S. Amdt. 1047 - To Modify Provisions Relating to Direct-To-Consumer Advertisements.

Prescription Drug User Fee Amendments of 2007

S. 1082 — 110^th Congress (2007–2008)

Summary

An act to amend the Federal Food, Drug, and cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes. (by CRS)

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Title

A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes.

Other Titles

• Prescription Drug User Fee Amendments of 2007
• Food and Drug Administration Revitalization Act
• Best Pharmaceuticals for Children Amendments of 2007
• Enhancing Drug Safety and Innovation Act of 2007
• Medical Device User Fee Amendments of 2007
• Pediatric Medical Device Safety and Improvement Act of 2007
• Pediatric Research Improvement Act
• Food and Drug Administration Revitalization Act
• Best Pharmaceuticals for Children Amendments of 2007
• Domestic Pet Turtle Market Access Act of 2007
• Enhancing Drug Safety and Innovation Act of 2007
• Medical Device User Fee Amendments of 2007
• Pediatric Medical Device Safety and Improvement Act of 2007
• Pediatric Research Improvement Act
• Pharmaceutical Market Access and Drug Safety Act of 2007
• An act to amend the Federal Food, Drug, and cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes.

Sponsor

Edward Kennedy

Co-Sponsors

Subjects

• Medicine
• Abortion
• Actions and defenses
• Administrative fees
• Administrative procedure
• Agriculture
• Agriculture in foreign trade
• Animals
• Antibiotics
• Biomedical engineering
• Budgets
• Business
• Canada
• Cancer
• Chemotherapy
• Child health
• Children
• Clinical trials
• Communicable diseases
• Communication in medicine
• Communications
• Conflict of interests
• Congress
• Congressional investigations
• Congressional oversight
• Congressional reporting requirements
• Consumer education
• Consumers
• Cosmetics
• Counterfeiting
• Criminal justice
• Data banks
• Defective products
• Department of Health and Human Services
• Drug abuse
• Drug adulteration
• Drug approvals
• Drug industry
• Drug interactions
• Drug law enforcement
• Drug therapy
• Drug utilization
• Drugs
• Education
• Electronic data interchange
• Elementary and secondary education
• Environmental protection
• Executive departments
• Eye diseases
• Families
• Federal advisory bodies
• Federal aid to education
• Federal aid to research
• Federal reserve system
• Fines (Penalties)
• Food
• Food additives
• Food and Drug Administration (FDA)
• Food industry
• Food preservation
• Food safety
• Food supply
• Foodborne diseases
• Foundations
• Fraud
• Generic drugs
• Genetic counseling
• Genetic engineering
• Genetics
• Government information
• Government paperwork
• Government publicity
• Hazardous substances
• Health information systems
• Health surveys
• Health warnings
• Higher education
• Imaging systems in medicine
• Import restrictions
• Intellectual property
• Internet
• Labeling
• Law
• Marijuana
• Meat
• Medical care
• Medical education
• Medical laboratories
• Medical records
• Medical statistics
• Medical supplies
• Medicinal plants
• Orphan drugs
• Packaging
• Parent and child
• Patent infringement
• Pesticides
• Pets
• Pharmaceutical research
• Pharmacists
• Physical examinations
• Politics and government
• Preschool education
• Prescription pricing
• Prices
• Produce trade
• Product development
• Product safety
• Protection of animals
• Public meetings
• Research and development
• Research grants
• Restrictive trade practices
• Risk
• Salmonella
• Scholarships
• Science policy
• Seafood
• Shellfish
• Skin cancer
• Skin diseases
• Small business
• Social services
• Strategic planning
• Student loan funds
• Technology
• Telecommunication
• Trade
• Turtles
• User charges
• Web sites

Related Bills

• H.R. 2900 (110^th) : Food and Drug Administration Amendments Act of 2007

Major Actions

Introduced	4/10/2007
Referred to Committee
Amendments (82 proposed)
Passed Senate	5/09/2007

