FDA has released a plan for enhancing drug safety. To pay for it, the agency has proposed a 29 percent rise in spending for a renewal of the Prescription Drug User Fee Act (PDUFA), from $304 million to $393 million. By definition, of course, such fees would be charged to the industry.

FDA is suggesting $87.4 million in new, additional fees to allow it to bolster several programs. The agency will solicit public comment on its plan (the meeting is set for February 16, 2007), which will soon appear in the Federal Register.

Here’s a quote from the news release:

“Three consecutive user fee programs—PDUFA I, II and III—have brought enormous public health gains to our and, indeed, the world’s consumers, by helping FDA make increasingly complex medications available to patients faster than was ever possible before without sacrificing quality,” said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. “Our proposed recommendations for PDUFA IV aim to top these accomplishments by achieving, above all, an impressive expansion and modernization of our drug safety system, and adding resources to enhance information technology initiatives.”

As many ClinPage readers know, the PDUFA renewal is offering a chance to tweak one of the basic mechanisms by which FDA operations are funded. Friends and foes of the agency are jockeying to use the legislation to reward or punish FDA according to their preference.

More For Technology

Buried in the proposal, however, are promising signs that FDA is keen to use technology a bit more widely. That is welcome and could benefit a small number of drug-safety software concerns engaged in research and software development in signal detection.

The agency is hardly asking for a Congressional mandate to require that electronic tools be used to streamline safety signal analysis. But FDA is proposing $8 million for more forward-looking research into longer-term research in clinical trial design and improvements to its antiquated, little-used electronic systems.

How They’d Spend It

The agency says $29 million of the proposed $87 million influx would go toward the agency’s efforts to monitor drug safety in the post-marketing arena. Some 80 employees would be hired in that effort. Over a period of five years, new scientific approaches and existing tools could be studied and enhanced.

FDA is proposing that what amounts to an arbitrary cutoff on its analysis of post-marketing issues (now a limit of three years) would be eliminated. Among other things, the agency wants to explore giving its drug safety staff “access to the best available databases to better analyze drug safety signals.”

FDA is asking for $4.6 million for 20 employees to study clinical trial design, something that might indirectly help to advance the agency’s primarily rhetorical Critical Path initiative.

Another modest but promising sum, $4 million, would be directed to computer “activities” devoted to moving the agency toward an all-electronic environment. Just the planning and evaluation of that transition would take five years, FDA says. At that point, however, secure email and 2-way electronic communication between FDA and industry might be possible.

Existing Programs

More than half of the $87.4 million in new funding would go to bolstering current programs that Congress has ignored or that inflation has withered. There would be $17.7 million in salary and support staff increases; $12 million in rent; and $20 million for workload charges that the FDA has already incurred but for which Congress has not appropriated funding.

Because of criticism of the haphazard FDA oversight of direct-to-consumer (DTC) advertising, the agency is proposing $6.2 million in new spending to hire 27 employees to review pharmaceutical TV advertising. We imagine a room filled with television monitors and FDA staffers spending hours, days, years staring carefully at commercials depicting amorous senior citizens in ski lodges.

Cloudy Prognosis

It’s too early to say how seriously the FDA plan will be received by Congress. Many new legislators are giving lip service to a brief interval in which they will temporarily suspend the usual bickering. Once the legislative process returns to normal, which is to say that it runs aground completely, FDA’s ideas could look more attractive.

At that stage, the FDA plan might be just enough of a change to win the backing of Democrats—and sufficiently modest in scale to appeal to Republicans hoping to minimize the size of another drug-safety witch hunt and the festival of litigation that accompanies it.

Ramping Up Phase IV

For industry, the prospect of additional FDA staff monitoring post-approval studies will have to be matched. Specifically, sponsors will need to continue to budget for additional post-approval studies, and not presume they will be able to take their time on such projects. Sponsors thus will be obliged to allocate additional resources to what happens after a drug is approved—and a bit less to finding drugs in the first place.

On that score, the most recent data are hardly fresh, dating to February of 2006. But they show that fewer sponsors are walking away from post-marketing commitments completely. Still, reports on post-marketing commitments for 47 percent of new drug applications (NDAs) and 50 percent of biologic license applications (BLAs) are more than 60 days late.

Like technology firms, contract research organizations (CROs) could benefit under the new FDA plan. They may be able to take on a few additional Phase IV studies that might have been put on the back burner just a few years ago.