The US Food and Drug Administration has proposed recommendations to Congress for the next reauthorisation of the Prescription Drug User Fee Act (PDUFA) which, if adopted, “would significantly broaden and upgrade the agency's drug safety programme,” increase resources for review of TV drug advertising and “facilitate more efficient development of safe and effective new medications for the American public.”
The FDA has recommended that annual user fees paid by drugmakers to have new products reviewed will increase by almost 30%, to $392.8 million, which it says would enable it to upgrade its drug safety programme and increase its resources to review television drug advertisements.
Nearly $38 million would be used to "ensure the safety" of approved drugs, and would enable the agency to hire 82 staff to perform post-marketing safety activities. About $8.6 million would be allocated to help the agency develop guidelines on designs for clinical trials and to move the FDA towards an "all-electronic environment."
The agency also plans to recommend that a separate new user-fee programme be created for pharmaceutical firms who want the agency to review their direct-to-consumer TV ads. This scheme would bring in around $6.2 million in fees in the first year, which would be used to employ 27 people to carry out the reviews.
Department of Health and Human Services' Secretary Mike Leavitt said the recommendations would greatly help the FDA’s “ability to monitor and respond to emerging drug safety issues,” as well as continuing the agency’s “commitment to scientific improvements and streamlining the drug approval process."
The chief executive of the Pharmaceutical Research and Manufacturers of America, Billy Tauzin, backed the PDUFA proposals, saying they call for “comprehensive improvements in all areas that are essential to timely safe and effective use of new medicines by millions of American patients.”
"Tainted and comprimised"
Much less happy was the US consumer group Public Citizen. Sidney Wolfe, director of its health research group, said that “the FDA's crucial drug regulatory functions are too important to be tainted and compromised by direct funding from the very companies whose drugs the agency reviews for safety.” He added that the FDA "should request these additional funds through the same process that funded the agency from 1906 through 1992 – that is, the money should come from the federal Treasury, not the pharmaceutical industry.”
Mr Wolfe concluded by saying that the entire annual amount of funds now sought from industry under PDUFA “is equivalent to fewer than two days of the current expenditures for the disastrous war in Iraq. Where are the congressional priorities?”
If approved the measures would come into effect from October 1 this year and the public will be able to comment on the draft proposal at a meeting scheduled for February 16.