\n
<\/p>\n
Others, though, remain skeptical.<\/p>\n
Under the law, Tavneos \u201creally shouldn\u2019t remain on the market,\u201d 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: \u201cI\u2019d at least like to see them go through peer review,\u201d Skydel said, \u201cbefore hanging my hat on them.\u201d<\/p>\n
H\u00f8eg, meanwhile, is skeptical that clinical evidence gathered since Tavneos was approved will do much to support its case. \u201cI suspect real world data, much of which were already available when we requested withdrawal in April, will not meet the FDA\u2019s evidentiary bar for approval,\u201d she wrote. \u201cWe do know the data were insufficient for ongoing marketing authorization [in] the EU and UK.\u201d<\/p>\n
Skydel additionally noted that at the time of Tavneos\u2019 approval, the FDA requested that additional post-marketing studies be conducted. But Amgen has fallen behind on deadlines for those studies. \u201cThis episode really, for me, highlighted the way that drugs are allowed to reach the market with open questions,\u201d Skydel said. \u201cOur capacity to answer those questions is really only as strong as FDA and industry\u2019s collaboration,\u201d he continued, as well as FDA\u2019s willingness to use its authority after a drug has gone on the market.<\/p>\n
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 \u201cis critical to protect the public health and the integrity of the drug approval process.\u201d Absent such a consequence, the agency stated, other companies will have an incentive to act deceptively.<\/p>\n
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 \u201cis built on a level of trust,\u201d he said. \u201cAnd 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.\u201d<\/p>\n