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S. 1421 - Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

Health. 114th Congress (2015-2016) View bill details
Sponsor:
Summary:
A bill to amend the Federal Food, Drug, and Cosmetic Act to authorize a 6-month extension of certain exclusivity periods in the case of approved drugs that are subsequently approved for a new indication to prevent, diagnose, or treat a rare disease or condition, and for other purposes. (by CRS) 
Status:
The bill has been referred to committee. 
There have been no votes on this bill.

Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

S. 1421 — 114th Congress (2015–2016)

Summary
A bill to amend the Federal Food, Drug, and Cosmetic Act to authorize a 6-month extension of certain exclusivity periods in the case of approved drugs that are subsequently approved for a new indication to prevent, diagnose, or treat a rare disease or condition, and for other purposes. (by CRS)
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At OpenCongress
Title
A bill to amend the Federal Food, Drug, and Cosmetic Act to authorize a 6-month extension of certain exclusivity periods in the case of approved drugs that are subsequently approved for a new indication to prevent, diagnose, or treat a rare disease or condition, and for other purposes.
Other Titles
  • Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
  • Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Sponsor
Orrin G. Hatch
Co-Sponsors
Subjects
  • Health
  • Administrative remedies
  • Department of Health and Human Services
  • Drug safety, medical device, and laboratory regulation
  • Drug therapy
  • Food and Drug Administration (FDA)
  • Government information and archives
  • Intellectual property
  • Prescription drugs
Related Bills
Major Actions
Introduced5/21/2015
Referred to Committee
Bill History

There have been no votes on this bill.

ActionDateDescription
Introduced5/21/2015
5/21/2015Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
5/21/2015Introduced in Senate
NumberSponsorDate OfferedStatus
scale for bar graph of contributions

Contributions

  1. November - December 2010 For $16,650 Against $0
  2. January - February 2011 For $89,900 Against $0
  3. March - April 2011 For $216,925 Against $0
  4. May - June 2011 For $161,395 Against $0
  5. July - August 2011 For $74,830 Against $0
  6. September - October 2011 For $179,531 Against $0
  7. November - December 2011 For $129,900 Against $0
  8. January - February 2012 For $77,261 Against $0
  9. March - April 2012 For $192,013 Against $0
  10. May - June 2012 For $135,764 Against $0
  11. July - August 2012 For $107,454 Against $0
  12. September - October 2012 For $330,571 Against $0
  13. November - December 2012 For $25,225 Against $0
  14. January - February 2013 For $62,654 Against $0
  15. March - April 2013 For $230,380 Against $0
  16. May - June 2013 For $224,983 Against $0
  17. July - August 2013 For $90,604 Against $0
  18. September - October 2013 For $107,054 Against $0
  19. November - December 2013 For $101,550 Against $0
  20. January - February 2014 For $60,999 Against $0
  21. March - April 2014 For $158,105 Against $0
  22. May - June 2014 For $264,112 Against $0
  23. July - August 2014 For $160,403 Against $0
  24. September - October 2014 For $292,302 Against $0
  25. November - December 2014 For $33,065 Against $0
  26. January - February 2015 For $81,709 Against $0
  27. March - April 2015 For $206,766 Against $0
  28. May - June 2015 For $170,787 Against $0
  29. July - August 2015 For $56,042 Against $0
  30. September - October 2015 For $142,701 Against $0
  31. November - December 2015 For $117,384 Against $0
  32. January - February 2016 For $69,923 Against $0
  33. March - April 2016 For $139,949 Against $0
  34. May - June 2016 For $227,523 Against $0
  35. July - August 2016 For $91,751 Against $0
  36. September - October 2016 For $90,459 Against $0
  37. November - December 2016 For $15,905 Against $0

Votes

    46 Organizations Supported and 0 Opposed; See Which Ones
    46 Organizations Supported and 0 Opposed; See Which Ones

    Organizations that took a position on
    Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

