Pharmaceutical Industry

Pharmaceutical Marketing News: FDA Revamps Approval Process for Generic Drugs

WASHINGTON - The Food and Drug Administration has announced a new policy which will accelerate review times for generic drugs it deems important to public health.

Under the new policy, drugs that normally would be selected for review within an average of 16 months would now be selected in six months.

Among those generic drugs that would be eligible for an accelerated review time would be drugs to be used in public health emergencies, drugs that are in short supply nationwide and drugs that do not already have a generic form on the market and have no blocking patents.

Up until now, the reviewed all generic drugs on a first come, first serve basis.

“This is a step away from our current practice where all applications sit in a queue toward a system that allows us to prioritize certain applications based on their public health impact,” said FDA Deputy Commissioner Scott Gottlieb. “Given the important role generic drugs play in public health, we need to make sure the process is as efficient as possible.”

Less than a quarter of all the generic drug applications the FDA receives are expected to benefit from the new policy.

The FDA announced the initiative at a generic drug industry conference in Washington, DC.