AGG Food & Drug Newsletter - February 2021

Arnall Golden Gregory LLP

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from colleagues in other related life science disciplines. We are thinking of all of you in these difficult times, and hope that you and your loved ones are healthy and safe.

Industry Insights

Meet the New Boss, Same as the Old Boss: OPDP Issues Its First Letter of 2021
By: Alan G. Minsk

New Year. Same types of issues. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued its first Warning Letter of 2021, and it identified many of the same types of unlawful promotional deficiencies that OPDP cited other companies for in the past (and which we have noted in previous Bulletins). More >

A Year in Review: FDA Enforcement in the Prescription Drug Advertising and Promotion World
By: Alan G. Minsk and Genevieve M. Razick

Good riddance to 2020 for so many reasons. But, as the "AGG Year in Review" of the Food and Drug Administration’s enforcement of prescription drug advertising and promotion has become an annual ritual, let’s take a quick peek back and review some themes and trends. More >

Life Sciences Investigations – 2020 Year in Review and 2021 Outlook
By: Aaron M. Danzig and Sara M. Lord

On February 11, 2020, AGG’s Government Investigations team leaders, Aaron M. Danzig and Sara M. Lord, conducted a webinar, titled “Life Sciences Investigations and Enforcement Actions: 2020 Year in Review and 2021 Expectations.” The presenters highlighted the government’s 2020 cases and investigations involving life sciences companies under the False Claims Act (FCA) and Anti-Kickback Statute (AKS), recent antitrust prosecutions, and the ever-expanding number of actions related to opioid enforcement. The webinar focused, in particular, on aspects of the cases that demonstrated new and continuing priorities in enforcement, as well as whether to expect changes or shifts in these areas under the new administration. More >

OTC Monograph Reform – Takeaways from FDA’s Webinar on Expedited Administrative Orders
By: Carolina M. Wirth

On January 27, 2021, the Food and Drug Administration held its second webinar since the enactment of the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) in March 2020, to further discuss over-the-counter (OTC) Monograph Reform and provide guidance on the Administrative Order process, with a particular emphasis on “safety orders.” Prior to the CARES Act, FDA had to engage in a multi-step public rulemaking process in order to establish or revise an OTC drug monograph. This process was not only burdensome but, more important, it made it challenging for the agency to be able to quickly implement changes to an OTC drug monograph to address safety issues. More >

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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