Questions about the evidence supporting Tavneos’ approval have raised concerns among researchers, regulators and drug manufacturers. Critics say the drug may not meet the FDA’s standard for substantial evidence of safety and effectiveness, while the FDA has warned that allowing the drug to remain on the market could undermine public health and the integrity of the approval process.
Critics question the evidence for Tavneos
Under U.S. law, Tavneos “really shouldn’t remain on the market,” said Joshua Skydel, a clinical fellow in rheumatology at Yale-New Haven Hospital and a fellow at the Yale Collaboration for Regulatory Stringency, Integrity, and Transparency.
The FDA requires substantial evidence of a drug’s safety and effectiveness before approval. Skydel said the case raises questions about key clinical trials, including studies cited by Amgen that have not yet been published. “I would like them to at least go through peer review before I hang my hat on them,” he said.
Hogue, however, is skeptical that clinical evidence gathered since Tavneos was approved will support the company’s claims. “We suspect that the real-world data that was already available at the time we requested the retraction in April would not meet the FDA’s standard of evidence for approval,” she wrote. “We know there is insufficient data to support continued marketing approval” in the European Union and the United Kingdom.
Post-marketing studies remain incomplete
Skydel also noted that the FDA required additional post-marketing studies when Tavneos was approved. Amgen has missed deadlines for completing those studies.
“For me, this episode really highlighted the way drugs reach the market with unanswered questions,” Skydel said. “Our ability to answer these questions is really only as strong as the collaboration between FDA and industry.” He also pointed to the FDA’s willingness to exercise its authority after a drug reaches the market.
FDA warns of broader consequences
In an April letter, the FDA argued that the stakes extend beyond patients with a single rare disease. Discontinuing the drug is “critically important to protect public health and the integrity of the drug approval process,” the agency said.
Without consequences, the FDA added, other companies could have an incentive to engage in deceptive practices.
Walter Craft, who voted to recommend Tavneos’ approval based on the information available at the time, is also concerned about the potential effects on the broader clinical-trial system.
The system “is built on a level of trust,” he said. “And when that trust is called into question because of narrow parochial interests, it puts the entire system at risk for other subsequent actors in that space.”
This article was first published by Undark. Please read the original article.
Source: arstechnica.com
