Home » News » News Library » FDA must comply with Plan B morning-after pill ruling, campaigners say

FDA must comply with Plan B morning-after pill ruling, campaigners say

PCJF will move for contempt if government does not comply

Reprinted from The Guardian

Reproductive-rights groups said on Wednesday they would ask a judge to hold the US Food and Drug Administration in contempt if it fails to comply with a court ruling that orders it to make the morning-after pill available to women of all ages.

On Tuesday, days ahead of a court-ordered deadline to make emergency contraception available to all women without prescription, authorities made Plan B One-Step available over the counter to women aged 15 and over. But the groups who sued the FDA said that decision did not go far enough and that the administration must remove all restrictions on emergency contraception by Monday.

The FDA said its decision was not related to the court order, but was a response instead to an application by Teva Pharmaceuticals, which manufactures Plan B One-Step, to make the product available to women 15 and older. “The FDA’s approval of Teva’s current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge’s ruling,” the agency said in a statement.

Andrea Costello, senior attorney at the Partnership for Civil Justice Fund, which represent plaintiffs in the original case, said the group will move for contempt if the government does not comply with the court order.

“This really seems like one more move in a long 12-year process of extraordinary delay and the inability to follow court orders,” Costello told the Guardian. “What the government’s done by approving the application for the manufacturer is really given a lot of indication that they don’t think they have to comply with the court’s order.”

On 5 April, a federal judge ruled that emergency contraception should be available to women of all ages without restrictions, citing the support of numerous medical groups and agencies including the FDA. The FDA said in December 2011 that “there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential”.

But in an unprecedented move, the FDA was overruled by the US secretary of health and human services, Kathleen Sebelius, who said she had concerns about the drug being available to 11-year-olds. Critics said it it was a way to shut down debate on a controversial issue ahead of the November 2012 presidential election.

In a tersely-worded judgment, US federal district court judge Edward Korma said the Obama administration had overruled the FDA for political reasons and criticized the FDA for wasting money and time in the case, which was first brought in 2001. The government can appeal the court’s decision, but that does not necessarily grant a stay of the order. The Department of Justice did not respond to requests for comment on Wednesday.

“The Obama administration is speaking out of both sides of its mouth when it comes to basic rights of women and girls, as shown by its political decision issued by the FDA late yesterday,” Costello said. “Just last week, President Obama stated, ‘When it comes to a woman’s health, no politician should get to decide what’s best for you.'”

Reproductive rights groups called the FDA’s decision an important step but still seek unrestricted access to emergency contraception. The FDA’s Tuesday decision limits Plan B One-Step access to those with a government-issued ID, a major point of contention for several groups.

“While we fully support this expansion of access to birth control, we continue to believe that the administration should lift all unnecessary restrictions to emergency contraception, consistent with the prevailing science and medicine,” Planned Parenthood said in a statement.

The American Medical Association, the American Congress of Obstetricians and Gynecologists and the American Academy of Pediatrics and other scientists and government health agencies have recommended unrestricted access to emergency contraceptives for years.

Women under the age of 17 will still need a prescription to get regular Plan B, which has a two-pill dosage. The morning-after medication Ella is still only available with a prescription; it can be taken within five days of having unprotected sex.

The government approved prescription-only access to morning-after contraception in 1999. In 2006, it approved non-prescription access to the medication for women 18 and older. The age restriction was lowered from 18 to 17 in 2009.