Industry pushes for faster generic approvals as costs rise
Generic drugmakers and others are pushing for faster FDA approval of generic drugs, particularly after a new report showed that 315 generic drug doubled in price since 2010. Many of the drugs with price increases don’t have competition, so more approvals are needed faster, manufacturers argue.
While the recent U.S. Government Accountability Office (GAO) report found that the price for generic drugs under Medicare Part D fell significantly since 2010, the agency also said there were “extraordinary” price increases for 315 generics. More than 300 of the 1,441 established generic drugs analyzed had at least one extraordinary price increase of 100% or more between first quarter of 2010 and the first quarter 2015, GAO said.
Plus, at a Congressional hearing on drug prices, Sen. Jerry Moran (R-KS) was concerned that the median time it takes for the FDA to approve a generic is now “nearly four years” despite the addition of about 1,000 new FDA employees and new user fee funds, the Regulatory Affairs Professional Society reported.
Moran also said that more than 4,000 generic applications are awaiting FDA approval, but 1,575 applications are awaiting a response from industry. And only 369 abbreviated new drug applications (ANDAs) have yet to receive some kind of a review communication from FDA.
Since the enactment of the Generic Drug User Fee Amendments (GDUFA) in 2012, FDA approval times have slowed down and the number of generic approvals has decreased, despite receiving $300 million in user fees, according to Senator Tom Cotton (R-Ark.).
As a result, Cotton recently introduced the Safely Advancing Valuable and Inexpensive New Generic Solutions Act, or the SAVINGS Act, which would require FDA to expedite the review process for generic drugs. It would also require the FDA to make a final approval decision within 150 days of receiving manufacturers’ priority review applications.
“The steady rise in prescription drug costs over the last several years has left many Arkansans wondering just how much more they can take. And as healthcare premiums rise under Obamacare, there’s now even less room in family budgets to spend more on prescription drugs,” Cotton said. “Regrettably, the current FDA backlog of new generic drug applications awaiting approval is only making this problem worse. Expediting the approval process for both the first and the second generic and requiring the FDA to make a decision in a timely fashion will increase competition in the prescription drug market and help lower costs for Arkansas families.”