What’s the Plan?

Why did the FDA block the morning-after pill, Plan B, from being sold over the counter?

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Last week, the FDA decided not to allow Plan B, currently a prescription-only oral contraceptive, to be sold over the counter.
The decision flew in the face of the recommendation of an advisory panel and caused womens rights activists and lawmakers to complain that the Bush administration was, once again, placing politics above science to win points with its conservative base.

Some members of Congress are demanding that the two FDA officials in charge of the decision– acting Commissioner Lester Crawford and Dr. Steve Galson, acting director of the agency’s Center for Drug Evaluation and Research– resign and that the agency reverse its decision.
Galson overruled the advisory panel—unusually; the FDA almost always follows advisory recommendations—on the grounds that not enough research had been done on its effects on girls 16 and under.

Plan B is a souped-up version of a regular hormonal contraception. If taken within 72 hours of having sex, it blocks pregnancy by preventing ovulation or fertilization. It works with 89 percent effectiveness if taken in time.

Although Plan B differs from RU-486, the controversial pill that induces abortion and ends pregnancy, opponents see it as morally equivalent, saying, moreover, that Plan B, if made easily available, would encourage promiscuity among teenagers.

On Wednesday, a dozen members of congress called for Galson and Crawford to resign for blowing off the panel.

Rep. Carolyn B. Maloney (D-N.Y.), one of 41 members of Congress, mostly Democrats, who last week wrote Crawford, asking him to revisit and overturn the decision, announced that she would introduce legislation today requiring the FDA to reconsider its Plan B stance and affirm that it is not politically driven.

Rep. Louise M. Slaughter (D-N.Y.), co-chair of the Congressional Pro-Choice Caucus, asked the General Accounting Office to probe the FDA’s decision-making process in this case. She said:

“The FDA’s decision to ignore its own scientific advisory board and its own staff clearly demonstrates the leadership would rather pander to conservative interests than protect women’s health and well-being.”

Michael Greene, a Harvard OB-GYN on the advisory panel, which in December voted 23 to 4 in favor of making Plan B available over the counter, told USA Today that colleagues were considering resigning in protest:

“E-mails suggesting mass resignations are already flying around among people who were on this committee. People are just hopping mad. The decision is blatantly contrary to the science and the facts, and so blatantly politicized.”

The Orlando Sentinel suggests that Galson, even if he had reservations about young women taking the pill, could still have approved it for adults:

The Bush administration keeps letting politics get in the way of sound public policy. The latest example is last week’s rejection by the federal Food and Drug Administration of over-the-counter status for emergency contraception. … OK, then, Mr. Galson. Approve it for women 18 and older. Prove you’re not just playing politics.

But the decision has its supporters. Wendy Wright, senior policy director for Concerned Women of America, a conservative public policy organization, said in a statement after learning of Galson’s decision:

“The morning-after pill is a pedophile’s best friend. Morning-after pill proponents treat women like sex machines.”

Because Plan B must be used within three days of sex, and is more effective the sooner it is used, proponents say that forcing women to get a prescription puts them at the mercy of clinic schedules and locations.
Ruth Rosen of the San Francisco Chronicle argues that Plan B actually prevents abortions:

To opponents of Plan B, who worry that easy access might increase sexual promiscuity and that teenagers should have clinical supervision, Wayne Shields, ARHP president responded: “These arguments … are red herrings. In fact, countries that allow OTC access to EC (emergency contraception) and offer comprehensive sex and sexuality education have far lower rates of teen pregnancy and abortion than we do. It’s a no-brainer.”

“A December 2002 study by the prestigious Alan Guttmacher Institute estimated that emergency contraception probably prevented 51,000 abortions in 2000. But many social conservatives support “abstinence only” as strongly as they oppose abortion.”

Some states—California, Washington, Hawaii, Alaska and New Mexico—have programs that allow pharmacists or nurses to dispense Plan B in emergencies without requiring women to see a doctor. But according to Rosen, these programs are not well known:

“Since 2002, for example, California has permitted women to obtain emergency contraception without a prescription but from a participating pharmacist. Yet a February 2004 Kaiser Family Foundation survey found that only 9 percent of California women knew about such “pharmacy access” and that only 18 percent of pharmacies were participating in the new program.”

Galson’s concerns about young girls may have merit. As an article on Alternet points out, Barr Pharmaceuticals, the company that makes Plan B, included only 29 girls under 17 in its label-comprehension study, out of 585 total participants. The FDA says it may still approve Plan B for sale if another study can prove that teenagers can interpret the label adequately. The Washington Post suggests before passing judgment on the FDA’s motivations, we should wait and see if the agency follows through on its promise:

“[T]hough the FDA has banned the drug from over-the-counter use, it left open a window for future approval. “We weren’t closing the door,” said Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research. Indeed, if the FDA ruling is taken at face value, the only thing required of Barr is that it either conduct more studies of the drug’s impact on younger women or come up with a plan to ensure that the drug is available only by prescription to girls younger than 16: According to Dr. Galson, the FDA was bothered by the paucity of data describing the impact of the drug on girls ages 14 to 16 and the absence of data on girls younger than that, some of whom might presumably try to buy the drug. The company says it is “months, rather than years” away from providing precisely such information. …

At this point, the FDA should be given the benefit of the doubt — but not indefinitely.”


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