Drug Shortages Prevention and Quality Improvement Act This bill addresses shortages of essential drugs and related issues. (Generally, an essential drug is one that is life-supporting, life-sustaining, or intended to treat or prevent a debilitating condition.) The Food and Drug Administration (FDA) may require a manufacturer of an essential drug to (1) submit data, or conduct studies to gather data, to determine the longest supported expiration date of a drug; or (2) make labeling changes regarding a drug's expiration period based on data provided under this bill or otherwise available to the FDA. The bill establishes civil monetary penalties for a manufacturer that (1) refuses such a request to provide data or modify a drug label's expiration information, or (2) fails to meet certain requirements to provide to the FDA timely information about essential drug shortages. The Government Accountability Office must conduct a study examining the process by which prescription drug manufacturers provide shelf life data to the FDA. The FDA must establish a pilot program to assess the facilities and processes of participating manufacturers of prescription sterile injectable drugs that have been deemed essential under a specified executive order. The assessment shall cover topics including supply chain management, manufacturing strategy and operations, and workforce management. Furthermore, the FDA must provide grants to certain nonprofit entities and institutions of higher education that agree to participate in the above pilot program. The grant funds must be used to upgrade the recipient's drug manufacturing facilities to utilize advanced manufacturing capabilities.
Sen. Benjamin L. Cardin
Sponsored bills
Prevent Interruptions in Physical Therapy Act of 2021 This bill allows a physical therapist to receive payment under Medicare for services provided to the physical therapist's patients by another physical therapist through a qualifying temporary arrangement, regardless of the geographic area or population served. Currently, physical therapists may only receive payment with respect to such arrangements for services provided in medically underserved, rural, or health professional shortage areas.
This concurrent resolution recognizes the disparity in wages paid to Black women and its impact on women, families, and the nation, and reaffirms Congress' support for ensuring equal pay and closing the gender wage gap.
This resolution recognizes and expresses support for efforts to promote democracy and human rights in Cuba.
Food Labeling Modernization Act of 2021 This bill imposes additional labeling requirements for food and addresses related issues. A food intended for human consumption must include on its principal display panel a summary of nutritional information using a system that (1) clearly distinguishes between products of greater or lesser nutritional value; and (2) uses standardized symbols to provide warning about products that are high in certain substances, such as trans fats. The Food and Drug Administration (FDA) must promulgate regulations establishing the requirements for such a system. Labels that use certain terms, such as whole wheat , fruit , or vegetable , must include additional information, such as the amount or quantity of that item in the food. The FDA must promulgate certain regulations relating to the use of the terms natural or healthy on food labels. The bill also imposes labeling requirements for certain foods that contain added coloring, added flavoring, phosphorus, caffeine, gluten, allulose, polydextrose, sugar alcohols, or isolated fibers. The FDA may, by regulation, deem a food ingredient to be a major food allergen. The FDA must also impose certain restrictions on the types of beverages that may be identified as infant formula or formula. The FDA must require food manufacturers to submit all information on the label of a food offered for sale in package form and update such submissions as necessary. The information must be made available in a public database on the FDA's website.
This bill designates the area between the intersections of 16th Street, NW and Fuller Street, NW and 16th Street, NW and Euclid Street, NW in the District of Columbia as Oswaldo Paya Way.
This resolution expresses the condolences of the Senate regarding the death of the Honorable Carl Levin, former Senator for Michigan.
This bill extends through October 18, 2021, the order issued by the Centers for Disease Control and Prevention (CDC) titled Temporary Halt in Residential Evictions To Prevent the Further Spread of COVID-19 and published on September 4, 2020. The bill also permits the CDC to further extend the order as it determines necessary.
This resolution expresses the condolences of the Senate regarding the death of the Honorable Mike Enzi, former Senator for Wyoming.
Reducing Unnecessary Senior Hospitalizations Act of 2021 or the RUSH Act of 2021 This bill establishes a program through which qualified group practices may provide certain items and services that are normally provided at hospital emergency departments to individuals who (1) are entitled to Medicare hospital services, (2) are enrolled for Medicare medical services, and (3) reside in qualified skilled nursing facilities.