Drug Safety, Medical Device, And Laboratory Regulation
US Congress 116th Congress
To provide for quality assurance of COVID-19 reimbursements and reporting. [HB-7037]
(1) establishes documentation requirements for testing, treatment, and reporting related to COVID-19 (i.e., coronavirus disease 2019); and (2) makes it unlawful to knowingly report a false diagnosis of COVID-19. To receive a federal reimbursement for the cost of a COVID-19 diagnostic test or treatment, the request for reimbursement must document that the administered COVID-19 test has been approved, cleared, or authorized by the Food and Drug Administration.Further, the Centers for Disease Control and Prevention must exclude from its official COVID-19
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Sponsored by: Rep. Bill Posey
Introduced In House on 05/27/2020
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Right to Test Act [HB-7017]
To allow States to approve the use of diagnostic tests during a public health emergency.
Sponsored by: Rep. Tom Emmer
Introduced In House on 05/26/2020
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Compensation for Americans Act of 2020 [HB-7007]
Requires the Department of State to negotiate with China to secure compensation for China's distortion of information related to the spread of COVID-19 (i.e., coronavirus disease 2019). The bill also contains other China-related provisions, such as those imposing sanctions on certain Chinese individuals and entities. As part of such negotiations, the President shall (1) freeze Chinese assets subject to U.S. jurisdiction; (2) suspend the required review of any proposed acquisition of a U.S. entity by a Chinese entity; (3) impose sanctions on Chinese
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Sponsored by: Rep. Ann Wagner
Introduced In House on 05/22/2020
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Stop Coronavirus Scams Act [HB-7002]
To amend title 18, United States Code, to increase the penalties for trafficking in counterfeit goods, services, or drugs related to a major disaster or emergency, and for other purposes.
Sponsored by: Rep. Jason Smith
Introduced In House on 05/22/2020
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Pandemic Anti-Monopoly Act of 2020 [HB-6989]
Places a moratorium on certain mergers and acquisitions during the COVID-19 (i.e., coronavirus disease 2019) pandemic. Specifically, the bill prohibits certain transactions such as acquisitions (1) by firms with over $100 million in revenue; (2) by financial institutions or equity funds with over $100 million in capitalization; and (3) involving firms with exclusive patents pertaining to COVID-19 pandemic-related production, manufacturing, distribution, or infrastructure. However, a waiver may be granted if the participating firms demonstrate that
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Sponsored by: Rep. Jesus Garcia
Introduced In House on 05/22/2020
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PART Act Pharmaceutical Accountability, Responsibility, and Transparency Act [S.3781]
A bill to increase reporting of, help mitigate potential shortages related to, and promote, accountability and transparency for pharmaceuticals and medical devices.
Sponsored by: Sen. Gary Peters
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 05/20/2020
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HOME Act Help Onshore Manufacturing Efficiencies for Drugs and Devices Act [S.3780]
A bill to encourage domestic advanced manufacturing of critical drugs and devices in order to address economic, health, and security concerns, combat shortages of critical drugs and devices, and promote increased domestic diversification of, and independence from foreign reliance on, pharmaceutical and medical device supply chains.
Sponsored by: Sen. Gary Peters
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 05/20/2020
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Medical Innovation Acceleration Act of 2020 [HB-6925]
Exempts non-invasive diagnostic devices from the regulatory authority of the Food and Drug Administration. The bill defines non-invasive diagnostic device as 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.
Sponsored by: Rep. Andy Biggs
Introduced In House on 05/19/2020
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MADE in America Act of 2020 Manufacturing API, Drugs, and Excipients in America Act of 2020 [HB-6930]
To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes.
Sponsored by: Rep. H. Morgan Griffith
Introduced In House on 05/19/2020
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Right to Test Act [S.3769]
Authorizes a state's public health department, or another entity designated by the state's governor, to approve a diagnostic test or diagnostic device (e.g., a test for the virus that causes COVID-19, or coronavirus disease 2019) for use during a public health emergency. Unless requested by the governor of the state, the Food and Drug Administration (FDA) must not, during the emergency, engage in certain enforcement actions related to such a test or device. Not later than 180 days following the end of the public health emergency, the FDA must review
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Sponsored by: Sen. Mike Lee
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 05/19/2020
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Safe and Secure Medicine Supply for Hardworking Americans Act of 2020 [HB-6885]
To amend the Federal Food, Drug, and Cosmetic Act to prohibit the importation of a drug or device that was manufactured at a banned foreign facility, to create incentives for pharmaceutical or device companies to increase manufacturing capacity in the United States, and for other purposes.
Sponsored by: Rep. Bill Flores
Introduced In House on 05/15/2020
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COVID–19 Testing Inventory Act [HB-6901]
Requires the Department of Health and Human Services to share information on a public website about tests to diagnose COVID-19 (i.e., coronavirus disease 2019) or detect the virus that causes the disease. The website must include, among other information, a list of testing sites and the number and type of diagnostic tests available for use in each state, territory, or tribe.
