dr. woodcock.now you are very familiar with the investigation that the aging committee under my leadership and senator mccaskill 's leadership has conducted into the pricing of certain prescription drugs. i want to follow-up on your comment about mylan's decision to introduce what is called an authorized generic of the epipen. i have to say that that strikes me as gaming the system. isentially, what mylan doing, as you confirmed, is just changing the label on its product, and then selling it for a lower price. but doesn't that have the effect of reducing the incentive for a true first generic to come onto the market? i know that you have approved others, and that some of them were recalled due to problems. but in general, the idea of a brand-name company simply swapping the label on its product, and then issuing it as a generic, strikes me as greatly reducing the incentive for a true first generic to come on the market. could you comment? dr. woodcock: i am no economist, but i would say that would

dr. woodcock, the floor is yours. >> thank you for this opportunity to testify. fda has no role in setting drug pricing. our actions serve to enhance competition, which has been shown to decrease drug prices. for example, i would like to go through some of the actions we do take that enhance competition. we often approve multiple drugs in a therapeutic class. they are separate drugs. for example, there are a lot of receive indianapolis born anti biotics. within a class, there may be a lot of drugs that compete in the market. also, we often approve different versions of the marketed drug once the patents have expired that are not exact copies under our 500 b 2 program, which is not generic but part of the legislation. these copies also can compete with the marketed drug. under the generics program, multiple, more less exact copies of a brand of drug can be approved once all exclustivety and patents expire. we frequently approve several copies at once. for example, recently, very recently, we approved eight crestors on the same day. so, there's a first generic, but