Washington, D.C.— Senator Tom Cotton (R-Arkansas) today sent a letter to Food and Drug Administration (FDA) Deputy Commissioner Robert Califf expressing concern over the rising cost of prescription drugs in Arkansas and inquiring about the agency’s role in reversing this trend.
While studies show that introducing new generic drugs into the market helps lower the cost of life-saving pharmaceuticals, many pending drug-approval applications are currently stuck in an FDA backlog. Worse, this backlog comes despite the 2012 passage of the the Generic Drug User Fees Act, which allowed the agency to collect $1.5 billion in revenue, hire 1,000 new employees, and create the Office of Generic Review to ensure timely reviews of generic drug applications.
In the letter, Senator Cotton highlights his concern over the FDA backlog and asks Deputy Commissioner Califf to clarify several FDA definitions and correlating data.
Senator Cotton’s questions pertaining to backlog definitions are:
- The agency has stated its goal to eliminate the backlog – how are you defining elimination?
- If the Agency is defining elimination in terms of actions beyond approval or withdrawal of an application (such as a tentative approval (TA) or complete response letter (CRL)), how long does the Agency anticipate it will take to respond to each of the current 3,875 ANDAs with either an approval, a rejection, or a withdrawal of the application?
- To what extent does the Agency identify and prioritize approving the second, third, and fourth generic to increase the number of generic competitors?
Senator Cotton’s questions pertaining to backlog data are:
- How many first generic applications and shortage applications are currently in the backlog?
- How does the expedited review process differ than the standard review process? Are there substantive differences during the actual review, or only a change in order within the queue?
- What is the average approval time for applications going through the expedited review process vs. the standard review process? How has this changed in recent years?