Von Eschenbach: FDA needs massive resources

Share this article:
In the FDA commissioner’s annual “State of the FDA” address to the Food and Drug Law Institute in April, Andrew von Eschenbach painted a picture of an agency that is currently facing enormous pressures and through heroic efforts is managing to perform its mandated mission, but which requires a huge infusion of financial and human capital.

This is necessary, he said, if the FDA is to meet future challenges posed by growing work volumes and by rapid advances in scientific understanding of health and disease processes at the most fundamental, molecular level.

“In spite of its rich history, the FDA is inadequate, and ill-equipped to meet the realities of today and tomorrow, with rapid changes in the scale, scope and complexities the agency is facing,” he said.

Von Eschenbach said a “first priority” for the agency must be to address issues related to maintaining its “intellectual capital”—the need to “build, expand, and support the agency’s workforce.” He called for the renewal of user fees levied on drug and device manufacturers to help meet the FDA’s resource needs, but insisted that FDA “does not, will not, and never will be influenced by user fees in its decision-making processes."

Share this article:
You must be a registered member of MMM to post a comment.

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.