The beginning of 2006 has already added several installments in the over-two-year saga to compel the Food and Drug Administration (FDA) to make a decision concerning over-the-counter availability of emergency contraception (EC). In the judiciary, a federal judge ruled that FDA officials must testify in a lawsuit. In the legislature, Representative Henry Waxman (D-CA) continued his investigation into the Plan B over-the-counter application, and two Senators placed a hold on President Bush’s FDA commissioner nominee.

FDA Must Testify in Trial

A federal judge recently ruled that Senior FDA officials must testify about the federal agency’s failure to decide whether the Plan B emergency contraceptive pill may be sold without a prescription. Plan B, a brand of emergency contraceptive pills, is a high dose of regular birth control pills that if taken within 72 hours of unprotected sexual intercourse can lower the risk of pregnancy by up to 89%. Over two years ago, the FDA’s own expert staff and advisory panels overwhelmingly voted to make Plan B available over the counter (OTC). OTC status is also favored by the American Medical Association (AMA), the American Academy of Pediatrics (AAP), the American College of Obstetricians and Gynecologists (ACOG) and more than 70 other medical and public health organizations.1

In January 2005, two advocacy groups and nine women filed suit against the FDA, alleging that the agency ignored a statutory deadline for deciding whether Plan B could be sold without a prescription. Attorneys for the FDA had appealed to maintain the confidentiality of agency documents, including correspondence about Plan B. New York Magistrate Viktor Pohorelsky questioned the FDA’s intentions and decided that “inquiry about contacts between those outside the agency and those within the agency is appropriate to expose whether improper influences led to the FDA’s actions.”2

This decision is the latest judicial action designed to compel the FDA to live up to its legal obligations. In December, Pohorelsky and U.S. District Judge Edward Korman refused to grant the FDA’s motion to dismiss the lawsuit.3 In separate rulings, each has said that the FDA seems to be conducting a “filibuster” in order to avoid making a decision that could be subject to judicial review.4

Rep. Waxman Questions FDA’s Delay Tactics

In the legislature, Representative Henry Waxman, ranking member of the House Government Reform Committee, sent a letter in early March to FDA Acting Commissioner Andrew von Eschenbach detailing emerging evidence that high officials at the FDA overruled their professional staff and ignored expert advisory committees when they rejected Barr Laboratories’ application. The letter explains that the agency justified its August 2005 decision to delay Barr’s application by claiming that the FDA needed more time to consider the “novel” issues raised by a proposal to require prescriptions only for those 16 and younger. Internal agency documents, however, revealed that these issues had been discussed for at least a year.5

As Waxman explains in his letter, after initially being told that its application was rejected at least in part because of concerns about adolescent women, Barr Laboratories took the FDA’s advice and presented a revised application which would allow Plan B to be sold without a doctor’s prescription to women and girls ages 17 and older and require a prescription for those under 16. In January 2005, the FDA delayed making a ruling on this revised application. Then, in August 2005, former FDA Commissioner Lester Crawford opened a 60-day public comment period on Barr’s application. Crawford said that the science supports giving nonprescription access to Plan B to women ages 17 and older. He added, however, that the application presented FDA “with many difficult and novel policy and regulatory issues,” including how to keep girls ages 16 and younger from obtaining the drug. The comment period expired in November 2005, but the agency still has not indicated when it might make a decision on the application.

Waxman alleges that the FDA created its own “Catch 22” in order to justify a predetermined political decision to block OTC sales of Plan B. The letter states that:

It was only after repeated urging from the FDA itself—despite a lack of scientific justification—that the manufacturers proposed over-the-counter access to women sixteen and over and prescription access for those younger. Yet the agency used these age restrictions to justify an indefinite delay, claiming that it needs more time to assess whether an over-the-counter switch can be restricted by age; how such a restriction could be enforced; and whether…[EC] can be marketed differently to different populations.6

In his letter to von Eschenbach, Waxman charges the FDA with “seriously mischaracterizing its analysis of the regulatory issues surrounding Plan B” and states that “in essence, the agency was well aware of the regulatory questions that would arise when it suggested age restrictions, but simply did not resolve them in a timely manner.”7

