AGG Food & Drug Newsletter - February 2023

Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup 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 sciences disciplines.

Industry Insights

The NAD Steps Out and Issues a Rare Decision on Prescription Drug Product Promotion
By Alan G. Minsk & Laura S. Dona

Channeling Joe Jackson’s 1982 catchy hit, “Steppin’ Out,” the National Advertising Division (“NAD”) of the BBB National Programs recently released a decision regarding a prescription drug advertisement, resulting in the company pulling a claim from its direct-to-consumer (“DTC”) ad. The NAD commonly publishes decisions regarding challenges to various other FDA-regulated product claims from cosmetic and over-the-counter drug companies, but it is not typical for the NAD to issue a decision concerning a prescription drug product promotion.

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The Sun Will Come Up Tomorrow (or Will It)? FDA Issues Notification About Orphan Drug Exclusivity in Light of Recent Court Decision
By Alan G. Minsk & Laura S. Dona

Recently, the Food and Drug Administration published a Notification to clarify its policy about orphan drug exclusivity. The agency issued the announcement because the U.S. Court of Appeals for the 11th Circuit found that FDA erred in approving a drug product, in violation of the Orphan Drug Act.

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Tell Me Lies, Tell Me Sweet Little Lies: The FTC and Some State Attorneys General Sue for Deceptive Advertising
By Alan G. Minsk, Matthew V. Wilson, & Kadeja A. Watts

In late November 2022, the Federal Trade Commission and a number of state attorneys general sued Google LLC and iHeartMedia, Inc. for airing approximately 29,000 deceptive endorsements by radio personalities, who promoted their experience with Google’s Pixel 4 phone in 2019 and 2020.

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What Is “Healthy Food”? FDA May Know the Answer
By Robert Durkin & Kadeja A. Watts

On September 28, 2022, the U.S. Food and Drug Administration issued a Proposed Rule to revise the criteria for when foods can be labeled with the nutrient content claim “healthy.” Since 1994, FDA has recognized that when a manufacturer describes a product as “healthy” on its label, it is implying an amount of nutritional content worth noting. Such practices tend to imply that the nutrient content of the food may help consumers maintain healthy dietary practices. However, the current definition of “healthy” allows manufacturers to use the claim on some foods that contain levels of nutrients not believed conducive to maintaining healthy dietary practices. Relying on the evolution of nutrition and dietary science knowledge since the 1990s, when FDA first established a definition for the implied nutrient content claim “healthy,” the Proposed Rule would update the definition of “healthy,” when used as a nutrition content claim, to be consistent with current research.

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Still Comfortably Numb: FDA Issues Revisions to Previous MDDS Guidance
By Alan G. Minsk & Laura S. Dona

Recently, the Food and Drug Administration published a revision to its final guidance document titled, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” originally issued on February 9, 2015. The agency updated certain areas of the guidance to be consistent with the final rule, “Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act.” FDA amended these medical device classification regulations so that the regulations conform to the medical software provisions in the Cures Act. The updated guidance also includes some minor changes to address industry comments.

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New California Law Requires Physicians to Provide Patients with Notice of the Federal Open Payments Program
By Jennifer D. Burgar & Charmaine A. Mech

A new California law – Assembly Bill 1278, which was signed by the Governor on September 29, 2022 – requires physicians to provide patients with notice of the federal Open Payments database. The federal Open Payments program was designed to increase transparency and accountability regarding the financial relationships between drug companies and healthcare providers. The Sunshine Act and Open Payments program requires drug companies and manufacturers to annually report payments made to covered recipients, such as physicians and teaching hospitals, which the Centers for Medicare & Medicaid Services (CMS) then publishes to the public through the Open Payments database. Since its inception in 2013, the Open Payments program has expanded beyond doctors and teaching hospitals to include reporting obligations for payments made to midlevel providers such as physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified nurse midwives.

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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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