S. 3187 - Synthetic Drug Abuse Prevention Act of 2012

Synthetic Drug Abuse Prevention Act of 2012

S. 3187 — 112^th Congress (2011–2012)

Summary

A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes. (by CRS)

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Title

A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes.

Other Titles

• Food and Drug Administration Safety and Innovation Act
• Biosimilar User Fee Act of 2012
• Generic Drug User Fee Amendments of 2012
• Medical Device User Fee Amendments of 2012
• Prescription Drug User Fee Amendments of 2012
• Food and Drug Administration Safety and Innovation Act
• Biosimilar User Fee Act of 2012
• Generic Drug User Fee Amendments of 2012
• Medical Device User Fee Amendments of 2012
• Prescription Drug User Fee Amendments of 2012
• Synthetic Drug Abuse Prevention Act of 2012
• Food and Drug Administration Safety and Innovation Act
• Biosimilar User Fee Act of 2012
• Generic Drug User Fee Amendments of 2012
• Medical Device User Fee Amendments of 2012
• Prescription Drug User Fee Amendments of 2012
• Synthetic Drug Abuse Prevention Act of 2012
• Food and Drug Administration Safety and Innovation Act
• Biosimilar User Fee Act of 2012
• Generic Drug User Fee Amendments of 2012
• Medical Device User Fee Amendments of 2012
• Prescription Drug User Fee Amendments of 2012
• Synthetic Drug Abuse Prevention Act of 2012

Sponsor

Tom Harkin

Co-Sponsors

• Michael B. Enzi

Subjects

• Health
• Administrative law and regulatory procedures
• Administrative remedies
• Advisory bodies
• Cancer
• Child health
• Congressional oversight
• Consumer affairs
• Department of Health and Human Services
• Disability and paralysis
• Drug safety, medical device, and laboratory regulation
• Drug therapy
• Drug trafficking and controlled substances
• Executive agency funding and structure
• Food and Drug Administration (FDA)
• Government employee pay, benefits, personnel management
• Government information and archives
• Government studies and investigations
• Health care costs and insurance
• Health care coverage and access
• Health information and medical records
• Health programs administration and funding
• Health technology, devices, supplies
• Medical research
• Medical tests and diagnostic methods
• Prescription drugs
• User charges and fees

Related Bills

• H.R. 3988 (112^th) : Generic Drug User Fee Amendments of 2012
• H.R. 4087 (112^th) : Prescription Drug Labeling Promotion Act of 2012
• H.R. 5334 (112^th) : To Amend Chapter V of the Federal Food, Drug, and Cosmetic Act to Expedite the Development and Review of Breakthrough Therapies.
• H.R. 5651 (112^th) : Prescription Drug User Fee Amendments of 2012
• S. 2236 (112^th) : Advancing Breakthrough Therapies for Patients Act of 2012
• S. 2289 (112^th) : Better Pharmaceuticals and Devices for Children Act of 2012
• S. 2516 (112^th) : Prescription Drug User Fee Amendments of 2012
• S. 2516 (112^th) : Prescription Drug User Fee Amendments of 2012

Major Actions

Introduced	5/15/2012
Amendments (47 proposed)
Passed Senate	5/24/2012
Passed House	6/20/2012
Passed Senate	6/26/2012
Signed by President	7/09/2012

