User Fees for Faster Drug Reviews?

by Food and Drug Administration (FDA)

A decade ago, the Food and Drug Administration was an obstacle to the delivery of novel drugs to patients because its drug review activities were under-funded and the staff couldn't review products in a timely way. The review of New Drug Applications, the so-called NDAs that companies file on all new pharmaceuticals they want to market, took unacceptably long to process — about two-and-a-half years.

Today, FDA staff review applications for new drug products in a year and as quickly as six months or less for priority drugs. The review staff increased by some 600. Better information and management systems were put in place to ensure uniformity in the quality and sophistication of the analytical reviews across the divisions that handle the different types of pharmaceuticals and biologics.

The difference: user fees.

In 1992, Congress, with the support of the administration, industry, and patient groups, passed a law that gave FDA the authority to collect user fees from manufacturers seeking marketing approval. Any time a company wants to submit a new drug or biologic to the agency so the product can go on the market, the company must pay a fee to support the review process. In addition, companies pay annual fees for each manufacturing establishment and for each prescription drug product marketed. Previously, taxpayers alone paid for product reviews through budgets provided by Congress. In the new program, industry provides the cash in exchange for FDA agreement to meet drug-review performance goals, which emphasize timeliness.

Companies supported the legislation because they wanted more predictable and faster reviews. While FDA's review standards remained unchanged, companies could get their products on the market faster if they met FDA's benchmarks. Patients supported it because they would get access to needed new medications faster. Congress supported the experiment because it could be undertaken without costing additional appropriations. And FDA's review divisions finally received the help they needed to do their job efficiently and effectively.

The user fee program worked so well that Congress renewed it in 1997 for another five years. Now, with expiration on the horizon, FDA wants to publicly evaluate a program that, after eight years, has reached a certain maturity but also has generated controversy. On Sept. 15, 2000, the agency will begin a public discussion to consider the changes that may be needed in any renewal of the Prescription Drug User Fee Act. The act, frequently referred to as PDUFA (pronounced pah DEW fah), created the user fee program.

"We want to understand from all of our constituents what they think about user fees," says FDA Commissioner Jane E. Henney, M.D.

Most observers expect the discussion to be lively. While the agency believes that the program enjoys support by many constituencies, FDA's leaders recognize that the program has raised sensitive questions and believe that, as constructed, it has some shortfalls. Views on the value and appropriateness of industry funding of the agency's review function vary widely, from strong industry support to complete rejection by some critics.

"By and large, our experience with PDUFA has been quite positive," says Alan Goldhammer, Ph.D., associate vice president of science and regulatory affairs at Pharmaceutical Research and Manufacturers of America (PhRMA) in Washington, D.C. PhRMA is a trade organization representing the nation's major pharmaceutical companies. "The time to approval in the review process has been coming down markedly since we instituted the program in 1992," he says. "At that time, it was like 30 months, incredibly long. Now, it is down on average to about 11 months to get a new drug through the process."

Some consumer groups, however, have been less dazzled by PDUFA's success in speeding up drug reviews. "It's a terrible system," says Sidney Wolfe, M.D., director of Public Citizen's Health Research Group in Washington, D.C. "The review of new drugs turns out to be too important to leave to user fees." He compares the industry's financial support for FDA's review system to charging criminals user fees to pay for the police department.

Not surprisingly, FDA's leadership falls somewhere in between. "Everyone is impressed with the speed of new drug reviews," Commissioner Henney says, "but the truth is, the program is barely surviving because of the way it was designed. We don't have the resources to do the things we believe are essential, such as adverse event reporting, because they were not part of the process" supported by PDUFA funds.

While everyone agrees PDUFA has fulfilled the initial intent of improving the timeliness of drug and biologic reviews, nearly everyone has complaints or concerns about some aspect of the program. For its part, the agency needs to preserve the level of resources provided by user fees. Yet FDA believes it's time to add critical activities, such as adverse event reporting and discussions with companies before applications are filed, to the functions supported by user fees. The growing debate means the public will have plenty to consider and discuss during the public meeting.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.