DOJ Clarifies Position on Fraud-on-the-FDA Theory of False Claims Act Liability

On June 3, 2022, the Civil Division of the Department of Justice filed a statement of interest in a relator’s action in the Southern District of Florida, arguing that “[c]onduct giving rise to a regulatory violations can also give rise to [False Claims Act] liability.” Specifically, requesting “that the ruling not foreclose the possibility that, under certain circumstances, conduct giving rise to violations of the [Federal Food, Drug and Cosmetic Act] or FDA regulations could be material to the government’s payment decisions and provide a basis for FCA liability assuming all necessary FCA elements are demonstrated,” also known as “fraud on the FDA.”

To read the full text of this Alert, please visit the firm website.

FDA’s Guidance Creates Administrative Burden for Animal Drug Compounding Documentation

On April 13, 2022, the FDA issued Guidance for Industry #256 about the enforcement policy regarding the compounding of animal drugs from bulk drug substances by or under the direct supervision of veterinarians or pharmacists in either state-licensed pharmacies or federal facilities. FDA has spent several years and gone through multiple iterations trying to develop new industry guidance on compounding animal medications. While changes have been made from previous iterations, FDA has implemented significant administrative burdens for documentation of clinical need and limitations on drug substances that can be compounded for office use.

FDA has taken the current position that drugs compounded from bulk substances violate the Federal Food, Drug and Cosmetic Act (FD&C Act) because they are not approved or indexed, are not made according to current good manufacturing practice and cannot satisfy the FD&C Act’s adequate directions for use provision. However, FDA has generally refrained from taking enforcement action against animal drugs compounded from bulk drug substances under certain circumstances when no other medically appropriate treatment options exist. Especially for animal drugs, compounding plays a crucial role in providing medically appropriate treatments for a wide variety of species of all different shapes and sizes―specifically, those for whom a single dosage form or level will not be medically appropriate.

To read the full text of this Duane Morris Alert, please visit the firm website.

Rick Ball to Speak at FDLI’s Introduction to Drug Law and Regulation Event

Duane Morris partner Rick Ball will be a speaker at FDLI’s “Introduction to Drug Law and Regulation,” a virtual course to be held on April 28, 2022. Mr. Ball’s topic will be “Violations and Enforcement.”

About the Program

Explore the essentials of drug law and regulation and gain a comprehensive understanding of the administrative agencies that impact this industry. Learn about patent and exclusivity issues, Rx to OTC switches, Good Manufacturing Practices (GMP), advertising and promotion, compliance, enforcement, and related issues. Case studies, hypotheticals, and ample time for Q&A are provided.

To learn more about this program and register, please visit the FDLI website.

FDA Final Guidance on Initiating Voluntary Recalls: Be “Recall Ready”

On March 4, 2022, FDA issued a final guidance to industry and FDA staff regarding the initiation of voluntary recalls under 21 CFR part 7, subpart C. The guidance applies to voluntary recalls of products subject to FDA’s jurisdiction, including any:

    1. Food, drug and device (human or animal use);
    2. Cosmetic and biological product (human use);
    3. Tobacco product;
    4. Item subject to a quarantine regulation under 21 CFR part 1240; and
    5. Devices that are electronic products regulated as radiology devices (subject to 21 CFR part 892) but not electronic products subject to 21 CFR parts 1003 and 1004.

In short, the final guidance clarifies FDA’s recommendations on how a firm should be prepared to facilitate the timely initiation of voluntary recalls, steps a firm should take if there is an indication of a problem with a distributed product and how to initiate voluntary recalls. The final guidance also explains how FDA works with firms to initiate a voluntary recall.

To read the full text of this Duane Morris Alert, please visit the firm website.

District Court of Delaware Rules for Generic Pharma’s Use of Skinny Label, but Permits Induced Infringement Suit to Proceed Against Insurer

In the recent opinion of Amarin Pharma v. Hikma Pharms. U.S., the District Court of Delaware dismissed Amarin’s complaint against Hikma for induced infringement of three patents when Hikma used a skinny label to carve out a patented indication. However, the court held that Amarin sufficiently pled to proceed with the complaint against an insurer, Health Net, for induced infringement.

To read the full text of this Duane Morris Alert, please visit the firm website.

Pharmaceutical Research and Manufacturers of America’s Revised Code Takes Effect

On January 1, 2022, the updated Code on Interactions with Health Care Professionals, published by the Pharmaceutical Research and Manufacturers of America (PhRMA), became effective. The updates reflect fraud and abuse concerns voiced by the Department of Health and Human Services’ Office of Inspector General in its November 2020 Special Fraud Alert. While it is not a legal document, companies that adopt the code’s rules are more likely to comply with federal fraud and abuse laws like the Anti-Kickback Statute.

To read the full text of this Duane Morris Alert, please visit the firm website.

DOJ Reinstates and Augments Prior Corporate Criminal Enforcement Policies

On October 28, 2021, Deputy United States Attorney General Lisa Monaco issued a memorandum marking the first major announcement on corporate criminal enforcement from the Department of Justice (“DOJ”) under the Biden Administration (“Monaco Memo”). Most notably, this memorandum: (1) reinstates the Individual Accountability Policy originally announced in the Yates Memo and (2) guides prosecutors to look at all prior misconduct, not just those instances similar to the misconduct at issue in the present investigation.

To read the full text of this post by Duane Morris attorneys Rick Ball, Eric Breslin and Brittany Pagnotta, please visit the Duane Morris White-Collar Criminal Law Blog.

FDA Issues Final Rule on “Intended Use”

On August 2, 2021, the Food and Drug Administration issued its final rule modifying its regulations on the intended use of medical devices, prescription drugs and biologics. Most importantly, the final rule repeals the 2017 rule’s “knowing clause,” which seemed to imply that a party may be accountable for off-label use if the party “should have known” the product was likely to be used off-label.

To read the full text of this Duane Morris Alert, please visit the firm website.

Trends in Early-Stage Boston Med-Tech Investment

By Stephen M. Honig

Duane Morris supports a proprietary platform in Boston that permits emerging life science and med device companies to pitch to a varied group of investors, from qualified angels to major pharmas. We also represent companies seeking financing and independent investors in this space. In assisting in due diligence during the first eight months of 2021, certain matters have been emphasized in diligence review.

Continue reading “Trends in Early-Stage Boston Med-Tech Investment”

Attorney General’s Memorandum Allows Prosecution for Noncompliance with Agency Guidance Documents

On July 1, 2021, U.S. Attorney General Merrick Garland published a memorandum that rescinds two previous memoranda―the Sessions Memorandum and Brand Memorandum―that prohibited Department of Justice attorneys from using noncompliance with federal agency guidance documents as a basis for civil and criminal enforcement cases. Garland’s memorandum states these previous policies were “overly restrictive,” “discouraged the development of valuable guidance” and hindered DOJ’s litigation of cases when relevant agency guidance was available.

To read the full text of this Duane Morris Alert, please visit the firm website.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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