Conflicts Abound in Choice to Head FDA Division Handling RU 486.

The Food and Drug Administration (FDA) has appointed Susan Allen, M.D., to be director of the Reproductive and Urologic Drug Products Division, the division that potentially would oversee the abortifacient's release were it to receive final FDA approval.

Allen is an abortionist who once headed the company set up by the Population Council - - the U.S. patent holder of RU 486 - - to market the abortifacient in the United States and to train physicians how to use it.

News of the appointment was first reported in the June 12, 2000, edition of the respected pharmaceuticals weekly The Pink Sheet. (Allen's appointment was confirmed in a phone interview with a staff member of the Reproductive and Urologic Drug Products Division.)

The publication also indicated that the Population Council anticipates that the FDA will act on its marketing application for RU 486 by September 30.

Allen's Association with RU 486 and the FDA

In 1996, the Population Council set up a company called "Advances in Health Technology" (AHT) to promote the drug and provide public education and handle doctor training. Allen, who said she has provided "thousands of abortions" in the United States, was appointed the company's first president and CEO.

In July 1996, Allen testified on behalf of AHT's proposed physician training program before the FDA's Reproductive Health Drugs Advisory Committee that was considering RU 486. Her proposals were not well received (see below).

Advances in Health Technology eventually became "Advances for Choice" in early 1997 and then, later that year, "Advances/ Neogen," as the Population Council instituted a series of changes in the corporate structure of the mifepristone project.1 What place or role Allen had in the new companies, if any, is unclear.

The Pink Sheet, the prescription pharmaceuticals weekly published by F-D-C Reports, states that Allen first joined the FDA's Reproductive and Urologic Drug Products Division in 1998 as a medical officer. She became the medical team leader for reproductive drugs in January of 1999.

In January 2000, when the previous director was promoted to another FDA position, Allen was tapped to serve as the acting division director. The Pink Sheet accurately predicted that her appointment as the division's permanent director would become effective June 18.

Allen's appointment raises a number of questions and serious concerns.

Even though The Pink Sheet reports that "Allen is presumably recused from mifepristone review as a result of her prior experience with the product," it offers no official FDA confirmation of such a recusal or explanation as to how someone with such close ties to the drug could have ever been hired to head the very division considering the drug.

Even if Allen were to recuse herself from any discussions of the drug's final approval, there remain serious questions. There are clear conflicts of interest involved in her administering the division which would presumably monitor distribution, review safety, and conduct post-marketing of RU 486. These would appear to be sufficient to compromise women's trust in the objectivity and integrity of the FDA and its determinations with respect to the drug and its protocol's safety and effectiveness.

Allen's appointment is all the more remarkable on another score. The same FDA committee which originally recommended approval of the drug in 1996 gave a dismissive, if not hostile, reception to Allen's proposal for training doctors how to use RU 486. This even though the panel was stacked with known abortion supporters, who were obviously sympathetic to the concept of chemical abortions.

Allen proposed that physicians, with no previous surgical abortion training or experience, would be trained to date pregnancies, manage complications, and perform surgical abortions as a back-up for failed chemical abortions in brief seminars. Transcripts from the hearing clearly indicate the panelists were appalled.

FDA guest speaker Richard Azziz, M.D., M.P.H., professor of obstetrics and gynecology at the University of Alabama at Birmingham, told Allen he thought they were "treading on very dangerous ground." He called the plan to "train nonsurgeons to do a procedure which is a D&C on a pregnant uterus" an "error" and "extremely risky." (All quotations are from transcript of FDA Mifepristone Hearing, 7/19/96.)

Committee member Vivian Lewis, M.D., told Allen that she agreed with Azziz. "I do not think you can teach somebody to do a surgical evacuation of the uterus in a simple seminar with a mannequin or something." Panelist Cassandra E. Henderson, M.D., said, "I think you can. You just cannot handle the complications."

Lewis told Allen that "if you are talking about in an emergency situation having the skill to be able to do this deftly, appropriately, and with minimal complication, such a person who has never been trained in that and who has only attended a seminar is the worst possible choice of person to do that."

After hearing the discussion between Allen and various panelists, committee chair Ezra C. Davidson, M.D., summarized the panel's reaction for the FDA by saying, "I think what you are hearing from the committee [in regard to] the issue of skills being discussed, [is that] there is considerable unease about how that certification and documentation is going to be done to ensure safe delivery of this regimen and management of its complications."

If statements given to the press by abortion advocates are accurate, the FDA is proposing safety measures, such as the certification of doctors, the identification of surgical backup, and the tracking and management of complications, that would track the kinds of concerns raised by the 1996 panel. (See NRL News, June 2000, page 16.)

Even if the Population Council were to agree to the proposed regulations as a condition of approval, what assurance would the American public have that such safeguards would be enforced with Allen in charge?

Congressional Representatives Take Notice, Ask Questions

Concerns about compromised public safety and possible conflicts of interest over the Allen appointment were serious enough to have prompted at least two members of Congress to raise the issue with the heads of the FDA and the Department of Health and Human Services (HHS), which oversees the FDA.

On June 16, just days before Allen's permanent appointment was to become official, Pro-Life Congressman Tom Coburn (R-OK) sent a letter to HHS secretary Donna Shalala expressing concern about the Allen appointment. In his letter, Coburn, a practicing physician who has closely monitored RU 486, asked Shalala pointedly, "What confidence can the American consumer have in a drug's safety when the FDA puts the sponsor's former licensee in charge of decisions about the release of the drug, or monitoring of the drug, or releasing information about the drug's safety?"

Seeking to find out more about the decision-making process that led to the controversial appointment, Coburn pressed Shalala to answer the following basic questions:

1) Who made the decision to hire Susan Allen?

2) Who made the decision to put Susan Allen in charge of the FDA's Reproductive and Urologic Drug Products Division?

3) What role will the FDA's Reproductive and Urologic Drug Products Division have in determining the final approval/disapproval of the marketing application for mifepristone?

4) What role will the Reproductive and Urologic Drug Products Division have in monitoring the distribution of mifepristone, the qualifications of doctors prescribing mifepristone, the conditions under which mifepristone is used, and the condition of the women who take mifepristone, the reporting of complications, and the ability of doctors to handle complications associated with mifepristone?

5) How aware are the FDA and HHS of the inherent conflict of interest involved in the hiring and promotion of Susan Allen and its ramifications for the confidence and safety of women taking mifepristone?

Pro-life Congressman Thomas J. Bliley, Jr. (R-Va), chairman of the House Commerce Committee, also raised the issue of Allen's appointment with Jane Henney, the current FDA commissioner, in a meeting on June 27, 2000. Henney told Bliley that Allen would recuse herself from all dealings with RU 486. Bliley told Henney he still wanted a formal response to the questions Coburn raised with Shalala's office.

To date, there has been no formal response from anyone at HHS or the FDA. Discussions between the Population Council and the FDA over issues holding up RU 486's final approval are ongoing, The Pink Sheet indicates, with September 30 as the next deadline for FDA action.

The FDA could issue approval at that time or could again delay the drug's introduction to the U.S. market by submitting a list to the Population Council of the issues the FDA still wants resolved before release.>EN