FDA authority to suspend trials barring women of childbearing potential recommended by AIDS task force.

FDA AUTHORITY TO HALT TRIALS EXCLUDING WOMEN PROPOSED in a draft recommendation by the National Task Force on AIDS Drug Development at its Jan. 19 meeting. FDA regs would be amended to provide the agency with the authority to place a clinical hold on trials involving drugs for life-threatening diseases if the sponsor is determined to be excluding women when there is no evidence of reproductive toxicity. If the exclusion continued, FDA would have the authority to terminate the sponsor's IND.

The recommendation is one of several developed by task force member Theresa McGovern, HIV Law Project. McGovern initially proposed them at the July 18 government/industry task force meeting in a report entitled, "Proposal to Eliminate Obstacles Facing Women in the Drug Development Process." The regulatory changes should allow the FDA to be careful where there is evidence of reproductive toxicity, "but a less restrictive alternative than exclusion of women exists," the task force said.

The task urged FDA to submit a proposed rule on the recommendation to HHS within 120 days and report on the progress of the rule at the next task force meeting in February.

Commenting on the recommendation, Center for Drug Evaluation & Research Director Janet Woodcock, MD, said: "We strongly agree with the concept that women of childbearing potential should not be excluded from Phase I trials of life-threatening diseases." However, she added: "We would be concerned about...this kind of regulation." She noted that FDA has been "told by sponsors...much early drug development is moving overseas due to FDA restrictions."

"This again would be another restriction that FDA would have on early drug development," Woodcock said. She favors a more informal approach. FDA has "been very successful...in talking to sponsors that come in with old-style restrictions in early drug development in life- threatening areas, in reversing these prohibitions and getting them to remove exclusions," Woodcock reported.

Asked about his firm's reaction to the proposal, Bristol-Myers Squibb Senior VP-Worldwide Clinical Research and Development Stephen Carter, MD, responded: "It surely won't drive us to Europe." Genentech Chairman Kirk Raab also responded: "I have to agree with Steve. I support this."

FDA Commissioner Kessler cautioned: "These things do take a number of months. We're talking about a regulatory document that has the force of law."

The task force also approved another recommendation developed by McGovern that would require drug sponsors to file gender accrual data as part of annual IND reporting.

The recommendation states that FDA should "amend existing regulations governing" the IND and NDA process "to require that a sponsor file gender accrual analysis in the annual IND." In addition, for NDAs and PLAs, the regs would "require sponsors to analyze clinical data by gender and assess potential differences between genders."