Lexology January 19, 2022
Skadden Arps Slate Meagher & Flom LLP

Takeaways

  • Despite predictions that the Biden administration would devote increased enforcement resources to the life sciences industry broadly, so far, the FDA and DOJ have focused their efforts on COVID-related conduct.
  • Although both the FDA and DOJ experienced lengthy delays in appointment and confirmation of top officials, the DOJ has recently announced new policies regarding corporate prosecutions, which could have significant consequences for life sciences companies.
  • The question remains: Will 2022 see an uptick in enforcement and policy changes or will the focus continue to be on COVID-related misconduct?

FDA Inspections Are Sharply Down and Enforcement Has Shifted to COVID Products

Fiscal year 2021 saw a dramatic drop in U.S. Food and Drug Administration (FDA) inspection activity. The...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma / Biotech
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