February 12, 2011

Easier Access Wanted For Plan B Contraceptive

Teva Pharmaceuticals Industries Ltd, the maker of the Plan-B morning-after pill is set to face the FDA in another debate over whether the contraceptive can be sold without a prescription for younger women and girls.

Earlier this week, the company said it had asked the FDA for permission to sell the drug without any age limits, the latest round in a decade-long struggle over the emergency contraceptive. Only women older than 16 can now buy the pill without a prescription.

Teva CEO Shlomo Yanai announced the move on Tuesday, calling it "an important milestone" for the product: Plan-B One-Step.

Medical groups, along with women's groups, have looked for wider access for the pill since 2001. But that effort stalled under then-President George W. Bush and touched off a multitude of legal actions and protests that the agency was letting politics overrun science.

The FDA allowed limited "behind the counter" sales for women 18 and older in 2006, but later lowered the age limit to 17.

Supporters of the emergency pill and others like it say they help reduce unwanted pregnancies or abortions and that easy access for girls and women of all ages is crucial for the medicines to work properly. Critics of the drug say they could lead to promiscuity and sexual abuse.

The FDA has been sued by women's groups over the way it has handled Plan B. In 2009 the agency was ordered to reconsider its decision. The FDA had no immediate comment on the status of its review.

Teva's Yanai said it was not immediately clear how the new application would affect the exclusivity for Plan B One-Step. He said the company saw higher sales in 2010, but would not offer any further details.

Teva, seeking wider access of the pill, gave the FDA additional data on a study of use of the contraceptive in girls between the ages of 11 and 16. It expects the FDA will rule on the new application within 10 months.

Supporters of Teva, including Planned Parenthood, said this week they were thrilled that the pharmaceutical was seeking wider access.

Susan Wood, former head of the FDA's Office of Women's Health who resigned in protest over the agency's handling of the drug, said the agency has all the information it needs to rule on wider access.

"This should be straight forward," Wood told Reuters.

A rival contraceptive of Teva's Plan B, from Watson Pharmaceuticals Inc and HRA Pharma, was approved by the FDA last year. The drug, called Ella, works for a longer time after unprotected sex but is only available with a prescription.

Plan B has been shown to be effective for up to three days after unprotected sex, while Ella works for up to five days.


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