The makers and regulators of U.S. medicine are drowning in a sea of lab notes, chemical breakdowns, patient records - every page of which has to be reviewed before a new drug hits the market.
So the Food and Drug Administration is embarking on the information superhighway and taking the pharmaceutical industry along for the ride, hoping computer savvy will speed new drugs to the market."It will just save enormous time," said FDA policy officer Edwin Dutra.
A company now spends about 10 years developing a new drug. The resulting FDA application is at least 200,000 pages long, data that take another two years to be scrutinized by agency scientists.
Under the five-year, $15 million "Smart Initiative," FDA is moving to accept all this data via computer. The goal is to cut agency review time by 30 percent and speed drug companies' own work by forcing them into the electronic age.
"We're trying to not only move the agency to be more paperless, but to facilitate all the companies we regulate to be more paperless," said FDA Deputy Commissioner Mary Jo Veverka.
"We are working very feverishly toward that," agreed Richard Reid-enbach of Eli Lilly & Co. The pharmaceutical giant hopes the changes will help it cut in half the 5,000 days spent getting each new drug to market.
Computers once couldn't handle everything from patient lists to complex X-ray images with one program. The software to do that is now emerging, allowing drug-makers to quickly analyze and update medical data and even guiding them through the myriad drug applications required by governments worldwide.
But the FDA has to ensure that turning to software, where the flick of a switch can change data, won't compromise patient safety.
The Smart Initiative, financed by the user fees drug companies pay the FDA, is establishing safety regulations for drug software and adapting FDA's equipment. Ultimately, standard FDA computers will read data submitted electronically from any company, on any software - data that have an audit trail similar to today's paper trail.
"When industry is done and pushes a button, we can start our review instantaneously," Dutra said.