The price of FDA's clinical trial plan
WASHINGTON - The FDA estimates that its proposed new rules to increase surveillance and reporting of adverse drug effects will cost drug sponsors and manufacturers some $24 million annually, although the rigor of its analysis is hard to evaluate.
In its proposal, published in the Federal Register last week, the agency said it "is proposing to amend the requirements for clinical study design and conduct and the sponsor reporting requirements in the investigational new drug application (IND) regulations. These amendments are intended to provide more complete and accurate information that would enable sponsors, investigators, and FDA to determine serious toxicities of investigational drugs more expeditiously during clinical studies."
The revisions stipulate additional data collection, and mandate a semiannual report that would require submission of experience data from worldwide use of a drug.
In describing the likely economic impact of the proposal, the Federal Register notice stated:
"Based on an estimated total of 480,602 annual burden hours, FDA