PDUFA IV Fees Will Go to Improve Postmarket Drug Safety

The FDA says it will significantly expand its postmarketing safety activities, adopting new scientific approaches to drug safety to meet its commitments under the Prescription Drug User Fee Act (PDUFA IV).

The agency plans to spend its PDUFA IV fees to fund epidemiology best practices and data acquisition ($7 million in fiscal 2008, increasing to $9.5 million in fiscal 2012); new drug trade name review ($5.3 million in fiscal 2008, rising to $6.5 million in fiscal 2012); and risk management and communication ($4 million in fiscal 2008, rising to $5 million in fiscal 2012).

In a draft Drug Safety Five-Year Plan that the agency updates annually and issued for comment Friday, the FDA says it intends to use the fees to increase the number of employees dedicated to adopting new scientific approaches to drug safety, reducing the risk of medication errors and improving adverse event detection and prevention programs.

The FDA cites problems in adverse event reporting for marketed drugs due to “under-reporting, the often poor quality of reports and the lack of systematic feedback to healthcare providers and consumers.” To address this, the agency plans to hire a contractor “to study the various mechanisms for collecting adverse events and determine optimal strategies for collecting adverse event data throughout the product lifecycle,” according to the plan.

In another use of the new PDUFA funds, the FDA plans to develop and implement agencywide and special-purpose postmarket IT systems, including the MedWatch Plus Portal, the FDA Adverse Event Reporting System, the Sentinel System (a virtual national medical product safety system) and the Phonetic and Orthographic Computer Analysis System to find similarities in spelling or sound between proposed proprietary drug names that might increase the risk of confusion and medication errors.