FDA Pregnancy Registry Guidance Should Stratify Drugs By Prevalence Of Use
This article was originally published in The Tan Sheet
Executive Summary
Stratification of drugs according to prevalence of use in women of childbearing age would assist industry in determining when pregnancy registries should be established, FDA's Reproductive Health Drugs Advisory Committee agreed at a meeting Oct. 18.
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Stratification of drugs according to prevalence of use in women of childbearing age would assist industry in determining when pregnancy registries should be established, FDA's Reproductive Health Drugs Advisory Committee agreed at a meeting Oct. 18. FDA's "Establishing Pregnancy Registries" draft guidance, posted in June, includes "any product expected to be used commonly by women of reproductive potential" as a criterion for determining the need for a registry (1 (Also see "Pregnancy Registry Recruitment Notices Should Be Cleared - FDA Guidance" - Pink Sheet, 14 Jun, 1999.)). "I don't see how any new drug that would come on the market, with rare exception, could not potentially be used in a reproductive age person," committee member Bonnie Dattel, MD, Eastern Virginia Medical School, commented during the committee's review of the draft. While the panel agreed registries should include all new drugs commonly used by women of reproductive potential, drug firms generally concurred with recent suggestions by the Pharmaceutical Research & Manufacturers Association that the guidance be narrowed to focus only on drugs with suspected risks. Merck's position, however, appears more in line with that of the committee. Limiting registries to drugs with suspected pregnancy risks "would preclude registries that may provide reassurance to health care providers and consumers," the firm said. Also, "the sponsor may choose to develop a pregnancy registry for products likely to be used in women of childbearing potential." Glaxo Wellcome said pregnancy review talks between FDA and the sponsor should be "entirely independent of the product review and approval process." The guidance says FDA may ask for pregnancy risk data under a Phase IV commitment. FDA "has the most opportunity to have an impact when something is new," FDA Office of Drug Evaluation IV Acting Director Sandra Kweder, MD, noted. "That is when we have the most levers to make something a Phase IV agreement with industry." The committee supported "generation-long" follow-up of patients in the registry, but industry commented on the "prohibitive" cost of lengthy registry timeframes. Bristol-Myers Squibb suggested disseminating information on normal or abnormal outcomes on product labeling or through a national information system, and called for use of national registries for therapeutic classes with more than one drug of concern. |