Contact: Caroline Rabbitt (202) 224-2353

Washington, D.C.- Senator Tom Cotton (R-Arkansas) today introduced the Safely Advancing Valuable and Inexpensive New Generic Solutions Act, or the SAVINGS Act, legislation that would require the Food and Drug Administration (FDA) to expedite the review process for both the first and the second introduced generic drugs. It would also require the FDA to make a final approval decision within 150 days of receiving the 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," said Senator Cotton. "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."

Background:

  • Prescription drug spending rose 12.6 percent in 2014 and is expected to continue to rise through 2018, according to March 2016 report issued by HHS.
  • 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 having received $300 million in user fees.
  • Academic studies have shown that every time a new generic enters the market drug prices significantly drop, and after the second generic is approved, prices continue to decline, leading to significant savings for consumers.
  • Cotton's SAVINGS Act would require the FDA to expedite the review of second generics and make a final decision within 150 days of receiving these Priority Review Abbreviated New Drug Applications (ANDAs).