FDA's Drug Safety Plan to Increase Post-Market Safety

Rockville, MD (Apr. 3)—In an ongoing effort to secure the safety of prescription drugs, the US Food and Drug Administration has released its draft five-year drug safety plan under the Prescription Drug User Fee Act (PDUFA). The plan expands from previous years' commitments to accelerate the drug evaluation process to expanding post-market safety evaluations and prevention. With the drug safety plan, FDA intends to reduce medication errors, increase staff, improve existing tools, develop new tools, gain access to new databases, and adopt new standard operating procedures.

Included in the draft [deleted PDUFA] are FDA's plans to evaluate current adverse event collection and to develop new reporting software and collection practices. FDA states that it is committed to identifying epidemiology best practices and will produce a new guidance to be finalized in FY 2011. The development and validation of risk management and risk communication tools are also planned. An evaluation and eventual upgrade of FDA's review of new drug trade names will be performed.

In an effort to increase resources, FDA intends to hire new staff and obtain access to databases that will enable increased post-marketing surveillance and epidemiology. Staff hires will include safety evaluators, risk management experts, medication error experts, and regulatory project managers. The Center for Drug Evaluation and Research (CDER) will expand the Office of Surveillance and Epidemiology (OSE) with new staff "distributed across the office, strengthening the capability and capacity of the organization in its post-marketing safety role." The Center for Biologics Evaluation and Research (CBER) will also increase its staff.

Under PDUFA IV, drug safety has an annual allocated budget of $29.29 million for FY 2008 that will increase each year with annual inflation. FDA has also been authorized by Congress to collect additional user fees to supplement the program's budget. FDA plans to increase user fee revenues from FY 2008 to FY 2012 in post-market activities from $13 million to $16 million; $7 million to $9.5 million in epidemiology best practices and new data acquisition; risk management and risk communication will increase from $4 million in to $5 million; and new drug trade name review will increase from $5.3 million to $6.5 million.

FDA's draft of PDUFA IV Drug Safety Five-Year Plan is available for downloadhere.