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
DOJ Announces Settlements with Three Pharma Companies for Allegations of Co-Pay Assistance Kickbacks Through Conduit Foundations
By: Jennifer Downs Burgar and Genevieve M. Razick
On April 4, 2019, the Department of Justice (DOJ) announced settlements with three pharmaceutical companies, Jazz Pharmaceuticals plc (Jazz), Lundbeck LLC (Lundbeck), and Alexion Pharmaceuticals (Alexion), related to allegations that the companies made inappropriate payments to patient assistance programs (PAPs) administered by third parties that the companies used as conduits. PAPs provide financial assistance, often in the form of assistance with insurance co-payments, to patients with limited financial means. PAPs may be administered by foundations established by pharmaceutical companies or through independent charitable organizations. More >
CMS Finalizes Rule Requiring Prescription Drug Price Information in Direct-to-Consumer Television Advertisements
By: Seth S. Ray, Christine Kirk, and Genevieve M. Razick
On May 10, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule requiring that direct-to-consumer television advertisements for prescription drugs and biological products include certain pricing information for products covered under the Medicaid or Medicare programs. The final rule follows CMS’s proposed rule published on October 18, 2018. After considering public comments, the agency decided to publish the final rule largely as proposed, with one modification regarding state law preemption, and other smaller changes to improve clarity. The final rule will take effect on July 9, 2019. More >
DEVICES
FDA Has Not Gone Away When It Comes to Unlawful Medical Device Promotion: Companies Receive Warning Letters for Violative Promotional Claims
By: Alan G. Minsk, Christine Kirk, and Genevieve M. Razick
In April 2019, the Food and Drug Administration issued two Warning Letters to medical device manufacturers, reminding industry that the agency will take enforcement action against unlawful promotion when it sees fit. One Warning Letter addressed promotional claims and misleading statements provided in marketing materials, including promotion of an unapproved device. The other Warning Letter related to modifications to an in-vitro diagnostic (IVD) assay that resulted in adulteration and misbranding of the product. More >