    46 organizations supported this bill

    Abigail Alliance for Better Access to Developmental Drugs
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Adult Polyglucosan Body Disease Research Foundation
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Association for Glycogen Storage Disease
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Batten Disease Support and Research Association
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Beyond Batten Disease Foundation
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    CARES Foundation
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Children's Cardiomyopathy Foundation
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Children's Medical Research Foundation
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Children's PKU Network
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Coalition for Pulmonary Fibrosis
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Cure HHT
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Cure SMA
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Desmoid Tumor Research Foundation
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Everylife Foundation for Rare Diseases
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Gene Spotlight Inc.
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Genetic Alliance
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    GIST Cancer Awareness Foundation
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Global Foundation for Peroxisomal Disorders
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Hannah’s Hope Fund
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Hope4bridget
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    International Fibrodysplasia Ossificans Progressiva Association
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    International Pemphigus and Pemphigoid Foundation
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Jonah's Just Begun-Foundation to Cure Sanfilippo Inc.
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Kids v Cancer
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Life Raft Group
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Little Miss Hannah Foundation
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Mary Payton's Miracle Foundation
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Mastocytosis Society
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    MLD Foundation
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    National Fragile X Foundation
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    National MPS Society
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    National Organization for Rare Disorders
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    National PKU Alliance
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    National Tay-Sachs & Allied Diseases Association
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Noah's Hope
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Organic Acidemia Association
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Parent Project Muscular Dystrophy
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Phelan-McDermid Syndrome Foundation
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    PKD Foundation
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Prader-Willi Syndrome Association
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    RASopathies Network
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Sarcoma Foundation of America
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Sephardic Health Organization For Referral & Education
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Taylor's Tale
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    Team Sanfilippo Foundation
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.
    The MAGIC Foundation
    Undersigned organizations (2015, September 17). 154 Organizations Sign on Letter on S. 1421. Retrieved June 6, 2016, from National Organization for Rare Disorders.

    0 organizations opposed this bill

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    View citations of support and opposition

    Includes reported contributions to congressional campaigns of Senators in office during the 114th U.S. Congress, from interest groups invested in the vote according to MapLight, November 29, 2010 – November 28, 2016.
    Contributions data source: OpenSecrets.org

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    Contributions by Legislator

