The maker of the Plan B morning-after pill is gearing up for another round with the Food and Drug Administration over whether the emergency contraceptive can be sold without a prescription for younger women and girls.
Teva Pharmaceutical Industries Ltd earlier this week said it had asked the FDA for permission to sell the drug without any age limits, the latest salvo in an decade-long battle over the pill. Only those 17 and older can buy it now without a doctor's order.
Chief Executive Shlomo Yanai announced the move on Tuesday, calling it "an important milestone" for the product, now sold as one pill called Plan B One-Step.
It is also the latest political challenge for the agency, which was widely criticized for its handling of the pill under the Bush Administration.
Medical and women's groups have sought wider access for Plan B, which Teva acquired in 2008, since 2001. But the effort stalled under President George W. Bush and sparked multiple legal actions and congressional protests that the agency was letting politics trump science.
FDA allowed limited "behind the counter" sales for women 18 and older in 2006 that required controversial identification checks. It later lowered the limit to age 17.
Plan B, first approved in 1999, contains a higher dose of the hormone progestin that has been widely used in regular birth control pills for decades. It had been sold in a two-pill version taken within 72 hours that now faces generic rivals.
Advocates for such emergency pills say they help reduce unwanted pregnancies or abortions and that quick, easy access for girls and women of all ages is critical for the medicines to work. Conservative critics charge they could lead to promiscuity and sexual abuse.
Women's groups have sued the FDA over its handling of Plan B, and in 2009 the agency was ordered to reconsider its decision. Representatives for the FDA had no immediate comment on the status of its review or Teva's new bid.
It was not immediately clear how the new application would affect exclusivity for Plan B One-Step, which Teva's Yanai said saw higher sales in 2010 but offered no details.
Teva gave the FDA additional data based on a study of actual use of the contraceptive in girls and teen-agers ages 11 to 16. It expects the agency to rule within 10 months.
Planned Parenthood, the Reproductive Health Technologies Project and other supporters said this week they were thrilled Teva was seeking wider access. Several conservative groups that have long opposed the drug either had no immediate comment or could not be immediately reached.
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 long had all the information it needs to rule on wider access.
"This should be straight forward," she told Reuters.
Last year, FDA approved a rival contraceptive pill from Watson Pharmaceuticals Inc and HRA Pharma. Their drug, called ella, works for a longer time after unprotected sex but is only available with a doctor's note.
Plan B has been shown effective for up to three days after intercourse, while ella works for five days.