PHARMACEUTICALS related term(s) Drugs

Addresses

State of the Union: President Trump, S645–S649 [24FE], H2287–H2295 [24FE]

Bills and resolutions

Abortion: reaffirm safety of medication abortion and preempt State restrictions on dispensing medication abortion (see H.R. 8734), H3346 [11MY]

Accelerating Access to Critical Therapies for ALS Act: reauthorize (see S. 4472), S2171 [30AP] (see H.R. 8205), H2824 [6AP]

Armed Forces: furnish stellate ganglion block to members with post-traumatic stress disorder (see H.R. 8764), H3392 [12MY]

Centers for Medicare & Medicaid Services: require Center for Medicare and Medicaid Innovation to test model implementing most-favored-nation drug pricing (see H.R. 7837), H2470 [5MR]

Children and youth: prohibit gender transition procedures on minors and impose civil penalties on persons who perform such procedures on minors (see S. 4426), S2128 [29AP] (see H.R. 8573), H3294 [29AP]

Colleges and universities: streamline process for institutions to research marijuana (see H.R. 8394), H2995 [20AP]

Courts: establish Federal tort for harm to women caused by chemical abortion drugs (see S. 4066), S1009 [11MR] (see H.R. 7902), H2481 [12MR]

Crime: provide for death penalty for anyone who knowingly deals fentanyl to person who dies from use (see H.R. 8766), H3392 [12MY]

Dept. of Defense: improve access to certain medications under TRICARE program (see S. 4106), S1090 [17MR]

Dept. of HHS: adjust which engineered cyclic peptides are qualifying single source drugs relative to drug price negotiation program (see H.R. 8857), H3550 [15MY]

——— ensure that Federally-qualified health centers are not required to pay more than 340B ceiling price for covered outpatient drugs at time of purchase (see H.R. 7391), H2040 [5FE]

——— ensure that women seeking chemical abortion are made aware of risks involved (see H.R. 7237), H1912 [23JA]

——— establish demonstration program to award grants to States to improve provision of recommended immunizations for children, adolescents, and adults through use of mobile vaccination units (see H.R. 7465), H2118 [10FE]

——— establish program to develop innovative antimicrobial drugs targeting most challenging pathogens and most threatening infections (see H.R. 7352), H2029 [4FE]

——— establish program to support health care providers and pharmacies in providing discounted insulin products to uninsured individuals (see S. 4512), S2278 [13MY]

——— improve access to pre-exposure prophylaxis (PrEP) to reduce transmission of HIV (see S. 3990), S802 [4MR] (see H.R. 7853), H2471 [5MR]

——— issue guidelines for addressing nitazene overdoses (see H.R. 8192), H2821 [2AP]

——— make determinations of exclusivity periods for which licensed biological products are eligible (see S. 4332), S1821 [16AP]

——— modernize clinical trials and remove barriers for participation in clinical trials (see S. 4440), S2128 [29AP]

——— provide for appropriate cost-sharing for insulin products covered under private health plans (see S. 4512), S2278 [13MY]

——— provide funding for trained school personnel to administer drugs and devices for emergency treatment of known or suspected opioid overdose (see S. 3588), S89 [7JA]

——— release of documents, communications, and other information relating to most favored nation pricing agreements and other private or confidential drug pricing deals struck with manufacturers (see S. 4355), S1857 [21AP]

——— require community health centers to provide behavioral and mental health and substance use disorder services (see H.R. 8201), H2824 [6AP]

Dept. of Labor: issue guidance and regulations regarding opioid overdose reversal medication and employee training (see S. 3812), S552 [10FE] (see H.R. 7479), H2118 [10FE]

——— provide States and local areas information on best practices to address effects of substance use disorder on workforce and provide grants for training related to treatment and prevention (see H.R. 8203), H2824 [6AP]

