Ensures extension of drug user fees and addition of similar fees for generics and biosimilars
The US Senate passed the FDA Safety and Innovation Act (FDASIA) yesterday by 92 votes to 4, ensuring funding for the agency in the coming years as well as introducing a number of additional measures designed to improve the operations of the agency.
All that remains is for FDASIA to be signed into law by President Obama, which is expected to take place within the next few days.
The headline news in the new act is the extension of the current system of prescription drug user fees to be extended to include generic and biosimilar drugs, increasing the total funding for the FDA deriving from fees to around $6bn in 2013-2017. The agency has promised that the additional funding will help it to reduce the backlog of generic approvals at the FDA.
As in previous years, the user fee legislation comes with a number of other regulatory reform elements attached, and on this occasion the emphasis has been on a number of measures designed to increase the security of the US medicines supply chain.
One such measure is a commitment to increase inspections of overseas manufacturing facilities, with resources for this effort provided by dropping the current requirement that the FDA inspect domestic facilities every two years. Now, the agency will allocate inspection resources on the basis of risk, regardless of their location.
FDASIA also covers incentives to accelerate the review of innovative new therapies, boosting paediatric research. These measures aim to increase the FDA's accountability and transparency, and putting in place stronger penalties for illegal activities such as medicines counterfeiting, as well as mechanisms to alleviate drug shortages.
A provision for a national track-and-trace system for medicines was included in earlier drafts of the legislation prepared by the Senate, but were dropped as part of the reconciliation process with the version debated by the House of Representatives. It has been suggested this topic will be addressed by separate legislation later in the year.
The current Prescription Drug User Fee Act (PDUFA) expires at the end of September, so a lot was riding on the passage of FDASIA.
"FDASIA reflects enhancements to PDUFA that were widely and strongly supported by stakeholders," said Biotechnology Industry Organization (BIO) president and chief executive Jim Greenwood.
"The legislation will enhance the development and review of innovative new therapies through increased transparency and scientific dialogue, advancements in regulatory science and strengthened post-market review," he added.
The Pharmaceutical Research and Manufacturers of America (PhRMA) also welcomed Congress' passage of FDASIA, with CEO John Castellani noting that the bill "will enhance the efficiency of FDA's human drug review programme, and will help bring safe, effective, and innovative medicines to patients in a timely manner".