center for Reproductive Rights, along with more than 70 different public-health organizations had filed a citizen petition with the goal of making Plan B attainable without a prescription and with no age restrictions. In 2003, Tevas, the manufacturer of Plan B applied for the drug to be available over the counter with the Food and Drug Administration (FDA). The FDA did not approve this application due to controversy about the potential message the drugs were giving to minors.
In 2006, despite the rejection of the citizen petition, the FDA ruled that Plan B would be available for women over 18 without a prescription. In 2009, in opposition to the ruling, Judge Korman lowered the age limit to 17. In 2011, Tevas once again files an application asking that Plan B gets a dual label status, which meant that it would be an over the counter drug without age limitations. The Health and Human Services (HHS) Secretary Kathleen Sebelius quickly stated that Tevas had no proof that the drug could be safe for all girls of childbearing age, and thus, the age limit could not be lowered. She was backed up by the Obama Administration.
Shortly after Sebelius prevented the FDA from approving Tevas' application, Judge Korman overturned Sebelius' decision and thus, the fight between the federal government and Judge Korman entered the courts. Today, the federal government announced that it will end its fight and comply with Judge Korman's ruling. According to the Department of Justice, it will send Judge Korman a compliance plan, hoping to work something out. If Judge Korman approves the plan, the appeal will be dropped. At the end of what was over 10 years of debate and controversy, Plan B One Step and other morning-after pills will be available over the counter without any age restrictions
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