December 22, 2021 - COVID-19, FDA, Healthcare, Pharma

Key Takeaways from FDLI’s Enforcement, Litigation, and Compliance Conference Keynote Address

FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the Consumer Protection Branch in 2021, and highlighted areas of focus and continued priority for 2022.

Below are three key areas of focus:

  1. COVID Fraud. Misconduct related to the pandemic and COVID-19 was and remains a top priority. The Consumer Protection Branch will continue its collaboration with the Federal Trade Commission (FTC) to address COVID fraud and prevent fake and unapproved treatments and cures from reaching consumers. Rao noted that the FTC is referring an increasing number of civil penalty actions to the Consumer Protection Branch, and DOJ will continue to pursue civil and criminal penalties where applicable.
  2. Opioids. The opioid epidemic remains a key area of focus for the Consumer Protection Branch. Rao pointed to examples of recent enforcement action, including Walmart and Purdue, and noted that the Consumer Protection Branch continues to pursue injunctive and civil penalty actions against local pharmacies, pharmacists, and prescribers in addition to manufacturers. Rao reiterated that it is important for manufacturers creating a product that can be used to manufacture a controlled substance to know their customers.
  3. Clinical Trial Fraud. Rao highlighted two recent cases in Southern Florida, Unlimited Medical Research and Tellus Clinical Research, both of which involved clinical trial fraud schemes involving fabricated data and falsifying data and medical records. The Consumer Protection Branch expects to bring further actions in the coming months.  The increase in use of remote clinical trial monitoring during the pandemic may contribute to an increase in clinical trial fraud enforcement actions going forward.

For questions on any of the topics discussed, please contact the authors or a member of MoFo’s FDA Regulatory + Compliance practice.