This Note will examine the federal Right to Try Act, which was enacted on May 30, 2018. The federal statute followed the passage of Right to Try legislation in thirty-eight states, including California. Much controversy has surrounded “Right to Try” as an alternative to preexisting pathways to investigational drug treatments, such as traditional clinical trials and the FDA-regulated Expanded Access program, also commonly known as “Compassionate Use.”
This Note will examine those criticisms, evaluate the federal Right to Try Act, and propose amendments through the lenses of health care quality, patient autonomy, and long-term scientific innovation. Some controversy stems from the federal Right to Try Act, which affirmatively absolves drug companies of legal liability in order to incentivize them to participate in Right to Try programs. This feature is yet to be proven effective and raises red flags in patients’ rights. This Note proposes to amend the federal Right to Try Act to include a comprehensive informed consent section mimicking both the California’s Right to Try Act and the safeguards used in the Oregon Death with Dignity Act. Additionally, the business structure that the federal Right to Try Act creates brings about exploitation concerns and exposes vulnerable patients to serious financial risks. Lastly, this Note proposes to amend the federal Right to Try Act to include anti-price gouging language and to reincorporate FDA oversight of charging as safeguards against exploitation.
Federal Right to Try Act: Heightened Informed Consent and Price Regulation Measures Will Improve Quality, Autonomy, and Exploitation Issues,
16 Hastings Bus. L.J. 207
Available at: https://repository.uchastings.edu/hastings_business_law_journal/vol16/iss2/6