Barr Laboratories, which produces Plan B, has been left out of the loop as the senators gird for battle against the agency. “We’ve heard so many rumors, we’ve quit reacting to them,” said Jake Hansen, the company’s chief lobbyist, “We’ve had people call us and say, ‘We hear you’re going to get something from the FDA this evening.’ We’ve gotten to the point where we’re sort of numbed by it.”
The Senate Health, Education, Labor and Pensions (HELP) Committee signed off on Crawford by voice vote, over objections from Murray, Clinton and Sen. Barbara Mikulski (D-Md.). Murray and Clinton announced their intention to block Crawford, now acting FDA commissioner, after an April meeting that was stalemated when he could not guarantee an end to the FDA’s Plan B delay.
The FDA first rejected Barr’s application for nonprescription Plan B sales more than a year ago, overruling a 24-3 positive recommendation from the agency’s advisory committee. Barr countered by proposing a bifurcated label, permitting only women older than 16 to buy the last-minute pregnancy prevention, to resolve the FDA’s concerns about influencing the sexual behavior of teenagers.
“We don’t comment on pending applications,” said FDA spokeswoman Suzanne Trevino. She declined to comment on the senators’ hold on Crawford, any aspect of the Barr-FDA relationship and the importance of removing the word “acting” from Crawford’s title.
During committee consideration of Crawford, the capital’s most active women’s-health advocacy groups joined forces to persuade senators receptive to their complaints that the FDA was placing ideology before science. Murray and Clinton took an interest; Sen. Edward Kennedy (Mass.), the committee’s top Democrat, joined their meeting with Crawford but declined to place the hold and yesterday voted to confirm him.
Before they decided to place the hold, Murray and Clinton coordinated with the Alan Guttmacher Institute, a nonprofit reproductive-rights think tank headed by the former lobbyist who originally promoted Plan B to Barr in the late 1990s. In particular, the think tank helped the senators develop a strategy for questioning Crawford during his March 17 HELP Committee hearing, said Heather Boonstra, a senior public-policy analyst at Guttmacher.
“We worked hard with Clinton’s office to make sure the right questions were asked, so we could understand Crawford’s right position on the drug,” Boonstra said. “To tell you the truth, that was not very fruitful.”
“We didn’t have conversations with Barr about our conversations on the Hill,” Boonstra added.
Hansen initially feared the hold would hurt Barr’s relationship with the FDA more than help it, but he soon realized the company could gain from being on the outside of congressional frustration with the agency.
“It gave us a great opportunity to go around and meet with committee members, Republican and Democratic, to talk to them,” Hansen said. “We probably have better relations with members of that committee than we did before.”
Ultimately, Hansen said, approval of Plan B is less vital to Barr than an FDA ruling on generic biologics. “It’s not that large of a product. We’d be delighted if the sales were 50 million. … If it were not approved, I doubt that it would really hurt the health of the company.”
Planned Parenthood, NARAL Pro-Choice America, the Reproductive Health Technologies Project (RHTP) and other abortion-rights groups, on the other hand, are eagerly awaiting the FDA’s response to the hold.
“What’s in front of the FDA is enough for them to approve this application — that is, make a decision, I should say,” said Joanne Howes, a lobbyist with the RHTP.
The flurry of public difficulties at the FDA began with Plan B and continued as an anonymous charge that Crawford had an affair with an agency employee derailed his committee confirmation for weeks. Even as an inspector general’s inquiry at the Department of Health and Human Services absolved Crawford, FDA advisory committee member Dr. David Hager revealed that he had written Crawford a letter echoing that Plan B is an abortion pill and urging a rejection of Barr’s application.
“It is such a mess,” said Kirsten Moore, president of the RHTP. She suggested that reproductive-rights advocates’ taking up the Plan B fight gives Barr needed political cover: “Barr [has] competing interests. They have a lot of products out there, and they can’t afford to have the same kind of adversarial relationship that we can” with the FDA.
Boonstra, of the Guttmacher Institute, said the chance that Murray and Clinton’s hold will play into Republican tropes of Democratic obstructionism is a risk abortion-rights groups must take in their battle with the FDA. One Republican fundraising letter has already mentioned the hold, calling Democrats the “block party.”
Barr and the reproductive-rights groups disagree on one important point. Hansen said he has confidence in Crawford and looks forward to the agency’s having a full-time commissioner, while Moore and her allies see Plan B as just one more reason that another FDA chief should be chosen.
“We will do what we can to work with senators who share our view … that Crawford is not the right leader,” Moore said.
Alex Glass, Murray’s spokeswoman, also criticized Crawford’s record as acting commissioner, saying, “His leadership’s called into question the independence of the FDA.”
No strategies for compromise or resolution of the hold are being publicly offered, and lobbyists working the issue said that little short of a swift FDA ruling on Plan B could resolve the impasse. The agency also has Sen. Tom Coburn (R-Okla.) to contend with, as Coburn will block Crawford’s nomination in protest of the FDA’s failure to place sexually-transmitted-disease warning labels on condoms.
The White House’s Office of Management and Budget (OMB) has yet to rule on a proposed regulation that would answer Coburn’s concerns by reevaluating the accuracy of protection claims on condom packages. The OMB met with three Coburn aides in March but officially delayed its decision yesterday.
Craig Orfield, spokesman for Sen. Michael Enzi (R-Wyo.), chairman of the HELP Committee, said Enzi would keep working to air senators’ concerns about the FDA, possibly in the form of more oversight hearings. Enzi tacitly addressed the looming hold in his opening statement before Crawford’s confirmation without naming Murray, Clinton or Plan B.
“I am not sure that the threat to hold up a nomination over one drug application currently under consideration at FDA is the right way to achieve a faster review, and to ensure a review process free from the pressures of politics,” Enzi said. “In fact, I strongly believe that the opposite would occur.”