June 11, 2013
Obama Administration Drops Bid To Restrict Sales Of Emergency Contraception
Brett Smith for redOrbit.com - Your Universe Online
The Obama administration announced on Monday that it will not dispute a federal judge's order to remove limitations on the purchase of emergency contraception, meaning young girls will soon be able to buy the popular Plan B One-Step pill without a prescription.The Food and Drug Administration (FDA) issued a statement Monday night saying that it would be dropping its appeal of the judge´s ruling.
“To comply with the order, the FDA has asked the manufacturer of Plan B One-Step to submit a supplemental application seeking approval of the one-pill product to be made available (over-the-counter) without any such restrictions,” the statement said. “Once FDA receives that supplemental application, the FDA intends to approve it promptly.”
The reversal comes after President Barack Obama had expressed personal reservations about removing the restrictions and supported Health and Human Services Secretary Kathleen Sebelius´s decision to overrule the initial FDA policy that would have made Plan B available over-the-counter and without age limitations. Obama invoked his two young daughters in making his concerns known.
A federal judge said the White House was blocking access to the drug based on politics, not science, and directed Sebelius to reverse her decision.
In its letter, the FDA said Teva Pharmaceuticals has been asked to “promptly” file an application asking for no age or sales restrictions to be placed on Plan B, adding that the “FDA will approve it without delay.”
After Plan B has been approved, the agency is expected to make similar arrangements for generic versions of the contraceptive drug.
Abortion rights advocates applauded the decision as a victory for women and public health in general.
“This is a huge breakthrough for access to birth control and a historic moment for women´s health and equity,” Cecile Richards, president of the Planned Parenthood Federation of America, said.
She added that the decision “will make emergency contraception available on store shelves, just like condoms, and women of all ages will be able to get it quickly in order to prevent unintended pregnancy.”
Anti-abortion groups criticized the government over the reversal, citing the fact that doctors and parents had been removed from the decision-making process.
"We're very concerned and disappointed at the same time because what we see here is the government caving to political pressure instead of putting first the health and safety of girls (and) parental rights," Anna Higgins, director at the Family Research Council, told Fox News.
Plan B was first approved in 1999 as a prescription-only drug. In 2001, the Center for Reproductive Rights petitioned the drug to be available without consulting a doctor. In 2011, political pressure pushed the FDA to lift all age restrictions after determining that the drug was safe enough to be made available without restrictions. Sebelius overruled that decision, saying the manufacturer had failed to determine risks for girls as young as 11, some of which can physically have children.
In a strongly worded April ruling, Judge Korman wrote that the Sebelius decision “was politically motivated, scientifically unjustified, and contrary to agency precedent.”
He also accused the federal government of dragging their feet with respect to dealing with the unresolved issue.
“The FDA has engaged in intolerable delays in processing the petition,” the judge wrote. “Indeed, it could accurately be described as an administrative agency filibuster.”