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

110th Congress (2007-2008) View amendment details
Sponsor:
This is an amendment to S. 1082 - Food and Drug Administration Revitalization Act
Senate Vote: Amendment SA 1047 agreed to in Senate by Unanimous Consent.

PASSED by voice vote on May 8, 2007.

Other Votes:

Prescription Drug User Fee Amendments of 2007

S. 1082 — 110th 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)
Learn More
At OpenCongress
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
    Major Actions
    Introduced4/10/2007
    Referred to Committee
    Amendments (82 proposed)
    Passed Senate5/09/2007
    Bill History
    Chamber/CommitteeMotionDateResult
    select this voteSenateAmendment SA 1018 agreed to in Senate by Unanimous Consent.5/02/2007PASSED by voice vote
    select this voteSenateAmendment SA 1025 agreed to in Senate by Voice Vote.5/02/2007PASSED by voice vote
    select this voteSenateAllard Amdt. No. 9825/02/2007This amendment DID NOT PASS the Senate
    41 voted YES 53 voted NO 6 voted present/not voting
    select this voteSenateDurbin Amdt. No. 1022, as Modified5/02/2007This amendment PASSED the Senate
    94 voted YES 0 voted NO 6 voted present/not voting
    select this voteSenateMotion to Invoke Cloture on the Dorgan Amdt. No. 9905/03/2007This amendment PASSED the Senate
    63 voted YES 28 voted NO 9 voted present/not voting
    select this voteSenateAmendment SA 990 agreed to in Senate by Voice Vote.5/07/2007PASSED by voice vote
    select this voteSenateCochran Amdt. No. 10105/07/2007This amendment PASSED the Senate
    49 voted YES 40 voted NO 11 voted present/not voting
    select this voteSenateMotion to Invoke Cloture on the Committee Substitute as Modified and Amended to S.10825/07/2007This motion PASSED the Senate
    82 voted YES 8 voted NO 10 voted present/not voting
    select this voteSenateAmendment SA 985 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 987 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1004 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1005 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1006 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1009 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1011 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1019 agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1026 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1041 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    currently selectedSenateAmendment SA 1047 agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1049 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1050 agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1053 agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1056 agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateGrassley Amdt. No. 10395/09/2007This amendment DID NOT PASS the Senate
    46 voted YES 47 voted NO 7 voted present/not voting
    select this voteSenateGrassley Amdt. No. 9985/09/2007This amendment PASSED the Senate
    64 voted YES 30 voted NO 6 voted present/not voting
    select this voteSenateDurbin Amdt. No. 10345/09/2007This amendment DID NOT PASS the Senate
    47 voted YES 47 voted NO 6 voted present/not voting
    select this voteSenateOn Passage - Senate - S.1082 as Amended5/09/2007This bill PASSED the Senate
    93 voted YES 1 voted NO 6 voted present/not voting
    ActionDateDescription
    Introduced4/10/2007
    4/10/2007Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
    Put on a legislative calendar4/18/2007Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
    4/24/2007Committee 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 calendar4/24/2007Placed on Senate Legislative Calendar under General Orders. Calendar No. 120.
    4/30/2007Measure laid before Senate by unanimous consent.
    5/01/2007Amendment SA 990 proposed by Senator Dorgan.
    5/01/2007Considered by Senate.
    5/01/2007The committee reported substitute amendment was modified by Unanimous Consent.
    5/01/2007Cloture motion on amendment SA 990 presented in Senate.
    5/01/2007Amendment SA 1004 proposed by Senator Landrieu.
    5/02/2007Considered by Senate.
    5/02/2007Amendment SA 982 proposed by Senator Allard.
    5/02/2007Amendment SA 983 proposed by Senator Vitter.
    5/02/2007Amendment SA 985 proposed by Senator Brown for Senator Brownback.
    5/02/2007Amendment SA 988 proposed by Senator Inhofe.
    5/02/2007Considered by Senate.
    5/02/2007Amendment SA 993 proposed by Senator Gregg.
    5/02/2007Considered by Senate.
    5/02/2007Amendment SA 1010 proposed by Senator Cochran to Amendment SA 990.
    5/02/2007Amendment SA 1011 proposed by Senator Stabenow.
    5/02/2007Amendment SA 1018 proposed by Senator DeMint.
    select this voteVote5/02/2007Amendment SA 1018 agreed to in Senate by Unanimous Consent.
    5/02/2007Amendment SA 1022 proposed by Senator Durbin.
    5/02/2007Amendment SA 1025 proposed by Senator Schumer.
