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Tue Dec 13, 2011, 07:27 PM

New Legal Challenge to Lift FDA Restrictions on Emergency Contraception [View all]


Center for Reproductive Rights Prepares New Legal Challenge to Lift FDA Restrictions on Emergency Contraception
Center will reopen its 2005 lawsuit against FDA and add HHS Secretary Kathleen Sebelius as a defendant in the case

12.13.11 - (PRESS RELEASE) The Center for Reproductive Rights announced today it will reopen its 2005 lawsuit against the Food and Drug Administration (FDA) for imposing unnecessary age restrictions on emergency contraceptives, and seek immediate relief to allow broader access to available drugs. The Center also plans to add U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius as a defendant in the reopened case for her role in overruling the FDA’s approval of Plan B One-Step last week.

“This fight is far from over. We intend to take every legal step necessary to hold the FDA and this administration accountable for its extraordinary actions to block women from safe, effective emergency contraception,” said Nancy Northup, president and CEP for the Center for Reproductive Rights. “It has been ten years of battling to bring emergency contraception out from behind the pharmacy counter. The FDA cannot simply continue moving the goal posts down the field for women’s reproductive health care.”

While U.S. District Court Judge Edward Korman found the contempt motion moot because late last night, the FDA decided to deny the 2001 Citizen Petition to lift age restrictions on emergency contraceptives— two years after the judge had ordered the agency to fairly reconsider the petition— he proceeded to invite the Center to reopen its 2005 lawsuit and agreed that the Center could add Secretary Sebelius as a defendant.

During the hearing, Judge Korman repeatedly noted the striking similarities between recent events —including last night’s denial of the Citizen Petition and Secretary Sebelius’ unprecedented decision to intervene and block the unrestricted sale of the drug—and the findings in 2009 that the FDA under the Bush Administration had “acted in bad faith and in response to political pressure.”

Here's an article from 2009 about the outcome of the previous case:


Judge: FDA Overstepped Bounds in Restricting ‘Plan B’ Contraceptive

In setting special requirements for the controversial contraceptive, the U.S. Food and Drug Administration "departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug from prescription to non-prescription use," says U.S. District Judge Edward Korman in a 52-page written opinion today.

The FDA has been requiring teens less than 18 years old to get a prescription, in order to use the over-the-counter Barr Pharmaceutical Inc. medication. As a result, pharmacies must keep it behind the counter, effectively requiring women 18 and older to ask a pharmacist to purchase it.

In his order today, however, Korman tells the FDA to make Plan B available to women age 17 and older within 30 days and to reconsider whether to require a prescription for teens of any age who seek access to the drug, according to Reuters and the Washington Post.

The Center for Reproductive Rights sued the FDA in U.S. District Court in Manhattan in January 2005, and the FDA subsequently approved Plan B for over-the-counter use in 2006. However, the center continued on with the lawsuit, challenging the manner in which the FDA handled the matter, reports the Wall Street Journal (sub. req.).

Note: there are embedded links in the articles on their original sites which lead to more information

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