Dept. of Veterans Affairs: award grants to develop, implement, and evaluate approaches and methodologies for prospective randomized control trials for neurorehabilitation treatments for chronic mild traumatic brain injury (see H.R. 6993), H615 [9JA]

——— eliminate copayments for medicines relative to preventive health services (see S. 4217), S1668 [26MR]

——— establish Office of Novel Therapeutics within Veterans Health Administration (see S. 4220), S1668 [26MR]

——— expand access to Veterans Community Care Program to include certain veterans seeking mental health or substance-use services (see H.R. 8737), H3391 [12MY]

——— furnish stellate ganglion block to veterans with post-traumatic stress disorder (see H.R. 8763), H3392 [12MY]

——— improve schedule for rating disabilities (see H.R. 8066), H2675 [24MR]

——— make opioid overdose rescue medications available to veterans and their caregivers (see S. 3758), S442 [2FE]

——— modify Precision Medicine for Veterans Initiative (see H.R. 8115), H2776 [26MR]

——— transmit veteran’s history of opioid prescriptions to Community Care health care provider (see H.R. 8679), H3340 [7MY]

Depts. of Defense and Veterans Affairs: set maximum cost-sharing amount for prescription drugs for Armed Forces members and veterans and set maximum price for prescription drugs procured by Federal agencies (see H.R. 8667), H3340 [7MY]

Depts. of HHS and State: formulate strategy to secure support from foreign countries, multilateral organizations, and others to facilitate development and commercialization of qualified pandemic or epidemic products (see H.R. 7879), H2476 [9MR]

Diseases and disorders: protect against seasonal and pandemic influenza (see H.R. 8447), H3067 [22AP]

Drugs: mitigate effects of coronavirus pandemic on incentives for development of orphan drugs (see H.R. 7693), H2327 [25FE]

——— modify requirements relating to prescription of controlled substances via Internet (see H.R. 6994), H615 [9JA]

——— prevent importation of illicit pill press machines with intent to counterfeit substances (see S. 4446), S2170 [30AP] (see H.R. 7184), H1171 [21JA]

——— prohibit certain acts related to fentanyl, analogues of fentanyl, and counterfeit substances (see H.R. 8005), H2620 [19MR]

——— reduce price of insulin, require pharmacy benefit managers to pass-through manufacturer rebates for insulin products, and promote generic and biosimilar competition (see S. 4189), S1614 [25MR]

——— require out-of-pocket expenditures for drugs to count towards individual’s deductible and out-of-pocket maximum (see H.R. 8270), H2885 [14AP]

——— require that opioid overdose rescue kits be located at public institutions of higher education (see H.R. 8499), H3122 [27AP]

FDA: accelerate patient access to innovative medicines and clinical trials for life-threatening diseases by establishing reciprocal approval mechanism with trusted international regulatory authorities (see H.R. 7953), H2550 [17MR]

——— enhance ability of outsourcing facilities to mitigate drug shortages by allowing short-term period to continue supplying market after drug is in shortage (see H.R. 7528), H2217 [12FE]

——— enhance drug manufacturing amount information reporting (see H.R. 8339), H2959 [16AP]

——— establish new prohibited acts relative to dietary supplements (see S. 3797), S509 [5FE] (see H.R. 7407), H2041 [5FE]

——— expand certain authorities relative to recall of controlled substances to apply to all drugs (see H.R. 7980), H2596 [18MR]

——— improve regulation of abortion drugs by prohibiting approval of new drugs, preventing labeling changes of existing drugs, and limiting dispensing of drugs remotely, by mail, or telemedicine (see S. 3697), S290 [27JA]

——— require drug labeling to include original manufacturer and supply chain information (see S. 3788), S509 [5FE] (see H.R. 8269), H2885 [14AP]

——— require regulatory review of pharmaceutical products from Chinese entities (see S. 4327), S1821 [16AP]

——— respect scientific judgement that mifepristone is safe and effective and ensure access to lifesaving, time-sensitive medication abortion care in U.S. is equitable and based on science (see S. Res. 732), S2305 [14MY] (see H. Res. 1285), H3531 [14MY]

