White House consultations are seldom, if ever, part of the Federal Food and Drug Administration (FDA) drug approval process, however, while the application for non-prescription sales of the emergency contraceptive Plan B was pending before the FDA, it was also the topic of discussion between a White House official and former FDA Commissioner Mark McClellan.1 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 sex can lower the risk of pregnancy by up to 89%. Barr Laboratories’ application to make Plan B available without a prescription to women ages 17 and older has been pending before the FDA for more than two years. The FDA has now indefinitely postponed the decision.

Bonnie Jones, an attorney from the Center for Reproductive Rights (CRR), recently revealed the clandestine meetings to federal Magistrate Viktor Pohorelsky as part of the organization’s court case against the FDA.2 On behalf of the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health, and others, CRR filed a suit in U.S. District Court in New York, claiming 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.

According to Newsday, 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. The entry refers to the application for non-prescription sales for Plan B that had been submitted by Women’s Capitol Corporation just days earlier.3 (Women’s Capitol Corporation, and, therefore, Plan B, has since been bought by Barr Laboratories.) In addition to being the former FDA Commissioner, McClellan, now administrator of the Centers for Medicare and Medicaid Services, worked as senior policy director for health care in the Bush White House in 2001 and 2002.

This new evidence of political influence on the FDA process came to light as Jones sought a judicial order to obtain deleted FDA emails concerning the application as well as permission to depose five agency officials. The Assistant U.S. Attorney on the case, Franklin Amanat, asked Pohorelsky to block the depositions, but the judge refused. He did not, however, rule on the email request, and it is unclear whether he will do so at a later date.

McClellan was expected to testify in Washington, DC on June13th.

References

1. Kathleen Kerr, “FDA chief’s secret ‘Plan B’ meeting,” Newsday, 12 May 2006, accessed 16 May 2006, <http://www.newsday.com/business/ny-bzplan124738768may12,0,5725642.story?coll=ny-business-print>.
2. Ibid.
3. Ibid.