    Namesort iconPartyState$ From Interest Groups
    That Supported    		$ From Interest Groups
    That Opposed
    Andrew Lamar AlexanderRTN$56,100$0
    Kelly AyotteRNH$60,200$0
    Tammy BaldwinDWI$85,273$0
    John BarrassoRWY$5,750$0
    Michael F. BennetDCO$209,225$0
    Richard BlumenthalDCT$29,350$0
    Roy BluntRMO$140,680$0
    Cory A. BookerDNJ$211,450$0
    John BoozmanRAR$3,200$0
    Barbara BoxerDCA$3,750$0
    Sherrod BrownDOH$150,360$0
    Richard BurrRNC$32,400$0
    Maria CantwellDWA$48,522$0
    Shelley Moore CapitoRWV$19,950$0
    Ben CardinDMD$56,950$0
    Tom CarperDDE$12,850$0
    Bob CaseyDPA$72,550$0
    Bill CassidyRLA$48,699$0
    Daniel CoatsRIN$750$0
    William Thad CochranRMS$23,100$0
    Susan M. CollinsRME$39,000$0
    Christopher A. CoonsDDE$17,983$0
    Bob CorkerRTN$67,816$0
    John CornynRTX$41,950$0
    Tom CottonRAR$58,083$0
    Mike CrapoRID$16,100$0
    Ted CruzRTX$57,650$0
    Steve DainesRMT$26,882$0
    Joe DonnellyDIN$19,300$0
    Dick DurbinDIL$70,400$0
    Mike EnziRWY$3,225$0
    Joni ErnstRIA$5,200$0
    Dianne FeinsteinDCA$36,310$0
    Deb FischerRNE$4,250$0
    Jeff FlakeRAZ$22,720$0
    Al FrankenDMN$69,911$0
    Cory GardnerRCO$21,000$0
    Kirsten E. GillibrandDNY$77,050$0
    Lindsey GrahamRSC$52,990$0
    Chuck GrassleyRIA$24,260$0
    Orrin G. HatchRUT$55,400$0
    Martin HeinrichDNM$55,875$0
    Heidi HeitkampDND$36,948$0
    Dean HellerRNV$21,632$0
    Mazie K. HironoDHI$23,071$0
    John HoevenRND$5,610$0
    Jim InhofeROK$16,850$0
    Johnny IsaksonRGA$29,400$0
    Ron JohnsonRWI$53,560$0
    Tim KaineDVA$131,400$0
    Angus S. King, Jr.IME$42,717$0
    Mark KirkRIL$29,850$0
    Amy KlobucharDMN$72,122$0
    James LankfordROK$39,286$0
    Patrick J. LeahyDVT$51,108$0
    Mike LeeRUT$20,674$0
    Joe Manchin, IIIDWV$6,750$0
    Ed MarkeyDMA$136,125$0
    John McCainRAZ$11,500$0
    Claire McCaskillDMO$101,033$0
    Addison "Mitch" McConnellRKY$89,125$0
    Bob MenéndezDNJ$32,580$0
    Jeff MerkleyDOR$50,516$0
    Barbara A. MikulskiDMD$6,600$0
    Jerry MoranRKS$18,400$0
    Lisa MurkowskiRAK$12,350$0
    Chris MurphyDCT$76,150$0
    Patty MurrayDWA$127,724$0
    Clarence "Bill" NelsonDFL$68,800$0
    Rand PaulRKY$16,196$0
    David PerdueRGA$52,100$0
    Gary C. PetersDMI$105,800$0
    Rob PortmanROH$47,439$0
    John "Jack" ReedDRI$11,000$0
    Harry ReidDNV$14,700$0
    Jim RischRID$8,150$0
    Charles "Pat" RobertsRKS$16,264$0
    Mike RoundsRSD$49,704$0
    Marco RubioRFL$36,755$0
    Bernie SandersIVT$8,125$0
    Ben SasseRNE$19,900$0
    Brian SchatzDHI$31,725$0
    Chuck SchumerDNY$152,384$0
    Tim ScottRSC$48,577$0
    Jeff SessionsRAL$7,200$0
    Jeanne ShaheenDNH$64,565$0
    Richard C. ShelbyRAL$6,000$0
    Debbie StabenowDMI$87,893$0
    Dan SullivanRAK$18,099$0
    Jon TesterDMT$82,700$0
    John ThuneRSD$27,970$0
    Thom TillisRNC$28,704$0
    Patrick J. ToomeyRPA$64,101$0
    Tom UdallDNM$52,821$0
    David VitterRLA$5,500$0
    Mark R. WarnerDVA$99,165$0
    Elizabeth WarrenDMA$195,697$0
    Sheldon WhitehouseDRI$42,250$0
    Roger F. WickerRMS$4,850$0
    Ron WydenDOR$101,850$0

    Add Data Filters:

