WASHINGTON — Seeking new ways to lower drug prices, White House advisers have raised the prospect of fast-tracking the review process for some brand-name medications submitted for approval to the Food and Drug Administration.
The FDA already prioritizes the review of drugs that are the first, second, and third generics of any given brand. The new idea, outlined in a report from the Council of Economic Advisers released Friday, might expand such a policy to brand-name drugs that treat similar diseases but can’t be interchanged like generics can be.
“A valuable policy option might be changing the criteria for expedited review to include new molecular entities that are second or third in a class, or second or third for a given indication for which there are no generics,” the report reads. “This would serve as a new pro-competition pathway that would enhance therapeutic price-competition by providing expedited entry into monopoly markets.”
