The CARES Act: 5 Things to Know for the Life Sciences, Pharmaceutical, and Medical Device Industries
By now, you have probably heard of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), an approximately $2 trillion stimulus package that was signed into law on March 27, 2020. The CARES Act is comprehensive and implements several regulatory adjustments that impact numerous industries, ranging from agribusiness to healthcare to education. Under Title III, Sec. 3101 et seq. of the CARES Act, included are significant provisions, in the context of ensuring medical product supply chain security, that affect the life sciences, pharmaceutical, and medical device industries. Here are the top 5 initiatives that your business should be aware of and consider:
- A requirement that the strategic national stockpile include personal protective equipment (PPE), ancillary medical supplies, and other supplies for the administration of drugs, vaccines, other biological products, medical devices, and diagnostic tests (Sec. 3102, amending the Public Health Service Act);
- Provision of limited liability protection for manufacturers of personal respiratory protective equipment, now qualified as “covered countermeasures” during a public health emergency (Sec. 3103, amending the Public Health Service Act);
- Priority regulatory review and inspections of certain drug applications, including an expedition of the development and review process for zoonotic animal drugs, and of medical devices to mitigate or prevent a shortage of devices critical for public health (Secs. 3111, 3121, and 3302, amending Chapter V of the Food, Drug and Cosmetic Act (FDCA));
- A requirement that certain drug manufacturers, or manufacturers of a device associated with certain drugs’ production, develop redundancy risk management plans in light of expedited regulatory review and inspections (Sec. 3111);
- A requirement that manufacturers of drugs and medical devices critical for public health during a public health emergency provide advance notice (6 months or as soon as practicable) to the Secretary regarding an anticipated discontinuance or interruption to manufacture and supply (Sec. 3121, amending Chapter V of the FDCA and the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA)).
The CARES Act also presents increased and new federal funding opportunities through the Food & Drug Administration (FDA), the National Institute for Innovation in Manufacturing Biopharmaceuticals, the National Institute of Standards and Technology, the National Science Foundation (NSF), and the National Institute of Health (NIH) for innovations in research, development, and manufacture in the following areas:
- Development and manufacture of COVID-19 related critical medications, new countermeasures, and biomedical supplies and equipment;
- Identification of and enforcement against counterfeit COVID-19 related medications;
- Emergency use authorization for pre- and post-market COVID-19 related countermeasures, therapies, vaccines, and research;
- Research and measurement science support for accurate and rapid testing of COVID-19; and
- Research through the Rapid Response Research (RAPID) program and others of COVID-19 prevalence, history, genetics, transmission, etiology, epidemiology, and virulence.
If you have any questions about how these provisions or others under the CARES Act impact your business, or if you need assistance pursuing any of these new funding opportunities, our team at Bernstein Shur can help. Please contact Attorney Christina A. Ferrari at firstname.lastname@example.org and (603) 665-8827.