Abstract
In the past few years, a number of states have passed “Right to Try” (RTT) laws. These laws aim to facilitate access by terminally ill patients to potentially lifesaving investigational products (most commonly drugs) that are not approved for the market but have passed phase I of the Food and Drug Administration’s (FDA’s) clinical trial process and continue to undergo testing in clinical trials. Two other conventional ways for patients to access potentially life-prolonging investigational drugs are through a clinical trial (if the patient meets enrollment criteria) or through the FDA’s expanded access program. This article discusses legal issues relating to the role of state and federal governments in expanded access to investigational drugs.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Federal Food, Drug and Cosmetic Act, 21 USC § 301, et seq.
Section 505, Food, Drug and Cosmetic Act, 21 USC § 355.
Roberts BS, Bodenheimer DZ. The Drug Amendments of 1962: the anatomy of a regulatory failure. Arizona State Law J. 1982:581–614.
21 CFR § 312.305; 21 CFR § 312.310(a)(1)-(2).
Yank YT, Chen B, Bennett C. Right to try legislation: progress or peril? J Clin Oncol 2015;33:2597–2599. http://jco.ascopubs.org/content/early/2015/07/14/JCO.2015.62.8057.full. Accessed July 8, 2016.
Johnson SR. Despite political support, state right to try bills show no takeup. Modern Healthc. October 17, 2015. www.modernhealthcare.com/article/20151017/MAGAZINE/310179969. Accessed July 8, 2016.
FDA. Individual patient expanded access applications: form 3926. Guidance for industry. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM432717.pdf. Accessed June 2016.
FDA. Expanded access to investigational drugs for treatment use—questions and answers. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/UCM351261.pdf. Accessed June 2016.
FDA. Charging for investigational drugs under an IND—questions and answers. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/UCM351264.pdf. Accessed June 2016.
Kearns L, Roxland B. Federal “right to try” bill: wrong on the law and wrong for patients. The Hill. http://thehill.com/blogs/congress-blog/healthcare/285093-federal-right-to-try-bill-wrong-on-the-law-and-wrong-for. Accessed June 28, 2016.
S. 2912, Trickett Wendler Right to Try Act of 2016, 114th Congress (2015-2016), § 2(b)(i) (introduced 5/10/2016).
Arizona v United States, ___ US___, 132 S Ct 2492, 2500, 183 LEd2d 351 (2012).
Maryland v Louisiana, 451 US 725, 746 (1981).
Lefaivre v KV Pharm Co, 636 F3d 935, 939 (8th Cir 2011).
Cipollone v Liggett Grp, Inc, 505 US 504, 516 (1992).
In re Celexa and Lexapro Marketing and Sales Practices Litigation (Marcus v Forest Laboratories and Forest Pharmaceuticals), 779 F3d 34, 35 (1st Cir 2015).
Freightliner Corp v Myrick, 514 US 280, 287 (1995).
Wyeth v Levine, 555 US 555, 574 (2009).
National Foreign Trade Council v Natsios, 181 F3d 38, 73 (1st Cir 1999) (citing Rice v Santa Fe Elevator Corp, 331 US 218, 230 (1947)).
Abigail Alliance for Better Access to Developmental Drugs v von Eschenbach (Alliance II), 495 F3d 695, 697 (DC Cir 2007) (en banc), reversing 445 F3d 470 (DC Cir 2006).
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Shapiro, R.S. Reconciling States’ “Right to Try” Legislation and FDA’s Expanded Access Program: Legal Issues. Ther Innov Regul Sci 51, 153–156 (2017). https://doi.org/10.1177/2168479016683217
Published:
Issue Date:
DOI: https://doi.org/10.1177/2168479016683217