Bill History

• All Votes
• All Actions
• Amendments

	Chamber/Committee	Motion	Date	Result
select this vote	Senate	Amendment SA 2121 agreed to in Senate by Unanimous Consent.	5/23/2012	PASSED by voice vote
select this vote	Senate	Amendment SA 2122 agreed to in Senate by Unanimous Consent.	5/23/2012	PASSED by voice vote
select this vote	Senate	Amendment SA 2125 agreed to in Senate by Unanimous Consent.	5/23/2012	PASSED by voice vote
select this vote	Senate	Amendment SA 2126 agreed to in Senate by Unanimous Consent.	5/23/2012	PASSED by voice vote
select this vote	Senate	Amendment SA 2129 agreed to in Senate by Unanimous Consent.	5/23/2012	PASSED by voice vote
select this vote	Senate	Amendment SA 2141 agreed to in Senate by Unanimous Consent.	5/23/2012	PASSED by voice vote
select this vote	Senate	Amendment SA 2151 as modified agreed to in Senate by Unanimous Consent.	5/23/2012	PASSED by voice vote
select this vote	Senate	Amendment SA 2131 agreed to in Senate by Unanimous Consent.	5/24/2012	PASSED by voice vote
select this vote	Senate	Amendment SA 2142 as modified agreed to in Senate by Unanimous Consent.	5/24/2012	PASSED by voice vote
select this vote	Senate	Amendment SA 2145 as modified agreed to in Senate by Unanimous Consent.	5/24/2012	PASSED by voice vote
select this vote	Senate	Amendment SA 2146 as modified agreed to in Senate by Voice Vote.	5/24/2012	PASSED by voice vote
select this vote	Senate	On the Amendment S.Amdt. 2111 to S. 3187 (No short title on file)	5/24/2012	This amendment DID NOT PASS the Senate 28 voted YES 67 voted NO 5 voted present/not voting
select this vote	Senate	On the Amendment S.Amdt. 2108 to S. 3187 (No short title on file)	5/24/2012	This amendment DID NOT PASS the Senate 46 voted YES 50 voted NO 4 voted present/not voting
select this vote	Senate	On the Motion to Table S.Amdt. 2143 to S. 3187 (No short title on file)	5/24/2012	This amendment PASSED the Senate 78 voted YES 15 voted NO 7 voted present/not voting
select this vote	Senate	On the Amendment S.Amdt. 2107 to S. 3187 (No short title on file)	5/24/2012	This amendment DID NOT PASS the Senate 43 voted YES 54 voted NO 3 voted present/not voting
select this vote	Senate	On the Amendment S.Amdt. 2109 to S. 3187 (No short title on file)	5/24/2012	This amendment DID NOT PASS the Senate 9 voted YES 88 voted NO 3 voted present/not voting
select this vote	Senate	On the Motion to Table S.Amdt. 2127 to S. 3187 (No short title on file)	5/24/2012	This amendment PASSED the Senate 77 voted YES 20 voted NO 3 voted present/not voting
select this vote	Senate	S. 3187 (112th): Food and Drug Administration Safety and Innovation Act	5/24/2012	This bill PASSED the Senate 96 voted YES 1 voted NO 3 voted present/not voting
select this vote	House	On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.	6/20/2012	PASSED by voice vote
select this vote	Senate	On the Cloture Motion S. 3187	6/25/2012	This motion PASSED the Senate 89 voted YES 3 voted NO 8 voted present/not voting
currently selected	Senate	S. 3187 (112th): Food and Drug Administration Safety and Innovation Act	6/26/2012	This bill PASSED the Senate 92 voted YES 4 voted NO 4 voted present/not voting