Waxman asked von Eschenbach to provide a response to his letter by March 27. Specifically, Waxman requested documents from the Center for Drug Evaluation and Research’s analysis of possible age restrictions for Plan B nonprescription sales. Waxman also requested “an account of why the Office of Chief Counsel apparently failed to respond to repeated requests for a timely legal analysis of Barr’s amended application.” Waxman adds that if the agency’s Office of Chief Counsel attorneys “did in fact prepare an analysis,” von Eschenbach should explain “why FDA announced in August 2005 that it was unable to resolve the key regulatory questions by that time.”8

Senators Place Hold on FDA Commissioner Nominee

Von Eschenbach is not only under fire from the House of Representatives but also from the Senate. In mid-March, President Bush nominated von Eschenbach, who is currently serving as Acting FDA Commissioner, to permanently head the agency. In addition to serving as Acting Commissioner of the FDA, von Eschenbach currently heads the National Cancer Institute, however, White House spokesperson Erin Healy said that he will relinquish that post should his nomination be confirmed by the Senate.9 Shortly after the nomination was announced, Senators Patty Murray (D-WA) and Hillary Rodham Clinton (D-NY) issued a statement saying that they will place a hold on his confirmation vote in the Senate because of the FDA’s delay in making a decision on EC.10

Appearing before the House Agriculture Appropriations Subcommittee in February, von Eschenbach stated that science, not politics, would play a role in the agency’s decision on Barr’s application. The Acting Commissioner said the delay in addressing the application is related to the potential “enormous complexity” of about 10,000 comments submitted to the agency during a 60-day comment period opened last year by former FDA Commissioner Lester Crawford.11

In June 2005, Murray and Rodham Clinton blocked a full Senate vote on Commissioner Crawford’s nomination because of the agency’s delay in addressing Barr’s application. The two Senators lifted their holed and allowed the vote to take place after Secretary of Health and Human Services Michael Leavitt promised the Plan B issue would be resolved by September 1, 2005. The two senators have since said that they were “double-crossed” by Leavitt.12

“This time around they are not going to get their nomination until a decision has been made,” Murray said. She also said, “you cross somebody and lose their trust, it becomes very difficult to do things the second time around.”13

References

1. Reproductive Health Technologies Project, “Plan B Over-the-Counter Application,” Press Release published 16 August 2005, accessed 28 September 2005, <http://www.rhtp.org>.
2. Kathleen Kerr, “FDA must testify about Plan B lag,” Newsday , 28 February 2006, accessed 21 March 2006, <http://www.newsday.com/news/health/ny-bzplan284644188feb28,0,4665620.story?coll=ny-health-print>.
3. Ibid.
4. Ibid.
5. Letter from Representative Henry Waxman (D-CA) to Food and Drug Administration Acting Commissioner Andrew von Eschenbach, 9 March 2006, accessed 21 March 2006, <http://www.democrats.reform.house.gov/Documents/20060309124932-06797.pdf>.
6. Ibid.
7. Ibid.
8. Ibid.
9. “Sens. Murray, Rodham Clinton Place Hold on Bush Nomination of von Eschenbach for FDA Commissioner Over Plan B Application,” Kaiser Daily Women’s Health Policy Report, 16 March 2006, accessed 21 March 2006, <http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=2&DR_ID=36043>.
10. “Statement by Senators Hillary Rodham Clinton and Patty Murray on Expected Nomination of Andrew von Eschenbach as FDA Commissioner,” Press Release published 15 March 2006, accessed 21 March 2006, <http://murray.senate.gov/news.cfm?id=252683>.
11. Ibid.
12. Marc Kaufman, “Bush names Cancer Institute Chief to Lead FDA,” Washington Post , 16 March 2006, accessed 21 March 2006, <http://www.washingtonpost.com/wp-dyn/content/article/2006/03/15/AR2006031502372.html>.
13. “Sens. Murray , Rodham Clinton Place Hold.”