The report must list penalties, settlements and payments by drug and sponsor
What the document says“``(17) a listing of penalties, settlements, or payments under section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353) for failure to comply with requirements under such section 505B, including, for each penalty, settlement, or payment, the name of the drug, the sponsor thereof, and the amount of the penalty, settlement, or payment imposed.''.”
Section 6603 adds a new paragraph (17) requiring the report to list penalties, settlements and payments under section 303 of the Federal Food, Drug, and Cosmetic Act for failing to meet the section 505B requirements, giving for each one the name of the drug, its sponsor and the amount.
What the document actually says“``(17) a listing of penalties, settlements, or payments under section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353) for failure to comply with requirements under such section 505B, including, for each penalty, settlement, or payment, the name of the drug, the sponsor thereof, and the amount of the penalty, settlement, or payment imposed.''.”
The report must list every penalty and settlement for these failures. For each one it must give the drug, the maker and the sum.
A count of penalties says little on its own. Naming the drug and the maker shows who was fined and how much.
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