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.
Industry Insights
PHARMACEUTICALS
Recent Third Circuit Case Will Impact FTC Enforcement in the Pharmaceutical Space and Beyond: FTC v. ShireViroPharma, Inc.
By: Jeffrey S. Jacobovitz and Christine Kirk
On February 25, 2019, the Third Circuit Court of Appeals issued a significant decision that will likely affect the scope, timing, and venue of future enforcement actions initiated by the U.S. Federal Trade Commission (FTC). In the case of FTC v. ShireViroPharma, Inc. (“Shire” or “Company”), the Court not only found for the defendant in the particular case at issue, but also made findings that may affect future FTC actions, particularly its holding regarding the “about to violate the law” standard in Section 13(b) of the FTC Act. Below, we provide a brief summary of the key holdings and potential implications of the case. More >
DEVICES
FDA’s Steps Toward a New Review Framework for Medical
Devices That Use Artificial Intelligence Algorithms
By: Alan G. Minsk and Genevieve M. Razick
On April 2, 2019, the Food and Drug Administration issued a statement by Commissioner Scott Gottlieb on steps toward a new review framework specifically tailored to promote the development of medical devices that use artificial intelligence algorithms. The statement announced that FDA released a discussion paper and request for feedback, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD), as a first step toward developing a new and tailored approach to help innovators and developers to bring artificial intelligence devices to market. The paper is for discussion purposes only and not meant as a draft guidance for industry. More >
U.S. Senate Finance Committee Chairman and Ranking Member Write to HHS-OIG Regarding Physician-Owned Distributorships' Potential Failures Under the Physician Payment Sunshine Act”
By: Jennifer Downs Burgar and Genevieve M. Razick
In a letter dated March 19, 2019, U.S. Senate Finance Committee Chairman Chuck Grassley of Iowa and Ranking Member Ron Wyden of Oregon wrote to the Department of Health and Human Services Office of Inspector General regarding potential failures of physician-owned distributorships (PODs) to disclose physician ownership or investment interests under the Physician Payment Sunshine Act. The Physician Payment Sunshine Act requires group purchasing organizations, including PODs (which are arrangements in which a physician purchases ownership interests in an entity that sells implantable medical devices for use in the physician’s surgeries), to report ownership or investment interests to the Centers for Medicare and Medicaid Services. More >
