US FDA slightly eases access to morning-after pill

Wed Apr 22, 2009 11:47pm BST

Quotes

   

*FDA obeys court; OKs non-prescription sales to 17-yr-olds

*Teva: process could take 10 months

*Plan B sales have doubled since 2006 (Adds details, reaction, background)

By Susan Heavey

WASHINGTON, April 22 (Reuters) - Seventeen-year-olds will soon have access to emergency contraception without a prescription, U.S. health regulators said on Wednesday, complying with a court order to ease restrictions on over-the-counter sales of the so-called "morning-after" pill.

Last month, a U.S. court ruled the Food and Drug Administration under the Bush administration had allowed politics to cloud its decision-making process regarding availability of the Plan B drug which had been restricted to those 18 and older.

It ordered the agency to allow nonprescription sales to 17-year-olds, and to reconsider its decision regarding over-the-counter access to Plan B.

The FDA on Wednesday said it would allow nonprescription access to 17-year-olds as soon as it received necessary information from the drug's maker, Barr Pharmaceuticals Inc, now part of Teva Pharmaceutical Industries Ltd (TEVA.TA).

"The government will not appeal this decision," the FDA said in a statement on its website.

Teva said it would comply with FDA's request but it could still take 10 months before the drug is available without a prescription for younger buyers.

"We will continue to work closely with FDA to ensure that all provisions of this decision are met," it said.

Women's health advocates cheered the FDA's decision, with some adding that access should be loosened even more, to allow shelf sales without age restrictions. They along with company officials argue it is critical for women to have quick access to the drug, which aims to prevent pregnancy when used within 24 hours of sexual intercourse.

"It's a good indication that the agency will move expeditiously to ensure its policy on Plan B is based solely on science," said Nancy Northup, president of the Center for Reproductive Rights, which initiated the lawsuit in 2005.

National Women's Health Network policy director Amy Allina said FDA's move "gets us part way to where we believe the FDA should be." But she added, "Putting it behind the counter does not make it safer or more effective. In fact, because it creates another barrier it's likely to make it less effective."

Plan B is a set of two pills that contain higher doses of progestin than are used in prescription birth control pills.

Conservative groups have opposed any nonprescription access to the drug, saying among other things that it could lead to promiscuity.

"The FDA violated its standards when it made the high dose Plan B available nonprescription to adults. But now the FDA is making the drug available to minors without parental consent," Concerned Women for America President Wendy Wright said in a statement. "The FDA should have challenged the decision."

Barr had earlier sought over-the-counter access for those 16 and older.

The FDA under President George W. Bush delayed making any decision for three years. Then In 2006 it allowed behind-the-counter sales to those age 18 and older who showed proof of age while still requiring a prescription for girls 17 and younger.

Even with the new FDA decision, the company would have to submit additional data on the drug for 16-year-olds, said Diana Zuckerman, head of the National Research Center for Women & Families.

Despite the limitations, sales of Plan B "have more than doubled" since it became available for adults from pharmacists in 2006, Teva said.

The FDA posted the announcement on its website here. (Editing by Carol Bishopric and Tim Dobbyn)




Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.