Navigation Links
U.S. District Court Finds the FDA's Actions on Plan B(R) Tainted by Politics
Date:3/23/2009

WASHINGTON, March 23 /PRNewswire/ -- Today a U.S. District Court ruled that the Food and Drug Administration (FDA) allowed politics to taint their decision to make Plan B(R) available over-the-counter (OTC) for individuals age 18 and older. The judge recognized that the FDA gave into political pressure and did not rely on the sound science that supported making Plan B available without a prescription for all age groups. Calling the FDA's procedure for approving the drug "capricious" and "arbitrary," the court ordered the FDA to reconsider its decisions regarding the Plan B switch to OTC use and ordered the FDA to permit Plan B's availability to 17 year olds without a prescription beginning in 30 days.

"This ruling validates what we have known all along - politicians trumped the scientists when it came to the FDA's handling of Plan B," said Kirsten Moore, President and CEO of the Reproductive Health Technologies Project. "Plan B is a safe and effective back-up contraceptive method that gives women of all ages an option to prevent unintended pregnancy. We urge the FDA and Duramed to work together to lift the unnecessary age restriction and put Plan B on pharmacy shelves to make timely access a reality for anyone who needs it."

This ruling comes in response to a lawsuit filed by the Center for Reproductive Rights against the FDA for its failure to make emergency contraception Plan B available over-the-counter. The lawsuit claimed that the FDA broke its own rules and regulations, ignored medical consensus, as well as the expertise of its own scientists and advisory committees by holding Plan B to an arbitrarily higher standard than other OTC products. The plaintiffs asked the court to order the FDA to make Plan B available over-the-counter for women of all ages.

Plan B is an FDA-approved, back-up birth control method that can prevent pregnancy in the first few days after sex. Containing a concentrated dose of the progestin hormone found in daily birth control pills, Plan B can reduce the risk of pregnancy by up to 89 percent when taken within 72 hours of sexual intercourse (the sooner a woman takes it, the more effective it is). Critics have argued that increased access to Plan B would lead to promiscuity or other risky health behaviors but these concerns are misplaced. Real world experience with EC and other contraceptives show that reducing barriers to access is important but not sufficient when it comes to reducing unintended pregnancy. Access must be coupled with information and education to help individuals make healthy choices throughout their lifetime.

For more information including a complete timeline of the approval process for Plan B OTC please visit: http://www.rhtp.org


'/>"/>
SOURCE Reproductive Health Technologies Project
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. New Integrated Medical Center and Critical Access Hospital for San Juan County Hospital District
2. Wayne County Community College District Presents Second Annual Child Car Seat Check Program
3. HealthLeaders-InterStudy Offers District Survival Kit to Arm Pharmaceutical Sales Teams With Local-Level Managed Care Market Intelligence
4. Philadelphia School District and Independence Blue Cross Partner to Improve Student Wellness and Reduce Childhood Obesity
5. Lee County School District online wellness program inspires employees to walk 200 million steps in 2 months
6. Sacramento Mother Dee Dee Abdur-Rahim and Deputy District Attorney Robin Shakely Join the American Lung Associations Faces of Influenza Campaign to Promote Annual Vaccination
7. Innovative Wellness Project Launched in Four Maine School Districts
8. iCRco Lands CR Contract with Thu Duc District Hospital in Vietnam
9. U.S. District Court in Delaware Reinstates Damage Awards to Cordis Corporation on Patents Infringed by Medtronic, Inc. and Boston Scientific Corporation
10. Watson Announces District Court Ruling in Naproxen Sodium Patent Suit
11. New Research Covers Current Trends and Future Directions of the High Performing Pharmaceutical District Sales Managers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/31/2016)... ... , ... The Global Wellness Summit (GWS), an annual conference for ... wellness, travel, spa and beauty in Europe. The organization asked its partner experts in ... and researchers - to forecast where wellness is headed in Europe. Predictions range from ...
(Date:5/31/2016)... ... May 31, 2016 , ... Interest is on the ... tool and as an orthogonal tool for RNAi hit validation. A key reason may ... guide RNAs—allows rapid generation of CRISPR RNA (crRNA) collections in arrayed formats. , ...
(Date:5/31/2016)... ... , ... Dr. Charles A. Ditta attained his Doctor of Medical Dentistry Degree ... 1986, where he graduated in the top ten percentile of his class. Dr. Ditta ... He has been a member in good standing for thirty years in the American ...
(Date:5/30/2016)... ... May 30, 2016 , ... As the CDC relaxes its stance on traditional ... to keep their households lice free. , According to a May 26 article ... keep kids in the classroom despite the fact that they may be harboring an ...
(Date:5/29/2016)... ... ... Whole Health Supply is happy to announce the favorable reception of its ... new style of nail clipper has a wider jaw opening that is useful for ... actual handle is 2.5mm thick to accommodate the cutting force. This is the maximum ...
Breaking Medicine News(10 mins):
(Date:5/30/2016)... , May 30, 2016 ... H1 2016" market research report with comprehensive information ... with comparative analysis at various stages, therapeutics assessment ... of administration (RoA) and molecule type, along with ... It also reviews key players involved in the ...
(Date:5/27/2016)... 2016 Hutchison China MediTech ... on the highly lucrative global oncology and immunology ... potential first-in-class or best-in-class tyrosine kinase inhibitor (TKI) ... strategic partners. HCM,s profitable Chinese healthcare business continues ... expect progress of the mid-to-late-stage pipeline during 2016-17 ...
(Date:5/26/2016)... 2016 A key trend that ... emergence of new treatments. Cardax, a development stage life ... The therapy is expected to fulfil large unmet medical ... conducting studies to develop new treatments for osteoarthritis. One ... involved in osteoarthritis are being investigated, and early trials ...
Breaking Medicine Technology: