New leadership means shifting enforcement priorities at the Department of Justice, and an anticipated uptick in enforcement actions. While life sciences companies have always received significant attention from DOJ, President Biden’s policy priorities, along with the ongoing COVID-19 pandemic, brings these companies even further into focus. This webinar will explore likely DOJ areas of focus and policy shifts impacting the life sciences industry, such as:
- The Biden Administration’s general focus on the life sciences industry, and the anticipated increase in collaboration between DOJ, HHS, and the FDA;
- Principal enforcement tools – the False Claims Act, the Food, Drug & Cosmetic Act, and the Anti-Kickback Statute;
- Fraud and abuse related to COVID-19 treatment, testing, and vaccines, as well as stimulus funding, and misuse of pandemic-related regulatory waivers;
- Clinical trial fraud, including attempts to broaden the scope of entities and individuals held liable for such misconduct;
- Investigations and enforcement related to the opioid crisis;
- Protection of healthcare consumers, including focus on drug pricing; and
- Scrutiny and enforcement of digital health tools and electronic health records.
If you have questions concerning this roundtable webinar, email Chayako Williams at email@example.com.
King & Spalding is an accredited provider of CLE credit in California, Georgia, Illinois, New York and Texas. We can issue reciprocal credit for attorneys licensed in Connecticut, Florida, and New Jersey. We will apply for credit in Colorado, North Carolina and Virginia (subject to MCLE Board approval). For jurisdictions not listed, attendees are provided with a Universal Certificate of Attendance. New York licensed attorneys: Transitional/Appropriate for newly-admitted and experienced attorneys. Financial aid is available for qualifying lawyers. For CLE-related questions, please contact Gisel Arias, firstname.lastname@example.org. King & Spalding, 1180 Peachtree Street NE, Atlanta, GA 30309. CA Provider #10947.