Rep. Susan Wild

Diverse and Equitable Participation in Clinical Trials Act or the DEPICT Act This bill requires applications for an investigational use exemption of a new drug or medical device to include information about the demographic diversity of the clinical trial population and addresses related issues. (Generally, a developer of a new drug or device may seek an investigational use exemption to facilitate clinical investigations, as part of the process to obtain approval to sell that drug or device.) Specifically, the Food and Drug Administration (FDA) must issue regulations to require applications for such exemptions to include certain information, including (1) demographic data disaggregated by subgroup, where such data is available, about the expected or potential patient population; (2) the applicant's enrollment targets for the clinical trials involved, disaggregated by age group, sex, race, and ethnicity; (3) a diversity plan for how the applicant will meet these targets; and (4) what is known about the patient population, such as comorbidities. The regulations must also require certain applicant reports to the FDA to address issues related to demographic diversity in clinical trials and product safety and effectiveness for demographic subgroups. The bill also authorizes the FDA to, in certain instances, require additional studies or surveillance after a drug or device has been approved if the clinical trials used in the application process did not meet the demographic enrollment targets.

This resolution expresses support for the goals and ideals of PCOS Awareness Month. Polycystic ovary syndrome (PCOS) is caused by a hormone imbalance. Symptoms can include infertility, weight gain, excess hair growth, and acne.

Albatross and Petrel Conservation Act This bill authorizes the United States Fish and Wildlife Service (USFWS) and the National Marine Fisheries Service (NMFS) to issue regulations to implement and enforce the Agreement on the Conservation of Albatrosses and Petrels, done at Cape Town, South Africa, on February 2, 2001. Specifically, the USFWS and the NMFS may take action to protect albatrosses and petrels and their habitats. The bill prohibits the taking of an albatross or petrel without a permit, authorization, or exemption. The FWS, in consultation with the NMFS, may authorize the taking of an albatross or petrel under exceptional circumstances or incidental to otherwise lawful activities. The bill gives the USFWS, the NMFS, and the Coast Guard authority to enforce this bill. Finally, the bill authorizes cooperation with other countries to achieve and maintain a favorable conservation status of albatrosses and petrels.

Steel Upgrading Partnerships and Emissions Reduction Act or the SUPER Act of 2021 This bill requires the Department of Energy (DOE) to establish programs to reduce greenhouse gas emissions from the production of iron, steel, and steel mill products. Specifically, DOE must establish a program of research, development, demonstration, and commercial application of advanced tools, technologies, and methods for low-emissions steel manufacturing. DOE, in collaboration with industry partners, institutions of higher education, and DOE's national laboratories, must also support an initiative for the demonstration of low-emissions steel manufacturing.

No Tax Breaks for Drug Ads Act This bill prohibits a tax deduction for expenses relating to direct-to-consumer advertising of prescription drugs. Direct-to-consumer advertising is any dissemination, by or on behalf of a sponsor of a prescription drug product, of an advertisement that is in regard to the drug product and primarily targeted to the general public.

PrEP Access and Coverage Act This bill requires private health insurance plans to cover prescription drugs that prevent HIV, including related screenings, diagnostic procedures, administrative fees, and clinical follow-ups, without any cost-sharing obligation for the plan holder. Further, insurance plans must not impose any preauthorization requirement for this coverage. These coverage requirements also apply to public health insurance programs, including Medicare, Medicaid, and the Children's Health Insurance Program. Additionally, the bill prohibits denying, limiting, or qualifying coverage or increasing premiums for disability insurance, long-term care insurance, or life insurance policies based on an individual taking medication for HIV prevention. The bill further requires the Department of Health and Human Services to award grants to states, or directly to eligible local organizations, to provide uninsured individuals and underinsured individuals access to prescription drugs and related services that prevent HIV. The Centers for Disease Control and Prevention also must develop a public awareness campaign that focuses efforts in communities with a high need for HIV prevention treatment.

SNAP Provisions to Lower Undue Struggle Act of 2021 or the SNAP PLUS Act of 2021 This bill expands the Supplemental Nutrition Assistance Program (SNAP) to permit the use of SNAP benefits to purchase prepared foods fit for immediate consumption and hot foods.

This bill revises enforcement provisions under the Animal Welfare Act (AWA), including by directing inspectors to confiscate or destroy in a humane manner animals found to be suffering physical or psychological harm as a result of failure to comply with the AWA.

Cures 2.0 Act This bill addresses pandemic preparedness and public health issues, caregiver and patient engagement, drug development, insurance coverage, and biomedical research. The Department of Health and Human Services (HHS) must undertake research and other activities concerning COVID-19 and develop a strategy for future pandemics and declared emergencies. Additionally, the bill specifies actions to combat antimicrobial resistance. HHS may award grants for caregiver training. The bill also addresses diversity in clinical trials, collecting patient experience data during clinical trials, and coverage for care related to participation in specified clinical trials. The bill modifies the timeframe and requires additional guidance relating to expedited approval of certain breakthrough drugs, devices, or products. It also establishes two intercenter institutes within the Food and Drug Administration (FDA) focused on particular diseases that meet specified criteria. The bill also addresses (1) coverage in Medicare, Medicaid, and the Children's Health Insurance Program for telehealth, genetic and genomic testing, and other services; (2) electronic prescribing standards for Medicare drug benefits; and (3) access to Medicare and Medicaid claims data by certain registries. Furthermore, the bill prohibits the use of geographic tracking or biometrics in Medicaid electronic visit verification systems. The bill establishes the Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health to accelerate biomedical research and innovation through grants, contracts, cash prizes, and other means. The FDA may work with ARPA-H to expedite the development of medical products through specified activities.

Accelerating Access to Critical Therapies for ALS Act This bill establishes grant programs to address neurodegenerative diseases, such as amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease), and contains other related provisions. The Department of Health and Human Services (HHS) shall award grants to eligible entities for scientific research utilizing data from expanded access to investigational ALS treatments for individuals who are not otherwise eligible for clinical trials.  The Food and Drug Administration (FDA) shall award grants to public and private entities to cover the costs of research and development of drugs that diagnose or treat ALS and other rare neurodegenerative diseases. HHS shall also establish the Public-Private Partnership for Neurodegenerative Diseases between the National Institutes of Health, the FDA, and at least one eligible entity (generally, an institution of higher education or a nonprofit organization). The partnership shall support the development and regulatory review of drugs that address ALS and other rare neurodegenerative diseases. The FDA shall publish on its website a five-year action plan for fostering the development of drugs that improve or extend the lives of people living with rare neurodegenerative diseases. The Government Accountability Office must report to Congress about the grants provided under this bill, including an analysis of the impact of such grants on research and development of treatments for ALS.