WASHINGTON _ The FDA early next month willconvene a public workshop to discuss how drugmanufacturers can more effectively address scientificissues involved in gender analysis, an ongoing discussionprompted by women's health advocates.

Last year they gained some momentum when the NationalInstitutes of Health issued guidelines for federally fundedresearch requiring investigators to include women andminorities in all human subject research. (See BioWorldToday, March 17, 1994, p. 1.)

"We are promoting our agenda on what scientific issuesshould be considered by drug makers when performinggender analysis on data generated from clinical trials,"said Ruth Merkatz, director of the FDA's Office ofWomen's Health.

"We are trying to raise the discussion about the safety andefficacy of a drug within the context of how a woman'sbiological processes are different from a man's, such ashow dramatic shifts in hormones might affect thepharmacokinetics of a drug," said Merkatz in aninterview with BioWorld Today.

Merkatz said her goal was to "develop decision trees thatcan be used by drug researchers to guide the drugdiscovery process so that gender analysis makes moresense scientifically."

Merkatz traced the current concerns about genderdifference to now discredited bans on womenparticipating in the early phases of clinical trials. "Thereused to be a virtual ban on testing drugs on women out ofconcern of their reproductive status," said Merkatz. "Thishad a chilling effect on the drug discovery process tolearn how drugs work in women."

FDA first issued guidelines on the needs of differentsegments of the population more than five years ago."Our first guideline, issued in 1989, was aimed attherapeutic needs of the elderly, focusing on the changesthat occur biologically as a person ages. Some of theseconsiderations include drug interactions and theslowdown in some bodily processes such as kidneyfunction," said Merkatz.

The FDA issued similar guidelines in 1993 to focus thescientific debate on how gender differences should beincorporated into analysis of drug therapies. Coincidentalwith the November workshop, the FDA is proposing thatthese gender guidelines be updated.

The 1993 gender guidelines provided guidance on theFDA's expectations regarding the inclusion of both menand women in drug development, analyses of clinical databy gender, assessment of potential pharmacokineticdifferences among genders, and when additional studiesshould be conducted on women.

Guidelines Led To More Debate

However, publication of these guidelines "led to a greatmany scientific questions on the part of the industry abouthow gender analysis should be performed," said Merkatz.

The revised gender guidelines, published in the Sept. 8,1995, Federal Register, explicitly require that clinical trialsponsors submit effectiveness and safety data by gender,age and racial subgroups and other subgroups of thepopulation of patients treated, as appropriate.

Such patients might include those with renal failure orpatients with different levels of severity of disease. TheFDA studied the inclusion of women in clinical trials andfound that sponsors have not made an effort to adequatelyassess potential gender differences. The FDA and theGeneral Accounting Office examined the clinical trialdata to see if the guidelines were being adhered to.

Both examinations "found that in about half of the casesthe data bases were not being analyzed to determinewhether there were differences in response to drugsbetween the two genders or among different racial groupsand age groups," according to the FDA.

The revised guidelines would require that sponsors notcollect any additional data, but would place newrequirements on how the data are presented. Thosemanufacturers that fail to make the appropriate genderanalyses risk having their new drug application orinvestigational new drug application returned. n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.