Drugmakers Failed to Complete 600 Safety Studies

Healthcare operators should anticipate tighter regulatory oversight as nearly 600 postmarket safety studies fall behind schedule.

Updated on Sept. 18, 2026 in Healthcare

Bold vector editorial illustration of a glass reagent vial resting on steel beams, representing systemic regulatory oversight gaps. — Federal regulators face mounting pressure as pharmaceutical and medical device manufacturers leave nearly 600 mandated postmarket safety studies unfinished. AI Illustration. Upload story photo >

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

Drug and medical device manufacturers have left nearly 600 FDA-required postmarket safety studies unfinished, representing approximately one-third of all ongoing trials. This regulatory gap highlights ongoing challenges in validating safety data for products that received accelerated approval.

Why it matters

Federal regulators mandate these studies to bridge safety data gaps left during initial product approval, meaning missed deadlines create long-term compliance risks. The failure to complete these trials also undermines the evidentiary basis for products that rely on public and private insurance reimbursements.

Nearly 600 FDA-required studies are currently behind schedule, accounting for one-third of all active requirements. This comes against a backdrop of $18 billion in Medicare and Medicaid spending between 2018 and 2021 on drugs approved with incomplete confirmatory trial data.

The players

Food and Drug Administration

The federal agency responsible for protecting public health through the regulation and supervision of food safety, tobacco products, and pharmaceutical drugs.

HHS Office of Inspector General

The watchdog agency within the Department of Health and Human Services that investigates waste, fraud, and abuse in federal healthcare programs.

The details

The FDA mandates these postmarket studies as a condition of approval when initial evidence is limited, requiring firms to monitor long-term outcomes after launch. Delays are significant; for example, a Tavneos safety study required 300 patients but had only 21 enrolled by fall 2025, and an eye-implant study for children remains at zero patients nine years after its protocol was accepted. These failures force providers and systems to operate with incomplete data regarding patient risks, such as the 76 cases of liver injury linked to Tavneos.

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

Market Landscape

This backlog highlights a systemic failure to execute the postmarket validation steps required under the FDA accelerated-approval pathway. The current situation follows a January 2025 report from the HHS OIG, which criticized the quality of evidence supporting products granted expedited market access.

Operators in the pharmaceutical and medical device space should review their internal trial milestones against FDA-mandated deadlines to avoid potential enforcement actions. Managers must also prepare for potential shifts in reimbursement policy that may tie future payments to the timely completion of confirmatory trials.

The takeaway

The significant backlog of required safety studies signals an impending shift toward stricter FDA oversight of accelerated-approval products. Companies should prioritize auditing their outstanding postmarket trial commitments to ensure compliance and avoid future clinical or financial risk.