Former Food and Drug Administration (FDA) Commissioner Lester Crawford stated last month in a deposition that even though he delayed a decision on Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B, he expected that the application would be approved or denied within six to nine months. Crawford said that the FDA had intended to allow over-the-counter sales of Plan B last year but delayed the move while determining how to limit sales so that it was only available over the counter for women ages 17 or older. Girls 16 and younger would still need a prescription.1 With Plan B still awaiting approval months later, Crawford's testimony further indicates that the FDA has strayed from normal procedure in its continued refusal to issue a decision on the application.
Crawford testified in a deposition for a lawsuit filed by the Center for Reproductive Rights (CRR) on behalf of the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health, and others.2 CRR filed the suit in U.S. District Court in New York , arguing that the FDA did not follow normal drug-approval procedure when it first denied the application. The lawsuit also argues that in failing to approve nonprescription sales, the agency violated women's rights to equal protection and privacy as guaranteed by the U.S. Constitution. A favorable judgment would compel the FDA to approve over-the-counter sales of Plan B. In his May 24th deposition, the agency's former chief said that he fully expected the decision to be made by now, “There was no—no talk of denials, there was talk of trying to get straight what the enforcement procedures would be.”
Crawford said he had expected the FDA would take six to nine months—“tops”—to work out the age enforcement issue following his August 2005 announcement that opened a 60-day public comment period on the application. He explained that science supported approval, but the application presented FDA “with many difficult and novel policy and regulatory issues,” including how to keep girls 16 years old and younger from obtaining the drug. The comment period, however, ended in November 2005, and the agency did not indicate, and has still not, when it might make a decision on the application.
“I made a decision that was correct,” Crawford testified, adding, “what I could not decide on is whether or not I could stand before the American people and say [that the age restriction] will be successfully enforced. That I could not decide.”3
In the sworn statement, Crawford said that he had personally reserved the right to decide whether to loosen the sales restrictions on the prescription-only emergency contraceptive pills, even though Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, would normally have been charge of such a decision. His account of the unusual, and perhaps unprecedented move, confirmed earlier testimony given a month prior by two senior agency officials, including Galson, who said that Crawford had shut them out of the decision making process.4
In fact, Galson testified on April 26 that in early 2005 Crawford declared that he was taking over the decision on Plan B. Galson testified that he, himself, was not necessarily planning to approve over-the-counter sales at the time but was “tending that direction.”5 Galson further testified that Crawford “told me that he was concerned about where we were heading because he knew that I was heading towards this recommendation, and he told me that he was going to make the decision on what to do with the application.” Galson added that he had never had a comparable decision on an application taken from him.6
In addition, Janet Woodcock, FDA deputy commissioner for operations, testified last month that she often was consulted by the FDA's commissioner on major decisions but that she was not told about Crawford's decision to open the comment period until about one day before he made the announcement. Woodcock also testified that Galson had speculated there were possible pressures being placed on Crawford from “Congress, the administration and so forth.”7
Annie Tummino, a plaintiff in the lawsuit, said of the senior official's testimony that, “This really shows an extraordinary level of involvement from the top down; it seems highly unusual and suspicious that Janet Woodcock and Steven Galson were cut out of the process.”8
Recently, in a hearing in the lawsuit, it was also revealed that another former FDA commissioner, Dr. Mark McClellan, who preceded Crawford, scheduled an April 2003 meeting with a White House official, Jay Lefkowitz, former deputy assistant to the president for domestic policy. A copy of McClellan's appointment calendar for April 21, 2003 , at which time he was FDA Commissioner, reading “Conference call w/Jay Lefkowitz re: Plan B submis,” was presented during trial. This was also highly unusual as the FDA does not normally consult with the White House about drug approval process.9
- Andrew Bridges, “Former FDA Chief: Agency Meant to OK Plan B,” Newsday , 13 June 2006 , accessed 16 June 2006 , <http://www.newsday.com/news/politics/
- Kathleen Kerr, “Two agency officials claim its chief cut them out of approval process for emergency contraceptive,” Newsday , 25 May 2006, accessed 16 June 2006, <http://www.newsday.com/business/
- See previous policy update “Secret White House Meeting on Plan B”