Charles Norwood: “I think that it is perfectly clear to me and perhaps to other Members that there really are people in our body that just…”

“I think that it is perfectly clear to me and perhaps to other Members that there really are people in our body that just do not like the pharmaceutical industry. It is a little baffling to me. I do not impugn their motives, I do not question their motives, I just do not understand it because this is a bill not about profits; but this is a bill about making sure that medications that are produced for adults are then further studied for children. I do not understand exactly why a system that has worked so well and has produced what we wanted it to do should be attacked so tonight. I have time only to make just one point, but the pharmaceutical industry does not choose which drug is to be studied. Therefore, it does not choose which drug can have 6 months' extension on its patent. Not every drug is eligible for pediatric exclusivity. The decision about whether to issue a written request, that rests with the FDA. That is not based on dollars and cents. It is based on which medication needs to be studied. If there is no written request, there is no opportunity for pediatric exclusivity which means the 6 months' extension on their patent. Hence, and for sure, blockbuster drugs like Rogaine and Viagra will never gain the ability to have pediatric exclusivity. Lastly, I think just on labeling, I want to point out to you that when you go to the drug store and you get your little plastic vial and it has a label on it, the label on the medication is the doctor's orders.”