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.
What it does: Adds SEC. 11__. ENSURING ADEQUATE INFORMATION REGARDING PHARMACEUTICALS FOR ALL POPULATIONS, PARTICULARLY UNDERREPRESENTED SUBPOPULATIONS, INCLUDING RACIAL SUBGROUPS at the end of title XI
Sen. Benjamin L. Cardin (D-MD)What it changes
1 change to S. 3187 · shown in the bill's text
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 sectionIn 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:
Read automatically from the Congressional Record. Check the original before relying on it.
As printed
SA 2125. Mr. CARDIN submitted an amendment intended to be proposed by him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes; which was ordered to lie on the table; as follows:
At the end of title XI, add the following:
SEC. 11__. 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, patients, and payors 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 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
(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 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.
Legislative Activity
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Senate amendment agreed to: Amendment SA 2125 agreed to in Senate by Unanimous Consent.
May 23, 2012
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Senate amendment agreed to: Amendment SA 2125 agreed to in Senate by Unanimous Consent.
May 23, 2012
Senate amendment proposed (on the floor): Amendment SA 2125 proposed by Senator Cardin.(consideration: CR S3497, S3500, S3507; text: CR S3497)
May 23, 2012
Amendment SA 2125 proposed by Senator Cardin. (consideration: CR S3497, S3500, S3507; text: CR S3497) 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.
May 23, 2012
Amendment SA 2125 agreed to in Senate by Unanimous Consent.
May 23, 2012
Senate amendment submitted
May 21, 2012