In FDLI Update, Attorneys Examine Federal Funding of Medical Countermeasures: Opportunities, Risks & Enforcement Trends
Life sciences companies must be mindful of both the opportunities and risks that are associated with accepting government funding for pandemic preparedness initiatives and ensure that their compliance infrastructure is intently focused on compliance with both regulatory and contractual commitments. This topic is examined in a Food and Drug Law Institute FDLI Update article authored by partner John Bueker, co-chair of the global litigation & enforcement group, life sciences regulatory & compliance counsel Beth Weinman and associate Jenna McCarthy.
The authors explain how the government’s focus on pandemic response and preparedness since the onset of the COVID-19 pandemic has led to significant federal spending for the development, manufacture, and distribution of medical countermeasures. Though this funding continues to provide immense opportunities for the life sciences industry, these opportunities are not without risk. If patient safety issues arise or potential non-compliances with FDA requirements are uncovered in connection with research, manufacturing, or marketing of these important medical products, the federal government will likely look to the False Claims Act (FCA) to try and recover money paid out by federal programs.
The authors note that taking steps to mitigate such risks, especially by investing in a robust compliance infrastructure, will enable companies to capitalize on opportunities to obtain financial support for infrastructure, research and development investments, and steady supply contracts while allowing a firm to contribute to the national effort to prepare for future threats to the public health.