Promising Pathway Act This bill establishes a provisional approval pathway for medicines intended for serious or life-threatening diseases, including illnesses posing a threat of epidemic or pandemic. The period of the provisional approval is for two years and is potentially renewable. The Food and Drug Administration (FDA) must establish a priority review system to evaluate completed provisional approval applications within 90 days of receipt. A provisional approval application may be approved if the FDA determines that (1) there is substantial evidence of safety for the drug; and (2) there is relevant early evidence of efficacy, based on adequate and well-controlled investigations. During the COVID-19 (i.e., coronavirus disease 2019) pandemic, or another epidemic or pandemic, the FDA must accept and review various portions of a provisional approval application on a rolling basis. The manufacturer of a provisionally approved drug must require patients to participate in an observational registry. A manufacturer that fails to comply with registry requirements is subject to civil penalties. A provisionally approved drug must be labeled as such. If a drug that receives provisional approval status is not brought to market within 180 days of the approval, the approval must be rescinded. The bill also limits the liability of a manufacturer of a provisionally approved drug with respect to any claim under state law alleging that the drug is unsafe or ineffective. Private health insurers and federal health care programs shall not deny coverage of a provisionally approved drug on the basis of it being experimental.
Sponsored bills
Estate Tax Rate Reduction Act This bill reduces the rate for the tax on estates, gifts, and generation-skipping transfers to 20%. (Under current law, the highest rate is 40%.) The bill also exempts the budgetary effects of the tax reduction from the Pay-As-You-Go (PAYGO) rules established by the Statutory Pay-As-You-Go Act of 2010 and the FY2018 congressional budget resolution.
This resolution expresses support for the goals and ideals of National Nurses Week.
Ensuring Access to General Surgery Act of 2021 This bill requires the Health Resources and Services Administration (HRSA) to study access by underserved populations to general surgeons. Specifically, HRSA must study (1) whether the health professional shortage area designation under the National Health Service Corps (NHSC) program accurately assesses adequacy of access to general surgeons, (2) whether another measure would be more accurate, and (3) potential methodologies for designating general surgery shortage areas. (The NHSC provides scholarships and student loan repayment awards to primary care, dental care, and mental health care providers who agree to work in areas that HRSA designates as having a shortage of those particular types of providers.) HRSA must also publish data comparing the availability and need of general surgery services in urban, suburban, and rural areas. On the basis of its study, HRSA may establish a methodology for designating general surgery shortage areas and make such designations. If any designations are made, HRSA must publish a list of general surgery shortage areas.
Back the Blue Act of 2021 This bill establishes new criminal offenses for killing, assaulting, and fleeing to avoid prosecution for killing a judge, law enforcement officer, or public safety officer. Additionally, the bill expands the list of statutory aggravating factors in death penalty determinations to also include the killing or attempted killing of a law enforcement officer, judge, prosecutor, or firefighter or other first responder; broadens the authority of federal law enforcement officers to carry firearms; and limits federal court review of challenges to state court convictions for killing a public safety officer or judge. Finally, it directs the Department of Justice to make grants to law enforcement agencies and nongovernmental organizations to promote trust and improve relations between law enforcement agencies and the communities they serve.
Thin Blue Line Act This bill expands the list of statutory aggravating factors in death penalty determinations to also include killing or targeting a law enforcement officer, firefighter, or other first responder.
This resolution expresses support for National Minority Health Month.
Accelerating Kids' Access to Care Act This bill requires state Medicaid programs to establish a process through which qualifying out-of-state providers may enroll as participating providers without undergoing additional screening requirements. Among other things, a qualifying provider must (1) serve minors, or adults whose condition began as a minor; and (2) have previously been screened for Medicare participation or for participation in the Medicaid program of the state in which the provider is located.
Equity in Neuroscience and Alzheimer's Clinical Trials Act of 2021 or the ENACT Act of 2021 This bill sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimer's disease and related dementias. Specifically, the National Institute on Aging (NIA) must establish and provide technical assistance to Alzheimer's research centers located in areas with higher concentrations of minority groups. These centers must establish diagnostic and treatment clinics designed to serve minority, rural, and other underserved populations; operate clinical trials; and carry out public outreach to encourage members of minority populations to participate in clinical trials and research. Additionally, the NIA must disseminate information to members of minority populations about participating in clinical trials and take other actions to enhance diversity with respect to the Alzheimer's research that it conducts or supports. The bill also directs the NIA to increase diversity among Alzheimer's researchers by encouraging the participation of individuals who are from groups that are underrepresented in clinical, behavioral, and social sciences.
Technical Reset to Advance the Instruction of Nurses Act or the TRAIN Act This bill modifies the methodology and application of Medicare Advantage nursing and allied health education payments for hospitals. Specifically, for 2010-2019, the bill eliminates the annual cap on total payments and excludes any resulting increase from factoring into calculations for graduate medical education payments for such hospitals. (The Centers for Medicare & Medicaid Services recently issued guidance providing for the recalculation and correction of certain payments to account for the annual payment cap.)