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:6/24/2016)... ... ... Those who have experienced traumatic events may suffer from a complex set of ... or alcohol abuse, as a coping mechanism. To avoid this pain and suffering, Serenity ... event. , Trauma sufferers tend to feel a range of emotions, from depression, guilt, ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda Cheng, ... treatment. Dr. Cheng has extensive experience with all areas of orthodontics, including robotic ... osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute Beauty Network, ... M. Weintraub as a prominent plastic surgeon and the network’s newest partner. ... the most handsome men, look naturally attractive. Plastic surgery should be invisible.” He ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... for human induced pluripotent stem (iPS) cells and other difficult to transfect cells, ... Cloning Medium. The PluriQ™ G9™ Gene Editing System is a complete ...
(Date:6/24/2016)... ... June 24, 2016 , ... Today, InhaleLabs.com ... ingestion of their medication by matching users with high quality water pipes within an ... with no commitment. , Inhale was founded by two brothers, Nick and Mike Hunter, ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Roche (SIX: RO, ROG; OTCQX: RHHBY) announced ... BRAHMS PCT (procalcitonin) assay as a dedicated testing solution ... this clearance, Roche is the first IVD company in ... sepsis risk assessment and management. PCT is ... levels in blood can aid clinicians in assessing the ...
(Date:6/23/2016)... , June 23, 2016 Research ... Pharma News Issue 52" report to their offering. ... in influenza treatment creates a favourable commercial environment for MedImmune ... growing patient base that will serve to drive considerable growth ... vaccine would serve to cap sales considerably, but development is ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 If ... Leaders Scholarship is any indication, the future is in ... at www.diabetesscholars.org by the Diabetes Scholars Foundation ... the way of academic and community service excellence. ... since 2012, and continues to advocate for people with ...
Breaking Medicine Technology: