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US industry welcomes Senate backing for PDUFA

User fee acts also introduced for generics and biosimilars as part of Food and Drug Administration Safety and Innovation Act (FDASIA)

The US Senate has voted to pass the latest version of the Prescription Drug Fee and User Act (PDUFA), the legislation that sets out the funding framework for the country's medicines regulator.

The latest version of the act, PDUFA V, is contained within the Food and Drug Administration Safety and Innovation Act (FDASIA), which was passed 96-1 to a generally positive reception from prominent industry organisations.

The PDUFA allows the FDA to collect fees from drug manufacturers to fund the drug review process in exchange for adhering to performance standards and is facing its fourth renewal since its introduction in 1992 with the latest version set to expire in September.

The renewal means the FDA can continue funding its regulatory efforts, with changes to be implemented as part of PDUFA V including a 6 per cent increase in industry user fees in return for improved communication from the FDA.

An early warning system for manufacturers regarding drug shortages will also be introduced, in response to a series of shortages over the past year in the US.

John Castellani, president and CEO of industry association Pharmaceutical Research and Manufacturers of America (PhRMA), praised the PDUFA for enabling the FDA to reduce median review times from 29 months in 1991 to 13 months in 2010.

He said: “By conducting the most collaborative, transparent negotiations in history, and by including input from a wide variety of stakeholders, the FDA laid the groundwork for legislation that is constructive and that merits bipartisan support.”

This support from both Republican and Democrats has meant FDASIA has passed through Senate with far less hassle than other legislation, with the bill now needing to pass through the House of Representatives.

Biotechnology Industry Organization (BIO) president and CEO Jim Greenwood was also supportive of the PDUFA V.

He said: “It 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.”

In addition to the PDUFA renewal, the FDASIA also includes the introduction of user fee programmes for generic drugs and biosimilars, which would provide additional FDA resources to review and regulate such products.

The Generic Drug User Fee Act (GDUFA) would see the FDA collect about $299m each year from 2013 to 2017 in return for eliminating application backlogs and ensure that foreign generic manufacturers are subject to appropriate regulatory scrutiny.

The Biosimilars User Fee Act would cover products that companies have attempted to launch onto the market using the abbreviated biosimilar approval pathway, with the FDA expecting a total of $128m in fees up to 2017. Overall, the FDA is set to receive an extra $2bn in new fees up to 2017.

The one senator to vote against the bill was Sen Bernie Sanders, an independent from Vermont.

He said: "The most pressing prescription drug issue in our country today is that Americans pay, by far, the highest prices in the world for their medicine and millions of people cannot afford the medications their doctors prescribe.

“I voted against this bill because it does far too little to address this crisis while it perpetuates a prescription drug system that continues to fail the American people."

25th May 2012


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