Title 21 — Food and Drugs
Chapter 9 — Federal Food, Drug, and Cosmetic Act
§ 399f. Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups
Statutory text
Communication plan
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.
Content
The communication plan described under subsection (a)—
shall take into account—
the goals and principles set forth in the Strategic Action Plan to Reduce Racial and Ethnic Health Disparities issued by the Department of Health and Human Services;
the nature of the medical product; and
health and disease information available from other agencies within such Department, as well as any new means of communicating health and safety benefits and risks related to medical products;
taking into account the nature of the medical product, shall address the best strategy for communicating safety alerts, labeled indications for the medical products, changes to the label or labeling of medical products (including black-box warnings, health advisories, health and safety benefits and risks), particular actions to be taken by health care professionals and patients, any information identifying particular subpopulations, and any other relevant information as determined appropriate to enhance communication, including varied means of electronic communication; and
shall include a process for implementation of any improvements or other modifications determined to be necessary.
Issuance and posting of communication plan
Communication plan
Not later than 1 year after , the Secretary, acting through the Commissioner of Food and Drugs, shall issue the communication plan described under this section.
Posting of communication plan on the office of minority health web site
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.
Legislative history
Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.
Food and Drug Administration Safety and Innovation Act
Pub. L. 112–144 title XI § 1138 · 126 Stat. 993
Enacted · 21 U.S.C. § 399f
(Pub. L. 112–144, title XI, § 1138, July 9, 2012, 126 Stat. 1125.)
Source evidence
Code source credit
(Pub. L. 112–144, title XI, § 1138, July 9, 2012, 126 Stat. 1125.)Enacted provision · exact public law section
SEC. 1138. ENSURING ADEQUATE INFORMATION REGARDING PHARMACEUTICALS FOR ALL POPULATIONS, PARTICULARLY UNDERREPRESENTED SUBPOPULATIONS, INCLUDING RACIAL SUBGROUPS. (a) Communication Plan.— 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. (b) Content.— The communication plan described under subsection (a)— (1) shall take into account— (A) the goals and principles set forth in the Strategic Action Plan to Reduce Racial and Ethnic Health Disparities issued by the Department of Health and Human Services; (B) the nature of the medical product; and (C) health and disease information available from other agencies within such Department, as well as any new means of communicating health and safety benefits and risks related to medical products; (2) taking into account the nature of the medical product, shall address the best strategy for communicating safety alerts, labeled indications for the medical products, changes to the label or labeling of medical products (including black-box warnings, health advisories, health and safety benefits and risks), particular actions to be taken by health care professionals and patients, any information identifying particular subpopulations, and any other relevant information as determined appropriate to enhance communication, including varied means of electronic communication; and (3) shall include a process for implementation of any improvements or other modifications determined to be necessary. (c) Issuance and Posting of Communication Plan.— (1) Communication plan.— Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue the communication plan described under this section. (2) Posting of communication plan on the office of minority health web site.— 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.
1 of 1 references resolved to an enrolled provision
Editorial Notes
Codification
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.