Bill History

• All Votes
• All Actions
• Amendments

	Chamber/Committee	Motion	Date	Result
select this vote	Senate	Amendment SA 1018 agreed to in Senate by Unanimous Consent.	5/02/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1025 agreed to in Senate by Voice Vote.	5/02/2007	PASSED by voice vote
select this vote	Senate	Allard Amdt. No. 982	5/02/2007	This amendment DID NOT PASS the Senate 41 voted YES 53 voted NO 6 voted present/not voting
select this vote	Senate	Durbin Amdt. No. 1022, as Modified	5/02/2007	This amendment PASSED the Senate 94 voted YES 0 voted NO 6 voted present/not voting
select this vote	Senate	Motion to Invoke Cloture on the Dorgan Amdt. No. 990	5/03/2007	This amendment PASSED the Senate 63 voted YES 28 voted NO 9 voted present/not voting
select this vote	Senate	Amendment SA 990 agreed to in Senate by Voice Vote.	5/07/2007	PASSED by voice vote
select this vote	Senate	Cochran Amdt. No. 1010	5/07/2007	This amendment PASSED the Senate 49 voted YES 40 voted NO 11 voted present/not voting
select this vote	Senate	Motion to Invoke Cloture on the Committee Substitute as Modified and Amended to S.1082	5/07/2007	This motion PASSED the Senate 82 voted YES 8 voted NO 10 voted present/not voting
select this vote	Senate	Amendment SA 985 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 987 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1004 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1005 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1006 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1009 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1011 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1019 agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1026 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1041 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
currently selected	Senate	Amendment SA 1047 agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1049 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1050 agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1053 agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1056 agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Grassley Amdt. No. 1039	5/09/2007	This amendment DID NOT PASS the Senate 46 voted YES 47 voted NO 7 voted present/not voting
select this vote	Senate	Grassley Amdt. No. 998	5/09/2007	This amendment PASSED the Senate 64 voted YES 30 voted NO 6 voted present/not voting
select this vote	Senate	Durbin Amdt. No. 1034	5/09/2007	This amendment DID NOT PASS the Senate 47 voted YES 47 voted NO 6 voted present/not voting
select this vote	Senate	On Passage - Senate - S.1082 as Amended	5/09/2007	This bill PASSED the Senate 93 voted YES 1 voted NO 6 voted present/not voting

