F.D.A. Rejection of Next-Day Pill

Wednesday, November 16, 2005

At the FDA, the fix against women was in

Compulsive cronyism takes its toll on another agency, as political appointees overrule science and good medicine

F or appearances' sake, President Bush's political appointees running the Food and Drug Administration could have waited for the actual scientists to finish their work before deep-sixing a contraceptive for women.

They didn't bother. The fix was in.

A new report from the nonpartisan Government Accountability Office, the watchdog arm of Congress, confirms suspicions that the FDA has been hijacked by politics. The FDA's handling of a request to approve an emergency contraceptive called Plan B for over-the-counter sale was "unusual," the GAO concluded in a report released Monday.

Unusual, yes.

Not to mention infuriating, disheartening and, in these days of compulsive cronyism, utterly unsurprising.

Plan B, also known as the "morning-after pill," has been available by prescription since 1999. It is less reliable than condoms or other readily available forms of contraception. However, Plan B is an excellent backup for couples whose contraception fails, and for girls or women who are sexually assaulted. If the hormone pill is taken with 72 hours of sex, it can reduce the incidence of pregnancy by up to 89 percent.

The efficacy of Plan B makes it an obvious candidate for over-the-counter sale. But some conservative groups are adamantly opposed to the contraceptive, saying it will encourage promiscuity among young women. They also call it the moral equivalent of abortion, since it's designed to prevent ovulation and fertilization.

These opinions seem to carry more weight at the top of the FDA than science or medicine.

Three separate FDA offices and one panel of outside advisers reviewed reams of research on Plan B and concluded that the contraceptive was safe and effective. They recommended the approval of Plan B for over-the-counter sale.

These medical professionals were overruled or outmaneuvered by three of President Bush's appointees. One was former Commissioner Mark B. McClellan, a brother of Bush's press secretary. Another was Dr. Steven Galson, director of the agency's center for drugs. He rejected the first Plan B application. A third was former Commissioner Lester Crawford, the Alabama veterinarian who rejected the revised Plan B application. (Crawford resigned amid speculation that he failed to disclose investments in the drug industry.)

No wonder the FDA is having trouble attracting and retaining good people these days.

"This report is a sad reminder of why I felt compelled to resign," one former midlevel manager told The Washington Post this week. She left her job this summer in protest of the FDA's direction.

It will take years for the FDA to restore its credibility. It will take even longer if President Bush can't figure out how to appoint people based on professional competence rather than politics and proximity.

We've been through all this before. Back in the early 1990s Plan B, then known as RU-486, was approved for use and widely available by prescription in Europe.

Is Plan B the same as RU486 (abortion pill)?

No, Plan B is not an abortifacient. It is an emergency contraceptive and should not be confused with RU486 or any other abortifacient. Plan B is not effective if a woman is pregnant.

1. What is emergency contraception?

Emergency contraception is a method of preventing pregnancy to be used after a contraceptive fails or after unprotected sex. It is not for routine use. Drugs used for this purpose are called emergency contraceptive pills, post-coital pills, or morning after pills. Emergency contraceptives contain the hormones estrogen and progestin (levonorgestrel), either separately or in combination. FDA has approved two products for prescription use for emergency contraception - Preven (approved in 1998) and Plan B (approved in 1999).

2. What is Plan B?

Plan B is emergency contraception, a backup method to birth control. It is in the form of two levonorgestrel pills (0.75 mg in each pill) that are taken by mouth after unprotected sex. Levonorgestrel is a synthetic hormone used in birth control pills for over 35 years. Plan B can reduce a woman's risk of pregnancy when taken as directed if she has had unprotected sex. Plan B contains only progestin, levonorgestrel, a synthetic hormone used in birth control pills for over 35 years. It is currently available only by prescription

3. How does Plan B work?

Plan B works like other birth control pills to prevent pregnancy. Plan B acts primarily by stopping the release of an egg from the ovary (ovulation). It may prevent the union of sperm and egg (fertilization). If fertilization does occur, Plan B may prevent a fertilized egg from attaching to the womb (implantation). If a fertilized egg is implanted prior to taking Plan B, Plan B will not work.

Why do you think it seems silly, Bella?