21 U.S. Code § 399f - Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups
The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Commissioner of Food and Drugs, shall review and modify, as necessary, the Food and Drug Administration’s communication plan to inform and educate health care providers and patients on the benefits and risks of medical products, with particular focus on underrepresented subpopulations, including racial subgroups.
Not later than 1 year after July 9, 2012, the Secretary, acting through the Commissioner of Food and Drugs, shall issue the communication plan described under this section.
The Secretary, acting through the Commissioner of Food and Drugs, shall publicly post the communication plan on the Internet Web site of the Office of Minority Health of the Food and Drug Administration, and provide links to any other appropriate Internet Web site, and seek public comment on the communication plan.
Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.