The newly passed legislation in Congress that will reform FDA and reauthorize the Prescription Drug User Fee Act for another five years is just one example of dynamic change that is occurring in the marketplace.
This week, I was able to speak with Jim Greenwood, President and CEO of BIO,(representing over 1100 biotechnology companies) to talk about the impact of the reforms – what went into them, and what did not (i.e., a regulatory pathway for follow-on biologics). We also discussed public perceptions of drug safety standards and how the COX-2 safety scares have shaped the public and policy maker psyche. Lastly, we discussed how the struggling image of the medicines industry affects public policy outcomes.
Mr. Greenwood represented Pennsylvania’s Eighth District in the U.S. House of Representatives from January 1993 through January 2005 where he served as a senior member of the Energy and Commerce Committee. From 2001 to 2004, Mr. Greenwood served as Chairman of the Energy and Commerce Committee Subcommittee on Oversight and Investigation with oversight authority over issues in the full Committee’s vast jurisdiction.