The Food and Drug Administration's ongoing efforts to move to an all-electronic review system may go a long way toward improvement -- if ever completed -- but observers say it is clear that procedures for drug approval and post-approval monitoring must change, too.
The issue came to a head last month with the uncovering of a November 2006 report that detailed the FDA's mismanagement of an upgrade to its computerized adverse-event reporting system, which FDA staff use for post-marketing drug safety inspection.
According to the Breckenridge Institute report, the new system could have been completed in 2005 but was delayed and ultimately shelved. Now replacing the system will cost an additional $25 million and will not be operational until 2009 or 2010.
The report identified a 10-year "pattern of organizational behavior" on the part of FDA's Center for Drug Evaluation and Research Office of Information Technology that contributed to the trouble.
Breckenridge's assessment team was "convinced that the root cause" of the situation was "cultural and can only be addressed by a significant change" at the center.
After obtaining a copy of the report, Senate Finance Committee leaders Max Baucus, D-Mont., and Charles Grassley, R-Iowa, demanded answers from the FDA.
"[W]hen coupling the BI report with the work of the Government Accountability Office, the Institute of Medicine and of [the] Finance Committee, we are faced once again with a devastating picture of the FDA that goes to the heart of its ability to successfully fulfill its mission for the American people," the senators wrote in a March 1 letter to FDA Commissioner Andrew von Eschenbach. They closed the letter by asking the FDA to brief the committee on its findings.
As of March 30, the FDA had not responded. "We have noted to them that they have missed the deadline for response and that they owe the Finance Committee a reply," Democratic committee spokeswoman Carol Guthrie said.
Last Wednesday, an FDA spokeswoman said a briefing is in the works.
On the front end of drug development, technological support also is also needed. "One thing seems certain, and that is that submissions of [new drug applications] must be done electronically for there to be any expectation that a complete and careful review" can occur within prescribed timelines, said John Pippin, a senior medical and research adviser at the Physicians Committee for Responsible Medicine.
Due to an agreement with the pharmaceutical industry, the FDA has six months to review applications for drugs that treat life-threatening and serious diseases. The forms typically exceed 100,000 pages of text. Shuttling drug data via high-speed networks would be a lot more conducive to thorough review than carting truckloads of paper.
Many companies already deliver drug applications electronically, but some of the submissions are "a hodgepodge of electronic and paper" materials, said Alan Goldhammer, the deputy vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America. "We want to reach the point where drug development [throughout the medicine's lifecycle] is all electronic."
Much of the difficulty in conducting effective drug surveillance is the FDA budget. The proposed fiscal 2008 request would give the agency $11.2 million to modernize the drug safety system at every stage of the product lifecycle. About four times that amount is necessary, said Andrew Emmett, director for science and regulatory affairs at the Biotechnology Industry Organization.
More money may be coming with the anticipated reauthorization of a program that collects fees from drug manufacturers for drug reviews and safety evaluations. The FDA recommended that Congress dedicate $4 million from the program toward the transition to an all-electronic review system -- and $29.3 million toward hiring more personnel for post-market drug safety activities.
But the manufacturers' fees are not enough to reverse years of neglect, said Arthur Levin, director of the nonprofit Center for Medical Consumers.
"You can have the best technology in the world," he said. "If you don't have the right [number of] staff to look at the data and do the analysis, so what?" He added that while he budget is tight in war-time, the FDA "didn't get money when we weren't fighting wars in lots of places."