FDA表明对Pdufa的关注，并计划举办公众会议(下)
Reviewers also are required to help with the drug-development process by meeting with sponsors of new products to discuss study protocols and other issues.
"The result is that our workforce and real resources for most programs other than PDUFA have contracted each year since 1992 while we struggle to ensure that enough funds are spent on the drug review process" to meet PDUFA goals, the FDA said.
In 2001, the FDA was permitted to charge fees of $309,647 per application submitted with clinical data and $154,823 per application submitted without clinical data. The agency also was permitted to charge certain other fees, including inspection fees for manufacturing facilities. The FDA said the fees are expected to total about $135 million in 2002.
However, the FDA expressed concern that these revenues, even combined with congressional appropriations, would be inadequate to allow it to achieve the review goals and perform its other functions. It noted that revenues have been lower than originally anticipated, pointing out that about 30% of applications received fee waivers in 2001.
Alan Goldhammer, associate vice president of regulatory affairs at Pharmaceutical Research and Manufacturers of America (PhRMA), told Reuters Health that the drug industry shares the agency's concerns but supports the act's renewal.
While serious consideration must be given to the agency's financial struggles, PhRMA believes it would be impossible to return to the pre-PDUFA model, in which the agency received all of its appropriations from Congress, Goldhammer said. Instead, the industry hopes a balance can be struck between appropriated funds and user fees that allows the FDA to fulfill its review goals as well as its public-health mission.
"There needs to be consideration given to what the appropriate role of appropriated money and user fees should be," Goldhammer said. He added that, in PhRMA's opinion, the legislation has played an important role in helping improve the review process, despite the growing burden on industry to cover the costs.
"I don't think anyone wants to see the program scrapped," he told Reuters Health., 百拇医药
"The result is that our workforce and real resources for most programs other than PDUFA have contracted each year since 1992 while we struggle to ensure that enough funds are spent on the drug review process" to meet PDUFA goals, the FDA said.
In 2001, the FDA was permitted to charge fees of $309,647 per application submitted with clinical data and $154,823 per application submitted without clinical data. The agency also was permitted to charge certain other fees, including inspection fees for manufacturing facilities. The FDA said the fees are expected to total about $135 million in 2002.
However, the FDA expressed concern that these revenues, even combined with congressional appropriations, would be inadequate to allow it to achieve the review goals and perform its other functions. It noted that revenues have been lower than originally anticipated, pointing out that about 30% of applications received fee waivers in 2001.
Alan Goldhammer, associate vice president of regulatory affairs at Pharmaceutical Research and Manufacturers of America (PhRMA), told Reuters Health that the drug industry shares the agency's concerns but supports the act's renewal.
While serious consideration must be given to the agency's financial struggles, PhRMA believes it would be impossible to return to the pre-PDUFA model, in which the agency received all of its appropriations from Congress, Goldhammer said. Instead, the industry hopes a balance can be struck between appropriated funds and user fees that allows the FDA to fulfill its review goals as well as its public-health mission.
"There needs to be consideration given to what the appropriate role of appropriated money and user fees should be," Goldhammer said. He added that, in PhRMA's opinion, the legislation has played an important role in helping improve the review process, despite the growing burden on industry to cover the costs.
"I don't think anyone wants to see the program scrapped," he told Reuters Health., 百拇医药