	Action	Date	Description
	Introduced	4/10/2007
		4/10/2007	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
	Put on a legislative calendar	4/18/2007	Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
		4/24/2007	Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment in the nature of a substitute and an amendment to the title. Without written report.
	Put on a legislative calendar	4/24/2007	Placed on Senate Legislative Calendar under General Orders. Calendar No. 120.
		4/30/2007	Measure laid before Senate by unanimous consent.
		5/01/2007	Amendment SA 990 proposed by Senator Dorgan.
		5/01/2007	Considered by Senate.
		5/01/2007	The committee reported substitute amendment was modified by Unanimous Consent.
		5/01/2007	Cloture motion on amendment SA 990 presented in Senate.
		5/01/2007	Amendment SA 1004 proposed by Senator Landrieu.
		5/02/2007	Considered by Senate.
		5/02/2007	Amendment SA 982 proposed by Senator Allard.
		5/02/2007	Amendment SA 983 proposed by Senator Vitter.
		5/02/2007	Amendment SA 985 proposed by Senator Brown for Senator Brownback.
		5/02/2007	Amendment SA 988 proposed by Senator Inhofe.
		5/02/2007	Considered by Senate.
		5/02/2007	Amendment SA 993 proposed by Senator Gregg.
		5/02/2007	Considered by Senate.
		5/02/2007	Amendment SA 1010 proposed by Senator Cochran to Amendment SA 990.
		5/02/2007	Amendment SA 1011 proposed by Senator Stabenow.
		5/02/2007	Amendment SA 1018 proposed by Senator DeMint.
select this vote	Vote	5/02/2007	Amendment SA 1018 agreed to in Senate by Unanimous Consent.
		5/02/2007	Amendment SA 1022 proposed by Senator Durbin.
		5/02/2007	Amendment SA 1025 proposed by Senator Schumer.
select this vote	Vote	5/02/2007	Amendment SA 1025 agreed to in Senate by Voice Vote.
select this vote	Vote	5/02/2007	Allard Amdt. No. 982
select this vote	Vote	5/02/2007	Durbin Amdt. No. 1022, as Modified
		5/03/2007	Considered by Senate.
		5/03/2007	Considered by Senate.
		5/03/2007	Cloture motion on the committee substitute amendment as modified presented in Senate.
		5/03/2007	Cloture motion on the measure presented in Senate.
		5/03/2007	Considered by Senate.
		5/03/2007	Considered by Senate.
		5/03/2007	Considered by Senate.
		5/03/2007	Considered by Senate.
		5/03/2007	Considered by Senate.
		5/03/2007	Considered by Senate.
		5/03/2007	Considered by Senate.
select this vote	Vote	5/03/2007	Motion to Invoke Cloture on the Dorgan Amdt. No. 990
		5/07/2007	Considered by Senate.
		5/07/2007	Considered by Senate.
		5/07/2007	Considered by Senate.
		5/07/2007	Considered by Senate.
		5/07/2007	Considered by Senate.
select this vote	Vote	5/07/2007	Amendment SA 990 agreed to in Senate by Voice Vote.
		5/07/2007	Considered by Senate.
		5/07/2007	Considered by Senate.
		5/07/2007	Considered by Senate.
		5/07/2007	Considered by Senate.
select this vote	Vote	5/07/2007	Cochran Amdt. No. 1010
select this vote	Vote	5/07/2007	Motion to Invoke Cloture on the Committee Substitute as Modified and Amended to S.1082
		5/08/2007	Considered by Senate.
		5/08/2007	Considered by Senate.
		5/08/2007	Proposed amendment SA 983 withdrawn in Senate.
		5/08/2007	Considered by Senate.
select this vote	Vote	5/08/2007	Amendment SA 985 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 987 proposed by Senator Brown for Senator Inhofe.
select this vote	Vote	5/08/2007	Amendment SA 987 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Considered by Senate.
		5/08/2007	Proposed amendment SA 988 withdrawn in Senate.
		5/08/2007	Considered by Senate.
		5/08/2007	Proposed amendment SA 993 withdrawn in Senate.
		5/08/2007	Amendment SA 998 proposed by Senator Brown for Senator Grassley.
		5/08/2007	Considered by Senate.
select this vote	Vote	5/08/2007	Amendment SA 1004 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1005 proposed by Senator Brown for Senator Levin.
select this vote	Vote	5/08/2007	Amendment SA 1005 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1006 proposed by Senator Brown for Senator Murkowski.
select this vote	Vote	5/08/2007	Amendment SA 1006 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1009 proposed by Senator Brown for Senator Hatch.
select this vote	Vote	5/08/2007	Amendment SA 1009 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Considered by Senate.
select this vote	Vote	5/08/2007	Amendment SA 1011 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1019 proposed by Senator Brown for Senator Casey.
select this vote	Vote	5/08/2007	Amendment SA 1019 agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1026 proposed by Senator Brown for Senator Feingold.
select this vote	Vote	5/08/2007	Amendment SA 1026 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1034 proposed by Senator Brown for Senator Durbin.
		5/08/2007	Amendment SA 1039 proposed by Senator Brown for Senator Grassley.
		5/08/2007	Amendment SA 1041 proposed by Senator Brown for Senator Obama.
select this vote	Vote	5/08/2007	Amendment SA 1041 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1047 proposed by Senator Brown for Senator Roberts.
currently selected	Vote	5/08/2007	Amendment SA 1047 agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1049 proposed by Senator Brown for Senator Enzi.
select this vote	Vote	5/08/2007	Amendment SA 1049 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1050 proposed by Senator Brown for Senator Enzi.
select this vote	Vote	5/08/2007	Amendment SA 1050 agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1053 proposed by Senator Brown for Senator Enzi.
select this vote	Vote	5/08/2007	Amendment SA 1053 agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1056 proposed by Senator Brown for Senator Reed.
select this vote	Vote	5/08/2007	Amendment SA 1056 agreed to in Senate by Unanimous Consent.
		5/09/2007	Considered by Senate.
		5/09/2007	The committee substitute as amended agreed to by Unanimous Consent.
		5/09/2007	Cloture motion on the bill withdrawn by unanimous consent in Senate.
		5/09/2007	Considered by Senate.
		5/09/2007	Considered by Senate.
		5/09/2007	Considered by Senate.
select this vote	Vote	5/09/2007	Grassley Amdt. No. 1039
select this vote	Vote	5/09/2007	Grassley Amdt. No. 998
select this vote	Vote	5/09/2007	Durbin Amdt. No. 1034
select this vote	Senate Vote on Passage	5/09/2007	On Passage - Senate - S.1082 as Amended
		5/10/2007	Message on Senate action sent to the House.
		5/10/2007	Received in the House.
		5/11/2007	Held at the desk.

