The bills before the full committee have been improved substantially through staff negotiation and our subcommittee mark-up earlier this week. It took some needed pressure and diplomatic negotiations to bring the piece of legislation we have before us today. I believe that these bills will achieve numerous goals such as providing additional resources to FDA to improve pre-market drug and device approval, create new post-market surveillance authorities, enhance clinical trial transparency and data mining, and ensure the adequacy of pediatric studies for drugs and devices.

I would like to thank Chairman Dingell and Chairman Pallone for working with our Republican staff to improve this legislation before we convened this mark-up.

In subcommittee, we were able to modify the Direct to Consumer Advertising (DTC) provision to protect this bill from a constitutional challenge and in a manner relying on existing FDA regulatory standards. In regard to Pediatric Exclusivity, we were able to ensure that a workable standard was in place as opposed to the original proposal that would have required FDA accountants to work over-time.

I’m also pleased that one of my concerns about how the new post-market surveillance regime would impact the independent practice of medicine. I am pleased that Mr. Waxman, Pallone, Dingell and their staffs worked with me to improve the language relating to restrictions on distribution and use, pursuant to elements of a drug’s Risk Evaluation and Mitigation Strategy. The original language threatened clinical decision making that is both lawful and based on scientific evidence and sound medical opinion, but I’m pleased that it has been tempered by the concerns I raised to these gentlemen.

I’m hopeful that our side, along with Committee leadership can hold together today and uphold the agreements made on these bills out of good conscience and a spirit of bipartisanship. It has already been shown that our collaboration on this endeavor has produced better legislation, and I hope that will be proved here once again today.