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.
Industry Insights
I Know There Was Something I Forgot to Do: FDA Issues Notice of Noncompliance for Failure to Submit Required ClinicalTrials.gov Information
By: Alan G. Minsk & Genevieve M. Razick
On April 27, 2021, the Food and Drug Administration issued its first Notice of Noncompliance to a pharmaceutical company for failure to submit required information to the ClinicalTrials.gov databank operated by the National Library of Medicine (which is a part of the National Institutes of Health). The agency has sent more than forty Pre-Notices of Noncompliance, but this is the first Notice of Noncompliance for a company’s failure to submit required summary results information. More >
A Series for FDA-Regulated Food Industry - Part 1: The Big Picture
By: Robert Durkin & Genevieve M. Razick
An old adage is that an “ounce of prevention is worth a pound of cure.” Perhaps no setting is a more appropriate example of this than a company whose business centers on food products regulated by the Federal Food and Drug Administration. Prevention and resolution of FDA-related regulatory compliance issues is the first step in mitigating or altogether preventing FDA enforcement actions. A sound regulatory compliance strategy is usually one that is based on individual products the company places into commerce, and takes into consideration the relative roles of both the company and those of its partners in the manufacturing and production chain. More >
Ninth Circuit Rules False Claims Act Suit Involving Off-Label Use of Medical Devices
By: W. Jerad Rissler
The United States Court of Appeals for the Ninth Circuit recently considered an Order of the Central District of California dismissing a qui tam False Claims Act (FCA) suit against a medical device manufacturer based on allegations that it: (1) marketed devices used in spinal fusion surgeries for an off-label and contraindicated use; (2) fraudulently obtained Food and Drug Administration (FDA) clearance; and (3) violated the Anti-Kickback Statute (AKS) by entering into rebate agreements with hospitals and providing remuneration to physicians. The Ninth Circuit affirmed the dismissal of the FCA claims based on first and third theories of liability. It partially affirmed and partially reversed the dismissal of the claims based on the second theory. More >
