* FDA to weigh wider access to Plan B contraceptive
* Teva wants age limit restriction lifted
* Drugmaker's bid gives agency 10-month deadline
* Over-the-counter access sought since 2001
By Susan Heavey
WASHINGTON, Feb 10 The maker of the Plan B
morning-after pill is gearing up for another round with the
U.S. Food and Drug Administration over whether the emergency
contraceptive can be sold without a prescription for younger
women and girls.
Teva Pharmaceutical Industries Ltd (TEVA.TA) 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 WPI.N 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.
(Reporting by Susan Heavey; Editing by Carol Bishopric)