Many of the safety and effectiveness studies the Food and Drug Administration orders as a condition of approval are behind schedule or overdue, according to federal records reviewed by The Washington Post in a report published Thursday. The studies at issue were required by the agency itself, not volunteered by industry.
The arrangement is deliberate. To get treatments to patients faster, the FDA allows companies to answer some remaining questions about a product after it is already on pharmacy shelves and in operating rooms. The unfinished-study problem is what happens when that second half of the bargain slips.
For patients, this is not an abstract regulatory story. It means the evidence behind a specific prescription or implant may be thinner than the word "approved" suggests, and that the study meant to settle the question may still be years away.
Requirements and Commitments Are Not the Same Obligation
The distinction matters for reading any headline on this subject. A postmarketing requirement is something the FDA compels a company to do, using authority under the Federal Food, Drug, and Cosmetic Act, the accelerated approval rules, or the Pediatric Research Equity Act. A postmarketing commitment is something a company agrees to do at the agency's request but is not legally required to complete.
Accelerated approval is the best-known version. The FDA can clear a drug for a serious condition based on a surrogate marker, such as tumor shrinkage, rather than waiting for survival data. The agency's accelerated approval program provides that if the confirmatory trial does not show clinical benefit, procedures exist that could lead to removing the drug from the market.
Congress tightened those levers in the Consolidated Appropriations Act for 2023. The FDA gained authority to require that confirmatory trials be underway before approval, to require progress reports every six months, and to use clarified withdrawal procedures.
Devices run on a parallel track. A Government Accountability Office review found that device postapproval studies averaged about three years, with the longest running nearly seven.
MedicalDaily Evidence Check: The Published Research Is More Mixed
A peer-reviewed analysis published in JAMA Network Open this summer paints a more favorable picture than the records framing alone would suggest, and readers deserve both.
The cross-sectional study by Maximilian Siebert of the Harvard-MIT Center for Regulatory Science and colleagues examined 370 FDA-approved drugs from 2016 through 2023. A subset of those approvals carried at least one postmarketing requirement or commitment, covering 88 efficacy or safety trials. Researchers found 76 of the trials, or 86.4 percent, were completed by the end of 2023, and 67 of the completed trials, or 88.2 percent, reported results either on ClinicalTrials.gov or in a publication.
One gap inside those numbers is worth flagging. Safety trials took longer to reach print than efficacy trials, with a median of 5.4 years to publication compared with 3.3 years. The safety questions are the ones patients tend to care about most.
The study has clear limits. It looked at drugs only, not devices, and at a subset of approvals. It measured whether results were disseminated rather than whether every study arrived on time. The authors nonetheless concluded that strengthening oversight and aligning incentives for timely reporting of results may be necessary so that evidence gathered after approval can inform clinical decisions. One co-author, Dr. Joshua Wallach, disclosed research grants from the National Institutes of Health, Arnold Ventures and the FDA through an academic regulatory science center.
One Drug Shows What a Failed Confirmation Looks Like
Tavneos offers a concrete case now moving through the system. The FDA's drug center proposed withdrawing the approval on April 27, on the grounds that new information indicated the drug had not been shown to be effective for its approved use and that the application contained untrue statements of material fact.
An agency investigation found that primary endpoint assessments for nine patients in the pivotal ADVOCATE trial had been re-adjudicated after the database was locked and after the trial was unblinded. The New England Journal of Medicine retracted the 2021 paper in late June at the request of two of its academic authors, and European regulators recommended revoking the European Union marketing authorization the same week. Amgen, which now markets the drug, has said it continues to believe the treatment is effective and is engaging with the FDA, and the drug remains on the market during that process.
The FDA had separately released postmarketing data in March identifying dozens of cases of drug-induced liver injury with possible or probable links to the drug, including fatal cases.
Patients taking Tavneos or any drug facing regulatory review should not stop on their own. Stopping treatment for active vasculitis without a plan carries its own serious risk, and that decision belongs with a prescribing clinician.
Questions Worth Asking at the Next Appointment
Patients can check a product's status themselves. The FDA publishes a postmarket requirements and commitments database, quarterly reports on accelerated approvals, and an oncology transparency effort called Project Confirm that tracks which cancer indications have converted to traditional approval or been withdrawn. Drug safety communications and recalls are also posted publicly.
Three questions are reasonable to raise with a clinician about a newer medication. Was this approved based on a surrogate marker or on a clinical outcome? Is a confirmatory trial still pending? And is there an older, better-studied option that would work as well?
Cost belongs in that conversation. Drugs still under confirmation are frequently expensive and often have no generic version, and insurers sometimes require prior authorization for them. Patients facing a denial can ask about appeals, alternative options, and manufacturer patient-assistance programs.
None of this means a recently approved product is unsafe. Accelerated approval has delivered treatments to patients who had no other option, and most postmarket trials in the published analysis were completed. The reasonable posture is informed rather than alarmed.
What to watch next: whether the FDA finalizes the Tavneos withdrawal, the agency's next quarterly accelerated approval report, and whether Congress revisits enforcement during user fee negotiations ahead of the September 2027 expiration. MedicalDaily will follow each.
Key Questions Answered
What do the records show? That many safety and effectiveness studies the FDA ordered as a condition of approval are behind schedule or overdue.
Does this mean approved products are unsafe? No. It means some remaining questions about long-term safety or benefit have not yet been answered by the required study.
What is the difference between a requirement and a commitment? A postmarketing requirement is legally compelled. A postmarketing commitment is agreed to at the agency's request and is not legally required.
Is the published research in agreement? Not entirely. A JAMA Network Open analysis of 370 drugs approved from 2016 to 2023 found 86.4 percent of the relevant trials completed and 88.2 percent of those reporting results, a more favorable picture than the records framing.
Which results take longest to appear? Safety trial results, at a median of 5.4 years to publication, compared with 3.3 years for efficacy trials.
Can patients look this up? Yes. The FDA posts a postmarket requirements database, quarterly accelerated approval reports, Project Confirm for oncology, and drug safety communications.
Should anyone stop a medication over this? No. Do not stop a prescribed medication without speaking to a qualified clinician. This article is general information and is not medical advice.
