Under the proposed Accelerated Approval Integrity Act, the FDA would be granted power to expedite the withdrawal of an accelerated approval status if the required post market studies are not completed within five years. However, trials may continue if the post marketing study has been completed and verified the clinical benefit, or the Secretary of Health and Human Services determines that adequate progress has been made.
The bill would also require drug companies to plan and initiate post market studies before a drug receives accelerated approval status.
