FDA May Loosen up Morning-After-Pill Restrictions

Well given this post, this news that the FDA is may loosen up the restrictions on the morning-after-pill, and allow non-prescription sale to women 18 years old or older seems worthy of note. Although, the whole thing could simply be political manuevering.

WASHINGTON, July 31 (Reuters) – Non-prescription sales of a “morning-after” contraceptive could be approved for women 18 and older within weeks, U.S. health officials said on Monday in a surprise announcement after years of delays.

[snip]

The sudden shift came one day before Acting FDA Commissioner Andrew von Eschenbach is set to appear before a Senate committee considering his nomination to become the agency’s permanent chief.

Two Senate Democrats said they still intended to block a vote on von Eschenbach’s nomination unless the agency makes a final decision on whether to approve over-the-counter Plan B sales.

“Today’s announcement is nothing more than another delay tactic. 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,” Sens. Patty Murray of Washington and Hillary Rodham Clinton of New York said in a statement.

[snip]

Plan B is a set of two pills, that contain higher doses of a hormone used in birth control pills, taken 12 hours apart to block the release or fertilization of an egg.

It is different from the RU-486 “abortion pill,” which can terminate an early pregnancy by blocking a hormone that keeps a fertilized egg implanted in the uterus.

Barr Pharmaceuticals Inc.’s shares increased in value, linked to this news, and has hit a two week high.

FILED UNDER: Economics and Business, Health, Science & Technology, US Politics, , ,
Steve Verdon
About Steve Verdon
Steve has a B.A. in Economics from the University of California, Los Angeles and attended graduate school at The George Washington University, leaving school shortly before staring work on his dissertation when his first child was born. He works in the energy industry and prior to that worked at the Bureau of Labor Statistics in the Division of Price Index and Number Research. He joined the staff at OTB in November 2004.

Comments

  1. Gollum says:

    Of course it’s political maneuvering. They did the same thing last year.

    Last year, Clinton and Murray permitted confirmation of former FDA Commissioner Lester Crawford when the agency agreed to act on the Plan B application by September. The FDA in August delayed the decision indefinitely for more study. Murray and Clinton said they had been misled.

    And here’s a little background.

    In December 2003, an F.D.A. advisory committee voted 23 to 4 to approve Barr’s application with no age restrictions. Six months later, however, a top agency official rejected the application, citing concerns that the pill would be available to young teenagers.

    . . .

    While the F.D.A. has insisted that its decisions to reject or delay the Plan B application were the result of scientific or regulatory concerns, a Congressional investigation found last year that top agency officials decided at one point to reject the application before its staff’s scientific review was even complete.

    and an interesting twist from Forbes last week:

    A group demanding easier access to the emergency contraceptive Plan B said Friday it seeks to subpoena White House e-mails and other documents as part of its lawsuit against the Food and Drug Administration.

    The Center for Reproductive Rights is seeking permission to request any e-mails, letters and records of conversations exchanged by the White House and the FDA to determine whether the administration weighed in with “instructions or directions” to regulators on how to proceed with a drug maker’s request to allow over-the-counter sales of the pills.