FDA Cites Six Drugmakers for Failure to Complete Required Pediatric Studies

WASHINGTON – The U.S. Food and Drug Administration issued a series of non-compliance letters to six pharmaceutical and biotechnology companies in February and March 2026 for failing to submit required pediatric study assessments for their approved drug products. The letters, made public by the agency, cite violations of the Pediatric Research Equity Act (PREA), a law designed to ensure drugs are properly evaluated for safety and effectiveness in children.

The companies receiving the notices include Evive Biotechnology Singapore, Tanvex BioPharma USA, Tris Pharma, Teva Pharmaceuticals, Azurity Pharmaceuticals, and Harrow Eye, LLC. According to the FDA, these firms missed final deadlines for submitting pediatric assessments or failed to secure a necessary deferral or extension for their studies. The products involved range from injections for chemotherapy side effects to an oral solution for epilepsy and an ophthalmic gel.

These public letters represent more than just a procedural slap on the wrist. They are a clear signal of operational or planning shortfalls that can have significant consequences for a company's reputation and financial standing. For small and mid-sized firms, particularly those in the capital-intensive biotech sector, maintaining a pristine regulatory record is paramount to securing funding and achieving critical growth milestones.

Under Section 505B(d)(1) of the Federal Food, Drug, and Cosmetic (FD&C) Act, the FDA is required to issue these letters to sponsors who are delinquent on their PREA obligations. The law mandates that drug sponsors study their products in pediatric populations unless they obtain a waiver or a deferral from the agency. These studies are critical for providing doctors with the data needed to safely prescribe medications to children.

Once a non-compliance letter is issued, the recipient has 45 calendar days to provide a written response. This response must explain the reason for the delay and propose a new date for submission. Consistent with the FD&C Act, the FDA posts both the initial non-compliance letter and the company's response on its public website 60 days after issuance, with redactions for confidential commercial information.

As of the FDA's latest update, four of the six companies issued letters in the recent period have responded. Teva Pharmaceuticals responded on March 6 to a February 6 letter regarding its drug Alvaiz. Azurity Pharmaceuticals responded on March 20 to a letter from February 3 concerning its product Eprontia. Tris Pharma and Evive Biotechnology also submitted responses. However, the agency’s records indicate no response had been received from Tanvex BioPharma USA for its product Nypozi or from Harrow Eye, LLC for its ophthalmic gel IHEEZO, which both received letters in February.

This enforcement action is a key mechanism for ensuring compliance with a law that has been in effect for over two decades. A specific example of the process can be seen in a letter sent to Shionogi, Inc. in October 2025 regarding its antibiotic Fetroja. The letter clearly stated the company had “failed to meet the postmarketing requirement (PMR) of the Pediatric Research Equity Act” and demanded a response outlining the reasons for the delay and a new timeline.

While these PREA non-compliance letters are distinct from the more severe FDA Warning Letters, which often precede legal action such as seizures or injunctions, they carry significant weight. A public notice of non-compliance can spook investors, complicate capital raising efforts, and create hurdles in due diligence for potential mergers or acquisitions. In our experience, investors and potential partners scrutinize these public records intensely, often viewing them as red flags for deeper management or process issues. Proactive financial risk management involves integrating these regulatory timelines directly into financial forecasting and operational planning to prevent such unforced errors. It is about building a resilient business structure that anticipates these hurdles, not just reacting to them. For companies navigating these complex regulatory and financial landscapes, the advisory team at C&S Finance Group LLC at csfinancegroup.com provides essential guidance on aligning operations with compliance obligations.

The FDA’s stated practice is to provide firms an opportunity for voluntary and prompt corrective action. The public posting of these letters serves to increase pressure on companies to fulfill their post-market commitments. The transparency is intended to hold sponsors accountable not only to the agency but also to the public and the medical community that relies on the data from these pediatric studies.

Moving forward, industry observers will be watching to see if the two non-responsive companies, Tanvex BioPharma and Harrow Eye, submit their overdue plans and assessments. Stakeholders will also monitor the FDA's annual reports on PREA compliance to determine if this recent cluster of letters signals a broader trend of enforcement or is part of routine regulatory oversight. The continued public disclosure of these actions ensures that compliance with pediatric research requirements remains a visible priority for both the agency and the pharmaceutical industry.