This article is from the source 'guardian' and was first published or seen on . It last changed over 40 days ago and won't be checked again for changes.

You can find the current article at its original source at http://www.guardian.co.uk/society/2013/may/02/fda-appeal-morning-after-pill

The article has changed 3 times. There is an RSS feed of changes available.

Version 0 Version 1
FDA files appeal over Plan B morning-after pill decision FDA files appeal over Plan B morning-after pill decision
(about 13 hours later)
The US Food and Drug Administration (FDA) on Wednesday appealed against a court order directing the agency to make emergency contraception pills available without a prescription to all girls of reproductive age. The Obama administration has lodged an appeal against a court ruling directing it to make emergency contraception available over the counter and without age restrictions.
The appeal is the latest foray in the years-long legal battle over the pill known as Plan B, a drug that has also sparked political and religious clashes. If taken up to 120 hours after unprotected sex, it is designed to prevent pregnancy. The appeal recommits the administration to a position adopted by Barack Obama during his re-election campaign that younger teens should not have unrestricted access to emergency contraceptives, against the overwhelming view of physicians.
Reproductive-rights groups said they would ask a judge to hold the FDA 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. Reproductive-rights groups had said they would ask a judge to hold the Food and Drug Administration in contempt if it failed to comply with a 5 April ruling that orders it to make the morning-after pill available to women of all ages.
The government is seeking to overturn district judge Edward Korman's ruling from 5 April that required the FDA to make the emergency contraception available over the counter to women of all ages within 30 days, 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". On Tuesday the FDA made one product, Plan B One-Step available over the counter to women aged 15 and over, granting an application made by the manufacturer. But the groups who sued the FDA said that decision did not comply with the original court order.
The justice department has asked the district court to stop its order from taking effect temporarily while the appeal is pending, said FDA spokeswoman Erica Jefferson. 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". That recommendation was overruled at the time by the health and human services secretary, Kathleen Sebelius. In a ruling last month, US federal district court judge Edward Korman described her decision as politically motivated and ordered all emergency contraception to be made available without restriction.
In lodging its appeal on Wednesday, the justice department has asked the district court to stop its order from taking effect temporarily while the appeal is pending.
Andrea Costello, senior attorney at the Partnership for Civil Justice Fund, which represent plaintiffs in the original case, said: "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 to make Plan B available over the counter 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.
The Associated Press contributed to this report