fda – Page 2 – Duane Morris Life Sciences Law

August 10, 2023 by Duane Morris

Nitrosamine Impurities FDA Guidance

By Alan Klein, Patrick Gallagher and Michael Fox

On August 4, 2023, the FDA issued a new Guidance to the pharmaceutical industry relating to large molecule drugs left unaddressed in its earlier nitrosamine Guidance publications. (Access the complete Guidance or the abbreviated version.)

Reacting to considerable input from the pharmaceutical industry, both brand and generic, following the agency’s Federal Register request for and receipt of extensive comments on these issues, including scientific data furnished to the agency by NDA and ANDA sponsors over the past year and a half, FDA has now provided drug manufacturers with critical guidelines for conforming their products to what the agency has determined to be safe nitrosamine exposure limits for patients. This comes on the heels of setting similar exposure limits for these products late last month by the European Union’s chief drug regulator, the European Medicines Agency. In its current Guideline, FDA has ranked impacted prescription drugs into 5 categories depending upon their carcinogenic potency, with “1” being the most potent, and “5” the least. Instructing the industry on their responsibility to minimize or eliminate nitrosamine impurities in their products to the extent feasible, the agency has extended the timeline for this task to August 2025, recognizing the complexity of this process and the need to avoid recalls and market disruptions of widely prescribed and important medications.

July 11, 2023 by Duane Morris

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.

July 5, 2023 by Duane Morris

Beauty and Personal Care Products Post-MoCRA Regulatory Compliance Checklist

MoCRA, Pub. L. No. 117-328, represents the first major statutory change to the authority of the Food and Drug Administration (FDA) to regulate cosmetics since the Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. § 361 et seq.,
in 1938 and the Fair Packaging and Labeling Act (FPLA), 21 C.F.R. § 701.3, in 1966.

This checklist outlines key regulatory compliance considerations that are specific to personal care products marketed in the United States following the enactment of the federal Modernization of Cosmetics Regulation Act (MoCRA) on December 23, 2022.

To read the full text of this Lexis Nexis Practical Guidance Checklist by Duane Morris attorneys Driscoll Ugarte, Rick Ball, Alyson Lotman, Kelly Bonner and Coleen Hill, please visit the firm website.

March 6, 2023 by Duane Morris

US FDA Looks to Move Cosmetics Work

Duane Morris attorney Kelly Bonner was quoted in an article in Chemical Watch on March 3.

“The US Food and Drug Administration has started its search for a deputy commissioner for its new human foods programme, and plans to move certain cosmetics functions to another part of the agency to advance oversight of the products. […]

The inclusion of cosmetics in the proposed restructuring is “very significant”, said Kelly Bonner, associate with law firm Duane Morris.

The move will allow the FDA to implement MoCRA more efficiently and effectively, she told Chemical Watch. To this end, the agency “anticipates closer collaboration between cosmetics and other FDA subject matter experts” in the Center for Drug Evaluation and Research and the Office of Women’s Health, she said.”

To read the full text of this article, please visit the Chemical Watch website (subscription required).

January 4, 2023 by Duane Morris

Year-End Appropriations Bill Overhauls FDA Cosmetics Authority

On December 23, 2022, Congress significantly expanded the FDA’s regulatory authority over cosmetics as part of its year-end Consolidated Appropriations Act of 2023, the first major statutory change to the Food, Drug and Cosmetics Act regarding the regulation of cosmetics since 1938. Passed with bipartisan support and garnering industry approval, the Modernization of Cosmetics Regulation Act contains a number of key provisions, requirements and dates for compliance.

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

August 22, 2022 by Duane Morris

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.

June 28, 2022 by Duane Morris

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.

April 21, 2022 by Duane Morris

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.

March 16, 2022March 16, 2022 by Duane Morris

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.

September 27, 2021September 27, 2021 by Duane Morris

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.