Drugs

CDER Drug Safety Priorities Report

The 2017 CDER Drug Safety Priorities Report lists activities of the Office of Surveillance and Epidemiology (OSE) to carry out its four core functions of pharmacovigilance, pharmacoepidemiology, medication error prevention and analysis, and risk management. The report lists these activities:

Pharmacovigilance/Pharmacoepidemiology – FDA and PatientsLikeMe signed a research collaboration agreement to explore the potential of patient-generated data to inform and enhance regulatory review activities and surveillance related to benefit-risk assessment and risk management. OSE is evaluating use of advanced technologies to aid agency drug safety evaluators in identifying reports most likely to demonstrate a causal relationship to a suspect medication. OSE also is exploring social media for pharmacovigilance and adverse event surveillance.
· Medication Error Prevention and Analysis – OSE revised the Phonetic and Orthographic Computer Analysis software program to better capture the shift in the type of errors that are being reported due to use of electronic prescribing.
Risk Management – OSE evaluated the relationship between drug development program characteristics and postmarket safety outcomes.

The report also discusses how real-world evidence will help to advance drug safety science. It defines real-world data as data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources, and real-world evidence as the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data.

Potential benefits of real-world data and real-world evidence in regulatory decision-making, according to the report, are:

informing therapeutic development and safety surveillance;
improving the efficiency of conducting clinical trials supporting regulatory decisions; and
filling important evidence gaps that are not typically addressed with traditional randomized clinical trials.

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