The FDA wants to pull its approval of a drug. It’s not so easy.

Others, though, remain skeptical.

Under the law, Tavneos “really shouldn’t remain on the market,” said Joshua Skydel, a clinical fellow in rheumatology at Yale New Haven Hospital and a researcher at the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency. The FDA has standards for drug approval, including substantial evidence of safety and effectiveness. In this case, the pivotal trial has been called into question, and several of the studies that Amgen has pointed to have yet to be published: “I’d at least like to see them go through peer review,” Skydel said, “before hanging my hat on them.”

Høeg, meanwhile, is skeptical that clinical evidence gathered since Tavneos was approved will do much to support its case. “I suspect real world data, much of which were already available when we requested withdrawal in April, will not meet the FDA’s evidentiary bar for approval,” she wrote. “We do know the data were insufficient for ongoing marketing authorization [in] the EU and UK.”

Skydel additionally noted that at the time of Tavneos’ approval, the FDA requested that additional post-marketing studies be conducted. But Amgen has fallen behind on deadlines for those studies. “This episode really, for me, highlighted the way that drugs are allowed to reach the market with open questions,” Skydel said. “Our capacity to answer those questions is really only as strong as FDA and industry’s collaboration,” he continued, as well as FDA’s willingness to use its authority after a drug has gone on the market.

In its April letter, the FDA argued that the stakes of this debate go beyond patients with one rare disease, stating that withdrawing the drug “is critical to protect the public health and the integrity of the drug approval process.” Absent such a consequence, the agency stated, other companies will have an incentive to act deceptively.

Walter Kraft, who voted to recommend approving the drug based on what he knew at the time, also worries about the potential for knock-on effects. The clinical trial system “is built on a level of trust,” he said. “And when that trust is put into question for a narrow parochial gain, it puts the whole system at risk for other subsequent actors in the space.”

This article was originally published on Undark. Read the original article.

Source: arstechnica.com — article syndicated from the publisher’s feed; all rights remain with the original publisher.