Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 This bill 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 (1) the product has been approved in one of the specified countries, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product. The FDA may decline approval if the FDA determines that the product is not safe or effective. The FDA may condition reciprocal approval on the conduct of postmarket studies. The FDA must issue a decision on whether to grant a request for reciprocal marketing approval within 30 days of receiving the request. Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.
Unconscionable Pricing Act This bill makes it unlawful for any person to sell, rent, or lease an emergency supply at an unconscionable price during a federally-declared emergency. A price is unconscionable if (1) it exceeds 10% of the average price for the same or similar emergency supply during the 30 days before the emergency was declared, and (2) such price increase is not related to the reasonable costs incurred to sell or rent the supply. The bill provides authority for the Federal Trade Commission and state attorneys general to enforce the requirements of this bill.
Right to Test Act This bill 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 and make a final determination concerning approval of the test or device.
COVID-19 Testing, Reaching, And Contacting Everyone (TRACE) Act This bill authorizes the Centers for Disease Control and Prevention to award grants for testing, contact tracing, monitoring, and other activities to address COVID-19 (i.e., coronavirus disease 2019). Entities eligible for these grants include certain clinics and hospitals, nonprofits, and schools.
This resolution expresses support for a National Day of Mourning for the lives lost as a result of COVID-19 (i.e., coronavirus disease 2019).
This resolution expresses the opposition of the House of Representatives to any plans by the Department of Defense to deliver COVID-19 (i.e., coronavirus disease 2019) vaccines to prisoners held at United States Naval Station, Guantanamo Bay, Cuba, until all Americans have had the opportunity to be vaccinated. Additionally, the resolution asserts that the government should prioritize U.S. citizens for COVID-19 vaccinations.
This resolution supports the designation of National Sanctity of Life Day.
This resolution expresses support for women nationwide to have access to comprehensive, convenient, compassionate, life-affirming, and high-quality health care.
This resolution expresses support for National Hydrocephalus Awareness Month. (Hydrocephalus is a buildup of fluid in the brain.)
Right to Test Act This bill 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 and make a final determination concerning approval of the test or device.
Cancel the Coin Act This bill prohibits the Department of the Treasury from minting or issuing any coin, including platinum bullion coins and proof platinum coins, having a nominal or face value exceeding $200.
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 This bill 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 (1) the product has been approved in one of the specified countries, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product. The FDA may decline approval if the FDA determines that the product is not safe or effective. The FDA may condition reciprocal approval on the conduct of postmarket studies. The FDA must issue a decision on whether to grant a request for reciprocal marketing approval within 30 days of receiving the request. Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.
