FDA’s New Rule Regulates Lab-Developed Tests Under FD&C Act

On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule that amends existing regulations to make explicit that in vitro diagnostic products and tests (IVDs), including laboratory developed tests (LDTs), are devices regulated under the Federal Food, Drug and Cosmetic Act (FD&C Act).

LDTs have increased in volume, complexity and importance in critical healthcare decision-making since 1976 when the Medical Device Amendments (MDA) were passed and FDA began exercising enforcement discretion. Accordingly, FDA has advised that increased oversight is needed for LDTs. However, some specific categories of LDTs will be covered under new targeted enforcement discretion policies.

Read the full Alert on the Duane Morris LLP website.

FTC Voices Support for March-In Rights on Patents to Help Control Drug Prices

The Federal Trade Commission (FTC) has announced its support of the federal government’s use of “march-in rights” as a mechanism to control the price of pharmaceuticals. The National Institute of Standards and Technology (NIST) late last year issued its “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” that would fundamentally change the use of march-in rights by allowing the government to exercise price control under the Bayh-Dole Act, which the FTC announced its support for last week. This shift is the latest effort by federal agencies to lower drug prices in the wake of President Joe Biden’s Executive Order on Promoting Competition in the American Economy.

Read the full Alert on the Duane Morris LLP website.

FDA’s Second Warning Letter of the Year Deals with Potentially Misleading Efficacy Claims About Inhaler

On August 15, 2023, the U.S. Food and Drug Administration (FDA) published a warning letter to AstraZeneca Pharmaceuticals LP, alleging that a professional sales brochure for its Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate) inhalation aerosol contained false or misleading claims regarding the drug’s efficacy.

In view of the warning letter—only the second of the year issued by the Office of Prescription Drug Promotion (OPDP)—companies should review their promotional materials to confirm that any efficacy claims are clearly supported by cited data and do not give rise to misleading impressions and regulatory scrutiny—even where such materials are intended for patients.

Read the full Alert on the Duane Morris LLP website.

Minor Procedural Updates to FDA Guidance on Q-Submissions

On June 2, 2023, the FDA issued its most recent guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The Q-Sub Program is used by the FDA to track the requests for feedback and interactions between the FDA and medical device companies prior to submitting for FDA approval. The 2023 guidance provides updated resources and tools for medical device companies, or submitters, looking to request feedback from the FDA during the development process of potential or planned medical devices.

Read the full Alert on the Duane Morris LLP website.

DOJ Announces an Enhanced Approach to Corporate Criminal Enforcement

On September 15, 2022, Deputy Attorney General Lisa O. Monaco of the Department of Justice (DOJ) delivered a speech at New York University addressing new guidance on corporate criminal enforcement. Her speech made it clear that DOJ is prioritizing investigations and prosecutions against corporate entities. DOJ’s approach in this area is fundamentally grounded in individual accountability and corporate responsibility. Building off those ideas, the new guidance provides for: (1) increased focus on individual liability; (2) consideration of the full criminal, civil and regulatory record of any company when deciding the appropriate resolution; (3) expanding voluntarily self-disclosure programs across DOJ; and (4) the consideration of compensation systems that reward or deter compliance when evaluating the strength of a company’s compliance program. Monaco also announced increased transparency and consistency by DOJ when determining issues related to monitors. DOJ intends these policies to communicate to corporate entities that it is “not accepting business as usual” and that personal liability and the specifics of a corporation’s cooperation and integration of compliance programs will be heavily scrutinized in criminal corporate prosecutions.

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

DOJ Filing Reawakens Fraud-On-The-FDA Theory Of Liability

On June 3, the U.S. Department of Justice Civil Division’s Washington, D.C., office filed a statement of interest in a relator’s action, arguing that “[c]onduct giving rise to a regulatory violation can also give rise to” False Claims Act liability.

The case is U.S. ex rel. Patricia Crocano v. Trividia Health Inc., before the U.S. District Court for the Southern District of Florida.

Specifically, the DOJ requested “that the ruling not foreclose the possibility that, under certain circumstances,” conduct that violates the Federal Food, Drug and Cosmetic Act or U.S. Food and Drug Administration regulations “could be material to the government’s payment decisions and provide a basis for FCA liability assuming all necessary FCA elements are demonstrated,”[3] colloquially known as “fraud on the FDA.”

This filing makes clear the DOJ’s decision to reawaken a theory of liability thought to be dead.

To read the full text of this article by Duane Morris attorneys Eric Breslin, Frederick R. Ball and Brittany Pagnotta, originally published in Law360, 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.

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.

FDA Clarifies Evidence Used to Determine “Intended Use” of Medical Products

On September 23, 2020, the U.S. Food and Drug Administration (FDA) published a proposed rule amending the agency’s regulations concerning “intended uses.” While the proposed rule does not signal a fundamental change in FDA’s position that all relevant sources of evidence may be considered, it attempts to make clear what sort of evidence is not on its own sufficient to demonstrate a product’s intended use.

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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