Many Accelerated Approval Drug Labels Lack Required Marketing Information
More than 10 percent of drugs marketed with an Accelerated Approval (AA) failed to include mention of the AA on the label, a new study has found.
In addition, none of the 110 labels reviewed included information on required postapproval studies, Jeromie Ballreich, of Johns Hopkins University, and colleagues wrote in Pharmacotherapy.
FDA guidance requires that drug labels note the AA status and specify the surrogate or intermediate endpoints that supported the approval. The FDA also requires these labels to describe what outcomes are being investigated in the required postmarketing trials.
Ballreich and his co-authors reviewed 110 AA indications across 62 drugs that had not received a full approval by the end of 2020. They then examined the labels to see whether they contained a description of the surrogate or intermediate clinical endpoint marker that supported the accelerated approval.
Thirteen percent contained insufficient information about approval status or supporting data; 7 percent did not mention AA but did mention surrogate markers (SM); 4 percent failed to mention AA or SM; and 2 percent mentioned AA but did not describe SM.
March 9, 2023
https://www.fdanews.com/
In addition, none of the 110 labels reviewed included information on required postapproval studies, Jeromie Ballreich, of Johns Hopkins University, and colleagues wrote in Pharmacotherapy.
FDA guidance requires that drug labels note the AA status and specify the surrogate or intermediate endpoints that supported the approval. The FDA also requires these labels to describe what outcomes are being investigated in the required postmarketing trials.
Ballreich and his co-authors reviewed 110 AA indications across 62 drugs that had not received a full approval by the end of 2020. They then examined the labels to see whether they contained a description of the surrogate or intermediate clinical endpoint marker that supported the accelerated approval.
Thirteen percent contained insufficient information about approval status or supporting data; 7 percent did not mention AA but did mention surrogate markers (SM); 4 percent failed to mention AA or SM; and 2 percent mentioned AA but did not describe SM.
March 9, 2023
https://www.fdanews.com/
