FDA Commissioner Hamburg Meets with Michigan Bio-Industry Leaders; Hears Perspectives on Regulatory Oversight Impacting Their Business Sectors
An update from MICHBIO
7.12.2010
MichBio hosted a CEO Forum Friday morning at its offices featuring Margaret Hamburg, MD, Commissioner of the U.S. Food & Drug Administration (FDA).
"Dr. Hamburg's visit was an incredible and unique opportunity for executives from a broad spectrum of our bioscience companies to voice their thoughts about the FDA, its approval review processes, changing regulations governing product safety, and overall oversight landscape," commented Stephen Rapundalo, PhD, president and CEO of MichBio. "The Forum's small group and informal format allowed for a frank dialog about sector-specific and shared experiences in dealing with the FDA."
Senior management representatives and CEOs from around Michigan and multiple industry sectors were represented. These included Adeona Pharmaceuticals, Altarum Institute, Ash Stevens, Asterand plc, Atek Medical, BD Diagnostics, Emergent Biosolutions, Jasper Clinical Research, JHP Pharmaceuticals, Kellogg Company, MPI Research, NSF International, Perrigo Company, Pfizer Inc., Phadia US, QuatRx Pharmaceuticals, Somanetics, Stryker Corporation and Terumo Medical. The discussion focused on regulatory and safety issues related to medical devices and equipment, pharmaceuticals, including innovator drugs, biologics, generic, OTC, vaccines and veterinary, diagnostics and testing including personalized medicine, food and nutrition, and other areas such as investigational research and products.
Joann M. Givens, FDA District Director based in Detroit, participated in the Forum, as well as Congressman John Dingell whose district includes Ann Arbor. In addition, several of Michigan's other federally elected representatives, including Sens. Levin and Stabenow, as well as Reps. Rogers and Schauer, sent regional- or Washington, DC-based staff to attend the event. Former Congressman and MichBio Board member, Joe Schwarz, MD, also participated.
"Commissioner Hamburg shared insights into the direction of regulatory policy under the Obama Administration, as well as her views on the challenges, needs and priorities at the FDA. Her remarks were invaluable to attendees as they work to navigate FDA approvals and compliance requirements for new therapies, devices, diagnostics, food products, and testing technologies" said Dr. Rapundalo. "Clearly, the main goal for the bio-industry and FDA is to insure patient safety while bringing medical innovation forward to improve healthcare for all Americans. Thus, a better understanding of policy positions and objectives through direct dialog such as what we had today should help us better achieve that common goal."
