Navigation Links
FDA Approves 'Plan B' Pill for 17-Year-Olds
Date:4/22/2009

Decision is latest involving controversial birth-control drug

WEDNESDAY, April 22 (HealthDay News) -- Responding to a federal judge's directive, the U.S. Food and Drug Administration said Wednesday that it will now allow 17-year-olds to get the controversial "morning-after" birth control pill without a doctor's prescription.

In 2006, the FDA said it would limit over-the-counter access to the pill, also known as Plan B, to women 18 and older. But U.S. District Judge Edward R. Korman ruled last month in a New York lawsuit that the FDA had to reconsider whether to make the drug available to all women, regardless of age, without a prescription. He ordered the agency to let 17-year-olds get the drug, and separately to evaluate whether all age restrictions should be lifted.

"On March 23, 2009, a federal court issued an order directing the FDA, within 30 days, to permit the Plan B drug sponsor to make Plan B available to women 17 and older without a prescription," the agency said in a statement issued Wednesday afternoon on its Web site. "The government will not appeal this decision. In accordance with the court's order, and consistent with the scientific findings since 2005 by the Center for Drug Evaluation and Research, FDA sent a letter to the manufacturer of Plan B that the company may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older."

Plan B is an extra high dose of regular birth control that needs to be taken within 72 hours of unprotected intercourse to be effective. Essentially, the drug prevents pregnancy by delaying ovulation. It does not interrupt an already implanted pregnancy.

Religious conservatives object to Plan B, saying it is the equivalent of an abortion pill because it can prevent a fertilized egg from attaching to the uterus, and could also encourage premarital sex.

Supporters of broader access to Plan B argue that it is safe and effective in preventing unwanted pregnancy, and could also help reduce the number of abortions. They also contend that the FDA's decision to limit access to the drug to women 18 and older was a concession to the conservative views of then-President George W. Bush and his administration.

When the FDA announced its approval of over-the-counter sale of the Plan B pill in August 2006, after three years of delay, the decision came with stiff restrictions: Women under the age of 18 could not purchase the pills without a doctor's prescription.

"Our assessment is that this younger age group would strongly benefit from consultation with a health-care provider before using the product," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said during a 2006 news conference. "The application did not contain enough information about this age group to make us comfortable to do the switch fully for those younger people."

The age restriction was also meant to ease concerns for pharmacists, Galson said. "We have all kinds of restrictions that click in at 18," he said. "We thought for this program to practically work, the age 18 made sense."

The FDA originally approved Plan B as a prescription drug in 1999. It is manufactured by Duramed Research Inc. of Bala Cynwyd, Pa.

More information

For more on Plan B, visit the FDA.



SOURCES: April 22, 2009, news release, U.S. Food and Drug Administration; Aug. 24, 2006, news conference with Steven Galson, M.D., director, U.S. Food and Drug Administration Center for Drug Evaluation and Research


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. AUDIO from Medialink and Forest Pharmaceuticals: FDA Approves Lexapro for Major Depressive Disorder in Adolescents
2. AUDIO from Medialink and Forest Pharmaceuticals: FDA Approves Lexapro for Major Depressive Disorder in Adolescents
3. FDA Approves New Indication for Wyeths TYGACIL (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia
4. U.S. FDA Approves New THERAKOS(TM) CELLEX(TM) Photopheresis System
5. FDA Approves Symbyax(R) as First Medication for Treatment-Resistant Depression
6. FDA Approves Two Hologic HPV Tests
7. U.S. Food and Drug Administration Approves New Female Condom
8. Congress Approves FY2009 Omnibus Appropriations Bill with $900 Million for The Global Fund
9. FDA approves ULORIC (febuxostat) for the chronic management of hyperuricemia in patients with gout
10. State Health Department Approves Closure Plan for Brownsville Tri-County Hospital
11. NUCRYST Approves $0.80 Per Share Cash Distribution to Shareholders
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Approves 'Plan B' Pill for 17-Year-Olds
(Date:10/13/2017)... ... ... Apple Rehab Shelton Lakes , which specializes in the delivery of sub-acute ... of a disaster drill on October 3rd. , Apple Rehab participated with the Shelton ... well as the Connecticut Long Term Care Mutual Aid Plan (LTC-MAP). The LTC-MAP ...
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association (VNA) of ... collection of specialty vendors and unique items from across the nation, this holiday-themed event ... wellness services offered by the VNA. The boutique will be open Saturday, November ...
(Date:10/13/2017)... NJ (PRWEB) , ... October 13, 2017 , ... Global ... at scenic Alexandria Park in Milford, NJ. This free event, sponsored by Global ... physical activity. The fun run is geared towards children of all ages; it ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... viewers the lowdown on sciatica in a new episode of "Success Files," which ... current events and innovation and investigates each subject in-depth with passion and integrity. ...
(Date:10/13/2017)... ... 13, 2017 , ... “The Journey: From the Mountains to the Mission Field”: ... souls in the Philippines. “The Journey: From the Mountains to the Mission Field” is ... Bible. She has taught all ages and currently teaches a class of ladies at ...
Breaking Medicine News(10 mins):
(Date:10/5/2017)... , Oct. 5, 2017  In response to ... Oral and Maxillofacial Surgeons (AAOMS) released prescribing recommendations ... to be used as a first-line therapy to ... Recognizing the value ... White Paper "Opioid Prescribing: Acute and Postoperative Pain ...
(Date:10/2/2017)... Oct. 2, 2017 Diplomat Pharmacy, Inc. (NYSE: ... Software and Consulting, LLC , and named its founder ... based in Tennessee , will operate ... expands EnvoyHealth,s service offerings for health care partners to ... "In an interoperable world, technology ...
(Date:10/2/2017)... COPENHAGEN, Denmark , Oct. 2, 2017 The ... tool in the struggle to reverse the tide of prescription ... plan for regulating their medicine intake and stepping down their ... is set to launch in December 2017; the first 100,000 ... access. Learn more at http://www.rebound-solution.com/ ...
Breaking Medicine Technology: