Underinvestment in technology to adequately document data may contribute to gaps in the Food and Drug Administration's drug review process.
The FDA has consistently treated IT as a deferrable spending item that could be dropped in lean budget years, leading to the use of old systems that do not collect sufficient information throughout the drug review process, particularly in the post-marketing phase. The total amount the agency has spent on IT is hard to calculate, but FDA IT spending was cut by $29.1 million in 2004 from what the agency had requested, according to an article by American Enterprise Institute fellow Scott Gottlieb in Health Affairs.
Instead of fixing systemic insufficiencies, the agency has patched the IT system with a veneer of a sophisticated IT network — for example, forms that physicians and manufacturers complete are now electronic, but rather than scanning in information automatically, they still have to key in the information by hand, which is inefficient and leads to errors. Most of the hesitation has been due to budget and vision constraints, according to the report.
"Right now, under the current system, if a drug safety problem is made apparent by a single case report, it may escape notice," Mr. Gottlieb wrote. "Even if similar signals are produced by other case reports, the likelihood of a causal relation is often simply debated unless more evidence emerges."