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.

Federal Circuit’s Rehearing Decision Confirms Induced Infringement Even When Skinny Label Was Used

In a recent 2-1 decision after a rehearing, GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the Federal Circuit confirmed that substantial evidence supported the jury’s findings of induced infringement throughout the term of GSK’s patent, including the “partial label period” when Teva used a skinny label to carve out a patented method.

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

FDA Issues Final Guidance on Form and Content of Unique Device Identifier Labeling System

On July 7, 2021, the U.S. Food and Drug Administration (FDA) issued a final guidance regarding the form and content of unique device identifier (UDI) labeling. The guidance will assist labelers of medical devices and FDA-accredited issuing agencies (who operate systems for issuing UDIs used by labelers) in meeting the requirements under 21 CFR Part 801, Subpart B, and the Unique Device Identification System Final Rule, 78 FR 58786 (September 24, 2013) (UDI Rule).

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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