General – Duane Morris Life Sciences Law

The United States Court of Appeals for the First Circuit’s opinion in United States v. Regeneron Pharmaceuticals, Inc. has sharpened the circuit split for demonstrating the effect of a kickback on healthcare decisions under the False Claims Act (FCA). The Regeneron court held that an FCA claim based on an alleged violation of the Anti-Kickback Statute requires demonstrating that an alleged unlawful kickback was the “but-for” cause of a submitted claim.

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February 24, 2025March 10, 2025 by Duane Morris

Federal Court Enjoins Enforcement of NIH’s Rate Change Notice Regarding Indirect Costs

By Dan Walworth, Rolando Sanchez, Frederick Ball, Geoffrey Goodale and Sara Smith

Since taking office, the Trump Administration has taken steps to reshape the United States’ federal funding infrastructure. One such action relates to the National Institutes of Health’s (“NIH”) rate change, imposing a 15% cap for indirect costs, for new grants and for existing grants awarded to institutions of higher education (“IHEs”). This rate change, which represents a drastic reduction from historical rates normally negotiated by grant recipients, will impact ongoing research programs and clinical trials, and will have a long-term impact on the United States’ research infrastructure and abilities.

On February 10, 2025, the day the rate change was intended to go into effect, three lawsuits were filed in the U.S. District Court for the District of Massachusetts challenging the rate change. The lawsuits were filed by a group of stakeholders, including twenty-two states, thirteen universities, three university associations and five associations. Also on February 10, 2025, a district court judge granted two temporary restraining orders (“TROs”), enjoining enforcement of the rate change within the 22 Plaintiff states, and enjoining enforcement nationwide with respect to institutions. On February 21, 2025, following a hearing on the Plaintiffs’ motions for injunctive relief, the district court ordered that the TROs entered on February 10, 2025 are extended and will remain in effect until further order of the Court.

February 13, 2025 by Duane Morris

AI-Powered Medtech: What Companies Need to Know About Regulatory and IP Risks

As the medtech AI market surges toward $615 billion by 2034, companies must navigate complex licensing, regulatory, and intellectual property challenges. Understanding these key issues is essential to unlocking the full potential of AI-driven healthcare innovation.

The global market value for medical technology utilizing artificial intelligence (AI) is projected to reach about $615 billion by 2034.

According to recent market reports, the global market value for medical technology utilizing artificial intelligence (AI) was estimated to be around $19 billion in 2023, with projections for significant growth to reach about $615 billion by 2034, a compound annual growth rate of over 35%.

The medtech AI market is experiencing a remarkable surge in adoption, driven by advancements in AI algorithms, increasing healthcare data availability, and rising demand for improved diagnostics and treatment options. Factors like personalized medicine, early disease detection, improved patient outcomes, and cost-efficiency are key drivers for the growth of this market. As of August 2024, FDA has authorized 950 artificial intelligence and machine learning (AI/ML) medical devices.

To read the rest of this article by Duane Morris partner Driscoll Ugarte, originally published in MC+CI Qmed, please visit the publication website.

February 12, 2025February 12, 2025 by Duane Morris

FDA Releases Draft AI Guidance – A New Era for Biotech, Diagnostics and Regulatory Compliance

The U.S. Food and Drug Administration’s recent release of two draft guidance documents on the use of artificial intelligence in drug development, biologics and medical devices has sparked both excitement and skepticism. As AI increasingly permeates these fields, the regulatory landscape is just beginning to take shape—and these proposed guidelines take a step in that direction by raising awareness of important questions about the future of AI innovation in life sciences. For therapeutic, medical device and diagnostics companies—whether already implementing AI or just beginning to explore its potential—the message is clear: The landscape is evolving, and future success will require thoughtful consideration of compliance, patient safety and privacy protection from the earliest stages of AI adoption.

Read the full Alert on the Duane Morris LLP website.

January 28, 2025January 28, 2025 by Duane Morris

FDA Issues Draft Guidance Q&A on Developing Potential Cellular and Gene Therapy Products

In November 2024, the U.S. Food and Drug Administration (FDA) issued draft Guidance responding to frequently asked questions about developing cellular and gene therapy (CGT) products. This draft Guidance supplements existing finalized and draft Guidance on CGT products.

Read the full Alert on the Duane Morris LLP Website.

January 23, 2025January 23, 2025 by Duane Morris

Federal Circuit Court Affirms Delisting of Patents Claiming Device Components of Drug Product Without Active Ingredient

In Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC (No. 2024-1936), the Federal Circuit affirmed the District Court of New Jersey’s order to delist from the FDA Orange Book Teva’s five patents claiming just device components of a drug product without reciting any active ingredient.

Read the full Alert on the Duane Morris LLP website.

November 6, 2024 by Duane Morris

Promoting Intimate Health and Wellness Products and Treatments: What Spas Need to Know

The global market for intimate wellness products is expected to grow to $81.4 billion by 2028, up from $51.9 billion in 2021, according to recent market research reports. Once taboo, or the topic of hush-hush conversations, intimate wellness brands are increasingly crossing over into mainstream wellness marketing, collaborating with well-known fashion and beauty brands and major retailers, expanding concepts of self-care for Gen Z consumers who are more inclusive and willing to explore individual concepts of pleasure.

To read the full article by Duane Morris associate Kelly Bonner, please visit the WellSpa360 website (registration required).

October 21, 2024October 21, 2024 by Duane Morris

FDA’s Final Guidance on Decentralized Clinical Trials Published

On September 18, 2024, the U.S. Food and Drug Administration (FDA) issued final Guidance on recommendations for conducting decentralized clinical trials (DCTs) for drugs, devices or biological products. Instead of using traditional clinical trial sites, DCTs hold some or all trial activities remotely at locations convenient for trial participants by, for example, using telehealth appointments, outsourcing visits to local healthcare providers, or conducting laboratory tests at outside facilities.

Read the Alert on the Duane Morris LLP website.

September 23, 2024 by Duane Morris

FDA’s Latest Draft Guidance on Medical Device PCCPs Incorporates FD&C Act Changes

The U.S. Food and Drug Administration (FDA) recently issued draft Guidance informing medical device manufacturers how to structure a predetermined change control plan (PCCP) to describe appropriate, intended future device modifications. The Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research in consultation with the Center for Drug Evaluation and Research and the Office of Combination Products in the Office of the Commissioner worked together to prepare this Guidance.

Read the full Alert on the Duane Morris LLP website.

September 3, 2024 by Duane Morris

House Oversight Committee Gives Pharmacy Benefit Managers Deadline to Correct Congressional Record of Allegedly Fraudulent Statements

On August 28, 2024, the U.S. House Committee on Oversight and Accountability issued letters to executives of three of the nation’s largest pharmacy benefit managers (PBMs), accusing them of providing false testimony before Congress. Each letter outlines the allegedly false statements and the evidence that the statements contradict. They also outline the statutory penalties for perjury before Congress—namely, monetary fines and imprisonment for up to five years. The letters give the PBMs until September 11, 2024, to correct the Congressional Record.

Read the Alert on the Duane Morris LLP website.