Drugmakers Missed Hundreds of FDA Safety Study Deadlines

Nearly 600 required safety studies for drugs and medical devices remain behind schedule.

Updated on Sept. 18, 2026 in Healthcare

Bold flat-color editorial illustration showing a metallic centrifuge, representing FDA medical research and regulatory oversight of safety study compliance. — Pharmaceutical and device companies have missed deadlines for nearly 600 FDA-mandated safety studies, potentially leaving patients at risk from products with incomplete long-term data. AI Illustration. Upload story photo >

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Should the FDA impose stricter penalties on drugmakers that fail to complete required safety studies?

Pharmaceutical and device companies have failed to complete nearly 600 postmarket safety studies required by the FDA as a condition of product approval. Federal spending on drugs with incomplete confirmatory trials topped $18 billion between 2018 and 2021.

Why it matters

Postmarket studies are critical safety measures required by regulators when products receive approval with limited clinical data. When these studies stall, the public may continue using medical products without a clear understanding of long-term risks.

Nearly 600 postmarket studies are currently behind schedule, representing about one-third of all active investigations. Medicare and Medicaid spent over $18 billion on drugs with incomplete confirmatory trials between 2018 and 2021.

The players

Food and Drug Administration

The federal agency responsible for protecting public health by ensuring the safety and efficacy of human drugs, biological products, and medical devices.

HHS Office of Inspector General

This department provides independent oversight of the Department of Health and Human Services to combat fraud, waste, and abuse in federal programs.

The details

Several high-profile cases highlight the issue, including the drug Tavneos, which was approved in 2021 with a requirement for a 300-patient safety study but had only 21 patients enrolled by fall 2025. This medication has since been linked to 76 cases of drug-induced liver injury and eight deaths, while an eye-implant study for children remains at zero enrollment nine years after its protocol was accepted.

2018-2021: Medicare and Medicaid spent $18 billion on drugs with incomplete trials.
May 2021: The Exondys 51 confirmatory study missed its completion deadline.
2021: The FDA approved Tavneos with a specific safety study requirement.
2024: The Paxlovid pregnancy safety study missed its completion deadline.
January 2025: HHS OIG issued a report regarding weak approval evidence.

Market Landscape

This backlog underscores systemic failures in the FDA accelerated-approval pathway, which allows companies to market products before long-term safety data is fully realized. These delays shift the burden of risk onto patients and taxpayers who fund treatments with unverified safety profiles.

Patients may be taking medications or using devices that lack sufficient long-term safety documentation, potentially exposing them to undetected medical risks. While this impacts the entire healthcare system, individuals concerned about specific treatments should consult their doctors regarding the status of safety trials.

The takeaway

Patients should actively verify if their prescribed medications are part of the accelerated-approval program and whether the required safety studies have been completed. Transparency from manufacturers regarding trial enrollment remains a vital factor for individuals making informed healthcare decisions.