Court Documents Reveal FDA Politicized Plan B Approval-Update

On August 24th, in an almost complete reversal of its 2004 decision, the Food and Drug Administration (FDA) approved Plan B emergency contraception to be sold over the counter, but only to women 18 and older.

Despite this long-fought victory for women’s health, recently released court documents in a suit filed against the Food and Drug Administration charge that the FDA faced undue political pressure by the Bush Administration to stymie over the counter sales of the Plan B morning after pill.

The documents were released as part of a lawsuit filed in January 2005 by the Center for Reproductive Rights against the FDA. Depositions were taken of FDA officials in the lawsuit. At the center of the controversy is a request by Barr Pharmaceuticals to sell its emergency contraceptive, Plan B, without a doctor’s prescription. These documents support the widespread impression that the Bush administration has politicized this women’s health issue, in order to appease its base.

When the FDA makes decisions based on politics and not science, public health suffers. For years, countless women who have been victims of rape or incest, or have had to contend with broken condoms or unprotected sex for any reason have faced obstacles in obtaining emergency contraception that would otherwise not have been there had this supposed independent federal agency not capitulated to the White House and its political agenda.

However, the tide seemed to turn on July 31 when the FDA announced that it would reopen discussion with Barr Pharmaceuticals regarding the approval of Plan B to be sold over the counter only to women 18 and older. Plan B, approved as a prescription in 1999, is a set of two high dose hormone pills that can prevent pregnancy if taken within 72 hours of sexual intercourse. The drug has come under fire from conservative groups, who have erroneously tagged it as an abortion pill (it instead blocks the release of an egg from an ovary). Barr Pharmaceuticals had failed in two attempts to win government approval to sell its Plan B drug more widely without a prescription. Its first application in 2003 covered women of all ages, but was rejected. The second was limited to women 16 and older. The FDA then postponed a decision.

The timing of the FDA’s announcement that it would reopen its discussions with Barr drew suspicion, as it came one day before the President’s presumptive nominee to head the FDA, von Eschenbach, was to testify at his Senate Committee confirmation hearing. Senator Patty Murray of Washington and Senator Hilary Clinton of New York have exercised a hold on von Eschenbach’s nomination until the FDA approves Plan B for over-the-counter use.

While the news of approval is welcoming--denying minors access aside--information has surfaced that the FDA’s rejection of Plan B’s move to over-the-counter status in the spring of 2004 may have been the Bush Administration’s plan all along. The FDA’s rejection came despite overwhelming support by its own scientists, and the subsequent resurrection of Plan B for women 18 and older (a move which came after the 2004 election).

Recently released depositions taken from senior FDA officials as part of a lawsuit filed by the Center for Reproductive Right’s (the Center), Tummino v. von Eschenbach, indicate the politicization of the issue was more widespread than previously known.

In the depositions taken earlier this year, Dr. John Jenkins, director of the FDA’s Office of New Drugs, testified that approval of Plan B was rejected in May 2004 by then-FDA Commissioner Mark McClellan—but the rejection occurred well before the FDA had completed its approval process of Plan B.

Even more damning, Dr. Florence Houn, a senior FDA scientist who was involved in reviewing the application, testified she was instructed by Dr. Janet Woodcock, a former acting deputy commissioner, of the need to appease the “administration’s constituents” by nixing the over-the-counter status for women of all ages, but then approving it down the road with an age restriction.

“She conveyed to me her assurance that this was the only way to go, to issue a non-approval letter to appease the administration's constituents, and then later this could be approved," Houn testified. However, Dr. Houn added in her deposition that she was unaware of any political pressure put on FDA officials.

This discovery of the undue political influence by the White House in the Plan B decision and contradictory statements made by McClellan (now head of the Center for Medicare & Medicaid Services, a division of the U.S. Department of Health & Human Services) and the former FDA official, Woodcock, led the Center to request subpoenas for White House documents on any and all communications between the Bush Administration and McClellan, as well as other FDA officials.

Not surprisingly, on August 11, the White House asked for a dismissal of the request, claiming the Center was demanding too many documents and asserted executive privilege.

Regardless of the FDA’s approval of Plan B to move to over the counter status, the lawsuit will continue. An August 24th statement released by the Center stated, “Months of testimony and discovery in our lawsuit show that the agency never intended to fairly consider the scientific evidence that Plan B is safe and effective for women of all ages and that high-level officials engaged in an intricate cover-up…”