by email
Dear Friend:
The Government Accountability Office (GAO) recently confirmed that
politics trumped science when the U.S. Food and Drug Administration (FDA) rejected an application to sell an emergency contraception (EC) pill, Plan B, over the counter.
EC is a high dose of regular birth control pills that can reduce the
rate of pregnancy by almost 90 percent when taken within 72 hours of
sexual intercourse. But timing is vitally important. The sooner EC is taken, the more likely it is to prevent pregnancy. Waiting for a
prescription can decrease quick access to EC and increase the chances of unintended pregnancies.
In late 2003, scientific staff and advisers at the FDA overwhelmingly
recommended the over-the-counter sale of Plan B, citing evidence that it could prevent as many as half of the three million annual unintended pregnancies in the United States without increasing the rates of unprotected sex. However, the FDA rejected the recommendation, saying it questioned whether young women could use Plan B safely without a doctor’s guidance.
I joined with 47 other Members of Congress in asking the GAO,
Congress’s nonpartisan investigative body, to issue a report on the FDA’s decision-making process concerning Plan B. The GAO found that the FDA review process in this case was “unusual” in four respects. First, the FDA directors who reviewed the application refused to sign the letter announcing the agency’s decision to turn it down. Second, unlike other applications for over-the-counter drugs, high-ranking officials were deeply involved in the review of Plan B. Third, it appears that the decision to deny over-the-counter access to EC was made before scientists finished reviewing the evidence. Fourth, the FDA director’s cited reason for rejecting the application – that concerns about the behavioral implications for younger teens and an unwillingness to address such worries by examining data on older teens – did not follow the agency’s traditional practices.
The fate of Plan B, and the women who rely upon it, has not been
settled. The GAO report has now explained why: When it comes to EC, good evidence and advice from scientists is not enough for high-ranking officials to put science and health before politics.
Sincerely,
Barbara Boxer
United States Senator
===================================================
For more information on Senator Boxer's record and other information,
please go to:
http://www.boxer.senate.gov
Printer-friendly format
Email this thread to a friend
Bookmark this thread
(1000+ posts)
Send PM |
Profile |
Ignore
