Premier issues a letter in response to Senate Health, Education, Labor and Pensions Committee Chair Murray and Ranking Member Burr’s bipartisan request for stakeholder input in the development of consensus policy proposals to improve the nation’s public health infrastructure and preparedness.
In its comments, Premier reflects on the lessons learned during COVID-19 response efforts and provides recommendations to modernize the country’s data infrastructure, strengthen the Strategic National Stockpile, mitigate drug and device shortages, combat the gray market, and leverage technology to prevent infections in nursing homes.
Included in Premier’s comments are recommendations for Congress to build on provisions in the CARES Act to prevent drug shortages by:
· Requiring manufacturers, including API manufacturers, to report the volume of product that is manufactured in each FDA registered facility;
· Expanding the FDA drug shortage list to include regional shortages as well as shortages based on strength and dosage form; and
· Temporarily extending expiration dates for drug shortage products if determined to be scientifically sound.
Premier also underscores that more can be done to make FDA’s device shortage program robust and akin to the drug shortage program at the FDA. This can be accomplished by:
· Requiring device manufacturers to provide information about production volume for their devices, including for the raw materials;
· Requiring device manufacturers to perform risk assessments, implement risk management plans, and identify alternate suppliers and manufacturing sites; and
· Providing FDA with authority to allow temporary importation of unapproved devices, with appropriate scientific and regulatory controls, when it’s in the interest of the public health.More COVID-19 coverage HERE.