    select this voteVote5/02/2007Amendment SA 1025 agreed to in Senate by Voice Vote.
    select this voteVote5/02/2007Allard Amdt. No. 982
    select this voteVote5/02/2007Durbin Amdt. No. 1022, as Modified
    5/03/2007Considered by Senate.
    5/03/2007Considered by Senate.
    5/03/2007Cloture motion on the committee substitute amendment as modified presented in Senate.
    5/03/2007Cloture motion on the measure presented in Senate.
    5/03/2007Considered by Senate.
    5/03/2007Considered by Senate.
    5/03/2007Considered by Senate.
    5/03/2007Considered by Senate.
    5/03/2007Considered by Senate.
    5/03/2007Considered by Senate.
    5/03/2007Considered by Senate.
    select this voteVote5/03/2007Motion to Invoke Cloture on the Dorgan Amdt. No. 990
    5/07/2007Considered by Senate.
    5/07/2007Considered by Senate.
    5/07/2007Considered by Senate.
    5/07/2007Considered by Senate.
    5/07/2007Considered by Senate.
    select this voteVote5/07/2007Amendment SA 990 agreed to in Senate by Voice Vote.
    5/07/2007Considered by Senate.
    5/07/2007Considered by Senate.
    5/07/2007Considered by Senate.
    5/07/2007Considered by Senate.
    select this voteVote5/07/2007Cochran Amdt. No. 1010
    select this voteVote5/07/2007Motion to Invoke Cloture on the Committee Substitute as Modified and Amended to S.1082
    5/08/2007Considered by Senate.
    5/08/2007Considered by Senate.
    5/08/2007Proposed amendment SA 983 withdrawn in Senate.
    5/08/2007Considered by Senate.
    select this voteVote5/08/2007Amendment SA 985 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 987 proposed by Senator Brown for Senator Inhofe.
    select this voteVote5/08/2007Amendment SA 987 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Considered by Senate.
    5/08/2007Proposed amendment SA 988 withdrawn in Senate.
    5/08/2007Considered by Senate.
    5/08/2007Proposed amendment SA 993 withdrawn in Senate.
    5/08/2007Amendment SA 998 proposed by Senator Brown for Senator Grassley.
    5/08/2007Considered by Senate.
    select this voteVote5/08/2007Amendment SA 1004 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1005 proposed by Senator Brown for Senator Levin.
    select this voteVote5/08/2007Amendment SA 1005 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1006 proposed by Senator Brown for Senator Murkowski.
    select this voteVote5/08/2007Amendment SA 1006 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1009 proposed by Senator Brown for Senator Hatch.
    select this voteVote5/08/2007Amendment SA 1009 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Considered by Senate.
    select this voteVote5/08/2007Amendment SA 1011 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1019 proposed by Senator Brown for Senator Casey.
    select this voteVote5/08/2007Amendment SA 1019 agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1026 proposed by Senator Brown for Senator Feingold.
    select this voteVote5/08/2007Amendment SA 1026 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1034 proposed by Senator Brown for Senator Durbin.
    5/08/2007Amendment SA 1039 proposed by Senator Brown for Senator Grassley.
    5/08/2007Amendment SA 1041 proposed by Senator Brown for Senator Obama.
    select this voteVote5/08/2007Amendment SA 1041 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1047 proposed by Senator Brown for Senator Roberts.
    currently selectedVote5/08/2007Amendment SA 1047 agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1049 proposed by Senator Brown for Senator Enzi.
    select this voteVote5/08/2007Amendment SA 1049 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1050 proposed by Senator Brown for Senator Enzi.
    select this voteVote5/08/2007Amendment SA 1050 agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1053 proposed by Senator Brown for Senator Enzi.
    select this voteVote5/08/2007Amendment SA 1053 agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1056 proposed by Senator Brown for Senator Reed.
    select this voteVote5/08/2007Amendment SA 1056 agreed to in Senate by Unanimous Consent.
    5/09/2007Considered by Senate.
    5/09/2007The committee substitute as amended agreed to by Unanimous Consent.
    5/09/2007Cloture motion on the bill withdrawn by unanimous consent in Senate.
    5/09/2007Considered by Senate.
    5/09/2007Considered by Senate.
    5/09/2007Considered by Senate.
    select this voteVote5/09/2007Grassley Amdt. No. 1039
    select this voteVote5/09/2007Grassley Amdt. No. 998
    select this voteVote5/09/2007Durbin Amdt. No. 1034
    select this voteSenate Vote on Passage5/09/2007On Passage - Senate - S.1082 as Amended
    5/10/2007Message on Senate action sent to the House.
    5/10/2007Received in the House.
    5/11/2007Held at the desk.
    NumberSponsorDate OfferedStatus
    select this voteS. Amdt. 982Allard, Wayne [R-CO]April 30, 2007Failed by roll call vote on May 1, 2007.

