Richard Burr: “we are at a lull in the movement of the drug safety bill, a bill to assure American consumers, American patients, that…”

“we are at a lull in the movement of the drug safety bill, a bill to assure American consumers, American patients, that there is more than just the acknowledgment by the Food and Drug Administration that a drug is safe and effective; that there is a mechanism post-approval as Americans across the country begin to take those medications; that we are watching for potentially any adverse reactions to a drug that a new population, an increased number of Americans that may be taking the drug. It is in an effort to make sure that if we see the signals of that unintended consequence, that we look more thoroughly at the benefits of that drug being on the market. When I left the floor earlier today, the sponsor of the importation amendment suggested that Vioxx was not beneficial to anybody. The fact is, I do not think it is the role of Members of the Senate--unless you are Dr. Coburn--to suggest that you practice medicine. There are physicians who found the advantages of Vioxx, while it was on the market, they found it was advantageous to thousands, if not hundreds of thousands, of patients.”