Update Accelerated Approval Labels with Required Info: Study

Researchers from Johns Hopkins University and elsewhere say drug manufacturers should update labels for drugs that received accelerated approval and don’t contain all the information required by FDA. In an article accepted for publication in Pharmacotherapy, the researchers report that their review of labels of all drugs with indications receiving accelerated approval after 1/1/1992 that had not received full approval by 12/31/2020 found 13% lacked sufficient information that approval was via the accelerated approval pathway or based on surrogate outcome measures.

“Labels for accelerated approval clinical indications that do not yet have full approval should be revised to include the information required in the FDA guidance to help guide clinical decision making,” the researchers conclude.

The study says that an FDA 2/2019 guidance on accelerated approval indication labels requires that the labels (1) describe that the indication was approved via accelerated approval, (2) specify the surrogate marker(s) that supported the accelerated approval, and (3) describe what specific outcomes are being evaluated in post-approval commitment trials.

It notes that accurate medication label information is very important for clinicians to make clinical decisions and says that labels that don’t comply with the guidance should be corrected by the manufacturers as they fail to provide information about the uncertainty surrounding the drug’s approval process, surrogate markers used, and clinical outcomes being examined in post-approval commitment trials.

“To incentivize manufacturers to update drug labels to meet the specifications determined in the FDA guidance and enforcement compliance,” the researchers say, “FDA could issue Warning Letters, have meetings with manufacturers, or issue fines for manufacturers with labels that continue to be non-compliant. These corrections would immediately enhance clarity and transparency to healthcare providers prescribing a range of medications. Ensuring clear and consistent language in accelerated approval drug labels would help increase transparency and improve the information available to healthcare practitioners and patients alike.”