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On November 14, the Government Accountability Office the investigative arm of Congressissued findings from a 16-month investigation into why, in May 2004, the FDA first refused to make Plan B available without a prescription. Barr Laboratories, which manufactures the drug, has revised its original application and is now requesting approval for over-the-counter sales for women older than 16.
In its 62-page report, the GAO describes what amounts to a paternalistic agency whose top officials cared more about teenage girls' sex lives than about the drug's safety. It documents an array of irregularitiesmost notably, the way officials informed FDA staff that the application would be rejected before the scientific review was complete. The action was unprecedented. Of 67 similar decisions over the past decade, Plan B marks the only one denied by upper management over staff recommendations.
"This was a politically motivated decision that came down from the highest levels of the FDA," said Senator Hillary Clinton, in a joint statement with Senator Patty Murray of Washington. The two Democrats had called for the GAO investigation back in June 2004, and have pressed for a decision on Plan B ever since.
With the GAO report in hand, reproductive-rights advocates and their legislative allies are looking to use its findings to forward their cause. As it stands, the FDA has indefinitely postponed a ruling on Plan B. Though the agency has admitted that Plan B is safe, it now says the age restrictionswhich the agency requested to begin withhave raised legal issues that need examining for months, maybe longer. That means the wait could last the entire Bush administration.
Kirsten Moore, of the D.C.-based Reproductive Health Technologies Project, has pushed for emergency contraception for more than a decade, and says her camp has "no real standing on Capitol Hill right now." Legislative allies are mostly Democrats, a minority in both chambers. They can make a certain amount of noise, but they don't have the power to schedule a hearing or pass legislation.
When asked what Plan B proponents should do now, Congressman Jerrold Nadler, a Manhattan Democrat and one of the 29 House members who requested the GAO report, sums up the sentiment. "I'm not sure we have leverage to do anything," he says, especially in the House, where conservative Republicans dominate the agenda. But that doesn't mean he and other elected officials won't try.
As Nadler puts it, "We have to wage a guerrilla war against the FDA."
As soon as the GAO had released its findings, 18 House Democrats sent a letter to Health and Human Services secretary Michael Leavitt, who oversees the FDA, urging him to "renounce categorically the manipulation of science depicted in the GAO report."
Congresswoman Louise Slaughter, a Niagara Falls Democrat and a co-chair of the Bipartisan Congressional Pro-Choice Caucus, signed the November 14 letter. She calls the report "a smoking gun" proving that political concerns have trumped science at the FDA, but says there's yet more to learn.
For starters, the GAO wasn't able to determine the role of certain top officials. Mark McClellan, who headed the FDA during the years covered by the report, refused to answer questions, as did his successor, Lester Crawford, who quit the agency without explanation this fall. And because the GAO has no authority to compel information from the White House, its report couldn't determine how far up the chain of command the politicking went.
"We need a hearing," says Slaughter. "We're desperate for a hearing."
She and other Democrats are pushing for one before the House Government Operations Committee, which has the power to subpoena witnesses and records. But Republicans control Congress, and thus the committees. And no one expects them to rush to get behind the effortnot when the goal is to probe apparently improper behavior by Bush appointees, let alone to ensure accessibility to an emergency contraceptive that religious conservatives wrongly equate with abortion.
Notes Nadler, who also signed the House letter, "Our hands are tied in many ways."
No one understands this kind of power bind better than Clinton. She and Murray have dogged Bush's FDA for years over Plan B, going so far as to place a "hold" on Crawford's nomination last June. Yet that tactic didn't go as planned. After securing promises that the FDA would act on the application, they lifted their hold, only to watch the agency postpone a decision yet again.
In light of the GAO's findings, Clinton and Murray are renewing their calls for a hearing before the Senate health committee, on which they sit. The senators, aides say, are hoping to use the latest evidence to convince Senator Michael Enzi, the Republican chair, of the need for further investigation. Enzi, if you recall, had assured the senators a hearing if they lifted their hold and the FDA didn't act. He, too, has failed to keep his promise, telling the senators that "other things take precedence," aides say.
As Alex Glass, Murray's spokesperson, puts it, "We've been pushing and pushing for an investigation. You've seen how far we've gotten."
Murray has pushed the matter in particularly novel ways. Last month, she introduced an amendment to the health and human services appropriations bill that would have shifted $3 million from Secretary Leavitt's office to the Office of Inspector General at HHS. The money would have helped pay for a broader Plan B investigation. When she offered her amendment, Oklahoma senator Tom Coburn, a conservative Republican, tried to add language calling for his own investigationthis one into why the FDA had approved the abortion pill, RU-486. Not wanting to confuse the two pills, Murray pulled the amendment.
Even a hearing wouldn't necessarily solve the problem. Explains one congressional aide, "We can investigate this issue to kingdom come, but the FDA has the power. And if it acts at the whim of the right wing, what can we do?"
Not much, it seems, but don't expect Plan B proponents to give up their cause. Clinton and Murray recently posted an online petition challenging the FDA to "make the decision now on emergency contraception based on the scientific evidence." The senators ended up garnering 10,000 signatures, submitting them to the agency in response to a request for "public comment." Clinton's political action committee, Friends of Hillary, generated an additional 15,600 signatures from fans for the effort.
The National Women's Law Center, in Washington, D.C., tracked down two former FDA lawyers to press its case. One of them, former lead counsel Peter Barton Hutt, worked for the Nixon administration and wrote the textbook on FDA law; the other, Nancy Buc, served as the FDA's head lawyer during the 1970s. Their conclusion?
If the FDA wants to impose an age restriction on Plan B, it can look to the precedent for a drug like Nicorette, the nicotine gum, says Judy Waxman, of the National Women's Law Center. You can buy it over the counter if you're 21 and older; if you're not, you must have a prescription. The process undertaken by the FDA for Plan B, she says, "is just another delay tactic. Now, they can drag this out until the end of the Bush administration."
Which is exactly what proponents expect. The agency has exhibited a bunker mentality, denying wrongdoing despite mounting evidence. The day the GAO report was released, an FDA spokesperson said the agency stood by its original decision.
"How crazy is that?," says Moore of the Reproductive Health Project. The longer the agency delays a Plan B decision, the worse it looks and the more its upper management digs in its heels. Not even the loss of credibility seems to matter anymore. As she concludes, "The FDA has shown itself to be driven by a narrow political agenda of a limited proportion of this country."