PharmaVoice Article About FDA Dispute with Drugmaker Includes Insight from Ted Sullivan
Ted Sullivan, a Health & Life Sciences partner in the Quarles & Brady Washington office, commented in a PharmaVoice article on the implications of the U.S. Food and Drug Administration’s (FDA) move to force removal from the market of a drug that allegedly received approval based on misleading data.
The FDA asserts that the 2021 approval of Tavneos, a drug eventually acquired by Amgen, was influenced by data that had been improperly manipulated. After efforts to get the company to voluntarily remove the drug from the market, the FDA now has published a proposal to force the drug’s removal.
Sullivan noted that the process in this case is in line with what should be expected and should send a message to drug manufacturers. An excerpt:
While the FDA’s proposal did not include evidence to back up its allegations, the recent escalations follow the agency’s typical playbook for pulling a drug from circulation, said Ted Sullivan, a partner at the law firm Quarles.
“In this situation, there were significant adverse event reports along with allegations of significant irregularities or misconduct of the key clinical trials,” Sullivan said in an email. “It is not surprising that FDA has taken this action, and it is in line with what I would have expected.”
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“The timeline for the current action seems about right, given what we know — FDA only discovered the clinical trial problems in the summer of 2025, and fairly quickly acted on this information to address the issues with Amgen,” Sullivan said. “There were also post-marketing data that suggested safety problems with the drug, but it can take some time for those to become apparent.”
In this regulatory environment, Amgen’s scuffle with FDA offers a key reminder to the industry, Sullivan said.
“Quite simply, don’t play games with your clinical trials data,” he said.