	Number	Sponsor	Date Offered	Status
select this vote	S. Amdt. 982	Allard, Wayne [R-CO]	April 30, 2007	Failed by roll call vote on May 1, 2007.
	To strike provisions related to market exclusivity. Show amendment details
	S. Amdt. 983	Vitter, David [R-LA]	May 1, 2007	Withdrawn on May 7, 2007.
	To require counterfeit-resistant technologies for prescription drugs. Show amendment details
	S. Amdt. 984	Vitter, David [R-LA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 985	Brownback, Samuel [R-KS]	May 1, 2007	Passed by voice vote on May 7, 2007.
	To establish a priority drug review process to encourage treatments of tropical diseases. Show amendment details
	S. Amdt. 986	Landrieu, Mary [D-LA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 987	Inhofe, James [R-OK]	May 1, 2007	Passed by voice vote on May 7, 2007.
	To amend the Head Start Act to require parental consent for nonemergency intrusive physical examinations. Show amendment details
	S. Amdt. 988	Inhofe, James [R-OK]	May 1, 2007	Withdrawn on May 7, 2007.
	To protect children and their parents from being coerced into administering a controlled substance in order to attend school, and for other purposes. Show amendment details
	S. Amdt. 989	Harkin, Thomas [D-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 990	Dorgan, Byron [D-ND]	May 1, 2007	Passed by voice vote on May 6, 2007.
	To provide for the importation of prescription drugs. Show amendment details
	S. Amdt. 991	Kohl, Herbert [D-WI]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 992	Kohl, Herbert [D-WI]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 993	Gregg, Judd [R-NH]	May 1, 2007	Withdrawn on May 7, 2007.
	To provide for the regulation of Internet pharmacies. Show amendment details
	S. Amdt. 994	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 995	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 996	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 997	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 998	Grassley, Charles [R-IA]	May 1, 2007	Passed by roll call vote on May 8, 2007.
	To provide for the application of stronger civil penalties for violations of approved risk evaluation and mitigation strategies. Show amendment details
	S. Amdt. 999	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1000	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1001	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1002	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1003	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1004	Landrieu, Mary [D-LA]	May 1, 2007	Passed by voice vote on May 7, 2007.
	To require the Food and Drug Administration to permit the sale of baby turtles as pets so long as the seller uses proven methods to effectively treat salmonella. Show amendment details
select this vote	S. Amdt. 1005	Levin, Carl [D-MI]	May 1, 2007	Passed by voice vote on May 7, 2007.
	To require the Food and Drug Administration to determine whether certain substances create any health risks and mislead consumers. Show amendment details
select this vote	S. Amdt. 1006	Murkowski, Lisa [R-AK]	May 1, 2007	Passed by voice vote on May 7, 2007.
	To modify provisions relating to required experience or certification for prescribing or dispensing certain drugs, and for other purposes. Show amendment details
	S. Amdt. 1008	Grassley, Charles [R-IA]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1009	Hatch, Orrin [R-UT]	May 2, 2007	Passed by voice vote on May 7, 2007.
	To insert provisions relating to antibiotic access and innovation and certain enantiomer drugs. Show amendment details
select this vote	S. Amdt. 1010	Cochran, Thad [R-MS]	May 2, 2007	Passed by roll call vote on May 6, 2007.
	To protect the health and safety of the public. Show amendment details
select this vote	S. Amdt. 1011	Stabenow, Debbie [D-MI]	May 2, 2007	Passed by voice vote on May 7, 2007.
	To insert provisions related to citizens petitions. Show amendment details
	S. Amdt. 1012	Vitter, David [R-LA]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1013	Vitter, David [R-LA]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1014	Vitter, David [R-LA]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1015	Hagel, Charles [R-NE]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1016	Specter, Arlen [D-PA]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1017	Gregg, Judd [R-NH]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1018	DeMint, Jim [R-SC]	May 2, 2007	Passed by voice vote on May 1, 2007.
	To amend the notification provision with respect to drugs deemed to have risk evaluation and mitigation strategies. Show amendment details
select this vote	S. Amdt. 1019	Casey, Robert [D-PA]	May 2, 2007	Passed by voice vote on May 7, 2007.