    To strike provisions related to market exclusivity.

    Show amendment details

    S. Amdt. 983Vitter, David [R-LA]May 1, 2007Withdrawn on May 7, 2007.

    To require counterfeit-resistant technologies for prescription drugs.

    Show amendment details

    S. Amdt. 984Vitter, David [R-LA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

    Show amendment details

    select this voteS. Amdt. 985Brownback, Samuel [R-KS]May 1, 2007Passed 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. 986Landrieu, Mary [D-LA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

    Show amendment details

    select this voteS. Amdt. 987Inhofe, James [R-OK]May 1, 2007Passed 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. 988Inhofe, James [R-OK]May 1, 2007Withdrawn 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. 989Harkin, Thomas [D-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

    Show amendment details

    select this voteS. Amdt. 990Dorgan, Byron [D-ND]May 1, 2007Passed by voice vote on May 6, 2007.

    To provide for the importation of prescription drugs.

    Show amendment details

    S. Amdt. 991Kohl, Herbert [D-WI]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 992Kohl, Herbert [D-WI]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 993Gregg, Judd [R-NH]May 1, 2007Withdrawn on May 7, 2007.

    To provide for the regulation of Internet pharmacies.

    Show amendment details

    S. Amdt. 994Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 995Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 996Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 997Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

    Show amendment details

    select this voteS. Amdt. 998Grassley, Charles [R-IA]May 1, 2007Passed 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. 999Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1000Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1001Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1002Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1003Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

    Show amendment details

    select this voteS. Amdt. 1004Landrieu, Mary [D-LA]May 1, 2007Passed 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 voteS. Amdt. 1005Levin, Carl [D-MI]May 1, 2007Passed 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 voteS. Amdt. 1006Murkowski, Lisa [R-AK]May 1, 2007Passed 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. 1008Grassley, Charles [R-IA]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    select this voteS. Amdt. 1009Hatch, Orrin [R-UT]May 2, 2007Passed 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 voteS. Amdt. 1010Cochran, Thad [R-MS]May 2, 2007Passed by roll call vote on May 6, 2007.

    To protect the health and safety of the public.

    Show amendment details

    select this voteS. Amdt. 1011Stabenow, Debbie [D-MI]May 2, 2007Passed by voice vote on May 7, 2007.

    To insert provisions related to citizens petitions.

    Show amendment details

    S. Amdt. 1012Vitter, David [R-LA]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1013Vitter, David [R-LA]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1014Vitter, David [R-LA]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1015Hagel, Charles [R-NE]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1016Specter, Arlen [D-PA]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1017Gregg, Judd [R-NH]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    select this voteS. Amdt. 1018DeMint, Jim [R-SC]May 2, 2007Passed 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 voteS. Amdt. 1019Casey, Robert [D-PA]May 2, 2007Passed 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. 1020Grassley, Charles [R-IA]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1021Clinton, Hillary [D-NY]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    select this voteS. Amdt. 1022Durbin, Richard [D-IL]May 2, 2007Passed by roll call vote on May 1, 2007.

    To ensure the safety of human and pet food.

    Show amendment details

    S. Amdt. 1023Durbin, Richard [D-IL]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1024Salazar, Ken [D-CO]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    select this voteS. Amdt. 1025Schumer, Charles [D-NY]May 2, 2007Passed 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 voteS. Amdt. 1026Feingold, Russell [D-WI]May 2, 2007Passed by voice vote on May 7, 2007.

    To require the Food and Drug Administration to publish certain annual reports.

    Show amendment details

    S. Amdt. 1027Durbin, Richard [D-IL]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1028Rockefeller, John [D-WV]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1029Sanders, Bernard [I-VT]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1030Sanders, Bernard [I-VT]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1031Sanders, Bernard [I-VT]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1032Sanders, Bernard [I-VT]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1033Sanders, Bernard [I-VT]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

    Show amendment details

    select this voteS. Amdt. 1034Durbin, Richard [D-IL]May 3, 2007Failed by roll call vote on May 8, 2007.

    To reduce financial conflict of interest in FDA Advisory Panels.

    Show amendment details

    S. Amdt. 1035Burr, Richard [R-NC]May 3, 2007Offered on May 2, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1036Corker, Bob [R-TN]May 3, 2007Offered on May 2, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1037Vitter, David [R-LA]May 3, 2007Offered on May 2, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1038Vitter, David [R-LA]May 3, 2007Offered on May 2, 2007.

