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Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of2019 or the DEVICE Act of 2019 This bill addresses design changes and reprocessing of medical devices. Reprocessing of medical devices is the process to clean and sterilize or disinfect devices for reuse. Specifically, medical device manufacturers must notify the Food and Drug Administration (FDA) (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device. A device may not be sold if the manufacturer violates these notification requirements. Rapid assessment tests intended to ensure the proper reprocessing of reusable medical devices are defined as medical devices. The FDA must publish a list of the types of rapid assessment tests for which premarket notification must include validated instructions for use and validation data.

This bill requires drug manufacturers to provide the Department of Health and Human Services with aggregate data related to product samples of drugs, devices, biologic products, and medical supplies given to hospitals, physicians, or other medical professionals during the previous calendar year, beginning in 2023.

Verified Innovative Testing in American Laboratories Act of 2020 or the VITAL Act of 2020 This bill expressly shifts the regulation of laboratory-developed testing procedures from the Food and Drug Administration (FDA) to the Centers for Medicare & Medicaid Services (CMS). Under current law, the FDA regulates the safety and effectiveness, as well as quality of design and manufacture, of laboratory-developed tests, while the CMS regulates clinical laboratories and testing processes. Historically, the FDA has exercised enforcement discretion and not enforced certain statutory and regulatory requirements with respect to these tests. The CMS must hold a public meeting to solicit recommendations to update existing regulations related to clinical laboratories, and the Department of Health and Human Services must report specified information to Congress, including an assessment of the availability and use of laboratory-developed testing procedures during the COVID-19 (i.e., coronavirus disease 2019) response.

This bill expands existing requirements relating to supply shortages of life-saving drugs to also apply to life-saving medical devices. Generally, a manufacturer must (1) notify the Food and Drug Administration (FDA) of supply interruptions in certain circumstances, (2) provide for the expedited review of a new device that may mitigate the shortage, and (3) allow the FDA to authorize the importation of the device for emergency medical care.

Commission on America's Medical Security Act This bill requires the Department of Health and Human Services to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine to report on the security of the U.S. medical product supply chain (i.e., supply of drugs and devices). Among other things, the report shall * assess the dependence of the United States, including the private sector, states, and federal government, on critical drugs and devices sourced or manufactured outside of the United States; and * provide recommendations to address supply vulnerabilities or potential disruptions.

Commission on America's Medical Security Act This bill requires the Department of Health and Human Services to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine to report on the security of the U.S. medical product supply chain (i.e., supply of drugs and devices). Among other things, the report shall * assess the dependence of the United States, including the private sector, states, and federal government, on critical drugs and devices sourced or manufactured outside of the United States; and * provide recommendations to address supply vulnerabilities or potential disruptions.

Preventing Opioid and Drug Impairment in Transportation Act This bill addresses drug and alcohol testing for transportation-related activities. Specifically, the bill requires * the National Railroad Passenger Corporation (Amtrak) to report on methods it uses to ensure supervisors of employees in safety-sensitive positions receive the required training on how to detect drug and alcohol use; * the Department of Transportation (DOT) to determine whether to mandate that Amtrak locomotive engineers and conductors report arrests due to drug or alcohol offenses; * DOT to report on the ability of pipeline companies that operate from Canada or Mexico into the United States to conduct the same drug and alcohol tests of safety-sensitive personnel that are required in the United States; * DOT to amend its auditing program to improve the efficiency of certain drug and alcohol regulations related to testing contractors working in multiple states; * the National Highway Traffic Safety Administration to study the ways it can reduce and better detect impaired driving, including marijuana- and opioid-impaired driving; * DOT to conduct a study regarding the accuracy of on-site oral fluid screening for tetrahydrocannabinol and opiate presence in order to reduce the potential impact on traffic safety due to drug and polysubstance-impaired drivers; * the Government Accountability Office to review DOT's process for setting guidelines and drug testing requirements for transportation employees; and * reports on whether to add fentanyl to the drug testing panel and the status of the guidelines for hair testing of transportation employees.

Professional Boxing Safety Enhancement Act of 2020 This bill repeals a provision allowing a professional boxing match to meet an alternative requirement in effect under regulations of a boxing commission that provides protection of the health and safety of boxers and that is equivalent to requirements otherwise provided under the Professional Boxing Safety Act of 1996. A boxer shall provide with the application for a boxing license, or its renewal, an original or certified copy of the results of medical tests that (1) were performed by a laboratory during the calendar year for which the license is being issued or no earlier than 30 days before the application is submitted, and (2) show that the boxer is not infected with the human immunodeficiency virus or the hepatitis virus. The bill requires an ambulance and emergency medical personnel with appropriate resuscitation equipment (currently, one or the other) to be continuously present on site.

