21 U.S.C. § 399f: Ensuring adequate…

Summary

The Secretary of Health and Human Services, through the FDA Commissioner, must review and update the FDA’s plan for telling doctors and patients about the benefits and risks of medical products. The update must focus on reaching underrepresented groups, including racial subgroups. The plan must follow the goals of HHS’s Strategic Action Plan to Reduce Racial and Ethnic Health Disparities, consider the type of product, and use health information from other HHS agencies and new ways to communicate. It must cover how to share safety alerts, label information and label changes (including strong warnings), actions for health professionals and patients, and how to identify affected subgroups. The plan must include a way to put the changes into practice. The Secretary must issue the plan no later than 1 year after July 9, 2012, post it on the FDA Office of Minority Health website (with links elsewhere), and ask the public for comments.

Title 21, §399f

Food and Drugs, Source: USLM XML via OLRC

(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 July 9, 2012, 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.

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.

§399f Ensuring Adequate Information Regarding Pharmaceuticals for All Populations, Particularly Underrepresented Subpopulations, Including Racial Subgroups

Summary

Title 21, §399f

Notes & Related Subsidiaries

Editorial Notes

Citations & Metadata