Docket Management
Docket: 02D-0018 - Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Prodcuts; Draft Guid
Comment Number: EC -6

Accepted - Volume 1

Comment Record
Commentor Ms. Amy Allina Date/Time 2003-03-31 16:53:39
Organization National Women's Health Network
Category Consumer Group

Comments for FDA General
1. General Comments The FDA Guidance for Industry on the Collection of Race and Ethnicity Data in Clinical Trials acknowledges that there are important physiological differences among racial and ethnic populations in regard to treatment outcomes with the use of medical products. The Guidance specifically states that Collection of data using standard categories (OMB designations) may enhance patient safety by helping the Agency evaluate potential differences in drug response among subpopulations and may help facilitate analyses seeking differences in response. (Guidance, page 3.) The draft Guidance is in concert with the Agency?s purported commitment to the study of therapeutics in diseases that have a disparate impact on people of color. The National Women's Health Network supports the Agency's fledgling attempt to collect and analyze data on racial and ethnic diversity from human study trials but additionally strongly encourages the Agency to mandate a proactive, rational and inclusive approach to the collection of the data of ethnic and racial diversity at the design phase of the human study trial. All such data requirements should apply to all medical products, including medical devices. In the words of former FDA Commissioner Jane Henney, It is only through participation of the many populations that will ultimately receive a new product that we can ensure that the medical products we approve are appropriate, safe and effective for all Americans, and not just a narrow cut of our country?s population. There are critical differences among ethnic populations in regard to disease susceptibility or predisposition, drug metabolism and treatment outcomes. It?s only when information pertaining to specific groups is available that physicians and other health care professionals can make truly informed decisions about treatment. Having an appropriately represented population in clinical trials is essential. (Remarks of Dr. Jane E. Henney, Commissioner of Food and Drugs, U.S. Food and Drug Administration, to the National Medical Association 2000 Annual Convention and Scientific Assembley, Washington, D.C. It is an established fact that differences in response to medical products have been observed in racially and ethnically diverse subgroups of the U.S. population. For example, a study of the different responses of black vs. white populations to the treatment of acne with the topical medicine Adapalene, presented at the 61st Annual Meeting of the American Academy of Dermatology, held in San Francisco between March 21-26, 2003, concluded that Adapalene demonstrated significantly greater efficacy in the reduction of inflammatory lesions and significantly greater cutaneous tolerability in black patients compared with white patients. The collection of race and ethnicity data from human study trials proposed in the draft Guidance falls short of the Agency's directive to respond to health and human service issues in a nondiscriminatory fashion. The FDA should require ethnic and racial diversity criteria as an essential factor in human study trial design, as is required by the NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research. The FDA should require that drugs, biologics, and medical devices be tested on diverse populations.

EC -6