    Amendment information not available.

    Show amendment details

    select this voteS. Amdt. 1039Grassley, Charles [R-IA]May 3, 2007Failed 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. 1040Clinton, Hillary [D-NY]May 3, 2007Offered on May 2, 2007.

    Amendment information not available.

    Show amendment details

    select this voteS. Amdt. 1041Obama, Barack [D-IL]May 3, 2007Passed by voice vote on May 7, 2007.

    To improve the safety and efficacy of genetic tests.

    Show amendment details

    S. Amdt. 1042Ensign, John [R-NV]May 3, 2007Offered on May 2, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1043Reed, John [D-RI]May 3, 2007Offered on May 2, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1044Kohl, Herbert [D-WI]May 3, 2007Offered on May 2, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1045Obama, Barack [D-IL]May 7, 2007Offered on May 6, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1046Stabenow, Debbie [D-MI]May 7, 2007Offered on May 6, 2007.

    Amendment information not available.

    Show amendment details

    currently selectedS. Amdt. 1047Roberts, Pat [R-KS]May 7, 2007Passed 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. 1048Snowe, Olympia [R-ME]May 7, 2007Offered on May 7, 2007.

    Amendment information not available.

    Show amendment details

    select this voteS. Amdt. 1049Enzi, Michael [R-WY]May 7, 2007Passed by voice vote on May 8, 2007.

    To modify provisions relating to user fees, and for other purposes.

    Show amendment details

    select this voteS. Amdt. 1050Enzi, Michael [R-WY]May 7, 2007Passed by voice vote on May 8, 2007.

    To provide for color certification reports.

    Show amendment details

    S. Amdt. 1051Stevens, Ted [R-AK]May 7, 2007Offered on May 7, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1052Corker, Bob [R-TN]May 7, 2007Offered on May 7, 2007.

    Amendment information not available.

    Show amendment details

    select this voteS. Amdt. 1053Enzi, Michael [R-WY]May 7, 2007Passed by voice vote on May 8, 2007.

    to modify provisions related to pediatric testing and medical products.

    Show amendment details

    S. Amdt. 1054Feingold, Russell [D-WI]May 7, 2007Offered on May 7, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1055Levin, Carl [D-MI]May 7, 2007Offered on May 7, 2007.

    Amendment information not available.

    Show amendment details

    select this voteS. Amdt. 1056Reed, John [D-RI]May 7, 2007Passed 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. 1057Gregg, Judd [R-NH]May 7, 2007Offered on May 7, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1058DeMint, Jim [R-SC]May 7, 2007Offered on May 7, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1059Sessions, Jefferson [R-AL]May 7, 2007Offered on May 7, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1060Hatch, Orrin [R-UT]May 7, 2007Offered on May 7, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1061Dorgan, Byron [D-ND]May 8, 2007Offered on May 8, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1062Dorgan, Byron [D-ND]May 8, 2007Offered on May 8, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1063Dorgan, Byron [D-ND]May 8, 2007Offered on May 8, 2007.

    Amendment information not available.

    Show amendment details

    S. Amdt. 1064Sessions, Jefferson [R-AL]May 8, 2007Offered on May 8, 2007.

    Amendment information not available.

    Show amendment details

    MapLight did not identify any interest groups that took a position on this vote.
    You may be able to explore campaign contributions data if you add interest groups.

    0 Organizations Supported and 0 Opposed

    Organizations that took a position on
    Food and Drug Administration Revitalization Act: Amendment SA 1047 agreed to in Senate by Unanimous Consent.

    0 organizations supported this amendment

    0 organizations opposed this amendment

    Need proof?

    View citations of support and opposition

    Includes reported contributions to congressional campaigns of Senators in office on day of vote, from interest groups invested in the vote according to MapLight, January 1, 2003 – December 31, 2008.
    Contributions data source: OpenSecrets.org

    Add Data Filters:

