"Our position is, the current system is working quite well," said Alan Goldhammer, a vice president at the industry's main lobbying group, Pharmaceutical Research & Manufacturers of America, or PhRMA, which agreed to the new rates.
If enacted, the Food and Drug Administration's revenue from application fees would undergo its greatest expansion since the user-fee system was created in 1992. Already, the industry accounts for 56 percent of the FDA's annual budget for drug reviews and expert staff.
Companies pay the fees when they apply for FDA review of new drugs, with amounts varying according to the specific products. Most companies keep the actual figures secret, but the cost can exceed millions of dollars a year. The new rates almost certainly would mean a sizable increase for each company.
The fees, under the Prescription Drug User Fee Act, or PDUFA, have been credited with stoking a huge increase in drug launches. But critics have said the fees also have made the FDA beholden to drug manufacturers and led to reckless approvals.
After months of negotiation by the FDA, PhRMA, and many consumer and patient advocacy groups, the industry committed to pay the FDA at least $392.8 million a year, or an increase of $87.4 million over the current base rate.
The increase would include $29 million for FDA scrutiny of drugs already on the market, or so-called post-market reviews. The FDA said it would hire 82 more experts to sift through real-world data from insurance firms, physicians and manufacturers to look for patterns of safety problems - a task it has been hard-pressed to do.
About $20 million in additional fees would go for new staff to handle, among other things, a crush of "consultations" with individual drug companies over their applications, the FDA said.
Nearly $12 million is needed to cover rent and other costs of the FDA's move to a new facility in Silver Spring, Md.
