21 U.S.C. § 399f — Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups
submitted 14 years ago by Pub. L. 112-144 to r/title-21-FOOD-AND-DRUGS · 344 words · no verdicts yet
A translation hasn’t been published for this section yet. The official text below is complete and authoritative.
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.
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.
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.
Source credit: (Pub. L. 112–144, title XI, § 1138, July 9, 2012, 126 Stat. 1125.)
- 2012Enacted · Pub. L. 112-144 · 126 Stat. 1125
A history note hasn’t been published yet. The record shows enactment by Pub. L. 112-144 on 2012-07-09.
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