The U.S. Senate on Tuesday evening joined the House of Representatives in approving a compromise FDA bill that includes a fifth five-year authorization of the Prescription Drug User Fee Act (PDUFA V), as well as provisions that expand the categories of drugs for which the agency will allow faster reviews and decisions.
President Obama is expected by July 4th to sign the measure, which the Senate passed 92–4, hours after voting 89–3 to close debate and bring the bill to a vote. Last week the House approved the bill in a unanimous voice vote. The bipartisan margins in both chambers reflect Congress’ interest in keeping agency drug review operations humming—and avoiding the loss of jobs funded through user fees.
The FDA Safety and Innovation Act (S.3187) includes PDUFA V among a set of user-fee measures that for the first time will include collection of the fees for biologic and generic drugs. For the federal fiscal year starting on Oct. 1, FDA expects to collect $720 million in prescription drug user fees, as well as $299 million in generic-drug user fees, and $20 million in biologic drug user fees.
Through the authorization period (FY 2013–FY 2017), the Congressional Budget Office (CBO) expects FDA to collect about $6.4 billion in total user fees projected from the bill, of which $4.068 billion will be prescription drug fees. The generic user fee is expected to generate $1.575 billion, compared with $128 million for the new biosimilar fee.
In return for the fee money, PDUFA V is projected to fund 2,599 full-time equivalent (FTE) staffers, while 450 FTEs will be supported through the new generic drug user fee and 72 through the new biosimilars user fee. More importantly, FDA is committed to reviewing and acting on 90% of standard applications within 10–12 months from the date of filing and on 90% of priority submissions within six to eight months from date of filing. However, the start of the agency’s first review cycle clock was pushed back to after its 60-day administrative filing review period.
Also, PDUFA V creates a new mid-cycle meeting to which FDA will call an applicant, generally within two weeks after the agency holds its own internal mid-cycle review meeting on an application. FDA hammered out PDUFA V during a year of talks with the Biotechnology Industry Organization (BIO) and Pharmaceutical Research Manufacturers of America (PhRMA).
The FDA bill reauthorizes two pediatric drug measures set to expire this year, the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Both suggest designating as “breakthrough” therapies drugs that alone or in tandem with other drugs treat a serious or life-threatening disease where preliminary clinical evidence indicates that the drug provides “substantial improvement over existing therapies on one or more clinically significant endpoints such as substantial treatment effects observed early in clinical development.”
The bill adds rare diseases as among topics that must be considered in a future fast-track guidance, required to be drafted 18 months after enactment; and changes FDA's inspection policy. The agency will regularly inspect domestic or overseas manufacturing plants based on risk to patient safety, a change from the current policy requiring mandatory inspections of domestic plants every two years.
However, the House and Senate avoided a potential stalemate by removing a provision requiring the tracking and tracing of every individual container of medicine. Track-and-trace had been part of the Senate version of the bill, but was opposed by biopharma giants.