——— set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions (see S. 3716), S344 [28JA]

——— strengthen regulation of compounding pharmacies and outsourcing facilities (see S. 3794), S509 [5FE]

——— withdraw approval of mifepristone for termination of intrauterine pregnancy (see S. 4066), S1009 [11MR] (see H.R. 7902), H2481 [12MR]

GAO: conduct study and submit report on price-related compensation and payment structures in prescription drug supply chain (see S. 3751), S377 [29JA]

Health: address high costs of health care services, prescription drugs, and health insurance coverage in U.S. (see H.R. 8840), H3531 [14MY]

——— end liability shield for vaccine manufacturers (see S. 3853), S578 [11FE]

——— provide private right of action for children and parents of children whose healthy body parts have been damaged by medical professionals practicing or participating in certain interventions (see H.R. 7651), H2258 [23FE]

Health care professionals: protect religious freedom of pharmacists choosing not to dispense or sell abortion-inducing drugs (see H.R. 8366), H2994 [20AP]

Income: prohibit kickbacks to pharmacy benefit managers (see H.R. 7895), H2481 [12MR]

Insurance: ban anticompetitive terms in facility and insurance contracts that limit access to higher quality, lower cost care (see S. 4027), S915 [9MR]

——— prohibit pharmacy benefit managers, insurers, and prescription drug or medical device wholesalers from being under common ownership with certain medical service providers (see S. 3822), S552 [10FE]

——— prohibit pharmacy benefit managers and pharmacies from being under common ownership (see S. 4509), S2277 [13MY] (see H.R. 8779), H3452 [13MY]

Medicaid: codify value-based purchasing arrangements and reforms relative to price reporting under such arrangements (see H.R. 7871), H2476 [9MR]

——— ensure adequate access to vaccines under Vaccines for Children program (see H.R. 8425), H3045 [21AP]

Medicare: provide coverage for pre-exposure prophylaxis (PrEP) furnished by pharmacists (see H.R. 7189), H1171 [21JA]

——— require Medicare Payment Advisory Commission reports to Congress on arrangements with pharmacy benefit managers relative to prescription drug plans and Medicare Advantage prescription drug plans (see S. 3729), S377 [29JA]

——— require prescription drug plan sponsors of part D prescription drug plan that use formulary to include certain generic drugs and biosimilar biological products on such formulary (see H.R. 8143), H2789 [27MR]

——— require sponsors of prescription drug plans and Medicare Advantage organizations offering such plans under part D to include certain drugs and biosimilar biological products on formulary (see S. 4323), S1820 [16AP]

National Fentanyl Awareness Day: designate (see S. Res. 704), S2129 [29AP] (see H. Res. 1234), H3295 [29AP]

NIH: establish National Institute for Biomedical Research and Development (see H.R. 7854), H2471 [5MR]

Patient Protection and Affordable Care Act: ensure taxpayer funds for health insurance coverage are available only to U.S. citizens, nationals, or aliens lawfully present (see H.R. 7817), H2470 [5MR]

Public Health Service Act: prohibit treatment of biologic as biological product based solely on presence of protein that is clinically inactive component in such biologic (see H.R. 8630), H3330 [30AP]

Social Security: affirm importance to people of U.S. and express that it must be preserved, protected, and strengthened for current and future generations (see S. Res. 579), S115 [8JA]

Tardive Dyskinesia Awareness Week: designate (see H. Res. 1265), H3342 [7MY]

Women: allow greater access to safe and effective oral contraceptive drugs intended for routine use and direct GAO to conduct study on Federal funding of contraceptive methods (see H.R. 8083), H2710 [25MR]

Messages

Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the U.S.: President Trump, S1838 [20AP], H2978 [20AP]

Remarks in House

Abortion: prohibit chemical abortions, H1342 [22JA]

