FDA calls for standardised racial and ethnic data

The US Food and Drug Administration has asked drug manufacturers to integrate race and ethnicity data into their analyses of new drugs by using the same general classifications used in other government data collection systems.

An analysis of drug dosage and interval modifications by age, race, and sex is also required in new drug applications.

The FDA currently requires drug sponsors to present safety and effectiveness data by age, race, and sex but does not specify how this is to be done. The new guidelines have asked companies to use the same broad categories established by the Office of Management and Budget and used in other government documents and data collection systems. The office uses five distinct racial categories: white; black or African American; Asian; American Indian or Alaskan Native; and Hawaiian or Pacific Islander.

Two ethnic categories, Hispanic and non-Hispanic, are used. The intention of the guidance is to uncover idiosyncratic drug reactions that may be particular to specific racial or ethnic groups and to standardise those groups into categories already used by the government for classification purposes.

Commenting on the policy, FDA spokeswoman Laura Bradbard said: "We want to make sure that when clinical investigators are asking people to identify their race and ethnicity, they use the same terms. That way different agencies can send different data back and forth without creating confusion."

Most drug trials used to be conducted on white males. But racial and sex differences occur in drug metabolism and therefore efforts have been made to include other groups in clinical trials and new drug testing. Elderly people in general, for example, have decreased liver and renal function, which impairs their ability to metabolise some drugs.

People of Asian and African origin have lower levels of an enzyme known as CYP2D6, which metabolises antidepressants, antipsychotics, and b blockers. Black people additionally have a poorer response than white people to b blockers and angiotensin converting enzyme inhibitors and also respond differently to certain types of glaucoma treatment and to interferon.

Although the current guidance calls for standardised ethnic and racial data, it says nothing about increasing the representation of these groups in drug trials.

Researchers in the Netherlands are calling for the systematic registration of patient’s ethnicity to help reduce health inequalities after a study into the incidence of cervical cancer showed that rates among Moroccan born women living in the northern part of the Netherlands were more than twice the national average.

The study published in the Dutch journal of medicine Nederlands Tijdschrift voor Geneeskunde (2003;147(2):70) looked at the country of birth in more than 1500 cases over 10 years, in the region which includes Amsterdam. Incidence was higher among women born in Morocco, Turkey, and Surinam but lower among those born in the Dutch Antilles. In 10% of cases data were not kept.

The FDA’s draft guidance is at www.fda.gov/bbs/topics/answers/2003/ans01193.html