	To express the sense of the Senate concerning orphan disease treatment in children. Show amendment details
	S. Amdt. 1020	Grassley, Charles [R-IA]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1021	Clinton, Hillary [D-NY]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1022	Durbin, Richard [D-IL]	May 2, 2007	Passed by roll call vote on May 1, 2007.
	To ensure the safety of human and pet food. Show amendment details
	S. Amdt. 1023	Durbin, Richard [D-IL]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1024	Salazar, Ken [D-CO]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1025	Schumer, Charles [D-NY]	May 2, 2007	Passed by voice vote on May 1, 2007.
	To express the sense of the Senate with respect to follow-on biologics. Show amendment details
select this vote	S. Amdt. 1026	Feingold, Russell [D-WI]	May 2, 2007	Passed by voice vote on May 7, 2007.
	To require the Food and Drug Administration to publish certain annual reports. Show amendment details
	S. Amdt. 1027	Durbin, Richard [D-IL]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1028	Rockefeller, John [D-WV]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1029	Sanders, Bernard [I-VT]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1030	Sanders, Bernard [I-VT]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1031	Sanders, Bernard [I-VT]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1032	Sanders, Bernard [I-VT]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1033	Sanders, Bernard [I-VT]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1034	Durbin, Richard [D-IL]	May 3, 2007	Failed by roll call vote on May 8, 2007.
	To reduce financial conflict of interest in FDA Advisory Panels. Show amendment details
	S. Amdt. 1035	Burr, Richard [R-NC]	May 3, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1036	Corker, Bob [R-TN]	May 3, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1037	Vitter, David [R-LA]	May 3, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1038	Vitter, David [R-LA]	May 3, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1039	Grassley, Charles [R-IA]	May 3, 2007	Failed by roll call vote on May 8, 2007.
	To clarify the authority of the Office of Surveillance and Epidemiology with respect to postmarket drug safety pursuant to recommendations by the Institute of Medicine. Show amendment details
	S. Amdt. 1040	Clinton, Hillary [D-NY]	May 3, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1041	Obama, Barack [D-IL]	May 3, 2007	Passed by voice vote on May 7, 2007.
	To improve the safety and efficacy of genetic tests. Show amendment details
	S. Amdt. 1042	Ensign, John [R-NV]	May 3, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1043	Reed, John [D-RI]	May 3, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1044	Kohl, Herbert [D-WI]	May 3, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1045	Obama, Barack [D-IL]	May 7, 2007	Offered on May 6, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1046	Stabenow, Debbie [D-MI]	May 7, 2007	Offered on May 6, 2007.
	Amendment information not available. Show amendment details
currently selected	S. Amdt. 1047	Roberts, Pat [R-KS]	May 7, 2007	Passed by voice vote on May 8, 2007.
	To modify provisions relating to direct-to-consumer advertisements. Actions May 8, 2007, 12:00 am ET - Amendment SA 1047 proposed by Senator Brown for Senator Roberts. May 8, 2007, 12:00 am ET - Amendment SA 1047 agreed to in Senate by Unanimous Consent. Full Text of this Amendment SA 1047. Mr. ROBERTS (for himself, Mr. Harkin, Mr. Burr, and Mr. Coburn) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows: Strike subparagraphs (E) and (F) of section 505(o)(5) of the Federal Food, Drug, and Cosmetic Act, as added by this Act, and insert the following: ``(E) SPECIFIC DISCLOSURES.-- ``(i) SERIOUS RISK; SAFETY PROTOCOL.--If the Secretary determines that advertisements lacking a specific disclosure about a serious risk listed in the labeling of a drug or about a protocol to ensure safe use described in the labeling of the drug would be false or misleading, the risk evaluation and mitigation strategy for the drug may require that the applicant include in advertisements of the drug such disclosure. ``(ii) DATE OF APPROVAL.--If the Secretary determines that advertisements lacking a specific disclosure of the date a drug was approved and disclosure of a serious risk would be false or misleading, the risk evaluation and mitigation strategy for the drug may require that the applicant include in advertisements of the drug such disclosure. ``(iii) SPECIFICATION OF ADVERTISEMENTS.--The Secretary may specify the advertisements required to include a specific disclosure under clause (i) or (ii). ``(iv) REQUIRED SAFETY SURVEILLANCE.