Studies suggest BiDil, a drug designed to remedy heart failure, has a strong success rate among African-Americans - although critics argue such claims have not been proven by the maker, NitroMed.
The FDA's stamp of approval could endorse the notion that races are biologically different with unpredictable ramifications, says Jonathan Kahn, a medical ethicist at Hamline University law school in St Paul, Minnesota.
Moreover, some critics say black Americans are too ethnically diverse and racially mixed a group to draw any conclusion. "When you talk about drugs for blacks, are you talking about Haitians? Somalians? Ethiopians? Jamaicans?" asked Mariano Rey, the director of the Centers for Health Disparities Research at NYU's School of Medicine.
Recent research into the human genome and DNA patterns suggest greater difference within racial groups than between them.
With annual sales projected at $1bn (£540m), critics say NitroMed has stressed the racial element for marketing purposes. BiDil increases levels of nitric oxide, which widens blood vessels, alleviating stress on the heart. Studies show African-Americans have deficiencies of nitric oxide.
A study by Anne Taylor of the University of Minnesota gave 525 African-Americans with moderate to advanced heart failure BiDil and the same number a placebo. Over three years, 32 people on BiDil died compared with 54 on the placebo. The number of first hospital admissions for heart failure among those on BiDil was 33% less than the others.
Among New Yorkers aged 45 to 54, the death rate from heart disease among black people is 55% higher than that among white people, the city's health and department says, although the discrepancies may be explained by differences in diet, exercise and access to healthcare.
Even those who support the drug's approval say that claims it has a specific effect on African-Americans are flawed since similar tests have not been run on other groups - a fact disputed by NitroMed.
To gain community support, NitroMed lobbied black political and professionals.
