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Gender Studies in Product Development: Public Hearing

In an effort to hear a broad range of opinions, FDA accepted public comment on the workshop topics in an open hearing facilitated by Dr. Ruth Merkatz, Dr. Roger Williams and Dr. Elaine Esber. The four speakers who presented testimony each emphasized the importance of understanding gender-related differences.

Dr. Elizabeth Lane of the Pharmacokinetics Laboratories reported on a Medline search in which she found that a higher clearance or lower bioavailability in women was reported for II drugs and with a ratio of greater than 1.5 in eight drugs. However, she suggested that the higher clearance appeared to be an artifact of smaller body weight in women.

Dr. Anne Nafziger of Bassett Healthcare observed that sponsors continue to be reluctant to include women with childbearing potential in all phases of trials yet exclusion from early trials impacts on dose finding and epidemiological studies of drug toxicity in women. Even the studies that generate relevant data on gender-related drug effects are rarely designed with that aim and as a result are underpowered to identify important gender differences (e.g., whether menstrual cycle has a clinical impact on PK/PD). On another topic, Dr. Nafziger urged authors to facilitate literature searches dealing with gender differences by indexing their publications using a standard key word recognized by Index Medicus.

Dr. Naomi Kaminski of the American Pharmaceutical Association noted that clinical literature tends to combine data from men and women despite the gender-related differences that have been observed during research. Pharmacokinetic and pharmacodynamic studies should result in relevant data so that the pharmacist understands a medication's effect on women and the impact of oral contraceptives and hormone replacement therapy. The speaker described a project of the American Pharmaceutical Association in which a research network of pharmacists is being established to participate in postmarketing studies that examine gender differences.

Ms. Julie Davids of ACT UP, Philadelphia urged that a regulation be issued quickly requiring women to be included in trials for serious or life threatening diseases. (On September 24, 1997, a proposed regulation to address this issue was published in the Federal Register.) She also asked attendees to consider research with people who are taking female hormones, noting that transsexuals who use these hormones are underrepresented in epidemiological research.

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