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FDA Wants Drug Industry to Fit the Bill
On Thursday, the United States Food and Drug Administration asked for a large increase in the annual fees paid by the pharmaceutical industry. The money will go towards costs associated with testing new drugs prior to their approval.
If the FDA’s request for additional funding via the increase in annual fees is granted by congress, the yearly fees for the pharmaceutical industry would rise from 29 percent, from 87 million, to 393 million dollars.
Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research stated, “This will allow FDA to significantly broaden and upgrade drug-safety programs, provide timely and rigorous review of television drug advertisements submitted to us for comment, and bring new medications to the American public in a careful, efficient manner”.
According to HealthDay News, The user fee program was first authorized by Congress in 1992 as part of the Prescription Drug User Fee Act (PDUFA) and has to be reauthorized by Congress every five years.
Critics of the proposal are worried that this will create a dependency relationship between the pharmaceutical industry and the FDA, which could ultimately compromise the “optimal vigilance around drug safety.”
For example, “Dr. Sidney Wolfe, director of Public Citizen's Health Research Group said, “"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. All the better ideas that have been discussed for improving FDA functions of reviewing new drugs, post-market safety studies and advertising should be included in the agency's upcoming budget proposal to the congressional appropriations committees. The agency 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."
Whether the funding comes from raising drug fees or somewhere else, the FDA needs more funding.
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