The President’s Council of Advisors on Science and Technology (PCAST) wants to double the output of “innovative new medicines that meet critical public health needs over the next 10 to 15 years, while continuing to increase drug safety.” PCAST suggested that one approach to achieving this goal would be to use the FDA’s Accelerated Approval Program for certain candidate drugs. These candidate drugs include drugs that either meet an unmet medical need or treat serious diseases (ALS checks both boxes). This approach could have the potential to benefit people with ALS. However, we need to proceed carefully. Although this approach has the potential to increase the number of available drugs, the increased speed of the approval process may potentially compromise drug safety.
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