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.
In This Issue
- Honesty Is Hardly Ever Heard, And Mostly What FDA Needs From Your Firm: Handling a Regulatory Call or Meeting With FDA
- Recent FDA Draft Guidance to Industry Offers Insight on “Content of Premarket Submissions for Device Software Functions”
- Federal Court Rejects Bid to Declare Co-Pay Assistance Program Lawful
- Attorney Spotlight
- Industry Recognition
- Seminar Recording
- Upcoming Webinars/Events
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Recent FDA Draft Guidance to Industry Offers Insight on “Content of Premarket Submissions for Device Software Functions”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Recently, the Food and Drug Administration issued a draft guidance, “Content of Premarket Submissions for Device Software Functions,” to help industry understand what it should include in regulatory marketing submissions to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 >
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Kevin M. Bell is a partner and co-chair of the Dietary Supplements industry team and Intellectual Property practice, as well as a leader of the Patent practice and a member of the Litigation practice. |
24 AGG Practices Recognized in 2022 “Best Law Firms” Rankings
AGG is pleased to announce the firm’s rankings in the 2022 U.S. News – Best Lawyers “Best Law Firms” guide. AGG earned six national rankings and 24 metropolitan rankings, including 15 Tier 1 practice rankings. “Best Law Firms” are recognized for professional excellence based on clients and peer evaluations. To be eligible for a ranking, a law firm must have a lawyer listed in the 27th Edition of The Best Lawyers in America® guide, which recognizes the top four percent of practicing attorneys in the U.S. AGG has 68 lawyers recognized as “Best Lawyers” including Food & Drug practice team leader Alan G. Minsk who was recognized for the fourth year in a row for exceptional service in FDA Law. To view the press release, please click here.
On November 16, AGG’s Employment Law team hosted its annual Employment Law Seminar titled “The World Turned Upside Down: Vaccines, Vacancies, & Other Vexations in the Pandemic Workplace.” This virtual program took a deep dive into the most pressing workplace issues of the day, including government vaccine mandates, OSHA rules, and the challenges presented by the "Great Resignation," an increasingly virtual workforce, and special twists in state law. To view the recording, please click here.
Honesty Is Hardly Ever Heard, and Mostly What FDA Needs From Your Firm: Handling a Regulatory Call or Meeting with FDA
Please join Food & Drug practice team leader Alan G. Minsk and of counsel and former Acting and Deputy Director of FDA’s Office of Dietary Supplement Programs Robert Durkin for a complimentary webinar on December 16 from 12:00 PM – 1:00 PM EST on how pharmaceutical, biologic, medical device, and food companies can handle a regulatory call or meeting with the Food and Drug Administration. These meetings discuss compliance concerns, typically relating to quality-related issues that FDA perceives could possibly cause harm to consumers of the company’s FDA-regulated products. Depending on a number of factors, there may be a potential opportunity for the company to extricate itself from a near-fatal experience or it can accelerate the company into a likely enforcement action, such as a consent decree or some other similarly devastating consequence. For more information or to register, please click here.
Alan Minsk To Present "Quality Agreements and What You Should Know and Consider"
