FDA tightens fast-track approval regsFDA says it plans to fine companies up to $10 million who lack “due diligence” in completing confirmatory trials for drugs granted accelerated approval.
Writing in the online edition of the Journal of the National Cancer Institute, the officials said they have been concerned with sponsors' due diligence for some time. The due diligence in conducting post-approval trials to confirm clinical benefit has been suboptimal.
“Among the 14 accelerated approvals that do not have completed trials showing clinical benefit, the five longest intervals since accelerated approval up to the January 1, 2010, cutoff date are 10.5, 6.4, 5.5, 5.5, and 4.7 years,” they said. In addition, they said they may require that a confirmatory trial be in progress before granting accelerated approval.
“Of the 26 accelerated approvals with confirmation of clinical benefit in clinical trials,” they wrote, “11 had intervals of more than 5 years between accelerated approval and successful conversion to regular approval (range = 5.5 to 12.6 years) and the five longest intervals between accelerated approval and successful conversion to regular approval were 12.6, 9.7, 8.1, 7.5, and 7.4 years.”
The FDA officials also said they may require that a confirmatory trial be in progress before granting accelerated approval. “Such a requirement would ensure that accelerated approval is part of the development plan of a drug for a new indication and not an afterthought,” they wrote.