Prescription Drug User Fee Act: New Fee Agreement Led By FDA

The Prescription Drug User Fee Act may include a new fee agreement, after the FDA agreed to work toward faster, more predictable reviews of new prescription drugs.

Under the draft agreement unveiled by the agency Thursday, the FDA will, in turn, receive millions of dollars in additional fees from drugmakers, AP reports.

An FDA spokeswoman confirmed that the new agreement would raise fees about 6 percent, collecting an estimated $40.4 million in new revenue for fiscal year 2012.

The deal follows months of meetings between FDA and drug industry officials working to extend a two-decade old program that supplements the FDA budget with company funding.

The latest agreement would require the FDA to provide more meetings and updates on the status of certain drug reviews, reports AP.

Dr. Janet Woodcock, director of the FDA's device center, said, We're starting to see a lot of innovative therapies come through as a result of all the investments in science over the last 30 years.”

"So this agreement will continue the review program that allows those products to move expeditiously through the regulatory process so they can reach the public in a timely way,” she said, AP reports.

Some of the new revenue will also be invested in computers and technology for research, as well as a system for tracking reports of drug side effects.

At present, the FDA tracks about 60 million patients across the U.S. through its Sentinel program. However, agency officials say the network will need to be much larger to spot emerging drug safety risks, reports AP. The deal must be approved and drafted into law by Congress before it expires on Oct. 1 2012. Lawmakers already have granted three 5-year extensions to the program. Since it passed in 1992, the Prescription Drug User Fee Act has given the FDA millions of dollars annually to review new products in exchange for quicker approvals. Last fiscal year, the FDA collected $573 million in user fees under the program, making up 62 percent of its total budget for prescription drug reviews, AP reports. Since 1992, the portion of FDA's budget underwritten by industry has steadily increased. This has brought criticism from consumer advocates who say the agency has become financially dependent on the companies it regulates. Woodcock countered that the portion of FDA funding taken from user fees is ultimately "up to Congress, and they can set it up however they want,” reports AP.
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