To ensure that adequate information is disseminated to health care providers and payors about the potential benefits and risks of medical products on all patient populations, particularly underrepresented subpopulations, including racial subgroups.

1. Adds SEC. 11__. ENSURING ADEQUATE INFORMATION REGARDING PHARMACEUTICALS FOR ALL POPULATIONS, PARTICULARLY UNDERREPRESENTED SUBPOPULATIONS, INCLUDING RACIAL SUBGROUPS at the end of title XI

   Adds a section

   In S. 3187 · Placed on Calendar Senate

   "(b) Financial Interest.--In this section, the term 'financial interest' means a financial interest under section 208(a) of title 18, United States Code.".

   Inserted: SEC. 11__. ENSURING ADEQUATE INFORMATION REGARDING PHARMACEUTICALS FOR ALL POPULATIONS, PARTICULARLY UNDERREPRESENTED SUBPOPULATIONS, INCLUDING RACIAL SUBGROUPS.

   Inserted: (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, patients, and payors on the benefits and risks of medical products, with particular focus on underrepresented subpopulations, including racial subgroups.

   Inserted: (b) Content.--The communication plan described under subsection (a)--

   Inserted: (1) shall take into account--

   Inserted: (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;

   Inserted: (B) the nature of the medical product; and

   Inserted: (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;

   Inserted: (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 healthcare 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

   Inserted: (3) shall include a process for implementation of any improvements or other modifications determined to be necessary.

   Inserted: (c) Issuance and Posting of Communication Plan.--

   Inserted: (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.

   Inserted: (2) Posting of communication plan on the office of minority health website.--The Secretary, acting through the Commissioner of Food and Drugs, shall publicly post the communication plan on the Internet website of the Office of Minority Health of the Food and Drug Administration, and provide links to any other appropriate webpage, and seek public comment on the communication plan.

   Original wording

   At the end of title XI, add the following:

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As printed