Ensuring Patient Access to Critical Breakthrough Products Act of2020 This bill provides for Medicare coverage of medical devices that are approved under the Food and Drug Administration (FDA) Breakthrough Devices Program. (Under the program, manufacturers work with the FDA to expedite the review and approval of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.) The bill allows designated medical breakthrough devices to be temporarily covered under Medicare during a three-year transitional period. The Centers for Medicare & Medicaid Services (CMS) must assign payment codes for such devices within three months of FDA approval. The CMS must also establish a process to allow for continued coverage after the transitional period has expired, taking into account any additional evidence or data the CMS deems necessary. The CMS must also provide for temporary and, where appropriate, permanent Medicare coverage of breakthrough devices for which there is no existing benefit category (i.e., classification).

This bill allows employers tax credits for domestic medical and drug manufacturing expenses and for advanced medical manufacturing equipment.

Horseracing Integrity and Safety Act of 2020 This bill recognizes the Horseracing Integrity and Safety Authority for purposes of developing and implementing a horseracing anti-doping and medication control program and a racetrack safety program. The authority shall establish an anti-doping and medication control standing committee and a racetrack safety standing committee to provide guidance to the authority on the development and maintenance of the programs. The Federal Trade Commission (FTC) shall have oversight over the authority. The authority shall submit to the FTC any proposed rule, standard, or procedure developed by the authority to carry out the horseracing anti-doping and medication control program or the racetrack safety program. The authority shall seek to enter into an agreement with the U.S. Anti-Doping Agency or an entity equal in qualification under which the entity acts as the anti-doping and medication control enforcement agency under this bill. Among the required elements of the horseracing safety program are sets of training and racing safety standards consistent with the humane treatment of horses, a system to maintain track surface quality, programs for injury and fatality analysis, investigation and disciplinary procedures, and an evaluation and accreditation program. The bill sets forth other provisions regarding (1) funding, conflicts of interest, and jurisdiction; (2) registration with the authority; (3) program enforcement; (4) rule violations and civil sanctions; (5) testing laboratories; (6) review of final decisions of the authority by an administrative law judge; (7) unfair or deceptive acts or practices; and (8) agreements with state racing commissions.

Affordable and Safe Prescription Drug Importation Act This bill addresses the importation of drugs from Canada and other foreign countries. The bill requires the Food and Drug Administration (FDA) to promulgate regulations within 180 days permitting wholesalers, pharmacies, and individuals to import certain prescription drugs from Canada. After two years, The FDA, may permit the importation of prescription drugs from other countries. The bill establishes a process for certifying foreign sellers—a licensed foreign pharmacy or foreign wholesale distributor.

Affordable and Safe Prescription Drug Importation Act This bill addresses the importation of drugs from Canada and other foreign countries. The bill requires the Food and Drug Administration (FDA) to promulgate regulations within 180 days permitting wholesalers, pharmacies, and individuals to import certain prescription drugs from Canada. After two years, The FDA, may permit the importation of prescription drugs from other countries. The bill establishes a process for certifying foreign sellers—a licensed foreign pharmacy or foreign wholesale distributor.

Ensuring Patient Access to Critical Breakthrough Products Act of2019 This bill provides for Medicare coverage of medical devices that are approved under the Food and Drug Administration (FDA) Breakthrough Devices Program. (Under the program, manufacturers work with the FDA to expedite the review and approval of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.) The bill allows designated medical breakthrough devices to be temporarily covered under Medicare during a three-year transitional period. The Centers for Medicare & Medicaid Services (CMS) must assign payment codes for such devices within three months of FDA approval. The CMS must also establish a process to allow for continued coverage after the transitional period has expired, taking into account any additional evidence or data the CMS deems necessary. The CMS must also provide for temporary and, where appropriate, permanent Medicare coverage of breakthrough devices for which there is no existing benefit category (i.e., classification).