--If the approved risk evaluation and mitigation strategy for a drug requires the specific disclosure under clause (ii), the Secretary shall-- ``(I) consider identifying and assessing all serious risks of using the drug to be a priority safety question under subsection (k)(3)(B); ``(II) not less frequently than every 3 months, evaluate the reports under subsection (k)(1) and the routine active surveillance as available under subsection (k)(3) with respect to such priority drug safety question to determine whether serious risks that might occur among patients expected to be treated with the drug have been adequately identified and assessed; ``(III) remove such specific disclosure requirement as an element of such strategy if such serious risks have been adequately identified and assessed; and ``(IV) consider whether a specific disclosure under clause (i) should be required. On page 101, strike lines 7 through 9. At the end of the bill, add the following: SEC. __. CIVIL PENALTIES; DIRECT-TO-CONSUMER ADVERTISEMENT. (a) Civil Penalties.--Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the following: ``(g)(1) Any applicant (as such term is used in section 505(o)) who disseminates a direct-to-consumer advertisement for a prescription drug that is false or misleading and a violation of section 502(n) shall be liable to the United States for a civil penalty in an amount not to exceed $150,000 for the first such violation in any 3-year period, and not to exceed $300,000 for each subsequent violation committed after the applicant has been penalized under this paragraph any time in the preceding 3-year period. For the purposes of this paragraph, repeated dissemination of the same or similar advertisement prior to the receipt of the written notice referred to in paragraph (2) for such advertisements shall be considered as 1 violation. ``(2) A civil penalty under paragraph (1) shall be assessed by the Secretary by an order made on the record after providing written notice to the applicant to be assessed a civil penalty and an opportunity for a hearing in accordance with this paragraph and section 554 of title 5, United States Code. If upon receipt of the written notice, the applicant to be assessed a civil penalty objects and requests a hearing, then in the course of any investigation related to such hearing, the Secretary may issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation, including information pertaining to the factors described in paragraph (3). ``(3) Upon the request of the applicant to be assessed a civil penalty, the Secretary, in determining the amount of a civil penalty, shall take into account the nature, circumstances, extent, and gravity of the violation or violations, including the following factors: ``(A) Whether the applicant submitted the advertisement or a similar advertisement for review under section 736A. ``(B) Whether the applicant submitted the advertisement for prereview if required under section 505(o)(5)(D). ``(C) Whether, after submission of the advertisement as described in subparagraph (A) or (B), the applicant disseminated the advertisement before the end of the 45-day comment period. ``(D) Whether the applicant failed to incorporate any comments made by the Secretary with regard to the advertisement or a similar advertisement into the advertisement prior to its dissemination. ``(E) Whether the applicant ceased distribution of the advertisement upon receipt of the written notice referred to in paragraph (2) for such advertisement. ``(F) Whether the applicant had the advertisement reviewed by qualified medical, regulatory, and legal reviewers prior to its dissemination. ``(G) Whether the violations were material. ``(H) Whether the applicant who created the advertisement acted in good faith. ``(I) Whether the applicant who created the advertisement has been assessed a civil penalty under this provision within the previous 1-year period. ``(J) The scope and extent of any voluntary, subsequent remedial action by the applicant. ``(K) Such other matters, as justice may require. ``(4)(A) Subject to subparagraph (B), no applicant shall be required to pay a civil penalty under paragraph (1) if the applicant submitted the advertisement to the Secretary and disseminated such advertisement after incorporating any comment received from the Secretary. ``(B) The Secretary may retract or modify any prior comments the Secretary has provided to an advertisement submitted to the Secretary based on new information or changed circumstances, so long as the Secretary provides written notice to the applicant of the new views of the