A White House scientific panel has recommended that FDA expand its accelerated approval program to a broader range of drugs.
The Report To The President On Propelling Innovation In Drug Discovery, Development, and Evaluation says that broader accelerated approvals will require the agency to “strengthen the enforcement of requirements that drug sponsors investigate drugs’ risks and benefits in the post-approval phase, and to ensure that FDA responds effectively to this knowledge.”
The report’s recommendations strive to “double the efficiency of drug development by decreasing clinical failure, clinical trial costs, time to market, and regulatory uncertainty.”
Allowing limited drug approvals is another option the report says FDA should explore for narrow indications. The report adds that FDA should work with academic researchers, patients, prescribers, drug sponsors, payors, and its Risk Communication Advisory Committee to develop and evaluate new tools and approaches for effectively communicating risks and benefits to patients and the public.