In order to get some prescription drugs to market quickly, the FDA will approve them provisionally. It will then require more data from their manufacturers, through additional long-term studies. But, David Hilzenrath reports for KFF Health News that too often the manufacturers never perform the required studies.
FDA records reveal that manufacturers drag their feet and delay hundreds of “postmarket” studies, at the risk of endangering the health and lives of Americans who take their drugs. Delays can run ten years and longer.
According to one cardiologist who examines this issue, the FDA’s requirements are essentially toothless. And, when the FDA approves drugs and devices provisionally, its approvals can do grave harm at great cost to patients, providers and the government. The manufacturers are the sole beneficiaries.
The Trump administration is speeding up FDA approval further. The FDA now requires only one clinical trial to show safety and efficacy, not two. Of course, this new policy just helps manufacturers more.
Today, about 600 post-market studies are delayed. Sometimes, the FDA allows manufacturers more time. Sometimes, it does not. But, only rarely does the FDA stop the products from being marketed. Tavneos, for example, has generated hundreds of millions in revenue for its maker, without proof of any clinical benefit and led to dozens of liver injuries. The EU has pulled it from the market but the FDA has failed to do so.
Here are a few other drugs and medical devices that could be unsafe, with manufacturers who have not complied with their obligation to conduct post-market studies.
The CustomFlex Artificial Iris: This is implanted in the eye to replace the iris. No study has occurred in the last seven years since the company submitted a letter saying it would undertake a study.
Paxlovid, a covid treatment. It remains unclear whether it is safe for pregnant women. The trial should have been finalized two years ago.
The Scandinavian Total Ankle Replacement system. A clinical trial with at least 500 patients never occurred. It should have begun more than 15 years ago. The trial included just 142 people, nearly half of whom had at least one poor outcome.
Oxaydo (originally named Oxecta), is supposed to address opioid addiction, reducing deaths and overdose. Pfizer, which markets the drug, never issued the final report due ten years ago. The drug has been discontinued.
Over the course of three years, Medicare spent $18 billion on these potentially unsafe drugs. Yet, the FDA continues to approve potentially dangerous drugs, some with no indication of clinical benefit. One drug approved for Duchenne muscular dystrophy, eteplirsen, required postmarket proof of clinical benefit. But, even without it, the FDA will never stop its sale.
What’s most insane is that this drug, with no proven clinical benefit, is the second most expensive drug on the market in the US, with an annual cost of between $750,000 and $1.5 million. In 2025, it earned its maker $538 million in revenues.