	Action	Date	Description
	Introduced	5/15/2012
		5/15/2012	Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
	Put on a legislative calendar	5/16/2012	Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 400.
		5/17/2012	Motion to proceed to consideration of measure made in Senate.
		5/17/2012	Cloture motion on the motion to proceed to the measure presented in Senate.
		5/21/2012	Motion to proceed to consideration of measure made in Senate.
		5/21/2012	Cloture motion on the motion to proceed to the measure withdrawn by unanimous consent in Senate.
		5/22/2012	Motion to proceed to consideration of measure made in Senate.
		5/23/2012	Motion to proceed to consideration of measure made in Senate.
		5/23/2012	Motion to proceed to consideration of measure agreed to in Senate by Unanimous Consent.
		5/23/2012	Measure laid before Senate by motion.
		5/23/2012	Amendment SA 2108 proposed by Senator Murkowski.
		5/23/2012	Amendment SA 2109 proposed by Senator Sanders.
		5/23/2012	Amendment SA 2121 proposed by Senator Grassley.
select this vote	Vote	5/23/2012	Amendment SA 2121 agreed to in Senate by Unanimous Consent.
		5/23/2012	Amendment SA 2122 proposed by Senator Harkin.
select this vote	Vote	5/23/2012	Amendment SA 2122 agreed to in Senate by Unanimous Consent.
		5/23/2012	Amendment SA 2125 proposed by Senator Cardin.
select this vote	Vote	5/23/2012	Amendment SA 2125 agreed to in Senate by Unanimous Consent.
		5/23/2012	Amendment SA 2126 proposed by Senator Harkin for Senator Reed.
select this vote	Vote	5/23/2012	Amendment SA 2126 agreed to in Senate by Unanimous Consent.
		5/23/2012	Amendment SA 2127 proposed by Senator Durbin.
		5/23/2012	Amendment SA 2129 proposed by Senator Grassley.
select this vote	Vote	5/23/2012	Amendment SA 2129 agreed to in Senate by Unanimous Consent.
		5/23/2012	Amendment SA 2130 proposed by Senator Burr.
		5/23/2012	Amendment SA 2131 proposed by Senator Coburn.
		5/23/2012	Amendment SA 2132 proposed by Senator Coburn.
		5/23/2012	Amendment SA 2141 proposed by Senator Cardin.
select this vote	Vote	5/23/2012	Amendment SA 2141 agreed to in Senate by Unanimous Consent.
		5/23/2012	Amendment SA 2143 proposed by Senator Paul.
		5/23/2012	Amendment SA 2151 proposed by Senator Manchin.
select this vote	Vote	5/23/2012	Amendment SA 2151 as modified agreed to in Senate by Unanimous Consent.
		5/24/2012	Considered by Senate.
		5/24/2012	Message on Senate action sent to the House.
		5/24/2012	Amendment SA 2107 proposed by Senator McCain.
		5/24/2012	Considered by Senate.
		5/24/2012	Considered by Senate.
		5/24/2012	Amendment SA 2111 proposed by Senator Bingaman.
		5/24/2012	Considered by Senate.
		5/24/2012	Considered by Senate.
		5/24/2012	Considered by Senate.
select this vote	Vote	5/24/2012	Amendment SA 2131 agreed to in Senate by Unanimous Consent.
		5/24/2012	Considered by Senate.
		5/24/2012	Amendment SA 2142 proposed by Senator Harkin for Senator Leahy.
select this vote	Vote	5/24/2012	Amendment SA 2142 as modified agreed to in Senate by Unanimous Consent.
		5/24/2012	Considered by Senate.
		5/24/2012	Amendment SA 2145 proposed by Senator Harkin for Senator Portman.
select this vote	Vote	5/24/2012	Amendment SA 2145 as modified agreed to in Senate by Unanimous Consent.
		5/24/2012	Amendment SA 2146 proposed by Senator Harkin for Senator Portman.
select this vote	Vote	5/24/2012	Amendment SA 2146 as modified agreed to in Senate by Voice Vote.
		5/24/2012	Proposed amendment SA 2130 withdrawn in Senate.
		5/24/2012	Proposed amendment SA 2132 withdrawn in Senate.
