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Benjamin M. Zegarelli

Associate

[email protected]

+1.212.692.6261

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Benjamin provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device, and biotech industries. With a clear focus on FDA regulatory counseling, Benjamin advises a breadth of health care industry clients on the federal and state laws surrounding manufacturer product development and marketing. His practice also includes advising clients on research approval, sales, and negotiating contractual relationships.

Benjamin has experience representing medical device companies in responding to significant unfavorable inspection observations, sometimes accompanied by a warning letter. He guides companies with compliance issues through the development stage of action plans and implementing corrective actions.

In his practice, Benjamin participates in the coordination of diligence reviews of transactions involving large pharmaceutical and medical device manufacturers. He is well versed in the process of developing policy positions and submitting comments to the FDA, as well as analyzing and drafting 510(k) applications for submission to the FDA. Benjamin reviews and drafts clinical study agreements for clients, analyzing both clinical study and human factors protocols with respect to legal requirements.

Benjamin has given numerous presentations on current health care industry topics, with titles such as Advertising and Promotion for Drugs, Devices and Biologics Using Social Media and Promotion of Investigational Drugs and Devices. He previously worked as a research chemist in the discovery group of a major research-based health care and pharmaceutical company. While in law school, he held the position of Executive Editor of the Cardozo Law Review.

Education

  • Benjamin N. Cardozo School of Law (JD, cum laude)
  • California Institute of Technology (MS, Synthetic Organic Chemistry)
  • Middlebury College (BA, Chemistry, summa cum laude)

Recent Insights

News & Press

Events

Viewpoints

Viewpoint
Over the past couple of years, FDA has introduced multiple programs allowing faster review of medical devices in order to get them to market more quickly. Some of the FDA’s efforts have been highly visible, such as the Breakthrough Devices program in the 21st Century Cures Act and the Software Precertification pilot program in the FDA’s Digital Health Innovation Action Plan. Others have been less trumpeted but are still significant developments for device manufacturers.
Recently the U.S. Department of Justice (DOJ) issued a statement that it had intervened in a False Claims Act (FCA) case against Insys Therapeutics, Inc. and consolidated five separate qui tam cases into one case, U.S. ex rel Guzman v. Insys Therapeutics, Inc., filed in the U.S. District Court for the Central District of California.
In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of approval or clearance.
On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers for Medicare & Medicaid Services under the Patient Protection and Affordable Care Act (P.L. 111-148, Sec. 6002, amending Social Security Act Sec. 1128G), also known as the Physician Payments Sunshine Act (PPSA).
Rules for clinical research are undergoing major changes in both the United States and the European Union.
This is the third installment of our year-in-review series covering major developments at FDA. While the previous two installments pertain to FDA actions on drugs and biologics, this post will address developments related to “traditional” medical devices and diagnostics (i.e., not software devices).
On Monday, November 13, our colleagues in the Antitrust Section published an alert on the recent FTC workshop, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” The workshop, which was held on November 8, 2017, began with two keynote addresses from FTC Acting Chairman Maureen Ohlhausen and FDA Commissioner Dr. Scott Gottlieb.
In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice ("DOJ") has been particularly aggressive in using the False Claims Act to pursue recoveries from individuals, health care providers, and drug manufacturers that participate in federal health benefit programs.
This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration ("FDA") refers to as "mobile apps." The goal of this post is to provide you with a basic understanding of FDA's evolving approach to mobile apps so that you can make informed decisions about the legal consequences of your app's functionality.
On Monday, September 11, our colleagues in the Antitrust Section published an alert describing a developing antitrust lawsuit against Franciscan Health System (“CHI Fanciscan”): State of Washington v. Franciscan Health System, et al. No. 3:17-cv-05690 (W.D. Wash. Aug. 31, 2017).

News & Press

Bethany Hills and Benjamin Zegarelli co-author this piece reviewing the 21st Century Cures Act that requires the FDA to develop a framework for evaluating evidence in the context of drug regulation and predicting how the FDA will implement the policy.
Three attorneys from Mintz authored the initial installment of a four-part series recapping key government policies, regulations, and enforcement actions from 2016 and discussing their potential impacts on 2017.
Bethany Hills, Chair of Mintz’s FDA Practice, and New York Associate Benjamin Zegarelli authored this Law360 column discussing the Eighth Circuit’s upholding the prison sentences for two food establishment executives.
Health Law attorney Joanne Hawana and Associate Benjamin Zegarelli authored a Law360 column on how the Senate Appropriations Committee’s approval of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies 2017 appropriations bill sets the stage for GMO legislation. 
FDA and Health Law attorney Joanne Hawana and New York Associate Benjamin Zegarelli authored this Law360 column discussing the growing public support for genetically modified organism and genetic engineering labeling on appropriate food products across the board.
The arrival of Health Law and FDA Member Practice Bethany Hills and New York Associate Ben Zegarelli is featured in The Deal’s “Movers & Shakers” column highlighting executive level moves and promotions.