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Discussions About Drug User-Fees


The Prescription Drug User Fee Act will expire in 2012 and FDA is working hard to renegotiate the act before that end date. The contenders: in one corner, the pharma industry; in the other, the general public and consumers - and just about everyone has an opinion about what needs to be changed.

The Prescription Drug User Fee Act (PDUFA) is up for renewal, and FDA is making sure that everyone who wants to have a say about upgrades and changes gets the a chance to voice their opinion.

On Monday, FDA held a public forum to hear thoughts from the general public, industry, and various gadflies about what they would like to see changed in the 18-year-old act.

Before PDUFA launched in 1992, it took close to two years to get a drug cleared through the FDA. PDUFA authorized the agency to charge drug companies a fee to offset the cost of reviewing the drug, thereby increasing the approval time substantially.

The act allowed FDA to better staff premarket review teams and speed drugs to review and approval. The act has expanded significantly over the years to include application standardization, timelines for submissions, and safety reviews. Since it was approved, the act has helped approve over 1,100 new drug applications.

On average, pharma companies pay between $500,000 and $1.25 million per drug application (depending on the need for clinical data review). In 2010, FDA expects to receive more than half a billion dollars in fees, according.

The drug industry doesn’t seem to mind. In a letter to FDA, the industry lobby group PhRMA fully endorsed the reauthorization of the act. However, it noted that the agency’s “ability to review new drug applications in a timely manner has decreased by the addition of new processes and the implementation of the requirements in FDAAA.”

David Wheadon, senior vice president of PhRMA, chastised FDA for being slow to respond to meeting requests and supply companies with assessment and minutes from meetings, hence slowing the review process.

“The optimal review and approval process is one that is both efficient and judicious,” Wheadon said. “Public health and safety are best served by a science-based balance between the need for timely and rigorous premarket review and postmarket surveillance. Throughout its history, PDUFA has allowed FDA to move closer to the appropriate balance, which is why we vigorously endorse a reauthorization of PDUFA in 2012.”

The Biotechnology Industry Organization (BIO) released comments stating that FDA should make sure that the current process is thoroughly evaluated before recommending changes, and ensure that any increases in user fees are justified.

“Biopharmaceutical companies pay application, establishment, and product fees because they benefit, as does the public, from more efficient reviews, timely scientific advice, and ongoing product evaluation,” said Andrew Emmett, director, scientific and regulatory affairs, BIO. “Newer medicines are increasingly more complex, and FDA needs the appropriate level of scientific training and review quality to fully evaluate the benefit and risks of a product.”

FDA now has two years before the 2012 expiration date to make changes to the act, recommend increases in fees, and add any new requirements. Congress is slated to vote on the act on January 15, 2012.

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