select this vote	Vote	5/24/2012	On the Amendment S.Amdt. 2111 to S. 3187 (No short title on file)
select this vote	Vote	5/24/2012	On the Amendment S.Amdt. 2108 to S. 3187 (No short title on file)
select this vote	Vote	5/24/2012	On the Motion to Table S.Amdt. 2143 to S. 3187 (No short title on file)
select this vote	Vote	5/24/2012	On the Amendment S.Amdt. 2107 to S. 3187 (No short title on file)
select this vote	Vote	5/24/2012	On the Amendment S.Amdt. 2109 to S. 3187 (No short title on file)
select this vote	Vote	5/24/2012	On the Motion to Table S.Amdt. 2127 to S. 3187 (No short title on file)
select this vote	Senate Vote on Passage	5/24/2012	S. 3187 (112th): Food and Drug Administration Safety and Innovation Act
		5/25/2012	Received in the House.
		5/25/2012	Held at the desk.
		6/20/2012	Mr. Upton moved to suspend the rules and pass the bill, as amended.
		6/20/2012	Considered under suspension of the rules.
		6/20/2012	DEBATE - The House proceeded with forty minutes of debate on S. 3187.
select this vote	House Vote on Passage	6/20/2012	On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.
		6/20/2012	Motion to reconsider laid on the table Agreed to without objection.
		6/20/2012	Message on House action received in Senate and at desk: House amendment to Senate bill.
		6/21/2012	Measure laid before Senate by unanimous consent.
		6/21/2012	Motion to concur in the House amendment made in Senate.
		6/21/2012	Cloture motion on the motion to concur in the House amendment presented in Senate.
		6/21/2012	Motion to concur in the House amendment with an amendment (SA 2461) made in Senate.
		6/21/2012	Motion by Senator Reid to refer to Senate Committee on Health, Education, Labor, and Pensions with instructions to report back forthwith with the following amendment (SA 2463) made in Senate.
		6/21/2012	Amendment SA 2461 proposed by Senator Reid.
		6/21/2012	Amendment SA 2462 proposed by Senator Reid to Amendment SA 2461.
		6/21/2012	Amendment SA 2463 (the instructions to the motion) proposed by Senator Reid.
		6/21/2012	Amendment SA 2464 proposed by Senator Reid to Amendment SA 2463.
		6/21/2012	Amendment SA 2465 proposed by Senator Reid to Amendment SA 2464.
		6/25/2012	Motion by Senator Reid to refer to Senate Committee on Health, Education, Labor, and Pensions with instructions to report back forthwith with the following amendment (SA 2463) fell when cloture on the motion to concur in the House amendment to the bill (S. 3187) was invoked in Senate.
		6/25/2012	SA 2463 (instructions to the motion to refer) fell when cloture invoked on the motion to concur in the House amendment to the bill (S.3187).
		6/25/2012	SA 2464 fell when SA 2463 fell.
		6/25/2012	SA 2465 fell when SA 2464 fell.
select this vote	Vote	6/25/2012	On the Cloture Motion S. 3187
		6/26/2012	Considered by Senate.
		6/26/2012	Motion by Senator Reid to concur in the House amendment to the bill (S. 3187) with an amendment (SA 2461) withdrawn in Senate by Unanimous Consent.
		6/26/2012	Considered by Senate.
		6/26/2012	Considered by Senate.
		6/26/2012	SA 2462 fell when SA 2461 withdrawn.
		6/26/2012	Proposed amendment SA 2461 withdrawn in Senate.
currently selected	Senate Vote on Passage	6/26/2012	S. 3187 (112th): Food and Drug Administration Safety and Innovation Act
		6/27/2012	Message on Senate action sent to the House.
	Presented to President	6/28/2012	Presented to President.
	Signed	7/09/2012	Signed by President.
	Enacted	7/09/2012	Became Public Law No: 112-144.