Sponsored by: Rep. Anna Eshoo
Introduced In House on 05/15/2020
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COVID–19 Accountability Act [HB-6863]
Authorizes sanctions in relation to the Chinese government's response to the COVID-19 (i.e., coronavirus disease 2019) outbreak. It also increases the research tax credit and imposes requirements related to the acquisition of items for the Strategic National Stockpile. The President shall periodically certify to Congress that the Chinese government (1) is cooperating with efforts related to the COVID-19 outbreak, (2) has prohibited wet markets, and (3) has released and dropped all charges for anyone involved in protests in Hong Kong related to COVID-19.
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Sponsored by: Rep. Gus Bilirakis
Introduced In House on 05/14/2020
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COVID–19 Testing Inventory Act [S.3738]
Requires the Department of Health and Human Services to share information on a public website about tests to diagnose COVID-19 (i.e., coronavirus disease 2019) or detect the virus that causes the disease. The website must include, among other information, a list of testing sites and the number and type of diagnostic tests available for use in each state, territory, or tribe.
Sponsored by: Sen. Edward Markey
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 05/14/2020
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COVID–19 Emergency Medical Supplies Enhancement Act of 2020 [HB-6858]
To enhance authorities under the Defense Production Act of 1950 to respond to the COVID-19 emergency, to provide additional oversight of such authorities, and to require a strategy on securing supply chains for medical materials, and for other purposes.
Sponsored by: Rep. Pramila Jayapal
Introduced In House on 05/13/2020
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EMPIL-DOC Act Expanding Medical Partnerships with Israel to Lessen Dependence On China Act [S.3722]
Authorizes a bilateral grant program with Israel to develop health technologies, with an emphasis on the use of technology, personalized medicine, and data in relation to COVID-19 (i.e., coronavirus disease 2019). Technologies to be developed through this program include, among others, artificial intelligence, respiratory assist devices, and diagnostic tests. In addition, the program conditions funding on a matching contribution from the government of Israel.
Sponsored by: Sen. Susan Collins
Read Twice And Referred To The Committee On Foreign Relations. on 05/13/2020
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The Heroes Act [HB-6800]
Responds to the COVID-19 (i.e., coronavirus disease 2019) outbreak and its impact on the economy, public health, state and local governments, individuals, and businesses. Among other things, the bill provides FY2020 emergency supplemental appropriations to federal agencies; provides payments and other assistance to state, local, tribal, and territorial governments; provides additional direct payments of up to $1,200 per individual; expands paid sick days, family and medical leave, unemployment compensation, nutrition and food assistance programs,
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Sponsored by: Rep. Raul Grijalva
Committee On Small Business And Entrepreneurship. Hearings Held. on 07/23/2020
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EMPIL–DOC Act Expanding Medical Partnerships with Israel to Lessen Dependence on China Act [HB-6829]
Authorizes a bilateral grant program with Israel to develop health technologies, with an emphasis on the use of technology, personalized medicine, and data in relation to COVID-19 (i.e., coronavirus disease 2019). Technologies to be developed through this program include, among others, artificial intelligence, respiratory assist devices, and diagnostic tests. In addition, the program conditions funding on a matching contribution from the government of Israel.
Sponsored by: Rep. Alexander Mooney
Introduced In House on 05/12/2020
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To direct the Comptroller General of the United States to submit a report describing the response of certain entities to the COVID-19 pandemic with respect to the development, regulatory evaluation, and deployment of diagnostic tests. [HB-6839]
Requires the Government Accountability Office (GAO) to report on diagnostic tests to diagnose COVID-19 (i.e., coronavirus disease 2019) or detect the virus that causes the disease. Specifically, the report must describe the response of, among others, laboratories, diagnostic test manufacturers, and government entities with respect to the development, regulatory evaluation, and deployment of diagnostic tests. The GAO must also assess standards, guidance, clinical processes, and intergovernmental coordination related to COVID-19 testing.
Sponsored by: Rep. Abigail Spanberger
Introduced In House on 05/12/2020
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COVID–19 Accountability Act [S.3683]
Authorizes sanctions in relation to the Chinese government's response to the COVID-19 (i.e., coronavirus disease 2019) outbreak. It also increases the research tax credit and imposes requirements related to the acquisition of items for the Strategic National Stockpile. The President shall periodically certify to Congress that the Chinese government (1) is cooperating with efforts related to the COVID-19 outbreak, (2) has prohibited wet markets, and (3) has released and dropped all charges for anyone involved in protests in Hong Kong related to COVID-19.
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Sponsored by: Sen. Martha McSally
Read Twice And Referred To The Committee On Finance. on 05/11/2020