On November 21st, the Food and Drug Administration (FDA) released final guidance for the 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review processes, which clarifies how the FDA will use third party review organizations (ROs) to review 510(k) submissions and EUA requests during a public health emergency. The guidance provides guidance on the FDA’s conduct of both the 510(k) Third Party Review Program and EUA third party review, including guidance on device eligibility and procedures for 510(k) Third Party Review Organizations, and expectations for Third Party review to ensure quality, consistency, and conflict prevention.

Continue Reading FDA releases final guidance on 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review

FDA approved drugs and medical devices are often studied further by sponsors and other firms to generate additional scientific information around other potential benefits and uses of those products.  Providing the results of this additional scientific activity to health care providers (“HCPs”) has led to enforcement from the U.S. Food and Drug Administration (“FDA), as those additional uses and benefits have not been evaluated by the FDA. If a firm communicates information about unapproved uses of an approved product, it could lead to a determination by FDA that the firm is promoting an unapproved intended use, which could lead to enforcement action for distributing a misbranded or adulterated product.  In an effort to provide recommendations on how to avoid FDA enforcement activity when providing the results of this additional scientific activity, FDA recently issued final guidance on how to communicate scientific information on unapproved uses (“SIUU”) of approved or cleared medical products to HCPs while avoiding FDA enforcement action.

Continue Reading FDA Clarifies Enforcement Policy Around Communications of Scientific Information on Unapproved Uses of Drugs and Medical Devices

On January 7, 2025, in the last weeks of the Biden Administration and before President Trump returned to the White House, the Food and Drug Administration (FDA) issued draft guidance, entitled “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.” This guidance provides recommendations on the use of AI intended to support a regulatory decision about a drug or biological product’s safety, effectiveness, or quality. The guidance discusses the use of AI models in the nonclinical, clinical, post-marketing, and manufacturing phases of the drug product life cycle. This is the first time FDA has proposed draft guidance on the use of AI for the development of drug and biological products and may provide insight on how AI models in medical product regulation should be assessed. The FDA is seeking public comment on the proposed guidance by April 7, 2025.     

Continue Reading FDA Proposes Framework to Assess AI Model Output Credibility to Support Regulatory Decision-Making

Federal policy efforts to advance health data exchange and interoperability are continuing to change rapidly. The latest changes are the publication of two final rules by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) finalizing parts of the Health Data, Technology, and Interoperability (HTI-2) Proposed Rule. These rules adopt requirements regarding the Trusted Exchange Framework and Common Agreement (TEFCA) (HTI-2 Final Rule), and create a new Information Blocking exception under Protecting Care Access (HTI-3 Final Rule), published on December 16th and 17th, respectively.

Continue Reading End of Year Regulations on Interoperability

Federal policy efforts to advance health data exchange and interoperability through the Trusted Exchange Framework and Common Agreement (TEFCA) have advanced rapidly in the past several months. Since TEFCA became operational in December 2023, the seven designated Qualified Health Information Networks (QHINs) have been facilitating data exchange under the TEFCA framework. The Sequoia Project, Inc., the TEFCA Recognized Coordinating Entity (RCE) or the organization responsible for providing oversight and the governing approach for QHINs, released over the past several months (on July 1, August 6, and November 13, 2024) its latest batch of Standard Operating Procedures (SOPs), which are written procedures or other provisions that are adopted pursuant to the Common Agreement. In the below summary, we outline a number of TEFCA-related policy developments and highlight considerations from the SOPs that are important to health information networks (HINs)/health information exchanges (HIEs) and other entities keeping apprised of interoperability policy developments.

Continue Reading RCE Issues Technical Guidance Governing TEFCA Exchange

Dr. John Pepe and Dr. Richard Sherman (“Relators”), acting as whistleblowers, brought a qui tam action against Fresenius Medical Care Holdings, Fresenius Vascular Care, Inc., and Dr. Gregg Miller (“Defendants”).  Relators’ complaint alleged that the Defendants engaged in fraudulent billing practices under the False Claims Act (“FCA”) and analogous state laws.  Last week, the United States District Court for the Eastern District of New York dismissed Relators’ case because they failed to plead their allegations with particularity as required by Federal Rule of Civil Procedure 9(b).

Continue Reading Stringent Requirements for Pleading Fraud Under Rule 9(b).