    Legislator Filters
    Legislator Filters
    Show All
    NamePartyState$ From Interest Groups
    That Supported
    $ From Interest Groups
    That Opposed
    Vote
    Daniel K. AkakaDHI$0$0Yes
    Andrew Lamar AlexanderRTN$0$0Yes
    Alan Wayne AllardRCO$0$0Yes
    Max BaucusDMT$0$0Yes
    Birch "Evan" BayhDIN$0$0Yes
    Bob BennettRUT$0$0Yes
    Joe BidenDDE$0$0Yes
    Jesse "Jeff" BingamanDNM$0$0Yes
    Christopher "Kit" BondRMO$0$0Yes
    Barbara BoxerDCA$0$0Yes
    Sherrod BrownDOH$0$0Yes
    Sam BrownbackRKS$0$0Yes
    Jim BunningRKY$0$0Yes
    Richard BurrRNC$0$0Yes
    Robert ByrdDWV$0$0Yes
    Maria CantwellDWA$0$0Yes
    Ben CardinDMD$0$0Yes
    Tom CarperDDE$0$0Yes
    Bob CaseyDPA$0$0Yes
    Clarence Saxby ChamblissRGA$0$0Yes
    Hillary ClintonDNY$0$0Yes
    Tom CoburnROK$0$0Yes
    William Thad CochranRMS$0$0Yes
    Norm ColemanRMN$0$0Yes
    Susan CollinsRME$0$0Yes
    Gaylord Kent ConradDND$0$0Yes
    Bob CorkerRTN$0$0Yes
    John CornynRTX$0$0Yes
    Larry CraigRID$0$0Yes
    Mike CrapoRID$0$0Yes
    Jim DeMintRSC$0$0Yes
    Chris DoddDCT$0$0Yes
    Mary Elizabeth DoleRNC$0$0Yes
    Pete DomeniciRNM$0$0Yes
    Byron DorganDND$0$0Yes
    Dick DurbinDIL$0$0Yes
    John EnsignRNV$0$0Yes
    Mike EnziRWY$0$0Yes
    Russ FeingoldDWI$0$0Yes
    Dianne FeinsteinDCA$0$0Yes
    Lindsey GrahamRSC$0$0Yes
    Chuck GrassleyRIA$0$0Yes
    Judd GreggRNH$0$0Yes
    Chuck HagelRNE$0$0Yes
    Tom HarkinDIA$0$0Yes
    Orrin HatchRUT$0$0Yes
    Kay Bailey HutchisonRTX$0$0Yes
    Jim InhofeROK$0$0Yes
    Dan InouyeDHI$0$0Yes
    Johnny IsaksonRGA$0$0Yes
    Tim JohnsonDSD$0$0Yes
    Ted KennedyDMA$0$0Yes
    John KerryDMA$0$0Yes
    Amy KlobucharDMN$0$0Yes
    Herb KohlDWI$0$0Yes
    Jon KylRAZ$0$0Yes
    Mary LandrieuDLA$0$0Yes
    Frank LautenbergDNJ$0$0Yes
    Patrick LeahyDVT$0$0Yes
    Carl LevinDMI$0$0Yes
    Joe LiebermanICT$0$0Yes
    Blanche LincolnDAR$0$0Yes
    Chester Trent LottRMS$0$0Yes
    Dick LugarRIN$0$0Yes
    Mel MartinezRFL$0$0Yes
    John McCainRAZ$0$0Yes
    Claire McCaskillDMO$0$0Yes
    Addison "Mitch" McConnellRKY$0$0Yes
    Bob MenéndezDNJ$0$0Yes
    Barbara MikulskiDMD$0$0Yes
    Lisa MurkowskiRAK$0$0Yes
    Patty MurrayDWA$0$0Yes
    Earl "Ben" NelsonDNE$0$0Yes
    Clarence "Bill" NelsonDFL$0$0Yes
    Barack ObamaDIL$0$0Yes
    Mark PryorDAR$0$0Yes
    John "Jack" ReedDRI$0$0Yes
    Harry ReidDNV$0$0Yes
    Charles "Pat" RobertsRKS$0$0Yes
    John "Jay" RockefellerDWV$0$0Yes
    Ken SalazarDCO$0$0Yes
    Bernie SandersIVT$0$0Yes
    Chuck SchumerDNY$0$0Yes
    Jeff SessionsRAL$0$0Yes
    Richard ShelbyRAL$0$0Yes
    Gordon SmithROR$0$0Yes
    Olympia SnoweRME$0$0Yes
    Arlen SpecterDPA$0$0Yes
    Debbie StabenowDMI$0$0Yes
    Ted StevensRAK$0$0Yes
    John SununuRNH$0$0Yes
    Jon TesterDMT$0$0Yes
    Craig ThomasRWY$0$0Yes
    John ThuneRSD$0$0Yes
    David VitterRLA$0$0Yes
    George VoinovichROH$0$0Yes
    John WarnerRVA$0$0Yes
    Jim WebbDVA$0$0Yes
    Sheldon WhitehouseDRI$0$0Yes
    Ron WydenDOR$0$0Yes

    Interest Groups that supported this amendment

    $ Donated

    Interest Groups that opposed this amendment

    $ Donated
    Loading…
    Date Range of Contributions
    Enter a custom date range