FDA Consumer magazine
May-June 2003
Table of Contents

FDA Issues Guidance on Race and Ethnicity Data

By Michelle Meadows

The Food and Drug Administration already requires drug companies to submit race and ethnicity data in drug applications when appropriate. But for the first time, the agency is recommending specific methods for collecting and characterizing racial and ethnic information about clinical trial participants.

In January 2003, the FDA published a draft guidance that recommends collecting racial and ethnic data with methods and categories designated by the federal Office of Management and Budget's (OMB) Directive 15, which was published in 1997. In this directive, OMB told all federal agencies to report statistics using these guidelines starting in January.

The recommended race and ethnicity categories include American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White, and Hispanic or Latino. The FDA's draft guidance recommends that drug companies use the OMB categories when collecting data from study participants within the United States. For studies conducted either inside or outside the United States, more detailed race and ethnic identities may be used, provided that they can be traced back to the major classifications. For example, an Asian person may report having origins in Japan.

Based on the OMB's directive, the FDA recommends that people who participate in clinical trials self-report their racial and ethnic group whenever possible, and that people be permitted to designate a multiracial identity. When self-reporting is not possible, the information should be obtained from an immediate relative or other knowledgeable source.

In a 1998 regulation known as the Demographic Rule, the FDA addressed the importance of collecting data on clinical trial volunteers by gender, race, and age. "The FDA suggested using the OMB categories in the preamble to the Demographic Rule, and the new guidance recognizes these categories as reflecting the FDA's current thinking on how to characterize the data," says Katherine Hollinger, a senior health promotions officer for the FDA's Office of Women's Health.

Using standard categories will make it easy to compare FDA data with health statistics collected by other federal agencies. "Another goal of the guidance," Hollinger says, "is to enhance consistency in sub-population characterization. This improves our ability to assess potential differences in the ways various racial and ethnic groups respond to drugs."

Some studies have shown racial differences in drug response. In the United States, whites are more likely than people of African or Asian heritage to have abnormally low levels of an enzyme that metabolizes drugs belonging to a variety of therapeutic areas, such as antidepressants, antipsychotics, and beta blockers. Other studies have shown that blacks respond less to several classes of antihypertensive agents, including beta blockers and angiotensin converting enzyme (ACE) inhibitors. Additionally, slower metabolism of some drugs in the psychotherapeutic class has been seen in people of Asian descent compared to whites and blacks. The differences are complex and may be due to genetic factors, diet, environmental exposure, sociocultural issues, or a combination of these factors.

Clyde Yancy, M.D., medical director of heart failure and transplantation at the University of Texas Southwestern Medical Center at Dallas, says when you look at heart disease, which disproportionately affects racial and ethnic minorities, you then have to ask: Are we confident that the treatment strategies we're using are effective?

"The fact that traditional therapies may have been less effective among blacks than whites points to a possible need for unique heart failure management strategies," Yancy says. Yancy and other investigators began a clinical trial in 2001, which was the first heart failure trial exclusively for black patients. Results are expected in the next two years.

In another study published in the May 3, 2001, issue of The New England Journal of Medicine, Yancy found that the beta-blocking drug Coreg (carvedilol) was as effective in blacks as non-blacks. "It's reassuring and pertinent for medicine to be able to say that this regimen works in African American patients," he says.

Despite reported differences in drug response, beta blockers and ACE inhibitors are still the most appropriate therapy to treat heart failure in blacks for now, according to Yancy. "What we don't want is for doctors to make treatment decisions just by looking at people when they walk in the door," he says. "Blacks represent a heterogenous group, and given the substantial benefit of beta blockers and ACE inhibitors, it would be a disservice to limit treatment in this population."

The FDA's draft guidance on the collection of race and ethnicity data in clinical trials is available in two formats:

horizonal rule