Horseracing Integrity and Safety Act of 2020 This bill recognizes the Horseracing Integrity and Safety Authority for purposes of developing and implementing a horseracing anti-doping and medication control program and a racetrack safety program. The authority shall establish an anti-doping and medication control standing committee and a racetrack safety standing committee to provide guidance to the authority on the development and maintenance of the programs. The Federal Trade Commission (FTC) shall have oversight over the authority. The authority shall submit to the FTC any proposed rule, standard, or procedure developed by the authority to carry out the horseracing anti-doping and medication control program or the racetrack safety program. The authority shall seek to enter into an agreement with the U.S. Anti-Doping Agency or an entity equal in qualification under which the entity acts as the anti-doping and medication control enforcement agency under this bill. Among the required elements of the horseracing safety program are sets of training and racing safety standards consistent with the humane treatment of horses, a system to maintain track surface quality, programs for injury and fatality analysis, investigation and disciplinary procedures, and an evaluation and accreditation program. The bill sets forth other provisions regarding (1) funding, conflicts of interest, and jurisdiction; (2) registration with the authority; (3) program enforcement; (4) rule violations and civil sanctions; (5) testing laboratories; (6) review of final decisions of the authority by an administrative law judge; (7) unfair or deceptive acts or practices; and (8) agreements with state racing commissions.

First Responder Medical Device Tax Relief Act This bill exempts a qualified emergency medical device from the excise tax on medical devices. The bill defines "qualified emergency medical device" as a medical device furnished by first responders or ambulance services in providing out-of-hospital or pre-hospital care, or transport to a medical care facility, for individuals with illnesses, injuries, or other medical emergencies or in need of medical transport, extrication, or evacuation.

Medical Innovation Acceleration Act of 2020 This bill exempts non-invasive diagnostic devices from the regulatory authority of the Food and Drug Administration. The bill definesnon-invasive diagnostic deviceas one that does not penetrate the skin or any other membrane of the body, is not inserted or implanted into the body, causes no more than ephemeral compression or temperature changes to in situ bodily tissues, and does not subject bodily tissues to ionizing radiation.

Biological Implant Tracking and Veteran Safety Act of 2019 This bill requires the Department of Veterans Affairs (VA) to adopt and implement a device identification system for use in identifying biological implants intended for use in medical procedures conducted in VA facilities. The VA may adopt the system developed by the Food and Drug Administration (FDA) or may develop its own comparable system. Additionally, the VA shall implement a compatible system for tracking the biological implants from human donor or animal source to implantation. The bill requires the VA to implement compatible inventory controls so patients can be notified if they have received a biological implant in a VA facility that is subject to a recall. The bill prescribes requirements for vendors from which the VA may procure biological implants of human and nonhuman origin. Under the bill, the VA shall (1) procure such implants under General Services Administration Federal Supply Schedules unless they are not available under such schedules, (2) accommodate reasonable vendor requests to undertake specified outreach efforts to educate VA medical professionals about the use and efficacy of implants, and (3) procure biological implants that are unavailable under such schedules using competitive procedures in accordance with the Federal Acquisition Regulation. In procuring biological implants, the VA must permit a vendor to use any of the accredited entities identified by the FDA as an issuing agency. Certain biological implants may be temporarily procured by the VA without relabeling under the standard identification system.

Help Onshore Manufacturing Efficiencies for Drugs and Devices Act or the HOME Act This bill contains provisions related to critical drugs and medical devices. The bill establishes within the Department of Health and Human Services (HHS) the Center for Domestic Advanced Manufacturing of Critical Drugs and Devices. The center shall establish and implement a program to provide grants and forgivable loans to support investment in advanced manufacturing for the domestic production of critical drugs, medical devices, and active pharmaceutical ingredients. Furthermore, a supplemental application for a critical drug approved by the Food and Drug Administration (FDA) may receive expedited review if, among other requirements, the applicant plans to produce the drug domestically after the approval of the supplemental application. (A supplemental application generally involves a change, such as a manufacturing change, to an existing application for FDA approval.) The bill also authorizes HHS and the Department of Defense to enter into multiyear high-volume contracts to purchase critical drugs and medical devices.

Manufacturing API, Drugs, and Excipients in America Act of 2020 or the MADE in America Act of 2020 This bill establishes a tax credit for taxpayers engaged in medical production activities in certain areas and contains other provisions related to pharmaceuticals. An eligible taxpayer may claim a tax credit equal to 30% of qualified expenditures related to the production of pharmaceuticals, medical devices, or other related items in a designated qualified opportunity zone with a poverty rate higher than 30%. In addition, the Food and Drug Administration shall continue a program to evaluate new drug manufacturing technologies included in an application for approval of a drug or biological product. The bill imposes various requirements on this program, including deadlines for evaluating such a technology. Furthermore, the Department of Health and Human Services shall establish or expand programs to promote regulatory consistency and cooperation with drug regulatory authorities in other countries.