FDA proposes hike in drug industry fees

[Ron Burgundy]

AP - The annual user fees the pharmaceutical industry pays the government to review its products prior to approval could rise nearly 29 percent to $393 million, under a draft proposal released Thursday by the Food and Drug Administration.

The $87 million increase in fees would in part bolster the FDA's oversight of the safety of drugs already on the market, allowing it to add 82 employees to do such review work, the agency said.

In the wake of the withdrawal of the painkiller Vioxx, Congress, the Institute of Medicine and others have criticized the agency's ability to track the safety of new drugs and respond quickly to problems. FDA commissioner Dr. Andrew von Eschenbach said the changes would bring about an "impressive expansion and modernization" of the agency's drug safety system.

The fee increases, which require congressional approval, also would allow the FDA to further expedite its review of drug applications, in part by improving its technology infrastructure. They also would cover the increased cost of salaries and benefits of drug reviewers within the FDA.

Separately, the FDA is proposing assessing drug companies a fee to review direct-to-consumer television advertisements before they air. The FDA currently has only a limited ability to curb distribution of drug ads that violate federal rules, according to a recent report by government auditors. The FDA expects to collect about $6 million in such fees, which would underwrite the salaries of 27 extra employees to review the TV ads. However, drug companies still would not be required to submit their ads for review.

The recommendations also include a pilot program that would leave it to drug companies to assess the appropriateness of any proposed names for new drugs — a task now performed by the FDA. Look- and sound-alike drug names can lead to medication errors, the FDA said.

The FDA also would spend nearly $5 million in new fees on developing guidelines for industry that can help expedite the development of new drugs and almost $12 million to defray the cost of moving workers to the FDA's new consolidated campus in Maryland, according to the proposal.

Since it was enacted in 1992, the Prescription Drug User Fee Act, or PDUFA, has authorized the FDA to collect fees from drug companies to underwrite the cost of reviewing their products. The law also requires the agency to stick to certain performance goals that make the approval process faster and more predictable. The current proposal was subject to negotiations with the drug industry, as well as input from patient and advocacy groups.

"The PDUFA proposals from America's pharmaceutical research companies and the Food and Drug Administration call for comprehensive improvements in all areas that are essential to timely, safe and effective use of new medicines by millions of American patients," said Billy Tauzin, president and chief executive of the Pharmaceutical Research and Manufacturers of America.

The law, which has twice been extended for five years, expires Sept. 30 unless renewed by Congress. Lawmakers expected to use the reauthorization as a vehicle for legislation to further reform the FDA.

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