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. We are thinking of all of you in these difficult times, and hope that you and your loved ones are healthy and safe.

Industry Insights

See Me, Feel Me: FDA Gives Guidance on Remote Interactive Evaluations of Drug Facilities During COVID-19
By: Alan G. Minsk & Carolina M. Wirth

Channeling The Who’s Tommy Soundtrack and the classic song “See Me, Feel Me,” the Food and Drug Administration issued a guidance document, “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency.” The facilities covered are those that manufacture pharmaceutical and biological products, those covered under the agency’s Bioresearch Monitoring Program, and outsourcing facilities registered under Section 503B of the Federal, Food, Drug and Cosmetic Act. More >

This Is Not A Drill ... FDA Publishes Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021
By: Carolina M. Wirth & Genevieve M. Razick

On March 26, 2021, the Food and Drug Administration (FDA) issued a new Federal Register notice finally announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug User Fee Program for Fiscal Year 2021. As we discussed in a previous Bulletin, the CARES Act, among other things, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow FDA to assess and collect user fees from qualifying owners of OTC monograph drug facilities and qualifying submitters of OTC monograph order requests (OMORs). The fees are meant to support FDA in its OTC monograph drug activities, including inspections of facilities associated with such products. More >

Arbitration as an Alternative to the Backlogged Courts
By: Rebecca L. Kolb

COVID-19 has disrupted everything, including litigation. Courts have been forced to delay in-person hearings and trials for a year or more, causing a backlog of varying degrees across the country. But business disputes have not slowed. Arbitration has long been recognized as a faster alternative to litigation. Although party tactics sometimes slow the process, arbitration still provides resolution more than one year sooner on average than trial through the court systems (even before the pandemic-created court backlog). For the life sciences industry specifically, the often global nature of the disputes lends it particularly well to arbitration. As one of the most significant sectors in the global economy, cross-border relationships (and disputes) are commonplace. More >

Recent DOJ Indictment with Criminal Wage Fixing and No-Poach Agreement
By: Jeffrey S. Jacobovitz

The Department of Justice’s Antitrust Division (DOJ) has once again indicted healthcare individuals and a healthcare company for violations of Section 1 of the Sherman Act. On March 30, 2021, the DOJ indicted a Regional Manager (United States v. Hee et al., Case No. 2:21-cr-00098-RFB-BNW (D. Nev.)), who was responsible for managing the office’s hiring of nurses and developing new customers that needed nurse staffing services in Nevada, Arizona, and Utah, as well as competing companies. Pharma companies, as well as healthcare companies, should be aware of this indictment because the DOJ continues to pursue Wage Fixing and No-Poaching Agreement cases in the health care area. More >