New Bill to Speed Up Generic Drug Approvals Introduced in Senate

U.S. Senators Susan Collins and Claire McCaskill have introduced the Increasing Competition in Pharmaceuticals Act, a bill to ensure that a clear process is in place for the U.S. Food and Drug Administration (FDA) to prioritize the review of generic drug applications. This bill is a response to the recent aggressive price hikes for a variety of drugs already in the marketplace.

“The bill’s aim is simple: faster, more affordable access to life-saving prescription drugs for those who need them most,” said Sen. McCaskill. “By fast-tracking the approval of certain generics, especially those subject to shortages or only one supplier, I’m hopeful we’ll be incentivizing competition that’ll drive down the cost of these life-saving medications.”

Other provisions of the bill include improving the U.S. FDA’s generic approval process, directing the U.S. FDA to report quarterly on the number of new drug applications filed, and creating a new generic priority review voucher that would be awarded in the event of a medical shortage or sole-source drug that reaches market.

The bill stems from a recent investigation opened by Sens. Collins and McCaskill in late 2015 to examine the causes, impacts, and potential solutions for this practice of drug pricing increases.

Source: U.S. Senate news release, March 3, 2016.