S.Amdt. 1286

SA 1286. Mr. MERKLEY submitted an amendment intended to be proposed by him to the bill H.R. 1256, to protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products, to amend title 5, United States Code, to make certain modifications in the Thrift Savings Plan, the Civil Service Retirement System, and the Federal Employees' Retirement System, and for other purposes; which was ordered to lie on the table; as follows:

At the appropriate place in division A, insert the following:

SEC. __. IMMEDIATE, MANDATORY EVALUATION OF POTENTIAL VIOLATIONS OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

(a) Immediate, Mandatory Evaluation and Report.--

(1) Immediate, mandatory evaluation.--The Secretary of Health and Human Services shall conduct an evaluation of the manufacture, distribution, and use of marijuana in States that have enacted laws legalizing, decriminalizing, or otherwise allowing the use of marijuana for purported medical use to determine--

(A) whether such activity conflicts with any provision of Federal law for which the Department of Health of Human Services is responsible; and

(B) whether such medical marijuana programs conflict with any provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) that is designed to ensure the safety and effectiveness of drugs used by the American public.

(2) Report.--Not later than 90 days after the date of enactment of this Act, and after an opportunity for public comment, the Secretary of Health and Human Services shall submit to Congress a report concerning the findings of the evaluation conducted under paragraph (1).

(b) Report on Research.--The Secretary of Health and Human Services shall report to Congress on efforts to respond to privately-funded research to evaluate marijuana for possible prescription use, after being subjected to the full regulatory processes, evaluations, and requirements of the Food and Drug Administration, including Phase II and III studies, risk evaluation and mitigation strategy, and all other requirements of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) regarding safe and effective reviews, approval, sale, marketing, and use of pharmaceuticals.