The US Food and Drug Administration (FDA) has now sent its proposals for three prescription drug user fee programmes to Congress.
They are the fifth authorisation of the Prescription Drug User Fee Act (PDUFA-V), plus two new programmes for human-use generic drugs and biosimilars which are modelled on PDUFA. This programme “has ensured a predictable, consistent and streamlined premarket programme for prescription drugs,” said FDA Commissioner Margaret Hamburg, and, as a result of the continued investment of PDUFA resources, the US now leads the world in first introduction of novel drugs, the agency noted.
The FDA says that the proposed Generic Drug User Fee (GDUFA) programme would provide it with needed funding at a time when generic drug applications are on the rise. Each year, it receives 800-900 new generic drug-related applications, which are becoming increasingly complex and frequently involve products manufactured outside the US.
In exchange for fees on facilities and product applications, GDUFA would include performance metrics such as review timeframes and a commitment to achieve parity between surveillance inspections of foreign and domestic establishments by FY2017. As a result, the FDA says its expects the proposal to effectively eliminate the review backlog and significantly reduce review times.
The proposed Biosimilar and Interchangeable Products User Fee programme is intended for products approved under the new abbreviated approval pathway established by the Biologics Price Competition and Innovation Act (BPCI) of 2009, a subtitle of the Affordable Care Act (ACA) of 2010.
Prior to the BPCI, competition in the biologic drug market was stifled, but its enactment will spark the development of a new segment of the industry, which will help spur innovation, improve consumer choice and drive down costs, says the FDA. The recommended programme, which would start in FY2013, includes fees for products in development to generate revenue in the near-term and provide the agency with the resources necessary to support development-phase meetings with sponsors of biosimilar product candidates, it adds.
The PDUFA-V recommendations envisage raising more than $712.8 million in fees each year over the next five years, including nearly $150 million in new fees over the period to enhance the FDA post-marketing surveillance system. Jim Greenwood, chief executive of the Biotechnology Industry Organisation (BIO), said the proposals are “a win-win” which, if enacted, “will help enhance and improve drug safety while providing efficient and comprehensive review of new drugs.”
GDUFA calls for the generic drug industry to pay $299 million annually in user fees for the next five years, beginning October 1, 2012. The Generic Pharmaceutical Association (GPhA) called the programme “an important landmark” which will “help assure that American consumers will continue to receive the significant cost savings from generics that within the last decade have provided more than $931 billion in savings to the nation’s health care system.”
The final recommendations, which the agency has developed in consultation with representatives of the pharmaceutical industry and patients and consumer advocates, “offer a great example of what can be achieved when the FDA, industry and other stakeholders work together on the same goal,” said Commissioner Hamburg.
“Human drug user fees have revolutionised the drug review process in the US since they were adopted 20 years ago, allowing the FDA to speed the application review process without compromising the agency’s high standards,” she added.
PDUFA was created by Congress in 1992, and must be reauthorised every five years. The current programme – PDUFA IV – expires on September 30 this year unless it is reauthorised by Congress. The agency’s recommendations have now been transmitted to Congress by Health and Human Services Secretary Kathleen Sebelius.
– The health subcommittee of the House Energy and Commerce Committee has announced that it will hold a hearing on the PDUFA reauthorisation on February 1, and another on the new generic and biosimilar user fee proposals on February 7.
