Plan B Activists Prepare for Next Battle at FDA

(WOMENSENEWS)–“He came. He delayed. And then he was gone.”

In the words of Belle Taylor-McGhee, director of the Oakland-based Pharmacy Access Partnership, that sums up the tenure of former Food and Drug Administration Commissioner Dr. Lester Crawford, who on Aug. 26 announced the FDA would indefinitely delay over-the-counter approval of emergency contraception and then on Sept. 23 suddenly resigned.

Crawford’s departure–and the appointment of acting FDA chief Dr. Andrew von Eschenbach to replace him–have stirred mixed hopes about the future of Plan B, the drug known as “emergency contraception” or the “morning-after pill” because it is 89 percent effective at preventing pregnancy if taken within 72 hours of unprotected intercourse.

“Emergency contraception will be the first test of whether von Eschenbach is committed to science driving decision-making at the agency,” says Susan Wood, the former director of the FDA’s Office of Women’s Health, who resigned in August to protest Plan B’s delay.

A concentrated, two-pill dose of the hormone progestin, Plan B is made by Barr Pharmaceuticals, Inc. of Woodcliff Lake, N.J., and has been available in the United States by prescription since July 1999. Costing $30 to $40, it could prevent an estimated 1.7 million unintended pregnancies annually if it were more widely available.

Plan B is sold over the counter in 34 countries, and is available without a prescription from pharmacists in eight states: Alaska, California, Hawaii, Maine, Massachusetts, New Mexico and Washington.

Wood Fears Rule-Making Delay

Wood resigned after Crawford announced that “scientific data” supported over-the-counter access for women over 17 and prescription-only access for women under 17, but said the FDA needed a 60-day period of public comment–followed by an indefinite period of “rule-making”–before making a decision on Plan B.

In a recent interview with Women’s eNews, Wood reiterated her objections to Crawford’s action, saying that under FDA regulations the rule-making process that Crawford put in motion could push back the drug’s approval for years, despite internal recommendations that it be offered over the counter to women.

“The senior professional staff who are normally included in these decisions were cut out of them,” said Wood.

Plan B’s over-the-counter sale has been stalled for two years amid charges that Crawford was responding to pressure from the Bush administration, but few expect the drug’s fortunes to improve with the agency’s leadership.

“I don’t think the situation will change under von Eschenbach,” says Dr. Robert Fenichel, the former FDA deputy division director of renal and cardiovascular drugs. “He has a fairly good reputation, but it’s not plausible the Bush administration invited him to take the job without ascertaining that the boat was no longer in danger of rocking.”

FDA spokesperson Susan Cruzan said the agency had “no comment” on how the new appointment may affect Plan B’s approval.

In a Sept. 28 interview with Forbes Magazine, Crawford said the flap over Plan B influenced his decision to resign. Like the controversy over the safety of the arthritis drug Vioxx and the side effects of antidepressants in children, the firestorm over emergency contraception “tired” him and made him feel he could no longer be “effective” at his job, he said.

Allegations are also swirling that Crawford failed to disclose relevant financial information to the Senate in July, when he was confirmed as commissioner after serving as the FDA’s interim head since March 2004.

While Crawford came to the FDA with experience as a veterinarian, his replacement, von Eschenbach, has since January 2002 directed the Bethesda-based National Cancer Institute and said last week he believes the FDA should speed up its drug approval process.

“Von Eschenbach comes to the table with more robust medical and scientific credentials and with hints of making change,” says Taylor-McGhee. “But he’s still a Bush crony and he plans to continue serving as head of the NCI while also running the FDA.”

Advocates Press Battle

As von Eschenbach takes the helm, health advocates are forging ahead in their battle for Plan B during the public feedback period.

The New York-based Women’s Liberation Birth Control Project is encouraging women to deluge the FDA with phone calls. It has also convinced 3,500 women to sign a pledge in which they promise to get prescriptions for Plan B and give the drug to other women.

The Washington-based NARAL Pro-Choice America has launched an e-petition campaign to put heat on von Eschenbach and pressure the FDA to approve the drug.

The Washington-based Planned Parenthood Federation of America is continuing to offer the drug at its 850 sites across the United States and is lobbying more states to allow pharmacists to dispense it.

Senators Hillary Rodham Clinton, D-N.Y., and Patty Murray, D-Wash., are calling for a congressional oversight committee to investigate the FDA’s actions and Crawford’s resignation. The independent General Accounting Office is conducting a second investigation.

And Tummino v. Crawford–a lawsuit that charges the FDA with violating the U.S. Constitution in its handling of Plan B–is making its way through federal court in New York.

Some suspect Crawford and his colleagues may even have skirted the law. “The FDA took more than the 180 days required to respond to Barr’s two applications for over-the-counter sale,” said Rachel Laser, senior council for the Washington-based National Women’s Law Center. “We are investigating the legal repercussions of this.”

Stalled Approval

In April 2003, Barr moved to put Plan B on drug store shelves here by applying for approval from the FDA. In May 2004, Crawford rejected the drug’s first application for over-the-counter sale, saying it may not be appropriate for women under 16.

“The FDA laid out two potential paths: study the drug’s effects in women as young as 11 or opt for an age restriction in the context of a split label,” says Dr. Carole Ben-Maimon, president and chief operating officer for Barr Pharmaceuticals. “We chose to go with the split label because we thought it would get us to our goal sooner.”

Health groups across the nation–from the Chicago-based American Medical Association to the New York-based Women’s Liberation Birth Control Project–were united in criticizing Crawford’s August decision to delay.

“The American Academy of Pediatrics and the American College of Obstetricians and Gynecologists both said the FDA’s concerns about safety in younger women were unwarranted,” said Fenichel. “Studies prove this drug is safe for women of all ages.”

Advocates also dismissed Crawford’s concerns about how to enforce age restrictions.

“We have any number of over-the-counter products that are monitored by age, including alcohol, cigarettes and the nicotine patch,” said Karen Pearl, interim president of Planned Parenthood Federation of America. “This delay is shameful because it shows the FDA is putting politics ahead of science.”

Molly M. Ginty is a freelance writer based in New York City.