Drugs

10 Accelerated Approval Reforms Evaluated

Center for Health Policy & Outcomes researchers have analyzed the advantages and disadvantages of 10 potential reforms to the FDA accelerated approval process. The reforms are broken out as those achievable that FDA action alone and those requiring a combination of government, payer, and life science industry actions. The evaluation is in a white paper published in the Journal of Comparative Effectiveness Research.

“The accelerated approval pathway for new drugs in the United States is often praised but faces growing criticism of whether it is finding the appropriate balance between uncertainty, access, and cost,” the researchers write. “Accelerated approval sits at the heart of many of the controversies regarding drug approval and pricing, and this analysis provides perspectives on how best to strengthen the pathway within the broader landscape of an innovative U.S. healthcare system.”

The evaluated policy reforms are:

strengthening the selection of surrogate endpoints;
developing standardized accelerated approval review templates;
require greater use of randomized controlled trials;
create a new label alert and patient material for accelerated approval drugs;
increase enforcement of requirements to complete confirmatory trials;
create an annual renewal cycle or sunset accelerated approvals lacking confirmatory evidence;
create a separate “safety-only” approval pathway that waives public or private insurance coverage requirements;
increase mandatory federal rebate levels until the time of full approval;
use pricing at marginal cost to incentivize completion of confirmatory trials, with consideration of a federal carve-out; and
require payment be based on outcomes-based contracts.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome