The FDA Wednesday issued a contract to technology consulting firm Booz Allen Hamilton to conduct an evaluation of the post-marketing study commitment (PMC) process for collecting medical information about pharmaceutical products after they’ve reached the marketplace.
The goal of the examination, the FDA said, is greater internal consistency across the medical Centers at FDA for requiring, requesting, facilitating and reviewing post-marketing study commitments.
“Even the largest and best designed pre-market studies cannot reasonably answer all of the important questions that may arise about medicines,” said Steven Galson, director of the FDA’s Center for Drug Evaluation and Research. “Continuing to evaluate drugs after they are approved is an important part of ensuring their safety and learning new things about their benefits.”
Booz Allen VP Susan Penfield said in a statement, “This new initiative is a continuation of our work with FDA where we are conducting studies in support of the FDA’s Prescription Drug User Fee Act initiatives.”
The evaluation is scheduled to begin in April and is expected to take approximately 12 months to complete.