Drug Safety, Medical Device, And Laboratory Regulation
US Congress 116th Congress
Global Health Security Act of 2020 [S.3656]
A bill to authorize a comprehensive, strategic approach for United States foreign assistance to developing countries to strengthen global health security, and for other purposes.
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COVID–19 International Response and Recovery Act of 2020 [S.3669]
A bill to respond to the global COVID-19 pandemic, and for other purposes.
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Protecting Our Pharmaceutical Supply Chain from China Act of 2020 [S.3635]
A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of, or reimbursement for, drugs manufactured in China, and for other purposes.
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Facilitating Innovation to Fight Coronavirus Act [S.3630]
Provides immunity from civil liability to health care providers for certain actions taken during the COVID-19 (i.e., coronavirus disease 2019) public health emergency and lengthens the terms of certain medical patents related to the treatment of COVID-19. Specifically, when testing for or treating COVID-19 during the public health emergency, a health care provider may not be held liable in any federal, state, or local civil proceeding for (1) using or modifying a medical device for an unapproved use or indication; (2) practicing without a license
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Securing America’s Medicine Cabinet Act of 2020 [HB-6708]
To support the advanced manufacturing technologies program of the Food and Drug Administration, to establish National Centers of Excellence in Advanced Pharmaceutical Manufacturing, and for other purposes.
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LOSS Act of 202 Limit Ongoing Shortages and Stabilize Supply Act of 2020 [HB-6660]
To amend the Federal Food, Drug, and Cosmetic Act to require the holders of approved applications for drugs to conduct a risk assessment to identify and evaluate risks to their supply chain and develop, maintain, and implement risk mitigation plans to address such risks, and for other purposes.
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Prescription for American Drug Independence Act of 2020 [HB-6670]
Requires the Department of Health and Human Services to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine to (1) establish a committee of experts on drug-supply issues, (2) convene a symposium to recommend strategies for ending U.S. dependence on foreign manufacturing of critical drugs, and (3) report on the symposium's proceedings.
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Protecting Our Pharmaceutical Supply Chain from China Act of 2020 [HB-6482]
To require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes.
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Responsible Relief for Americans Act [HB-6396]
Revises and establishes economic assistance measures in response to COVID-19 (i.e., coronavirus disease 2019). Specifically, the bill provides funding for and authorizes the Small Business Administration (SBA) to guarantee paycheck protection loans made to small businesses. Recipients of such loans are eligible for forgiveness of amounts expended for specified costs such as payroll. Small businesses may request an advance of up $10,000 on an SBA disaster loan for which they have applied in response to COVID-19. Further the bill requires the SBA
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CARES Act Coronavirus Aid, Relief, and Economic Security Act [S.3548]
Addresses economic impacts of, and otherwise responds to, the COVID-19 (coronavirus) outbreak. The bill authorizes emergency loans to distressed businesses, including air carriers, and suspends certain aviation excise taxes. With respect to small businesses, the bill establishes, and provides funding for, forgivable bridge loans; and provides additional funding for grants and technical assistance. The bill also provides funding for $1,200 tax rebates to individuals, with additional $500 payments per qualifying child. The rebate begins phasing out
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Protecting Our Pharmaceutical Supply Chain from China Act of 2020 [S.3537]
A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes.
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Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 [S.3545]
Establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country for the treatment or prevention of COVID-19 (i.e., coronavirus disease 2019) and there is an unmet need relative to certain diseases. Specifically, the bill requires the product's sponsor to demonstrate, among other things, that the product has been approved for the treatment or prevention of COVID-19
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VITAL Act of 2020 Verified Innovative Testing in American Laboratories Act of 2020 [S.3512]
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
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Commission on America’s Medical Security Act [HB-6282]
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
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Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 [HB-6260]
Establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country for the treatment or prevention of COVID-19 (i.e., coronavirus disease 2019) and there is an unmet need relative to certain diseases. Specifically, the bill requires the product's sponsor to demonstrate, among other things, that the product has been approved for the treatment or prevention of COVID-19
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Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 [HB-6260]
Establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country for the treatment or prevention of COVID-19 (i.e., coronavirus disease 2019) and there is an unmet need relative to certain diseases. Specifically, the bill requires the product's sponsor to demonstrate, among other things, that the product has been approved for the treatment or prevention of COVID-19
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Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2020 [HB-6258]
Establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country and there is an unmet need. Specifically, the bill requires the product's sponsor to demonstrate, among other things, that their product has been approved in one of the specified countries, the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and there
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Cameron’s Law [HB-6238]
Increases the rate of the tax credit for clinical testing expenses for rare diseases or conditions from 25% to 50% (orphan drug tax credit). The bill also requires the Centers for Disease Control and Prevention to complete a study and report on enhancing and expanding the infrastructure to track the epidemiology of rare diseases or conditions.
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Preventing Essential Medical Device Shortages Act of 2020 [S.3468]
A bill to require the manufacturers of certain essential medical devices to notify the Food and Drug Administration when such manufacturers become aware of a circumstance that could lead to a shortage of such devices, and for other purposes.
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Commission on America’s Medical Security Act [S.3478]
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
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