POLICY BRIEFINGS

FDA Moves to Harmonize Human Research Protections


The Food and Drug Administration (FDA) released two proposed rules last week that aim to harmonize human subject research protections between the FDA and the U.S. Department of Health and Human Services (HHS)’s Common Rule. The FDA proposes to incorporate the Common Rule’s requirement to focus informed consent forms on key information for prospective research volunteers. The FDA would also allow the option of waiving documentation of informed consent if the research only poses minimal risk and the research volunteers belong to a “cultural group or community in which signing forms is not the norm, and there is an appropriate alternative mechanism for documenting that informed consent was obtained.” The annual continuing review check-in could also be waived if the study has concluded and researchers are only working on data analysis or follow-up clinical data obtained from participants as a part of their clinical care. The new proposed rules would also update the definition of private information and private identifiable information to better align with the Common Rule. The proposals include a single institutional review board (IRB) requirement, which would allow the use of one IRB to review a study for all sites, instead of having IRBs at every study location.


Roselyn Tso Sworn In to Lead IHS


U.S. Department of Health and Human Services Secretary Xavier Becerra formally swore in Roselyn Tso as Director of the Indian Health Service (IHS) on Tuesday. Tso is a member of the Navajo Nation. She has previously served as the IHS Navajo Area director and in other leadership roles at IHS for nearly four decades.


Recently Introduced Health Legislation


H.R.8984 — To amend the Internal Revenue Code of 1986 to provide a deduction for certain charity care furnished by physicians, and for other purposes; Sponsor: Higgins, Clay [Rep.-R-LA-3]; Committees: House - Ways and Means; Energy and Commerce

H.R.8988 – To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage; Sponsor: O’Halleran, Tom [Rep.-D-AZ-1]; Committees: House - Energy and Commerce; Education and Labor; Ways and Means

S.4951 — A bill to amend title 38, United States Code, to prohibit collection of copayments for the first three outpatient mental health care visits of veterans each calendar year, and for other purposes; Sponsor: Ossoff, Jon [Sen.-D-GA]; Committees: Senate - Veterans’ Affairs

S.4953 — A bill to repeal prescription drug price control provisions of the Inflation Reduction Act; Sponsor: Lee, Mike [Sen.-R-UT]; Committees: Senate – Finance

S.4965 — A bill to amend title XVIII of the Social Security Act to remove in-person requirements under Medicare for mental health services furnished through telehealth and telecommunications technology; Sponsor: Sullivan, Dan [Sen.-RAK]; Committees: Senate – Finance

S.Res.804 — A resolution designating September 2022 as “National Childhood Cancer Awareness Month”; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.Res.805 — A resolution supporting the designation of the week of September 18 through September 24, 2022 as “Telehealth Awareness Week”; Sponsor: Schatz, Brian [Sen.-D-HI]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.4970 — A bill to amend the Higher Education Act of 1965 to promote comprehensive campus mental health and suicide prevention plans, and for other purposes; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate - Health, Education, Labor, and Pensions

S.4978 — A bill to amend the Public Health Service Act to reauthorize the State offices of rural health program; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate - Health, Education, Labor, and Pensions

H.R.8994 — To direct the Secretary of Health and Human Services to establish the Emergency Medical Services (EMS) Grant Program through which the Secretary may make grants to EMS organizations, and for other purposes; Sponsor: Kim, Andy [Rep.-D-NJ-3]; Committees: House - Energy and Commerce

H.R.8995 — To require the Secretary of Health and Human Services to establish a program to reimburse health care providers for furnishing rabies postexposure prophylaxis to uninsured individuals; Sponsor: Bera, Ami [Rep.-D-CA-7]; Committees: House - Energy and Commerce

H.R.8999 — To amend the Occupational Safety and Health Act of 1970 to provide for the expiration of emergency temporary standards after 6 months; Sponsor: Cawthorn, Madison [Rep.-R-NC-11]; Committees: House - Education and Labor

H.R.9001 — To secure schools, to increase access to mental health resources, and for other purposes; Sponsor: Flores, Mayra [Rep.-R-TX-34]; Committees: House - Judiciary; Education and Labor; Ways and Means

H.R.9002 — To direct the Secretary of Veterans Affairs to establish a pilot program for gynecologic cancer care coordination at the Department of Veterans Affairs, and for other purposes; Sponsor: Garcia, Sylvia R. [Rep.-D-TX-29]; Committees: House - Veterans’ Affairs

H.R.9005 — To direct the Secretary of Veterans Affairs to carry out a pilot program for the cognitive care of veterans, and for other purposes; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House - Veterans’ Affairs

H.R.9007 — To authorize the Secretary of Health and Human Services to provide grants to medical and other health profession schools to expand or develop education and training programs for substance use prevention and treatment, and for other purposes; Sponsor: Kim, Andy [Rep.-D-NJ-3]; Committees: House - Energy and Commerce

H.R.9011 — To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish a process to allow the holders of abbreviated new drug applications to make labeling changes to include new or updated safety-related information, and for other purposes; Sponsor: McEachin, A. Donald [Rep.-D-VA-4]; Committees: House - Energy and Commerce

H.R.9019 — To amend title XVIII of the Social Security Act to require complete and accurate data set submissions from Medicare Advantage organizations offering Medicare Advantage plans under part C of the Medicare program to improve transparency, and for other purposes; Sponsor: Porter, Katie [Rep.-D-CA-45]; Committees: House - Ways and Means; Energy and Commerce



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