By Kari Huus Reporter
updated 3/5/2004 12:07:11 PM ET 2004-03-05T17:07:11

The morning after pill appeared to be headed for over-the-counter sales, but advocates, as well as scientists and former FDA officials, say election-year politics are derailing the effort.

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The emergency contraceptive, known as Plan B, has been judged safe through years of prescription use, and effective in preventing pregnancy 89 percent of the time when taken within 72 hours of unprotected sex. Its proponents believe that widespread access to Plan B could prevent up to half of the unintended pregnancies and abortions in the United States.

In December, a Food and Drug Administration joint advisory panel charged with weighing the benefits and public health risks of Plan B voted 23-4 in favor of allowing women to buy the drug without a prescription. Normally, this determination would suggest nearly automatic FDA approval.

But something happened on the way to market.

As the Feb. 20 deadline for a final FDA decision on Plan B approached, the drug's owner, Women's Capital Corp. (since bought by Barr Laboratories), was headed into meetings with the FDA about the precise language of Plan B labeling for over-the-counter packaging when it was told the application was under review. Two weeks later, the company and FDA scientists were facing a barrage of questions. The Feb. 20 deadline was pushed back three months, and approval of over-the-counter sales is now anything but certain.

"The law is very clear that these decisions need to be based on science," says a former FDA official who was on hand during the joint advisory panel review and voting. "The delay is a signal that it is not being based on science," says the former official, who spoke on condition of anonymity.

Concerted campaign
What had happened in the interim was a concerted campaign against the drug by socially conservative groups, leading to a letter from 49 conservative members of Congress urging President Bush and FDA Commissioner Mark McClellan to reject the FDA panel’s recommendation.

The Jan. 9 letter, drafted by Rep. Dave Weldon, R-Fla., focused on fears that the availability of emergency contraception would prompt teenage girls to become more sexually active, endangering their health.

“Data on adolescent risk-taking indicates that young people are risk-takers and will engage in risky behaviors that increase their chances of acquiring STDs, becoming pregnant and participating in drug, alcohol and nicotine abuse. We have attached a news article from the United Kingdom that indicates the over-the-counter availability of levonorgestrel as causing significant increases in STI’s among adolescents.”

Levonorgestrel is the active ingredient in Plan B. It is also an ingredient in some common birth-control pills.

The argument took a page from one of Plan B's most vocal opponents, Concerned Women for America, a nonprofit group that lobbies to "bring Biblical principles into public policy." It was supported by a variety of pro-life groups, including the Catholic Church, which argue that emergency contraception can act to induce abortion, a view that is based on a definition of pregnancy at odds with the one broadly accepted in the medical community.

Those who are pressing for more study of Plan B are adamant that they are doing so out of public health concerns, not religious convictions or ideological grounds.

"My boss wishes there were no abortion pill (RU-486) or morning after pill available, but that’s not all it’s about," says an aide to one of the letter's signatories, a pro-life Republican Congressman. "We can argue this on two levels, but right now we’re focused on the public safety aspect."

"What (the signatories) are saying more specifically is: Good night — this is safe for children before making it available (over the counter)," says the aide, who spoke on condition of anonymity.

Plan B's opponents are also raising questions about the diligence of the FDA review panel. "I couldn’t believe the cavalier attitude of some people on the committee," says Wendy Wright, senior policy director of Concerned Women for America. She says members were "hell bent on getting (the drug) into the hands of people."

The Republican congressional aide charges that most of the panel members were Clinton administration appointees who supported over-the-counter sales of Plan B to please pro-choice groups.

'Volumes of research'
In fact, nearly all of the 30 members of the joint panel have been appointed under the Bush administration. Following standard FDA practice, the panel also brought in a few outside experts.

"Anything related to levonorgestrel was reviewed by the FDA," says Kirsten Moore, who heads the Reproductive Health Technologies Project, a national nonprofit organization that advocates reproductive freedom for women. "There are volumes of data that exist about use of levonorgestrel as emergency contraception or as regular birth control among a broad population of women."

Following the circulation of the Weldon letter, Moore's organization prompted 80 members of Congress who support the wider availability of Plan B to write a letter of support to FDA Commissioner McClellan, urging that he give the go-ahead to over-the-counter sales.

Meanwhile, panel members have been responding to follow-up questions on Plan B, mostly related to use by teens, by breaking out data from existing studies to more clearly show the effects on younger women.

"In the science, I and everyone I know who has given FDA these additional breakdowns (believe) there’s nothing there," says James Trussell, director of Princeton University's Office of Population Research. "Older and younger groups are the same, no matter what the question. ... In no group does the drug affect a woman's tendency to engage in risky sexual behavior."

By May 20, the fate of Plan B should be decided. It could be rejected for over-the-counter sales altogether. It could be sold with an age restriction, requiring those purchasing it to show ID, for instance. Or it could be put on hold for years by additional research requirements.

Reshuffle at FDA
The outcome is made even more uncertain by reshuffling at the FDA. On Feb. 20, President Bush announced that he intended to nominate McClellan to head Medicare and Medicaid. FDA deputy Lester Crawford will be acting commissioner of the agency.

Supporters of Plan B are already afraid that the loss of McClellan, a well-respected physician and economist who has risen quickly through government postings, could mean the loss of the battle.

McClellan's departure is "unfortunate," says Trussell. "He had strong credentials as a real scientist, and one would have hoped he could resist pressure to make a decision based on anything other than science."

In yet another appeal to McClellan, 48 members of Congress wrote another letter on Feb. 26, asking him to approve Plan B for over-the-counter sales before leaving his post. They argue that the FDA panel has already considered questions now being raised.

"As you review the data on Plan B and decide whether to make this crucial drug available to more women, we urge you to ensure that FDA carries on its mission as a science-based agency, even in the face of political pressure," said the letter, drafted by Sen. Henry Waxman, D-Calif.

If McClellan leaves Plan B in limbo, it is unclear who will make the final decision on over-the-counter sales. In normal times, the commissioner delegates responsibility to the directors in the office of approvals. Thus it could fall into the hands of the acting director of the FDA’s Center for Drug Evaluation, Steve Galson, who has vowed that the Plan B application would rise or fall on its scientific merits.

Or the decision could fall to Crawford. But in this political climate there is also a chance that the final decision will get kicked upstairs, to a higher authority, Secretary of Health and Human Services Tommy Thompson, a social conservative from Wisconsin. Thompson, who oversaw one of the most restrictive anti-abortion policies in the country in his home state, was decried by pro-choice groups as unfit to protect women's health when he was first appointed to the Cabinet post. If the decision is indeed political, and falls to Thompson, it would very likely put Plan B's over-the-counter aspirations on death row.

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