	Number	Sponsor	Date Offered	Status
select this vote	S. Amdt. 2107	McCain, John [R-AZ]	May 17, 2012	Failed by roll call vote on May 23, 2012.
	To allow the importation by individuals of safe and affordable drugs from Canada. Show amendment details
select this vote	S. Amdt. 2108	Murkowski, Lisa [R-AK]	May 17, 2012	Failed by roll call vote on May 23, 2012.
	To prohibit approval by the Food and Drug Administration of genetically engineered fish unless the National Oceanic and Atmospheric Administration concurs with such approval. Show amendment details
select this vote	S. Amdt. 2109	Sanders, Bernard [I-VT]	May 17, 2012	Failed by roll call vote on May 23, 2012.
	To revoke the exclusivity of certain entities that are responsible for violations of the Federal Food, Drug, and Cosmetic Act, the False Claims Act, and other certain laws. Show amendment details
	S. Amdt. 2110	Sanders, Bernard [I-VT]	May 17, 2012	Offered on May 16, 2012.
	Show amendment details
select this vote	S. Amdt. 2111	Bingaman, Jeff [D-NM]	May 17, 2012	Failed by roll call vote on May 23, 2012.
	To provide substantial savings in health care costs to the Federal government and consumers by fostering competition among generic pharmaceutical manufacturers and ensuring that anti-competitive "pay-for-delay" settlements between brand-name and generic pharmaceutical manufacturers do not block generic drugs from entering the market. Show amendment details
	S. Amdt. 2114	Grassley, Charles [R-IA]	May 21, 2012	Offered on May 20, 2012.
	Show amendment details
	S. Amdt. 2115	Grassley, Charles [R-IA]	May 21, 2012	Offered on May 20, 2012.
	Show amendment details
	S. Amdt. 2116	Grassley, Charles [R-IA]	May 21, 2012	Offered on May 20, 2012.
	Show amendment details
	S. Amdt. 2117	Rockefeller, John [D-WV]	May 21, 2012	Offered on May 20, 2012.
	Show amendment details
	S. Amdt. 2118	Rockefeller, John [D-WV]	May 21, 2012	Offered on May 20, 2012.
	Show amendment details
	S. Amdt. 2119	Rockefeller, John [D-WV]	May 21, 2012	Offered on May 20, 2012.
	Show amendment details
	S. Amdt. 2120	Grassley, Charles [R-IA]	May 21, 2012	Offered on May 20, 2012.
	Show amendment details
select this vote	S. Amdt. 2121	Grassley, Charles [R-IA]	May 21, 2012	Passed by voice vote on May 22, 2012.
	To provide employee protections for the Commissioned Corps of the Public Health Service Act. Show amendment details
select this vote	S. Amdt. 2122	Harkin, Thomas [D-IA]	May 21, 2012	Passed by voice vote on May 22, 2012.
	In the nature of a substitute. Show amendment details
select this vote	S. Amdt. 2125	Cardin, Benjamin [D-MD]	May 21, 2012	Passed by voice vote on May 22, 2012.
	To ensure that adequate information is disseminated to health care providers and payors about the potential benefits and risks of medical products on all patient populations, particularly underrepresented subpopulations, including racial subgroups. Show amendment details
select this vote	S. Amdt. 2126	Reed, John [D-RI]	May 21, 2012	Passed by voice vote on May 22, 2012.
	To make effective the proposed rule of the Food and Drug Administration relating to sunscreen drug products. Show amendment details
select this vote	S. Amdt. 2127	Durbin, Richard [D-IL]	May 22, 2012	Offered on May 21, 2012.
	To require manufacturers of dietary supplements to register dietary supplement products with the Food and Drug Administration. Show amendment details
	S. Amdt. 2128	Gillibrand, Kirsten [D-NY]	May 22, 2012	Offered on May 21, 2012.
	Show amendment details
select this vote	S. Amdt. 2129	Grassley, Charles [R-IA]	May 22, 2012	Passed by voice vote on May 22, 2012.
	To provide deadlines for the issuance of certain regulations and to require a GAO report on the implementation of the clinical trial registration and reporting requirements under the Public Health Service Act. Show amendment details
	S. Amdt. 2130	Burr, Richard [R-NC]	May 22, 2012	Withdrawn on May 23, 2012.
	To ensure transparency in Food and Drug Administration user fee agreement negotiations. Show amendment details
select this vote	S. Amdt. 2131	Coburn, Thomas [R-OK]	May 22, 2012	Passed by voice vote on May 23, 2012.
