PPD to evaluate FDA's post-market spontaneous adverse event surveillance system

Oct 28 2009

PPD, Inc. (Nasdaq: PPDI) today announced it has been awarded a contract by the U.S. Food and Drug Administration (FDA) to evaluate the agency’s Center for Drug Evaluation and Research (CDER) post-market spontaneous adverse event surveillance system. The company will conduct a thorough evaluation of the value of the spontaneous adverse event reports to support safety-related regulatory actions and report its findings to the FDA and the public.

The award of $2.7 million for year one, is part of a two-year project of FDA’s Initiative for Maximizing the Benefit of Passive Adverse Event Collection throughout a Product’s Life Cycle (IMPACT). IMPACT, launched in 2008, is intended to fulfill a Prescription Drug User Fee Act (PDUFA) IV commitment.

Under the contract, PPD will comprehensively evaluate this FDA public health surveillance system. First, the system will be described, including key objectives, components and the regulatory framework (e.g. relevant laws). The focus of the evaluation is the review and analysis of the system’s role to support safety-related regulatory actions and the provision to FDA of a report detailing study results, conclusions and recommendations for maximizing the system’s ability to support safety-related regulatory actions for drugs and therapeutic biologics throughout a product’s life cycle. This complex and unprecedented evaluation of the FDA spontaneous adverse event surveillance system will involve the development and implementation of innovative methodologies. The FDA will use these findings to develop an implementation strategy for ensuring optimal use of the system as part of its pharmacovigilance efforts to protect public health.

PPD will apply drug safety and pharmacoepidemiological expertise integral to its industry-leading safety services, which include signal detection, global expedited case processing period report development, risk management plans/REMS, pregnancy registries, endpoint adjudication, safety monitoring committees, and adverse event and medical information contact centers.

“Epidemiology is important to evaluating drug safety risks, and we are pleased the FDA recognized our strong capabilities and commitment to patient safety and regulatory compliance,” said Christine Dingivan, M.D., chief medical officer of PPD. “The contract enables us to assist the FDA in this important endeavor and demonstrates our breadth of drug safety and pharmacoepidemiology services.”