Navigation Links
Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step

SILVER SPRING, Md., Dec. 7, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration (FDA) has been carefully evaluating for over a decade whether emergency contraceptives containing levonorgestrel, such as Plan B One-Step, are safe and effective for nonprescription use to reduce the chance of pregnancy after unprotected sexual intercourse.


Plan B One-Step is a single-dose pill (1.5 mg levonorgestrel tablet) which is effective in decreasing the chance of pregnancy if taken within 3 days after unprotected sexual intercourse.  The product contains higher levels of a hormone found in some types of daily use oral hormonal contraceptive pills and works in a similar way to birth control pills.  

Plan B One-Step was originally approved in July 2009 for use without a prescription for females age 17 and older and as a prescription-only option for females younger than age 17.  In February 2011, Teva Women's Health Inc. submitted a supplemental application seeking to remove the prescription-only status for females younger than age 17 and to make Plan B One-Step nonprescription for all females of child-bearing potential.

The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step.  Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.

It is our responsibility at FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence.  The review process used by CDER to analyze the data applied a risk/benefit assessment consistent with its standard drug review process.  Our decision-making reflects a body of scientific findings, input from external scientific advisory committees, and data contained in the application that included studies designed specifically to address the regulatory standards for nonprescription drugs.  CDER experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential.

I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.  

However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency's decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential.  Because of her disagreement with FDA's determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved.  Following Secretary Sebelius's direction, FDA sent the complete response letter to Teva today.  Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.

Media Inquiries: Erica Jefferson, 301-796-4988,
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Statement by KCP Chairman Dr. Edward Jones in Response to FDA Advisory Committee on Benefits and Risks of Erythropoietin-Stimulating Agents in Treatment of Kidney Patients
2. Statement From The National Conclave on HIV/AIDS Policy for Black Clergy
3. Statement by US Oncology on FDA Label on Erythropoiesis Stimulating Agents (ESAs)
4. AIDS Action Council Statement on World AIDS Day 2007: Leadership Needed for a National Strategy to Stop the AIDS Epidemic
5. Statement of Andrea Kavanagh, Director, Pure Salmon Campaign, on the Science Sea Lice Study
6. Statement from the American Diabetes Association Related to ACCORD Trial Announcement
7. Media Statement: MHA Keystone Center for Patient Safety & Quality OHRP Ruling
8. Statement from Eli Lilly and Company: Response to Connecticut Attorney General News Release
9. Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
10. Statement From the Lupus Foundation of America Regarding the Release of Top-Line Results From a Study of Rituxan for the Treatment of Lupus
11. VA Statement on Smoking Cessation Research Program
Post Your Comments:
(Date:12/1/2015)... , Dec. 1, 2015 ... today announced that its Chief Executive Officer, ... the Oppenheimer Annual Healthcare Conference in New ... in the conference through a webcast on ... , --> ...
(Date:12/1/2015)... India and PITTSBURGH , ... today announced that it expects to be the first ... markets funded by international donors, TLE400 (Tenofovir Disoproxyl Fumarate ... mg) for $99 per patient, per year. Mylan partnered ... TLE400. The significantly reduced price could generate savings of ...
(Date:12/1/2015)... Breg, Inc ., a premier provider ... it has been awarded three contracts by Novation, a ... will have access to improved pricing for Breg,s portfolio ... goods dedicated to advancing orthopedic care.  ... population, rising prevalence of chronic conditions and the health ...
Breaking Medicine Technology:
(Date:12/1/2015)... Angeles, CA (PRWEB) , ... December 01, 2015 , ... ... United States, today announced that its iconic bottle has won top honors in Beverage ... category. The Company also announced that it has been selected as a 2015 ...
(Date:12/1/2015)... ... December 01, 2015 , ... Growth in medical payments per workers’ compensation ... utilization of hospital and nonhospital care, according to a recent study by the Workers ... 16th Edition , found medical payments per claim with more than seven days of ...
(Date:12/1/2015)... ... December 01, 2015 , ... CloudLIMS today ... Golden Bridge Business Awards under the New Products and Services category for its ... sample management software that helps labs organize data and track samples ...
(Date:12/1/2015)... ... December 01, 2015 , ... Diabetic ... United States. Podiatrists are well aware that psychology-based patient non-compliance (disobedience of a ... catastrophic contributors to diseases of the diabetic foot. The American Board of ...
(Date:12/1/2015)... IL (PRWEB) , ... December 01, 2015 , ... ... keeping their independence is everything. That is why Hollister Incorporated has launched the ... to offer this next product in the VaPro touch free catheter portfolio,” said ...
Breaking Medicine News(10 mins):