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 December 2019

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and articles from members of AGG outside the Food and Drug Practice.

In this Issue

 Industry Insights

“A Perfect Storm”: OPDP Sends Warning Letter Regarding Print Advertisement for Drug to Treat Opioid Use Disorder—Failure to Disclose Serious Risks, Including Potential for Fatal Overdose
By: Seth S. Ray  

On December 2, 2019, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent a Warning Letter to the sponsor of a drug that is indicated for the prevention of relapse to opioid dependence, following opioid detoxification. According to OPDP, the sponsor’s print advertisement was false or misleading, because it omitted important risk information associated with the use of the drug. The print ad failed to disclose the potential for fatal overdose in this vulnerable patient population, and, as OPDP noted, opioid dependence and misuse is a significant public health concern and national crisis affecting millions of people. More

Is Your Cosmetic Product Really Natural? Congress Pushes for Legislation to Define the Term “Natural” for Cosmetics 
By: Carolina M. Wirth

The use of the term “natural” on the labeling of FDA-regulated products has been the source of many lawsuits in recent years, and even the subject of enforcement actions by the Federal Trade Commission (FTC). However, neither the FTC nor the FDA have established a definition for the term “natural.” More >

Understanding USP 800: A Resource for Long-Term Care Providers 
By: Jennifer L. Hilliard and Robert Durkin

When many long-term care providers first hear about USP General Chapter <800> Hazardous Drugs–Handling in Healthcare Settings (“USP 800”), they naturally confuse it with the final EPA hazardous pharmaceuticals rule (“EPA Rule”), which became effective in August 2019. While there certainly are areas in which the two overlap, the provisions of the EPA Rule concern hazardous pharmaceuticals once they are no longer used for their intended purpose and thus become waste. USP 800, however, concerns hazardous drugs (“HDs”) throughout their entire post-manufacturing lifecycle—from receiving and storage through disposal. As such, USP 800 is likely to have a profound effect on pharmacy and health care facility operations. 
More >

Upcoming Events

AGG Partner Alan G. Minsk and Of Counsel Seth S. Ray will present a complimentary one hour webinar titled "FDA Regulation of Rx Drug and Medical Device Advertising and Promotion: The Year in Review" on January 30th.

Industry Activities and Recognition
AGG Partner Alan G. Minsk will serve on FDLI’s 2020 Food and Drug Law Journal Editorial Advisory Board 
AGG Partner Alan G. Minsk will serve on Food and Drug Law Institute’s 2020 Food and Drug Law Journal Editorial Advisory Board (EAB) for its 75th year of publication. As a member, he will serve as a peer reviewer of manuscript submissions, advise on content and editorial direction, and serve as a resource for student editors at Georgetown University Law Center.

Arnall Golden Gregory Would Like to Wish You Happy Holidays
and the Best for 2020!

This newsletter is published by Arnall Golden Gregory’s Food and Drug and Government Affairs and Public Policy Practices. This information presented provides a general summary of recent legal and regulatory developments. It is not intended to be, and should not be relied upon, as legal advice. For more information about the Food and Drug Practice, please contact Alan Minsk.
©2019. Arnall Golden Gregory LLP. All Rights Reserved.  Atlanta | Washington, DC

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