Federal Judge Strikes Age Restriction on Morning-after Pill

Image: Federal Judge Strikes Age Restriction on Morning-after Pill Undated photo of Edward R. Korman, U.S. district judge serving on the U.S. District Court for the Eastern District of New York.

Friday, 05 Apr 2013 09:00 AM

 

Share:
  Comment  |
   Contact Us  |
  Print  
|  A   A  
  Copy Shortlink
The “morning after” pill can be made available to women of all ages and without a prescription, a federal judge ruled yesterday, dealing a blow to U.S. restrictions on access to the contraceptive.

U.S. District Judge Edward Korman in Brooklyn, New York, excoriated the Food and Drug Administration for what he called a 12-year delay in making the emergency contraceptive, Teva Pharmaceutical Industries Ltd.’s Plan B, available over-the-counter. While acknowledging opponent contentions that increased access to contraception may encourage sexual conduct by minors, Korman said the case isn’t about “the potential misuse of Plan B by 11-year-olds.”

“These emergency contraceptives would be among the safest drugs sold over-the-counter, the number of 11-year-olds using these drugs is likely to be minuscule,” Korman wrote. “The invocation of the adverse effect of Plan B on 11-year-olds is an excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions.”

Korman, 70, ordered the FDA make the drug available without limits in 30 days. His ruling followed a reproductive rights group’s request to reopen a lawsuit over access to the contraceptive, claiming the FDA acted in bad faith when it placed restrictions on the drug.
Delay, Obstruction.

“The plaintiffs should not be forced to endure, nor should the agency’s misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction,” said Korman, a former federal prosecutor appointed to the bench in 1985 by President Ronald Reagan, a Republican.

Korman’s ruling expands on a 2009 decision in which he ordered the pill made available without a prescription to women as young as 17. The judge ruled then that the age restrictions were arbitrary and based more on political pressure than safety.

The pill and generic versions of it are now kept behind pharmacy counters and sold without prescription only to women 17 and older.

“Today science has finally prevailed over politics,” Nancy Northup, president and chief executive for the Center for Reproductive Rights, said in a statement. “This landmark court decision has struck a huge blow to the deep-seated discrimination that has for too long denied women access to a full range of safe and effective birth control methods.”

Erica Jefferson, a spokeswoman for the FDA, declined to comment on the ruling or the possibility of an appeal to the U.S. Court of Appeals in New York.

The 2005 case was reopened after Northup’s group petitioned Korman in February 2012 claiming it was the most efficient way for the group to overturn the FDA’s age restraints on the drug.

Lawyers for the group accused the FDA of persistently treating emergency contraception different from other medicines.

The group previously supported Israel-based Teva in a failed bid to make the emergency contraceptive, Plan B One-Step, available in stores to all ages.

U.S. Secretary of Health and Human Services Kathleen Sebelius ordered the FDA to reject that application in December 2011 because of the “cognitive and behavioral” differences in girls of the youngest reproductive age. The reproductive rights group asked to add Sebelius as a defendant in the case.

The FDA’s rules for approving drugs for over-the-counter sale are the same for aspirin as they are for contraceptives, Korman said. The standard for determining whether any drug should be made available over-the-counter turns solely on the ability of the consumer to understand how to use that drug safely and effectively, Korman said.

Korman rejected the FDA’s request that he remand the case for administrative rulemaking proceedings. The agency has engaged in “intolerable” delays since an initial citizen petition was filed more than 12 years ago, Korman said.




© Copyright 2014 Bloomberg News. All rights reserved.

Share:
  Comment  |
   Contact Us  |
  Print  
  Copy Shortlink
Around the Web
Join the Newsmax Community
>> Register to share your comments with the community.
>> Login if you are already a member.
blog comments powered by Disqus
 
Email:
Retype Email:
Country
Zip Code:
 
Hot Topics
Follow Newsmax
Like us
on Facebook
Follow us
on Twitter
Add us
on Google Plus
Around the Web
You May Also Like

Pope's Good Friday Message: 'Remember All the Abandoned People'

Friday, 18 Apr 2014 18:05 PM

The plight of immigrants, the poor, the sick, the elderly, unemployed and prisoners dominated Pope Francis' Good Friday  . . .

US to Extend Keystone XL Comment Period, Delaying Decision

Friday, 18 Apr 2014 14:32 PM

The Obama administration said Friday it's extending its review of the Keystone XL pipeline - a procedural punt that coul . . .

Clinton Sought GOP Support for Health Care

Friday, 18 Apr 2014 17:00 PM

President Bill Clinton's advisers estimated early in his term that passing a health care overhaul would require a delica . . .

Newsmax, Moneynews, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, NewsmaxWorld, NewsmaxHealth, are trademarks of Newsmax Media, Inc.

 
NEWSMAX.COM
America's News Page
©  Newsmax Media, Inc.
All Rights Reserved