    Legislator Filters
    Legislator Filters
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    		NamePartyState$ From Interest Groups
    That Supported    		$ From Interest Groups
    That Opposed
    		Andrew Lamar AlexanderRTN$56,100$0
    		Kelly AyotteRNH$60,200$0
    		Tammy BaldwinDWI$85,273$0
    		John BarrassoRWY$5,750$0
    		Michael F. BennetDCO$209,225$0
    		Richard BlumenthalDCT$29,350$0
    		Roy BluntRMO$140,680$0
    		Cory A. BookerDNJ$211,450$0
    		John BoozmanRAR$3,200$0
    		Barbara BoxerDCA$3,750$0
    		Sherrod BrownDOH$150,360$0
    		Richard BurrRNC$32,400$0
    		Maria CantwellDWA$48,522$0
    		Shelley Moore CapitoRWV$19,950$0
    		Ben CardinDMD$56,950$0
    		Tom CarperDDE$12,850$0
    		Bob CaseyDPA$72,550$0
    		Bill CassidyRLA$48,699$0
    		Daniel CoatsRIN$750$0
    		William Thad CochranRMS$23,100$0
    		Susan M. CollinsRME$39,000$0
    		Christopher A. CoonsDDE$17,983$0
    		Bob CorkerRTN$67,816$0
    		John CornynRTX$41,950$0
    		Tom CottonRAR$58,083$0
    		Mike CrapoRID$16,100$0
    		Ted CruzRTX$57,650$0
    		Steve DainesRMT$26,882$0
    		Joe DonnellyDIN$19,300$0
    		Dick DurbinDIL$70,400$0
    		Mike EnziRWY$3,225$0
    		Joni ErnstRIA$5,200$0
    		Dianne FeinsteinDCA$36,310$0
    		Deb FischerRNE$4,250$0
    		Jeff FlakeRAZ$22,720$0
    		Al FrankenDMN$69,911$0
    		Cory GardnerRCO$21,000$0
    		Kirsten E. GillibrandDNY$77,050$0
    		Lindsey GrahamRSC$52,990$0
    		Chuck GrassleyRIA$24,260$0
    		Orrin G. HatchRUT$55,400$0
    		Martin HeinrichDNM$55,875$0
    		Heidi HeitkampDND$36,948$0
    		Dean HellerRNV$21,632$0
    		Mazie K. HironoDHI$23,071$0
    		John HoevenRND$5,610$0
    		Jim InhofeROK$16,850$0
    		Johnny IsaksonRGA$29,400$0
    		Ron JohnsonRWI$53,560$0
    		Tim KaineDVA$131,400$0
    		Angus S. King, Jr.IME$42,717$0
    		Mark KirkRIL$29,850$0
    		Amy KlobucharDMN$72,122$0
    		James LankfordROK$39,286$0
    		Patrick J. LeahyDVT$51,108$0
    		Mike LeeRUT$20,674$0
    		Joe Manchin, IIIDWV$6,750$0
    		Ed MarkeyDMA$136,125$0
    		John McCainRAZ$11,500$0
    		Claire McCaskillDMO$101,033$0
    		Addison "Mitch" McConnellRKY$89,125$0
    		Bob MenéndezDNJ$32,580$0
    		Jeff MerkleyDOR$50,516$0
    		Barbara A. MikulskiDMD$6,600$0
    		Jerry MoranRKS$18,400$0
    		Lisa MurkowskiRAK$12,350$0
    		Chris MurphyDCT$76,150$0
    		Patty MurrayDWA$127,724$0
    		Clarence "Bill" NelsonDFL$68,800$0
    		Rand PaulRKY$16,196$0
    		David PerdueRGA$52,100$0
    		Gary C. PetersDMI$105,800$0
    		Rob PortmanROH$47,439$0
    		John "Jack" ReedDRI$11,000$0
    		Harry ReidDNV$14,700$0
    		Jim RischRID$8,150$0
    		Charles "Pat" RobertsRKS$16,264$0
    		Mike RoundsRSD$49,704$0
    		Marco RubioRFL$36,755$0
    		Bernie SandersIVT$8,125$0
    		Ben SasseRNE$19,900$0
    		Brian SchatzDHI$31,725$0
    		Chuck SchumerDNY$152,384$0
    		Tim ScottRSC$48,577$0
    		Jeff SessionsRAL$7,200$0
    		Jeanne ShaheenDNH$64,565$0
    		Richard C. ShelbyRAL$6,000$0
    		Debbie StabenowDMI$87,893$0
    		Dan SullivanRAK$18,099$0
    		Jon TesterDMT$82,700$0
    		John ThuneRSD$27,970$0
    		Thom TillisRNC$28,704$0
    		Patrick J. ToomeyRPA$64,101$0
    		Tom UdallDNM$52,821$0
    		David VitterRLA$5,500$0
    		Mark R. WarnerDVA$99,165$0
    		Elizabeth WarrenDMA$195,697$0
    		Sheldon WhitehouseDRI$42,250$0
    		Roger F. WickerRMS$4,850$0
    		Ron WydenDOR$101,850$0

    Interest Groups that supported this bill

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    		$ Donated
    		Non-profit foundations$2,521,782
    		Health, Education & Human Resources$1,301,294
    		Children's rights$563,701
    		Health & welfare policy$547,752

    Interest Groups that opposed this bill

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    		$ Donated
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