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UPDATE: Politics Trumps Science as FDA Denies Access to Plan B

MISSING reported that the FDA extended the February 20, 2004 deadline for its decision on the over-the-counter status of Plan B, a form of emergency contraceptive. The FDA extended its deadline 90 days and ultimately, on May 7, 2004, decided not to allow the contraceptive to be sold over-the-counter.[1] Planned Parenthood Federation of America's (NCRW Member Center) Vice President for Medical Affairs Dr. Vanessa Cullins remarked: "There is no scientific reason to restrict access to this safe, effective backup method of contraception. Comprehensive scientific data shows that Plan B meets the FDA's criteria for over-the-counter status. The FDA's decision proves only one thing: dangerous anti-choice ideology is trumping scientific fact at the expense of women's health and well-being."[2]

In an indication that the suspicions of Dr. Cullins migh be true, Steven K. Galson, acting director of the FDA’s Center for Drug Evaluation and Research, said that he made the decision to reject the application for Plan B on his own—ignoring the recommendations of his staff. [3] In addition, the Kaiser Family Foundation and the Washington Post reported on June 18th that internal documents from the FDA show that three seperate levels of reviewers disagreed with the decision. The reviewers disagreed in particular with the primary basis for the rejection: the contention that there was not enough information on how Plan B would affect young women. Director of the FDA's Office on New Drugs, Dr. John Jenkings, wrote in one internal memo that Plan B, in fact, did not pose any particular risk to younger women and that "former commissioner Mark B. McClellan and...Steven K.Galson appeared to be introducting a different standard for evaluating Plan B than the FDA had applied to other contraceptives." [4]

On a more optimistic note, the American Medical Association (AMA) voiced its opposition to the FDA's decision at its annual meeting on June 14th. The AMA approved a resolution opposing the FDA's rejection of Plan B and urging doctors to write advance prescriptions for the drug. [5] In addition, after a meeting with Steven K. Galson in early June, Rep. Jim Greenwood (R-Pa) stated that he was confident that the FDA will reverse its decision (for women over 16) within the next six months. About the political nature of the decision, Greenwood commented: "maybe some folks thought it would be more comfortable politically to give an approval after the election." [6]

TAKE ACTION: NARAL and the Feminist Majority are campaigning against the FDA's decision.
To join NARAL's campaign, click here:
http://www.naral.org/takeaction/EC_prescription.cfm
To join the Feminist Majority's campaign, click here:
http://capwiz.com/fmf1/issues/alert/?alertid=5773586

Endnotes

1. Associated Press. (2004, May 7). FDA Bars Over Counter Morning-After Pill. http://www.nytimes.com/aponline/health/AP-Morning-After-Pill.html. [Return to text]

2. Planned Parenthood Federation of America. (2004, May 6). FDA Corrupts Science with Ideology, Denies Women Essential Access to Plan B Emergency Contraception. http://www.ppfa.org/about/pr/040506_EC.html. [Return to text]

3. Kaiser Family Foundation, Kaiser Daily Reproductive Health Report. (2004, June 18). FDA Scientist Disagreed With Agency's Reasons for Rejecting OTC Status for EC Plan B, Internal Documents Show. http://www.kaisernetwork.org/daily_reports/rep_repro_recent_reports.cfm? dr_cat=2&show=yes&dr_DateTime=18-Jun-04#24285. [Return to text]

4. Marc Kaufman, The Washington Post. (2004, June 18). Staff Scientists Reject FDA's Plan B Reasoning. Page A02. [Return to text]

5. Cnn.com. (2004, June 15). Doctors put spotlight on Plan B pill.
http://www.cnn.com/2004/HEALTH/06/15/morning.after.ap/ [Return to text]

6. Kaufman, Ibid.

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