Secretary on the advertisement and provides a reasonable time for modification or correction of the advertisement prior to seeking any civil penalty under paragraph (1). ``(5) The Secretary may compromise, modify, remit, with or without conditions, any civil penalty which may be assessed under paragraph (1). The amount of such penalty, when finally determined, or the amount charged upon in compromise, may be deducted from any sums owned by the United States to the applicant charged. ``(6) Any applicant who requested, in accordance with paragraph (2), a hearing with respect to the assessment of a civil penalty and who is aggrieved by an order assessing a civil penalty, may file a petition for de novo judicial review of such order with the United States Court of Appeals for the District of Columbia Circuit or for any other circuit in which such applicant resides or transacts business. Such a petition may only be filed within the 60-day period beginning on the date the order making such assessments was issued. ``(7) If any applicant fails to pay an assessment of a civil penalty-- ``(A) after the order making the assessment becomes final, and if such applicant does not file a petition for judicial review of the order in accordance with paragraph (6); or ``(B) after a court in an action brought under paragraph (6) has entered a final judgment in favor of the Secretary, the Attorney General shall recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of the 60-day period referred to in paragraph (6) or date of such final judgment, as the case may be) in an action brought in any appropriate district court of the United States. In such an action, the validity, amount, and appropriateness of such penalty shall not be subject to review.''. (b) Direct-to-Consumer Advertisement.-- (1) IN GENERAL.--Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended by inserting after the first sentence the following: ``In the case of an advertisement for a prescription drug presented directly to consumers in television or radio format that states the name of the drug and its conditions of use, the major statement relating to side effects, contraindications, and effectiveness referred to in the previous sentence shall be stated in a clear and conspicuous (neutral) manner.''. (2) REGULATIONS TO DETERMINE NEUTRAL MANNER.--The Secretary of Health and Human Services shall by regulation establish standards for determining whether a major statement, relating to side effects, contraindications, and effectiveness of a drug, described in section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) (as amended by paragraph (1)) is presented in the manner required under such section. (As printed in the Congressional Record for the Senate on May 7, 2007.)
	S. Amdt. 1048	Snowe, Olympia [R-ME]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1049	Enzi, Michael [R-WY]	May 7, 2007	Passed by voice vote on May 8, 2007.
	To modify provisions relating to user fees, and for other purposes. Show amendment details
select this vote	S. Amdt. 1050	Enzi, Michael [R-WY]	May 7, 2007	Passed by voice vote on May 8, 2007.
	To provide for color certification reports. Show amendment details
	S. Amdt. 1051	Stevens, Ted [R-AK]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1052	Corker, Bob [R-TN]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1053	Enzi, Michael [R-WY]	May 7, 2007	Passed by voice vote on May 8, 2007.
	to modify provisions related to pediatric testing and medical products. Show amendment details
	S. Amdt. 1054	Feingold, Russell [D-WI]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1055	Levin, Carl [D-MI]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1056	Reed, John [D-RI]	May 7, 2007	Passed by voice vote on May 8, 2007.
	To require the FDA to conduct consumer testing to determine the appropriateness of the labeling requirements for indoor tanning devices. Show amendment details
	S. Amdt. 1057	Gregg, Judd [R-NH]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1058	DeMint, Jim [R-SC]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1059	Sessions, Jefferson [R-AL]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1060	Hatch, Orrin [R-UT]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1061	Dorgan, Byron [D-ND]	May 8, 2007	Offered on May 8, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1062	Dorgan, Byron [D-ND]	May 8, 2007	Offered on May 8, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1063	Dorgan, Byron [D-ND]	May 8, 2007	Offered on May 8, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1064	Sessions, Jefferson [R-AL]	May 8, 2007	Offered on May 8, 2007.
	Amendment information not available. Show amendment details