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
The FDA must create a plan to better inform doctors and patients about medicine risks and benefits, focusing on underrepresented groups like racial subgroups. The plan must address safety alerts, label changes, and new ways to communicate, including online. The FDA must publish this plan and let the public comment.
(a) Communication plan
The Secretary* of Health and Human Services, acting through the FDA Commissioner*, must review and update the FDA's plan for informing and educating health care providers and patients. This plan covers the benefits and risks of medical products, with special focus on underrepresented groups, including racial subgroups.
(b) Content
This plan must consider the goals of the Department's Strategic Action Plan to Reduce Racial and Ethnic Health Disparities. It must consider the specific medical product involved, and any relevant health information from other agencies within the Department*, plus new ways to communicate safety information.
Depending on the product, the plan must cover the best way to communicate safety alerts, approved uses, and label* changes — including serious "black-box" warnings and health advisories. It must cover what specific actions health care providers and patients should take, information identifying particular groups affected, and other relevant details. This includes using different forms of electronic communication.
The plan must also include a process for putting any needed improvements or changes into practice.
(c) Issuance and posting of communication plan
Within one year of July 9, 2012, the Secretary, through the Commissioner, must issue this communication plan. The Secretary must post the plan publicly on the FDA's Office of Minority Health website, link to other relevant websites, and ask the public for comments on it.
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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