Navigation Links
Federal Court Rules FDA Must Reconsider Plan B Decision
Date:3/23/2009

FDA Ordered to Make a Decision Based on Scientific Fact, Not Politics

NEW YORK, March 23 /PRNewswire-USNewswire/ -- Today, the U.S. District Court for the Eastern District of New York rejected the Food and Drug Administration (FDA) decision to limit over-the-counter access to the emergency contraceptive Plan B to women over 18, ruling that it was based on politics and ideology, rather than science. The court ordered the agency to reconsider its decision. It also ordered the FDA to act within 30 days to extend over-the-counter access, which is currently limited to 18 year olds and over, to 17 year olds.

"Today's ruling is a tremendous victory for all Americans who expect the government to safeguard public health," said Nancy Northup, president of the Center for Reproductive Rights, which brought the suit against the FDA.

"The message is clear -- the FDA should put medical science first and leave politics at the lab door. We are encouraged that the agency, now under new leadership, will take that message to heart."

The Center for Reproductive Rights sued the FDA in 2005 for failing to grant over-the-counter status to Plan B against the advice of scientific experts and in violation of its own procedures and regulations. In 2006, the FDA agreed to make Plan B available without a prescription, but only to women over 18 and only behind the pharmacy counter. The Center continued to pursue its lawsuit, Tummino v. von Eschenbach, to ensure that Plan B would be granted true over-the-counter status and made available to all women, including young women who might benefit most from this form of contraception.

"According to the FDA's own rules, the only legitimate criteria for making a drug available without a prescription are safety and efficacy," said Northup. "Emergency contraception is proven safe and effective and today, all women -- including young women for whom the barriers and the benefits are so great -- are one step closer to having the access they need and deserve."

The Court found that the FDA "acted in bad faith and in response to political pressure," "departed in significant ways from the agency's normal procedures," and engaged in "repeated and unreasonable delays." In addition, the court found that the FDA's justification for denying over-the-counter access to 17 year olds "lacks all credibility," and was based on "fanciful and wholly unsubstantiated 'enforcement' concerns."

Before its action on Plan B, the FDA had never restricted a non-prescription drug based on a person's age, nor had the Bush Administration ever been consulted by the FDA about an over-the-counter drug application. Depositions of senior FDA officials by the Center in 2006 indicated that the Bush Administration sought to unduly influence the agency during the Plan B application review process. Testimony also indicated that officials involved in the decision-making process were concerned about losing their jobs if they did not follow the Administration's political directives.

Other evidence uncovered during the lawsuit showed that the agency repeatedly departed from its own established procedures during the FDA case, from filling the reproductive health committee with political "operatives" to making a decision to reject over-the-counter access to Plan B before completion of the standard review.

The Center's battle to make Plan B available over-the-counter to women of all ages began in 2001, when it filed a citizens' petition with the FDA on behalf of over 70 medical and public health organizations to grant the drug over-the-counter status. On January 21, 2005, the Center filed Tummino v. von Eschenbach in the U.S. District Court for the Eastern District of New York on behalf of the Association of Reproductive Health Professionals (ARHP); National Latina Institute for Reproductive Health; individuals from a grassroots advocacy group, the Morning-After Pill Conspiracy; and parents who seek over-the-counter access for their daughters. On March 30, 2007, the Center asked for summary judgment in the case, arguing that the evidence gathered during discovery made it unnecessary for the court to hold a trial and that the court should order the agency to make Plan B available without a prescription to all women.

For more information on this case and the Center for Reproductive Rights, please visit www.reproductiverights.org.

The Center for Reproductive Rights is a nonprofit legal advocacy organization dedicated to promoting and defending women's reproductive rights worldwide.

    CONTACT: Dionne Scott
    (917) 733-4357
    DSCOTT@REPRORIGHTS.ORG

    Liza Tanner
    (202) 207-3645
    ltanner@prismpublicaffairs.com



'/>"/>
SOURCE Center for Reproductive Rights
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. MDMA Names New Director of Federal Affairs
2. Federal research plan to determine nanotech risks fails to deliver
3. Federal Employee Program Maintains Low Health Premiums In 2008
4. AMERIGROUP Contracts with Federal Government to Offer Medicare Advantage Health Plans in Seven States
5. SNM applauds NAS study showing need to restore federal nuclear medicine research funding
6. ACM Helps Medicaid Programs Comply With Federal Deficit Reduction Act Mandates
7. Boise(R) BEWARE(TM) Meets New Federal Guidelines Set Forth by Medicaid
8. HIV/AIDS Cases Among State and Federal Prison Inmates Fell for the Sixth Straight Year During 2005
9. Bristol-Myers Squibb Finalizes Settlement of Previously Disclosed Federal Investigation into Pricing, Sales and Marketing Practices
10. Federal Trade Commission Attempts To Suppress Best-Selling Authors First Amendment Rights
11. CPF Urges Congress to Increase Funding for IPF Research in 2009 Federal Budget
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their media with ... X," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Color ... users can now reveal the media of their split screens with growing colorful ...
(Date:6/26/2016)... ... , ... Quality metrics are proliferating in cancer care, and are derived from ... of the beholder, according to experts who offered insights and commentary in the current ... For the full issue, click here . , For the American Society of ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are confused ... endometriosis. These women need a treatment plan to not only alleviate symptoms and ... help for preservation of fertility and ultimately achieving a pregnancy. The specialists at ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , ... Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. , ... our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... people are unfamiliar with. The article goes on to state that individuals are now ... of these less common operations such as calf and cheek reduction. The Los Angeles ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Any dentist who has ... of the current process. Many of them do not even ... technical difficulties and high laboratory costs involved. And those who ... it at such a high cost that the majority of ... Dr. Parsa Zadeh , founder of Dental Evolutions ...
(Date:6/23/2016)... 2016 Capricor Therapeutics, Inc. ... biotechnology company focused on the discovery, development and ... enrollment in its ongoing randomized HOPE-Duchenne clinical trial ... of its 24-patient target. Capricor expects the trial ... of 2016, and to report top line data ...
(Date:6/23/2016)... , June 23, 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new affiliate with ... Latin America . ... ... ... ...
Breaking Medicine Technology: