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Right to Try Investigational Drugs Signed Into Law

Right to Try Investigational Drugs Signed Into Law

On May 30, 2018, S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Pub. L. No. 115-176, “Right to Try Act”) was signed into law. The Right to Try Act amends the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”) to establish national standards and rules by which certain investigational drugs may be provided to terminally ill patients. Under the Right to Try Act, a patient diagnosed with a life-threatening disease or condition, who has exhausted approved treatment options and is unable to participate in clinical trials involving certain investigational drugs, may seek the opportunity to drug treatments that are not approved by the U.S. Food & Drug Administration (FDA).

The Right to Try Act exempts the provision of eligible investigational drugs to eligible patients from a number of requirements and restrictions under the FD&C Act and other laws. The manufacturer or sponsor of an eligible investigational drug must report annually to the FDA on any use of drugs dispensed under the Right to Try Act. The FDA will post an annual summary report of such use on its website.

The Right to Try Act incorporates the regulatory definitions of “life-threatening” diseases that are: (1) a disease or condition where the likelihood of death is high unless the course of the disease is interrupted, and (2) a disease or condition with potentially fatal outcomes, where the end of clinical trial analysis is survival.

Under the new law, a sponsor or drug manufacturer may only recover the direct costs of making its investigational drug available. Direct costs are costs that can be specifically and exclusively attributed to providing the drug for the investigational use under the Right to Try Act. Direct costs include costs per unit to manufacture the drug (e.g., raw materials, labor, and non-reusable supplies and equipment used to manufacture the quantity of drug needed for the use for which charging is authorized) or costs to acquire the drug from another manufacturing source, and direct costs to ship and handle (e.g., store) the drug. Direct costs exclude costs incurred primarily to produce the drug for commercial sale (e.g., costs for facilities and equipment used to manufacture the supply of investigational drug, but that are primarily intended to produce large quantities of drug for eventual commercial sale) and research and development, administrative, labor, or other costs that would be incurred even if the clinical trial or treatment use for which charging is authorized did not occur.

The FDA announced that it stands “ready to implement this legislation in a way that achieves Congress’ intent to promote access and protect patients. The FDA is dedicated to achieving the goals that Congress set forth in this legislation, so that patients facing terminal conditions have an additional avenue to access promising investigational medicines.”

© Copyright 2018 Squire Patton Boggs (US) LLP

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About this Author

John E. Wyand, Squire Patton Boggs, Healthcare Lawyer, UK
Partner

John Wyand, a Partner in our Healthcare policy practice group in Washington DC, focuses on advising healthcare and life sciences companies and providers on legal, policy and regulatory issues. Additionally, he regularly assists hospitals and physician groups in developing strategies for hospital/physician alignment, mergers and acquisitions, and fraud and abuse compliance.

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Meg Gilley, Public Policy Advisor, Squire Patton Boggs Law firm
Public Policy Advisor

Meg has substantial healthcare experience and comes to the firm from the American College of Surgeons (ACS), where she served as a Congressional Lobbyist. At ACS, she advocated on behalf of the nearly 80,000 Members of the College and worked closely with the Senate Committees on Finance and HELP, with an issue area focus on Medicare payment, health information technology, health insurance and hospital delivery systems. 

Meg also brings a strong state government affairs background through her work with the Georgia Hospital Association and Georgia Regents University and Health System. While living in Atlanta, she obtained a Master of Public Health and successfully defended her thesis on lessons Georgia could learn from successful state and local government strategies to reduce childhood obesity rates. 

Meg previously worked in the office of US Congressman Jack Kingston (R-Georgia) who joined Squire Patton Boggs in February 2015. In this role, she advised him on numerous healthcare issues, and was also the Congressman’s advisor in his role as Ranking Member on the Agriculture Subcommittee of Appropriations. In this position, she counseled him on matters related to food safety and inspection, FDA regulation, country of origin and food labeling, and food and nutrition programs.

A native of Savannah, GA, Meg holds a Master of Public Health from Georgia State University and a Bachelor of Political Science from the University of Georgia.

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