President Barack Obama yesterday signed into law the bipartisan FDA bill that sailed through both chambers of Congress last month—a measure that includes a fifth five-year authorization of the Prescription Drug User Fee Act (PDUFA V), and provisions that expand the categories of drugs for which the agency will allow faster reviews and decisions.
“The FDA reforms help create a more predictable, safe, and effective regulatory process that encourages the immense investment to get a concept from discovery to commercialization, giving patients access to high-quality products in a timely fashion," Joe Panetta, president and CEO of the San Diego regional life sciences group BIOCOM, said in a statement.
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 fees for biologic and generic drugs. PDUFA V is projected to fund 2,599 full-time equivalent (FTE) staffers, whose duties will include helping FDA carry out its commitment under the law to review and act 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. In return, the start of the agency’s first review cycle clock was pushed back to after its 60-day administrative filing review period.
In addition, 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 biopharma industry’s two largest groups, Biotechnology Industry Organization (BIO) and Pharmaceutical Research Manufacturers of America (PhRMA).
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 designed to support 450 FTEs, and $20 million in biologic drug user fees to support 72 FTEs. 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.
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 that is required to be drafted 18 months after enactment; and adds five or more years of data exclusivity to the end of patent terms for “qualified infectious disease products,” under a section designed to speed up development of new antibiotic drugs.
Also, the bill 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.
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 and was not included in the House version.
“While enactment of S. 3187 marks an important moment for innovators across industry, research and clinical care settings, its most important beneficiaries are the patients and families that will be helped by the next generation of affordable medical products this bill will help to foster,” US Health & Human Services Secretary Kathleen Sebelius said in a statement.