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Editorial

Should patients in need be given access to experimental drugs?

, PhD (William F and Virginia Connolly Mitty Chair, Director) & , PhD MPH MA (Rudin Postdoctoral Fellow)

Bibliography

  • Expanded Access Submissions Receipt Report Oct 1, 2013-Sep 30, 2014. Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/INDActivityReports/UCM430188.pdf
  • This is not the case in the 17 states that have passed so-called “Right to Try” laws, which will be discussed elsewhere in this editorial
  • For the most recent numbers from the FDA, see Expanded Access Submissions Receipt Report Oct 1, 2013- Sep 30, 2014. Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/INDActivityReports/UCM430188.pdf
  • Buhles WC. Compassionate use: a story of ethics and science in the development of a new drug. Perspect Biol Med 2011;54(3):304-15
  • Darrow JJ, Sarpatwari A, Avorn J, et al. Practical, legal, and ethical issues in expanded access to investigational drugs. N Engl J Med 2015;372:279-86
  • See, for example, United States, Congress. House, Committee on Government Reform. Compassionate Use of Investigational New Drugs: Is the Current Process Effective?: Hearing before the Committee on Government Reform, House of Representatives 107th Congress, 1st Session, June 20, 2001. U.S. Government Printing Office; DC, USA: 2002
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  • The Abigail Alliance mission. Available from: www.scotusblog.com/archives/07-444-cb.pdf [Last accessed 28 March 2015]
  • Abigail Alliance v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007). Available from: www.scotusblog.com/archives/07-444_ob.pdf
  • Biotechnology Industry Organization. BIO statement on compassionate use 2014. Available from: https://www.bio.org/articles/bio-statement-compassionate-use
  • PhRMA. Principles on conduct of clinical trials communication of clinical trials results. Available from: http://www.phrma.org/sites/default/files/pdf/042009_clinical_trial_principles_final_0.pdf [Last accessed 29 December 2014]
  • Drug and Device Law. On “right to try” legislation. 2014. Available from: http://druganddevicelaw.blogspot.com/2014/10/on-right-to-try-legislation.html
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  • Caplan A. Right-to-try laws do nothing to pay for unapproved drugs. Iowa City Press-Citizen 2014. Available from: http://www.press-citizen.com/story/opinion/editorials/2014/08/20/right-try-laws-nothing-pay-unapproved-drugs/14302827/
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  • Bateman-House A. Are right to try laws a good idea? National Coalition for Cancer Survivorship 2014. Available from: http://www.canceradvocacy.org/news/guest-post-are-right-to-try-laws-a-good-idea/
  • Wilkens RB. Is ‘right to try’ the right fit for better access to investigational drugs? IRB Advisor 2015;21-3
  • Congressman Michael McCaul. Available from: http://mccaul.house.gov/sites/mccaul.house.gov/files/Andrea%20Sloan%20CURE%20Act.pdf
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  • Caplan A, Plunkett C, Levin B. Selecting the right tool for the job. Am J Bioeth 2015;15(4):1526-32

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