Photo of Benjamin Zegarelli

Benjamin Zegarelli is an Associate in the firm’s Health Law Practice. He 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 given numerous presentations on current health care industry topics and held the position of Executive Editor of the Cardozo Law Review.

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. Both speakers focused on the beneficial effects of greater competition on prescription drug prices and signaled that the branded drug manufacturers may be discouraging generic drug manufacturers from entering the market. However, Acting Chairman Ohlhausen stated that any FTC antitrust enforcement actions in this space will be based on the specific facts of a case rather than a broad-based action against particular industry practices.

The alert goes on to summarize the content of each of the four workshop panels:

  • Panel 1: Generic Drug Competition: Understanding Demand, Price and Supply Issues
  • Panel 2: Understanding Intermediaries: Pharmacy Benefit Managers
  • Panel 3: Understanding Intermediaries: Group Purchasing Organizations
  • Panel 4: Potential Next Steps to Encourage Entry and Expand Access Through Lower Prices

Click here to read the full summary of the FTC workshop.

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. In fact, from 2009 to 2016, DOJ collected $19.3 billion from health care False Claims Act settlements and judgments, with $2.5 billion recovered in fiscal year 2016, alone. (More DOJ false claims statistics can be found here.) DOJ’s enforcement efforts are not solely targeted against garden variety billing fraud, but also involve claims arising from alleged violations of health care regulatory requirements. Among other things, the DOJ has been targeting claims for reimbursement for off-label uses of regulated products. DOJ’s aggressive policy of holding manufacturers accountable for off-label claims under the False Claims Act is entirely consistent with FDA’s stance on off-label communications as described in the January memo. However, recent court interpretations of off-label communications as protected First Amendment speech, as well as interpretations of the causality component of False Claims Act claims, have apparently caused DOJ to reconsider its strategy with respect to such cases. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 5

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. Continue Reading Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps

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). The Washington State Attorney General’s office accuses CHI Franciscan of accumulating a controlling share of the “Orthopedic Physician Services” market through incremental acquisition which has led to substantial lessening of competition and illegal price fixing, in violation of Section 7 of the Clayton Act and Section 1 of the Sherman Act, respectively, as well as Washington State antitrust laws.

The alert cautions that health care provider acquisition strategies may come under antitrust scrutiny, even when acquisitions target multiple small physician practices, if the cumulative effect of such acquisitions results in substantial condensation of market share in a particular area of health care services.

For greater insight on this issue, read the full alert here.

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion.  Not surprisingly, FDA has taken a hard-line approach in its guidance on off-label communications, similar to the Agency’s forceful January 2017 memo. This aggressive stance has not, however, translated into increased enforcement. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue describing how FDA’s regulatory scheme has persisted in light of the key First Amendment decisions involving off-label promotion. Even though FDA hesitated in and ultimately rejected promulgating regulations that would make any action “that directly or indirectly suggests to the physician or to the patient that an approved drug may properly be used for unapproved uses for which it is neither labeled nor advertised” (37 Fed. Reg. 16,503, 16,504) into a matter warranting enforcement action, the Agency used this reasoning to shape an off-label communication policy. As I described in Part 2, FDA’s policy enjoyed some support from federal courts; however, this support was only temporary. More recently, federal courts have shown support for the idea that truthful and non-misleading promotions of off-label uses of drugs and devices by manufacturers are protected under the First Amendment. A review of the pivotal cases in this area will help put FDA’s off-label policy in perspective, especially in light of FDA’s reaction to these cases in a memorandum published in January 2017. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy might end up a few years from now. This post focuses on the history of FDA’s off-label communication and promotion policy, and while it is by no means a comprehensive history, I attempt to reveal some of the origins and early development of the Agency’s approach to off-label uses and promotion.  In fact, FDA’s early position on off-label communications closely resembles the Agency’s stance on the subject today. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to receive input from interested industry stakeholders and members of the public about possible alternatives for off-label regulation, seemingly a first step in exploring more liberal (or possibly stricter) enforcement standards.  However, in January, FDA released a new final rule amending the definitions of “intended use” applicable to drugs and devices in 21 C.F.R. §§ 201.128, 801.4, which would affect how off-label uses are considered with respect to intended use of regulated products, and issued a memo discussing its current position on off-label uses and communications.  In short, all of FDA’s actions since the November public hearing have shown that it intends to continue strict enforcement of off-label promotion despite changes in the highest levels of government and strongly negative industry response. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1

Since the 21st Century Cures Act became law on December 13, 2016, we have been blogging on regulatory and clinical areas affected by its provisions (see herehere and here). On March 14, 2017, FDA made further progress on its Cures Act obligations by releasing in the Federal Register a proposed list of Class II devices that may be exempted from premarket notification (or 510(k)) requirements. The list is currently open for public comment until May 15, 2017.  Under the Cures Act, the final list of exempted devices must be published by July 11, 2017.

Continue Reading Cures Act Developments: FDA Proposes Class II Device Exemptions

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible. However, given the political climate in the federal government and the lack of an appointed FDA commissioner, it is unclear whether FDA will hold its ground or be forced to retreat.

Continue Reading FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds