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 August 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

OPDP Issues Untitled Letter: How NOT to Present Risk Information in a DTC TV Ad
By: Seth S. Ray and Genevieve M. Razick

On July 25, 2019, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued an Untitled Letter stating that a Direct-to-Consumer television advertisement (TV ad) made numerous false or misleading representations about the risks associated with a prescription drug product. The TV ad included claims and representations about the indication and uses for the drug, but failed to include important risk information associated with the drug. More >

Attention Pharma Industry: Update your Drug Product Listings Now
By: Alan G. Minsk and Christine Kirk

FDA recently reminded pharmaceutical manufacturers and other registered drug establishments to confirm that all product listing records are current and to remove outdated listings. The agency will soon begin deactivating old drug listing records; those not updated as of September 12, 2019 (and each January thereafter) may be deemed inactive and removed from FDA’s databases. FDA has noted that drugs with inactivated listing records may not be legally marketed in the U.S. until the records are brought up to date. Deactivation may also pose issues for reimbursement or supply chain tracking. More >

FDA Says a Medical Device Sterilizer’s Promotion Is Too Hot to Touch
Alan G. Minsk and Genevieve M. Razick 

The Food and Drug Administration, channeling Kool & The Gang’s 1979 hit, “Too Hot,” issued a 
Warning Letter to a medical device company that marketed a sealed sterilization container for unlawful promotion. We will not discuss the specific facts of the particular Warning Letter in this Bulletin, but highlight some of the key points, in our opinion, and provide some observations. More >

Class Action Antitrust Lawsuit Filed Against Jubilant DraxImage
By: Jeffrey S. Jacobovitz

A major antitrust class action case was filed in Alabama against Jubilant DraxImage, a supplier of radiology medicines. The case was brought by Jeffrey Jacobovitz of AGG and Labaton Sucherow LLP, a class action firm based in New York. Mr. Jacobovitz represents UPPI, the trade association for independent nuclear pharmacies. Labaton represents the class Plaintiff, Ion South-Mobile LLC, an independent nuclear pharmacy. The case alleges that Jubilant has monopolized the market and is a sole source supplier of two critical radiopharmaceutical medicines needed by consumers and the pharmacies. The allegations include violations of Section 2 of the Sherman Act and anticompetitive conduct involving “tying” and “bundling” of the products. Jubilant has raised prices on two nuclear medicines between 500 percent and nearly 1800 percent. Jubilant has acknowledged in their public filings that the Federal Trade Commission has opened an investigation against them. Consumers and hospitals are also affected by these actions.

EKRA: New Kickback Law Creates Risk for Common Medical Lab Marketing Practices
By: H. Carol Saul and Genevieve M. Razick

As in the healthcare industry generally, many, or even most, lab companies compensate an employee salesforce based on a range of commission structures (“base plus bonus”). The Eliminating Kickbacks in Recovery Act of 2018 (EKRA), a law recently passed by Congress, creates new and material risk around this long-standing incentive compensation structure. EKRA is part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the Support Act), a comprehensive federal legislative initiative aimed at addressing the opioid crisis, which was signed into law on October 25, 2018. EKRA was a last minute addition to the Act and was introduced in the House and agreed to by both the House and Senate in just over a week. More >

Upcoming Events

AGG Partner Alan G. Minsk will moderate the FDA General Session entitled “Regulatory Challenges for Combination Products” at the 29th Annual Sharing Alliance Sharing Conference in Baltimore, Maryland on September 17th.  

AGG Partner Anuj Desai will moderate a panel discussion and Q&A at the International Trademark Association’s conference titled “Then and Now: Evolution of IP Mediation in Israel & What the Future Holds” in Israel. He will also present on “Introduction to Intellectual Property Mediation” at the conference on September 24th.

AGG Partner Brian A. Teras and Associate Joel N. Gosser will present a complimentary webinar "Money, Money, Money: Raising Capital and Exit Transactions for Life Sciences Companies" on October 3rd.

AGG Partner Kevin Coy will speak at the Endpoint Clinical's User Group Meeting presenting on GDPR, Brexit and European Union and United States Privacy Shield Issues in London on October 9th.

AGG Partner Alan G. Minsk will present a FDANews' webinar "Patient Prescription Drug Labeling" on October 29th.

Industry Activities and Recognition 

AGG Partner Recognized by Best Lawyers 2020 
AGG Partner Alan G. Minsk was recognized in the FDA Law category in the 2020 Best Lawyers in America guide, which lists attorneys recommended by their peers. More >

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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