More Generic Drug Approvals Not Enough

FDA efforts to speed more new generic drugs to market probably won’t do much to reduce high drug prices. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), acknowledged in testimony before the Senate Health, Education, Labor & Pensions (HELP) Committee on Tuesday that there is only a handful of applications pending approval at the agency that are likely to inject in the market the kind of robust competition that policy makers believe could help bring down the cost of medicines. FDA is evaluating only six applications for new “first generics,” Woodcock stated, and just nine applications for current sole-source products-two areas where additional generic drugs can impact competition.

Senator Patty Murray (D-Wash.), ranking minority member of the committee, had asked FDA officials whether faster FDA approval of more generics and biosimilars could help reduce drug prices. Woodcock described CDER efforts to reduce the number of review cycles involved in the review and approval of new generic drugs and the agency’s support for more research on developing complex generic therapies, such as topicals and other non-oral therapies. But Murray had to acknowledge that even very fast FDA approval of the 15-pending innovative generic therapies “alone won’t solve the drug pricing problem.”

The hearing was scheduled to launch the process of reauthorizing proposed new user fee programs before Sept. 30, 2017. Woodcock was joined at the witness table by Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), and Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH). They all described key features in the pending user fee agreements for prescription drugs and biologics, medical devices, generic drugs, and biosimilars. The HELP committee plans another hearing on user fees in early April to hear from patient groups and and industry. HELP Committee Chairman Senator Lamar Alexander (R-Tenn.) emphasized the need to complete the reauthorization process by the end of July for FDA to avoid having to prepare notices for thousands of staffers informing them that they may lose their jobs. Such a development would delay approvals, harm patients and threaten biomedical industry jobs, Alexander commented.

While FDA has greatly accelerated its approval process for generic drugs, achieving a record 835 approvals in 2016, Woodcock acknowledged that the Generic Drug User Fee Amendments (GDUFA II) program offers some important improvements. A main goal is to reduce the multiple review cycles involved in processing most generic-drug applications and to achieve an eight-month expedited review of potential first generics. Another goal is to ensure timely inspection of generic-drug production facilities.

Senator Murray and Democrats on the HELP committee protested the timing of the FDA user fee hearing just as the Senate was being pressed to consider legislation making significant changes in the nation’s healthcare system. But Alexander insisted that fast action on user fees was critical to avoid devastating consequences for FDA.