The Food and Drug Administration has sent recommendations to Congress on establishing user fee programs for generic and biosimilar drugs.
Legislation is required to create the new programs, which would be modeled on the 20-year-old Prescription Drug User Fee Act (PDUFA), according to the agency.
Under PDUFA, the FDA collects fees for certain applications for a new drugs or biologics, and it also assesses fees on certain manufacturing establishments. In fiscal 2012, for instance, a new drug application that includes clinical data costs $1.8 million; establishment fees are $520,000. In return, the FDA agrees to review applications according to set deadlines.
"Human drug user fees have revolutionized the drug review process in the United States since they were adopted 20 years ago, allowing the FDA to speed the application review process without compromising the agency’s high standards," said FDA Commissioner Margaret Hamburg in a statement.
The PDUFA requires congressional reauthorization every 5 years. The current program expires in September, so the FDA also sent recommendations to Capitol Hill on how the next PDUFA program should look.
A generic drug user fee program is crucial because the agency is being flooded with applications, according to the agency. Generics now account for two-thirds of prescriptions written in the United States. The FDA receives 800-900 generic-drug-related applications each year. With user fees, the agency aims to eliminate a backlog of reviews and "achieve parity between surveillance inspections of foreign and domestic establishments by the 2017 fiscal year." Many generic products are manufactured overseas.
The Generic Pharmaceutical Association said that under the agency plan, the industry would pay $299 million a year for 5 years, beginning in fiscal 2012. In a statement, GPhA lauded the agency for completing its recommendations.
"This is an important landmark that could not have been achieved without the extraordinary efforts of the FDA, my colleagues in the generic industry, and all other stakeholders," said GPhA president and CEO Ralph G. Neas.
For biosimilar drugs – essentially generic forms of biologic products – the FDA said that the fees it recommended would apply to products in development now, to "generate revenue in the near-term and to provide FDA with the resources needed to support development-phase meetings with sponsors of biosimilar biological product candidates."
The agency expects more of these products to come online in the future, in part because the Affordable Care Act created a quicker path to market through a subtitle of the law, the Biologics Price Competition and Innovation Act (BPCI).
The Biotechnology Industry Organization (BIO) did not comment specifically on the biosimilar user fee program, but it has expressed support for the program, with caveats, in the past.
BIO president and CEO Jim Greenwood commended the FDA for completing recommendations on the PDUFA reauthorization, noting in a statement that the law had "contributed to the approval of more than 1,200 new medicines and initially reduced review times for the newest, most innovative drugs by more than a year."
Mr. Greenwood added, "In light of the scientific and regulatory complexities of modern drug development, the PDUFA V recommendations include a set of enhancements that seek to reinforce FDA’s review performance and get back-to-basics for patients with the goal of minimizing development and review issues that can delay patient access to needed treatments."