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

• OPDP Issues Untitled Letter: How NOT to Present Risk Information in a DTC TV Ad
• Attention Pharma Industry: Update your Drug Product Listings Now 
• FDA Says a Medical Device Sterilizer’s Promotion Is Too Hot to Touch
• Class Action Antitrust Lawsuit Filed Against Jubilant DraxImage
• EKRA: New Kickback Law Creates Risk for Common Medical Lab Marketing Practices
• Upcoming Events
• Industry Activities and Recognition

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and other registered drug establishments to confirm that all product listing records are current and to remove outdated listings.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
By: 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 >