Industry pushes for faster generic approvals as costs rise

October 7, 2016

Generic drugmakers and others are pushing for faster FDA approval of generics.

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.”

 

In addition, the controversy over Mylan Pharmaceutical’s price hike on its EpiPen-- which doesn’t have generic competitors-has led to an additional 13 co-sponsors on a bill to encourage faster development of generic drugs. Rep. Kurt Schrader (D-Ore.) introduced the “Lower Drug Costs to Reduce Competition Act” with Rep. Gus Bilirakis (R-Fla.) in March, in response to Turing Pharmaceutical’s significant price hike on the price of Daraprim for life-threatening toxoplasmosis.

“Some of our most vulnerable constituents depend on access to life-saving pharmaceuticals,” Schrader told USA Today. “We know many of these patients’ costs could be lowered if generic competitors were available. Our bipartisan proposal will encourage generic competition, lower drug costs, and allow treatments to come to market faster.”

Meanwhile, manufacturers are hoping for faster drug approvals after FDA meets on October 21 to discuss the second generation of GDUFA. As part of the changes, FDA says it will begin offering eight-month and 10-month reviews of ANDAs between 2018 and 2022, RAPS said.

FDA also plans to quicken its reviews of “sole-source” generic drugs, which could increase competition, help with drug shortages, and may even drive down the cost of expensive generics that have no competition, according to RAPS.