CDC: disapprove revised immunization guidelines for children, H669 [13JA]

Cordele, GA: anniversary of Adams Drugstore (business), H3524 [14MY], E415 [4MY]

Dept. of Veterans Affairs: interim rule relative to determining disability benefit eligibility, H2238 [23FE]

——— reimburse State homes for cost of, or furnish to State homes, certain costly medications provided to veterans who receive nursing home care in such State homes (H.R. 1970), H3298 [30AP]

——— stellate ganglion block treatment for post-traumatic stress disorder funding, H3537, H3538 [15MY]

Domestic policy: lower cost of consumer products and increase affordability, H2548 [17MR]

FDA: publish final rule relative to nonclinical testing methods (S. 355), H941 [20JA]

Health care professionals: tribute to pharmacists, H1989 [4FE]

Insurance: improve services provided by pharmacy benefit managers, H2237 [23FE]

Kennedy, Sec. of HHS: call for resignation, H911 [15JA]

Medicare: assure pharmacy access and choice for beneficiaries (H.R. 4317), H928 [20JA]

Merced, CA: anniversary of Valley Prescription and Compounding Pharmacy, E446 [14MY]

Myers, Wayne: Pennsylvania Pharmacists Association Pharmacist of the Year award recipient, H2487 [16MR]

NIH: establish National Institute for Biomedical Research and Development (H.R. 7854), H2556 [18MR]

Remarks in Senate

Budget: create point of order against reconciliation legislation that does not lower out-of-pocket health care costs, S1906 [22AP]

——— establish deficit-neutral reserve fund relative to reducing price of prescription drugs through adoption of Most Favored Nation drug pricing, S1915, S1916 [22AP]

——— establish deficit-neutral reserve fund to study economic impact of confidential drug pricing agreements between Federal agencies and pharmaceutical manufacturers, S1917 [22AP]

Children and youth: prohibit gender transition procedures on minors and impose civil penalties on persons who perform such procedures on minors (S. 4426), S2294 [14MY]

Domestic policy: science and research funding, S246 [15JA]

Drugs: reduce price of insulin, require pharmacy benefit managers to pass-through manufacturer rebates for insulin products, and promote generic and biosimilar competition (S. 4189), S2092 [29AP]

FDA: improve regulation of abortion drugs by prohibiting approval of new drugs, preventing labeling changes of existing drugs, and limiting dispensing of drugs remotely, by mail, or telemedicine (S. 3697), S292 [27JA]

——— restore in-person dispensing requirements for chemical abortion drugs, S284 [27JA]

Health: address health care affordability by establishing health savings accounts for out-of-pocket costs, increasing price transparency, and expanding access to safe and nutritious food, S1849 [21AP]

Insurance: improve services provided by pharmacy benefit managers, S1701 [13AP]

Medicare: assure pharmacy access and choice for beneficiaries, S1701 [13AP]

——— implementation of drug price negotiation program, S65 [7JA]

National Fentanyl Awareness Day: designate (S. Res. 704), S2089, S2109 [29AP]

Senate: legislative priorities, S560 [11FE]

Social Security: affirm importance to people of U.S. and express that it must be preserved, protected, and strengthened for current and future generations (S. Res. 579), S119 [8JA]

Reports filed

Combating Illicit Xylazine Act: Committee on the Judiciary (Senate) (S. 545), S1820 [16AP]

Texts of

S. 3797, Prohibiting Tianeptine and Other Dangerous Products Act, S512 [5FE]

S. Res. 579, affirm importance of Social Security to people of U.S. and express that it must be preserved, protected, and strengthened for current and future generations, S118 [8JA]

S. Res. 704, National Fentanyl Awareness Day, S2135 [29AP]

S. Res. 732, respect FDA scientific judgement that mifepristone is safe and effective and ensure access to lifesaving, time-sensitive medication abortion care in U.S. is equitable and based on science, S2309 [14MY]