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Without doubt, 2020 was a year like no other. To use an often-repeated — some might say overused — term, 2020 was unprecedented, for everyone and especially for the pharmaceutical industry.
In response to the global public health crisis caused by the COVID-19 pandemic, which stretched nearly to the breaking point the ability of federal, state, and local governments to provide health care resources to people across the country, the pharmaceutical industry delivered — and continues to innovate — promising vaccines and therapies.
As the pandemic forced the slowdown of much of life as we know it, government regulators at the state and federal levels continued to grapple with the opioid crisis, including conducting investigations and enforcement actions — and finally, last year, reaching settlements with the parties responsible for the public health catastrophe impacting millions of families across the country.
In addition to meeting the challenges of these two ongoing public health emergencies, government regulators, including the Food and Drug Administration, the Department of Justice, and the Office of Inspector General, continued to vigorously pursue their more ordinary work, conducting investigations and enforcing the laws and regulations governing the pharmaceutical and life sciences industries.
2020 was a year for the record books in so many ways, and Loeb’s FDA Regulatory & Compliance team continues to monitor and report on the developments that impact our pharmaceutical and life sciences clients. We’re pleased to present our FDA Regulatory & Compliance 2020 Year in Review, featuring highlights of the most notable developments of this year as well as some of our predictions for 2021.
- Summary
- Pandemic-Related Activities
- Regulatory Activities
- Enforcement – Investigations, Suits and Settlements
- 2021 – What to Expect
The Loeb team also wants to take a moment to wish you good health and safety as we move past this very challenging year and look forward to better times ahead in 2021.
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Co-Chair, Life Sciences