FDA Approves Plan B OTC Status For Women Eighteen And Over

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Main Category: Sexual Health / STDs
Also Included In: Women's Health / Gynecology
Article Date: 24 Aug 2006 - 9:00 PDT

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The FDA has today approved Plan B, known as 'The Morning After Pill', as an over-the-counter (OTC) option for adult women. Women who are 17 years old or less will need a doctor's prescription if they want access to the emergency contraception.

Plan B is an emergency contraception. If a woman had unprotected sex she can reduce her chances of getting pregnant by 89% if she receives treatment within 72 hours. Plan B consists of two pills.

Plan B contains a high dose of an ingredient used in prescription birth control pills. The treatment has been available to all women as a prescription drug for some time - as of today, women aged 18 years or more can get it at a pharmacy without needing a doctor's prescription (OTC).

The FDA said it has allowed Plan B to have its new OTC status because the makers, Duramed, a subsidiary of Barr Pharmaceuticals, will make it available with "rigorous labeling, packaging, education, distribution and monitoring program." In the Convenient Access, Responsible Education (CARE) program, Duramed has committed to:

-- Provide consumers and healthcare professionals with labeling and education about the appropriate use of prescription and OTC Plan B, including an informational toll-free number for questions about Plan B;

-- Ensure that distribution of Plan B will only be through licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed healthcare practitioners, and not through convenience stores or other retail outlets where it could be made available to younger women without a prescription;

-- Packaging designed to hold both OTC and prescription Plan B. Plan B will be stocked by pharmacies behind the counter because it cannot be dispensed without a prescription or proof of age; and

-- Monitor the effectiveness of the age restriction and the safe distribution of OTC Plan B to consumers 18 and above and prescription Plan B to women under 18.

Plan B was first approved in the USA in 1999 as a prescription medication. In 2003 the drug was submitted to the FDA for OTC status. In 2003 an Advisory Panel recommended that Plan B become an OTC drug for all women, regardless of age. Even though the FDA nearly always goes along with what the panel recommends, on this occasion it didn't. It remained a prescription only drug. In 2004 the drug was submitted again, this time Barr Pharmaceuticals proposed restricting sales to older teenagers and women. The FDA did not move. Until today, Plan B has only been available to women with a doctor's prescription. Various reasons have been given for the delay by the FDA - the most prominent one being that it needs to write the rules on how age restrictions can be enforced.

Last year Dr. Andrew von Eschenbach became acting FDA Chief Commissioner. This year he wanted his post to become permanent. In order to get confirmation he needs the OK from a Senate Committee. Senators Hillary Clinton and Patty Murray blocked his confirmation, saying they would not budge until he did something about Plan B. Swiftly, the FDA pulled out all the stops and did in a few months what it couldn't over three years - change Plan B's status from a prescription only medication to an OTC drug.

The FDA has been accused by many doctors and scientists of sitting on its hands for all these years because of pressure from politicians. The FDA should base its decisions on scientific evidence, not political pressure. A Government Accountability Office said the FDA's handling of Plan B was 'highly unusual'.

-- More Information on Plan B from the FDA

Written by: Christian Nordqvist
Editor: Medical News Today
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today