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
Honesty Is Hardly Ever Heard, And Mostly What FDA Needs From Your Firm: Handling a Regulatory Call or Meeting With FDA
By: Alan G. Minsk & Robert Durkin
From the 1978 52nd Street album, Billy Joel sings, “Honesty is such a lonely word, everyone is so untrue; honesty is hardly ever heard, and mostly what I need from you.” While we don’t want to start out this Bulletin on such a melancholy note, the lyrics have come to mind as we have had recent client regulatory calls with the Food and Drug Administration. Part of our day-to-day job is to help clients respond to FD-483s, Warning Letters, and other compliance and enforcement actions brought by FDA and similar regulatory bodies. At times, regulators, such as FDA, will request a meeting or — with the pandemic — a call. Depending on a number of factors, which we will discuss, this call or meeting can be a potential opportunity for the company to extricate itself from a near-fatal experience or it can, alas, accelerate the company into a likely consent decree or some other similarly devastating consequence. More >
Recent FDA Draft Guidance to Industry Offers Insight on “Content of Premarket Submissions for Device Software Functions”
By: Alan G. Minsk & Laura S. Dona
Recently, the Food and Drug Administration issued a draft guidance, “Content of Premarket Submissions for Device Software Functions,” to help industry understand what it should include in regulatory marketing submissions to assist the agency in evaluating the safety and effectiveness of device software functions. The guidance applies to both software in a medical device (“SiMD”) and software as a medical device (“SaMD”). More >
Federal Court Rejects Bid to Declare Co-Pay Assistance Program Lawful
By: Jennifer D. Burgar & W. Jerad Rissler
The United States District Court for the Southern District of New York recently rejected Pfizer’s request for a declaration that its co-pay program would not violate the Anti-Kickback Statute (“AKS”). The case is Pfizer Inc. v. United States Department of Health and Human Services, Case No. 1:20-cv-04920-MKV (S.D.N.Y. Sept. 30, 2021). The case involved two separate co-pay assistance programs for tafamidis, a drug that treats Transthyretin Amyloid Cardiomyopathy (“ATTR-CM”), a rare, progressive condition that causes deposits of amyloid protein to be deposited in the heart muscle. More >
