By Lisa Seachrist

Washington Editor

WASHINGTON — Calling 1997 a "perfectly splendid year of unprecedented achievement," the FDA's Lead Deputy Commissioner, Michael Friedman, outlined a future for the agency where the workload is increasing in an era of finite resources, the science is rapidly progressing and the deadlines for drug approvals are accelerating.

"Taken together all the different types of product applications and submissions — for drugs and biologics and devices and food colors and additives and veterinary therapeutics," Friedman said, "our workload has increased about 12 percent annually for the last several years."

In addition, Friedman noted that a number of new public health assignments, ranging from tobacco regulations to the Food Safety Initiative, are added responsibilities for the agency — not all of which came with additional resources.

Nevertheless, Friedman added the agency achieved a 96 percent on time performance for review of drugs under the Prescription Drug User Fee Act (PDUFA), and the median time to approval for all drugs dropped to 12 months for 1996.

"We estimate that more than 11 million Americans received a newly marketed drug this year that would not have been available until 1998 without PDUFA," Friedman said. "And the financial cost for this acceleration in review times? Eight dollars per patient."

The FDA has increased its performance by an average of 17 percent each year for the last several years. Friedman noted the agency will require changes in management to continue to handle a 12 percent annual increase in total applications and produce performance gains of 17 percent a year when its budget grows at 1.3 percent in constant dollars.

Friedman's review of his agency's performance and look at its post-FDA reform future came during last week's annual meeting of the Food and Drug Law Institute, in Washington.

"We certainly subscribe to the president's balanced budget program," Friedman said. "The pressures are not likely to be eased anytime soon because the steady rise in the number of new medical therapies is a direct consequence of a robust science environment."

FDA Chief Scientific Officer Needed

In order to deal with the "intellectual tsunami" that threatens to overwhelm the agency, Friedman called for the agency to begin to incorporate the evolving science into the regulatory framework. He called for the agency to leverage the expertise of the National Institutes of Health and other scientific agencies.

In addition, Friedman called for the appointment of a permanent chief scientific officer to lead the agency into the next century.

"Since it is in the industry's interest, and in the interest of the general public, for FDA to remain on the scientific cutting edge, you could help us identify superior candidates," Friedman told the group.

Finally, Friedman suggested the agency and industry work out a method that would allow companies to confidentially share their long-range research plans with the agency.

"If we are to be prepared to deal with the novel and innovated products, we need to know what is coming," he said. "That way, the agency could develop access to the right science base and be ready when products come in for market approval."

Biotech Executives Call FDA Responsive

H. Stewart Parker, president and CEO of Targeted Genetics Corp., in Seattle, and Tom Wiggans, president and CEO of Connetics Corp., in Palo Alto, Calif., told BioWorld Today they believed the agency was already doing a good job recruiting the scientific expertise that is needed to review applications.

"FDA has been responsive to adding the expertise needed to review applications as genomics and biotech companies have come to the agency," Wiggans said. "I believe that there is a lot of room for improvements in responding to requests for meetings and speeding the review of an application before we take the next bold step into the future."

Parker agreed that the agency was responsive to getting the necessary scientific expertise and that to date the FDA has worked in a very collaborative fashion with Targeted Genetics, a gene therapy company.

"We really do share a lot of our plans with the sector of the agency that reviews gene therapy," Parker said. "They are willing to help accelerate products into the clinic when they can establish that any pending questions will be answered. For us, the more that we share the better."

Allan Goldhammer, director of technical affairs at the Biotechnology Industry Organization, said that during the reauthorization negotiations for PDUFA, Friedman pointed out that from a strictly strategic planning perspective, it would help to have some advanced warning about what types of applications are likely to be submitted to the agency.

For example, if the FDA knew in September that in the next quarter 25 new drug applications were to be submitted, it could make sure that the appropriate personnel are ready to deal with the influx.

"The agency is like a business that needs to allocate its resources appropriately," Goldhammer said. "It places a real burden on the system if 25 new drug applications suddenly show up at the agency. This is something that will be discussed during the implementation meetings for PDUFA II." *