	To require an independent assessment of the Food and Drug Administration's review of drug applications. Show amendment details
	S. Amdt. 2132	Coburn, Thomas [R-OK]	May 22, 2012	Withdrawn on May 23, 2012.
	To provide that a portion of the performance awards of each employee of the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Biologics Evaluation and Research be connected to an evaluation of the employee's contribution to goals under the user fee agreements. Show amendment details
	S. Amdt. 2133	DeMint, Jim [R-SC]	May 22, 2012	Offered on May 21, 2012.
	Show amendment details
	S. Amdt. 2134	Blumenthal, Richard [D-CT]	May 22, 2012	Offered on May 21, 2012.
	Show amendment details
	S. Amdt. 2135	Blumenthal, Richard [D-CT]	May 22, 2012	Offered on May 21, 2012.
	Show amendment details
	S. Amdt. 2136	Blumenthal, Richard [D-CT]	May 22, 2012	Offered on May 21, 2012.
	Show amendment details
	S. Amdt. 2137	Rockefeller, John [D-WV]	May 22, 2012	Offered on May 21, 2012.
	Show amendment details
	S. Amdt. 2138	Vitter, David [R-LA]	May 22, 2012	Offered on May 21, 2012.
	Show amendment details
	S. Amdt. 2139	Schumer, Charles [D-NY]	May 22, 2012	Offered on May 21, 2012.
	Show amendment details
	S. Amdt. 2140	Schumer, Charles [D-NY]	May 22, 2012	Offered on May 21, 2012.
	Show amendment details
select this vote	S. Amdt. 2141	Cardin, Benjamin [D-MD]	May 22, 2012	Passed by voice vote on May 22, 2012.
	To require the Commissioner of Food and Drugs to report to Congress on issues with respect to small businesses. Show amendment details
select this vote	S. Amdt. 2142	Leahy, Patrick [D-VT]	May 22, 2012	Passed by voice vote on May 23, 2012.
	To modify and limit certain exemptions to the Freedom of Information Act. Show amendment details
select this vote	S. Amdt. 2143	Paul, Rand [R-KY]	May 22, 2012	Offered on May 21, 2012.
	To amend the Federal Food, Drug, and Cosmetic Act concerning claims about the effects of foods and dietary supplements on health-related conditions and disease, to prohibit employees of the Food and Drug Administration from carrying firearms and making arrests without warrants, and to adjust the mens rea of certain prohibited acts under the Federal Food, Drug, and Cosmetic Act to knowing and willful. Show amendment details
	S. Amdt. 2144	Hatch, Orrin [R-UT]	May 22, 2012	Offered on May 21, 2012.
	Show amendment details
select this vote	S. Amdt. 2145	Portman, Robert [R-OH]	May 22, 2012	Passed by voice vote on May 23, 2012.
	To facilitate the development of recommendations on interoperability standards to inform and facilitate the exchange of prescription information across State lines. Show amendment details
select this vote	S. Amdt. 2146	Portman, Robert [R-OH]	May 22, 2012	Passed by voice vote on May 23, 2012.
	To amend the Controlled Substances Act to place synthetic drugs in Schedule I. Show amendment details
	S. Amdt. 2147	Hatch, Orrin [R-UT]	May 22, 2012	Offered on May 21, 2012.
	Show amendment details
	S. Amdt. 2148	Kohl, Herbert [D-WI]	May 22, 2012	Offered on May 21, 2012.
	Show amendment details
	S. Amdt. 2149	Kohl, Herbert [D-WI]	May 22, 2012	Offered on May 21, 2012.
	Show amendment details
	S. Amdt. 2150	Snowe, Olympia [R-ME]	May 23, 2012	Offered on May 22, 2012.
	Show amendment details
select this vote	S. Amdt. 2151	Manchin, Joe [D-WV]	May 23, 2012	Passed by voice vote on May 22, 2012.
	To amend the Controlled Substances Act to make any substance containing hydrocodone as schedule II drug. Show amendment details
	S. Amdt. 2152	Portman, Robert [R-OH]	May 23, 2012	Offered on May 22, 2012.
	Show amendment details
	S. Amdt. 2461	Reid, Harry [D-NV]	June 21, 2012	Withdrawn on June 25, 2012.
	To change the enactment date. Show amendment details
	S. Amdt. 2462	Reid, Harry [D-NV]	June 21, 2012	Offered on June 20, 2012.
	Of a perfecting nature. Show amendment details
	S. Amdt. 2463	Reid, Harry [D-NV]	June 21, 2012	Offered on June 20, 2012.
	To change the enactment date. Show amendment details
	S. Amdt. 2464	Reid, Harry [D-NV]	June 21, 2012	Offered on June 20, 2012.
	Of a perfecting nature. Show amendment details
	S. Amdt. 2465	Reid, Harry [D-NV]	June 21, 2012	Offered on June 20, 2012.
	Of a perfecting nature. Show amendment details