User Fees for Faster Drug Reviews? : Part 3

by Food and Drug Administration (FDA)

(Page 3 of 3)

For FDA, another problem is the sense of "haves and have-nots" within the agency. The review programs supported by user fees have more resources, while other parts of FDA, divisions with important public health missions, often go without.

"User fees distort the distribution of labor at the FDA in that it piles up a large amount of funds for reviewing new drug applications," Wolfe says, "but does not provide funds for other essential public health functions like reviewing drug advertising, except at the beginning, or adequate funds for the increased load in post-market surveillance."

FDA's budgetary statistics show that as user fees flowed into the agency, appropriations to support other activities have remained unchanged or have declined. As a result, the percentage of FDA activities and resources devoted to drug reviews has increased from 17 percent before Congress passed PDUFA to 28 percent in fiscal year 1999. Meanwhile, funding for other programs, from color additives in foods to post-market surveillance to manufacturer and import inspections, has drifted downward.

Balancing Benefits and Costs

Even in user fee-funded operations, the additional resources have come at a cost. Industry insisted on performance goals and standards that resulted in increased pressure to meet deadlines, increased tracking and reporting requirements and a sense of micro-manage- ment. For the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, the agency's primary review centers for drugs and biological products, PDUFA has been a Faustian bargain.

On one hand, says CDER director Janet Woodcock, M.D., the user fee program provides enough staff to meet the performance deadlines and more scrutiny during drug development, but the intense schedules "create a sweatshop environment that's causing high staffing turnover." Highly trained scientists and experts want to do more with their careers than crank out reviews, so many leave within three years, preventing the agency from building an institutional memory of previous reviews.

Staff turnover can be disruptive for the industry as well. "When your technical reviewer changes," Suydam says, "it throws the process into a tizzy."

In addition to the current impacts of the user fee program on FDA's activities, Suydam worries about the future. Several recent studies by the University of California at San Diego, Anderson Consulting and PriceWaterhouseCoopers have tried to look into the future and predict how the drug development process will evolve and how FDA will need to respond.

The studies predict that the pharmaceutical industry will quadruple the annual output of new drugs while reducing development time to market by one-third. They also project a 65 percent increase by 2008 in the number of so-called new molecular entities (NMEs) moving into early clinical development. NMEs are chemically unique drugs that are completely different than any other drug on the market. These compounds require additional scrutiny since there are no similar drugs to which they can be compared.

Once an NME is approved, companies will create "fast-followers" with related compounds that try to target different patient segments. For example, a fast-follower might have a similar therapeutic effect but reduced side effects.

Computer technologies will improve the predictive modeling of new drugs, and computer simulations will optimize clinical trial design and increase the amount of clinical information collected. Finally, information technologies will streamline electronic submissions to the agency.

To handle these changes, FDA "regulators will assume an expanded role as knowledge integrators exerting increased influence on every phase of new product development," according to the studies. To make this work, FDA reviewers will need to spend more time advising companies about protocol design and making themselves available for an ongoing dialogue throughout the drug development process.

In addition, the studies concluded, "regulators face major challenges in staying current with scientific advances, managing ever-increasing information and communicating more effectively." FDA's staff will need "new strategies to seamlessly manage growing information on a product over its life cycle."

FDA's management sees serious challenges ahead, especially if budgetary resources remain inadequate. "What these studies have envisioned for FDA," Suydam says, "is nowhere near anything we can do now."

Whether user fees will play a part in addressing these future problems remains unclear.

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.