FDA does an about turn on Plan B contraceptive pills

After years of dilly dallying over it's stand on over-the-counter sales of the "morning-after" contraceptive officials at the U.S. Food and Drug Administration (FDA) suddenly appear to be doing an about turn.

The FDA now says the contraceptive Plan B could be approved for women 18 and older within weeks.

Plan B will be kept behind pharmacy counters and women will need to ask for them but anyone under 18 will need a prescription.

The surprise move comes almost a year after it was thought the contraceptive was doomed and is being regarded with suspicion by many as it comes just before President Bush's nominee, acting FDA Commissioner Andrew von Eschenbach is about to appear before a Senate committee considering his nomination to become the agency's permanent chief.

An FDA advisory panel of the agency's independent scientific advisers overwhelmingly backed nonprescription sales for all ages in 2003.

Democrat Senators Patty Murray and Hillary Rodham Clinton in particular are skeptical and see the move as yet another delaying tactic and have every intention of blocking a vote on von Eschenbach's nomination unless the agency makes a final decision on whether to approve over-the-counter Plan B sales.

The senators say ' the FDA continues to shirk its duty to serve as an independent agency dedicated to no other goal than the promotion of sound science and the well-being of the American people'.

However Barr Pharmaceuticals who produce Plan B are optimistic and believe everything could be settled in a matter of weeks.

A year ago the FDA indefinitely postponed a decision on Plan B which led to criticism that the agency was allowing political influence overrule science.

Many conservatives believe easy access to Plan B could lead to greater promiscuity, particularly among teenagers as the pills can prevent pregnancy if taken within 72 hours of sexual intercourse.

But women's groups argue that over-the-counter sales could reduce the number of abortions because more women would be able to get the pills in time without going through the hassle of getting a prescription.

Barr had intended Plan B to be available over the counter to females age 16 and older, but FDA officials felt evidence was lacking that younger women could take the pills safely and now believe 18 is the appropriate age for non-prescription sales.

The contraceptive is a set of two pills that contain higher doses of a hormone used in birth control pills.

When taken 12 hours apart they block the release or fertilization of an egg and are not the same as RU-486 the "abortion pill," which can terminate an early pregnancy by blocking a hormone that keeps a fertilized egg implanted in the uterus.

When asked to explain the sudden change of heart an FDA spokeswoman said von Eschenbach wants to spend Tuesday's hearing on less contentious issues and on his own plans for the agency if confirmed as its chief.

Laws in eight states in the U.S., already allow women to buy Plan B from certain pharmacies without a prescription and with no age restrictions.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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