The United States District Court for the Northern District of Indiana recently dismissed a case involving allegations of fraudulent Medicaid claims and self-referrals.  The case, United States of America and State of Indiana ex rel. Bradley A. Stephens v. Nuclear Cardiology Associates (“NCA”), serves as a critical reminder of the stringent requirements for pleading fraud under the False Claims Act (FCA) and the Stark Law.

Continue Reading General Allegations Without Representative Examples Are Insufficient to Survive a Motion to Dismiss

The FDA recently provided its opinion on a pharmaceutical television ad that should help other pharmaceutical companies in their own advertisements.  The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) informed pharmaceutical company AbbVie that their television ad for migraine medication, Ubrelvy, featuring Serena Williams “…makes false or misleading representations and suggestions about the efficacy of Ubrelvy.” The letter focused on efficacy claims made in the advertisement.  The 30-second ad shows Serena Williams experiencing symptoms of a migraine while getting ready to go on stage. The ad then goes on to show how one dose of Ubrelvy helped Serena feel better, and she is later shown smiling and laughing as she walks onto a talk show stage. The FDA’s letter explains that in the original storyboard for the ad, Serena experiences migraine pain in the afternoon and feels better before her talk show appearance in the evening. The FDA contends that the televised ad does not accurately portray the time lapse that was in the storyboard version. The FDA stated that, “This compelling before-and-after presentation in conjunction with claims such as, “One dose works fast to eliminate migraine pain” and “UBRELVY QUICKLY ELIMINATES MIGRAINE PAIN” (emphasis added) misleadingly suggests that Ubrelvy eliminates migraine pain and symptoms more quickly than was demonstrated in the clinical trials.” The letter also claims that the ad “…misleadingly suggests that Ubrelvy will provide a greater treatment benefit to patients suffering from migraine headache than has been demonstrated.” 

Continue Reading FDA Calls Out a Migraine TV Ad for Misleading Viewers

In the world of False Claims Act (“FCA”) litigation, the recent case United States ex rel. Robert C. O’Laughlin, M.D. v. Radiation Therapy Services, P.S.C., et al. serves as an important reminder of the need for concrete evidence when asserting qui tam FCA claims.

Continue Reading The Anatomy of a Failed Qui Tam Case: Lessons from U.S v. Radiation Therapy Services

The United States District Court for the Eastern District of Michigan recently dismissed a False Claims Act (“FCA”) lawsuit brought against the City of Detroit.  The core issue in United States ex rel. Lynn v. City of Detroit revolved around Detroit’s annual certifications and assurances to comply with federal laws and regulations as a condition for receiving federal funds.  The relators argued that these certifications were false, thus constituting fraudulent claims under the FCA.

The court’s decision to grant summary judgment in favor of Detroit was based on the distinction between future promises and fraud.  The court noted that the certifications in question were forward-looking statements about future compliance, not assertions about past or present compliance.  This distinction was crucial because, under established legal principles, fraud claims must relate to misrepresentations about past or existing facts.  Future promises, on the other hand, are considered contractual and do not constitute fraud.

While some courts have recognized a “promissory fraud” exception, allowing fraud claims based on future promises if the plaintiff can prove that the defendant had no intention of complying at the time the promise was made, the Sixth Circuit has not endorsed this exception in the FCA context.  Though even if it had, the outcome here would not change.  The court explained that relators in this case failed to allege or provide evidence that the City officials who signed the certifications had no intention of complying with federal laws and regulations at the time they made the certifications.

This dismissal underscores the critical distinction between future promises and fraud, as well as the stringent requirements for invoking the promissory fraud exception.  In the end, the court’s ruling provides a clear message: future promises of compliance, without more, cannot form the basis of a fraud claim under the FCA.  

Note: Our lawyers leveraged AI in creating this blog post.  As we explore the potential of generative AI in the legal space, it is our intention and our practice to be transparent with our readers and to showcase the results we are achieving using generative AI with publicly available resources. Crowell’s AI group is comprised of lawyers and professionals across our global offices, including from Crowell & Moring International (CMI), our international public policy entity, with decades of sector-specific experience. We intend to lead by example in our own responsible use of AI, as it pertains to both the risks and benefits. Should you have questions about the use of generative AI in the legal sector or Crowell’s use of AI, please contact inovation@crowell.com.