On the recordNovember 13, 2001
First of all, the gentleman knows that he offered three amendments to the committee, two of which were accepted; and the gentleman voted for the bill in committee. On the last part, I want to make it clear to the House that current law section 502(n) and 301(z) in the regulations that interpret that law prohibit the marketing of exclusivity until the pediatric indication is on the label. That is the law today. What we do in this bill is go further. We make it a priority review on the pediatric indication, and we put a time certain after which it is misbranding if the pediatric indication is not on the label. The point I am making is that the problem the gentleman is concerned about is already covered in the law as a violation. A pharmaceutical company is prohibited under the law today to market a drug's exclusivity without the pediatric indication being on the label. That is, under current law, prohibited.
Source
govinfo.gov
