Political Quotes

“Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 5811) to amend the Federal Food, Drug, and Cosmetic Act with respect to postapproval study requirements for certain controlled substances, and for other purposes, as amended. The Clerk read the title of the bill. The text of the bill is as follows: H.R. 5811 Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. POSTAPPROVAL STUDY REQUIREMENTS. (a) Purposes of Study.--Section 505(o)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)(B)) is amended by adding at the end the following: ``(iv) To assess a potential reduction in effectiveness of the drug for the conditions of use prescribed, recommended, or suggested in the labeling thereof if-- ``(I) the drug involved-- ``(aa) is or contains a substance for which a listing in any schedule is in effect (on a temporary or permanent basis) under section 201 of the Controlled Substances Act; or ``(bb) is a drug that has not been approved under this section or licensed under section 351 of the Public Health Service Act, for which an application for such approval or licensure is pending or anticipated, and for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act; and ``(II) the potential reduction in effectiveness could result in the benefits of the drug no l…”