Policy & Medicine Compliance Update
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October 2023 Issue
October 2023
We begin our coverage this month by examining the complex world of medical education. The article focuses on the distinctions between IME and company-led programs and provides some essential considerations for life science companies, including appropriate oversight of third-party medical education providers.
We also review two recent and significant regulatory updates. The most recent involves the FDA’s newly proposed rule on LDTs. Under the proposal, the FDA explicitly asserts that LDTs are considered IVDs and, thus, medical devices under the Federal Food, Drug, and Cosmetic Act. Consequently, the Agency plans to phase out its enforcement discretion not to require certain requirements for LDTs.
Next, we examine the FDA’s draft guidance on addressing postmarketing requirement non-compliance for 505(o)(3) safety PMRs. We believe that, eventually, the FDA will extend this approach to other categories of PMRs, such as those required for Accelerated Approvals.
Shifting to governance and operations, Melissa Hunt explores the fundamental distinctions between legal and compliance. This topic is vital for attorneys who take on active compliance roles.
Finally, we examine Teva’s generic price-fixing settlement with the Justice Department in the litigation space. In addition to the now-standard DPA, the settlement incorporates new requirements involving product divestiture and charitable donations.
Articles
FEATURE
Navigating the Foggy World of Medical Education
IME, Company-Led Programs & Third-Party Involvement
By Dr. Seth B. Whitelaw
Summary: In today’s healthcare environment, medical education is more important than ever. However, the requirements for manufacturers are exceedingly complex and nuanced, especially when conducting company-led programs and working with third-party medical education providers. This article provides an overview of those requirements and some crucial considerations for manufacturers endeavoring to provide high-quality, compliant programs.
Tags: IME, CME, Company-Led Education, Third Party Oversight, Accreditation, Due Diligence, Monitoring, Auditing
Regulatory Update
Regulating Laboratory Developed Tests Back on FDA’s “Front Burner”
By Marc J. Scheineson, Esq.
Summary: On October 3, 2023, the FDA proposed a new rule explicitly classifying LDTs as devices under the Federal Food, Drug, and Cosmetic Act. This article explores the history and implications of the new proposed rule.
Tags: FDA, LDTs, Devices, IVDs, Draft Guidance
Holding Manufacturers Accountable
FDA’s Draft Guidance on Postmarketing Requirement Noncompliance
By Kirt Kraeuter, Staff Writer
Summary: The FDA’s draft guidance on postmarketing requirements is another attempt to hold manufacturers accountable for meeting their obligations and to respond to criticism that the Agency has not done enough. However, unlike other government efforts, the FDA has taken a thoughtful and balanced approach to address the problem of delays in completing drug safety PMRs.
Tags: FDA, Postmarketing, 505(o)(3) safety PMRs, Accelerated Approval Program, HHS-OIG, Clinical Trials, Civil Monetary Penalties
Governance & Operations
Back-to-Basics
Understanding the Distinct but Complementary Roles of Legal & Compliance
By Melissa Hunt
Summary: Within life sciences, legal and compliance have distinct but complementary roles. Understanding the distinctions is essential, especially for attorneys acting in compliance roles.
Tags: Legal, Compliance, Practice of Law, Compliance Program, Federal Sentencing Guidelines, Attorney-Client Privilege, Training, Monitoring, Auditing, Discipline, Communication, Corrective Action
Litigation & Enforcement
Deferred Prosecution, Divestiture & Donations
Teva’s Price-Fixing Resolution Breaks New Ground
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: In August 2023, the Justice Department announced a settlement with Teva Pharmaceuticals USA, Inc. As part of that settlement, Teva admitted to participating in three separate antitrust conspiracies that affected three essential medicines. In addition to the standard DPA provisions and fines, the government requires Teva to divest and make charitable donations of certain drug products.
Tags: DOJ, DPA, Divestiture, Donations, Price-Fixing, Market Allocation, Bid-Rigging, Teva, Glenmark, Apotex, Sandoz, Taro, Antitrust, Sherman Act, Anticompetitive, Conspiracy, Compliance Program, Monitor, Kickbacks, False Claims
About THE Authors & Contributors[1]
Melissa Hunt: Ms. Hunt is a Health Law attorney with over fourteen years of compliance experience working in various roles for life science companies. In addition, she has been a guest lecturer on off-label promotion and the First Amendment at Seattle University School of Law
Kirt Kraeuter: Besides being a staff writer for the Policy & Medicine Compliance Update and providing compliance advisory services, Mr. Kraeuter is the former Senior Director of Corporate Compliance at Moderna.
Maureen Lloyd: Ms. Lloyd is the Executive Director of LLOYDMJMC LLC. and a Policy & Medicine Compliance Update Editorial Board member.
Marc J. Scheineson: Mr. Scheineson is a Life Science Partner with Alston & Bird LLP and a Policy & Medicine Compliance Update Editorial Board member.
David Davidovic: Mr. Davidovic is the President of pathForward and the former Vice President and Global Head of Commercial Services for Roche and Genentech. He also is a member of the Policy & Medicine Compliance Update Editorial Board.
Dr. Seth B. Whitelaw: Dr. Whitelaw is a Senior Fellow and Adjunct Professor of Life Science Compliance at Mitchell Hamline School of Law, President & CEO of Whitelaw Compliance Group, LLC, and the Editor of the Policy & Medicine Compliance Update.
Robert Wilkey: Mr. Wilkey is the Principal Attorney at Wilkey Legal Consultants, LLC, and focuses on complex civil litigation and legal consultation involving class action matters within the pharmaceutical, medical device, environmental, and consumer protection fields. He is also a senior staff writer with the Policy and Medicine Compliance Update.
From all of us here (virtually) at Policy & Medicine Compliance Update, we hope all our readers and their families are safe and healthy. As always, thank you for subscribing and your continuing support in making us the most comprehensive, up-to-date compliance publication for life science compliance professionals.
Wishing you all the best,
Dr. Seth B. Whitelaw
Editor
sbwhitelaw@whitelawcompliance.com
[1] The views expressed in the articles are solely those of the authors and do not reflect those of the authors’ current or former employers and clients.