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Features
The Realities of “Right to Try”
In May 2018, President Donald Trump signed
into law the Trickett Wendler, Frank Mon-
giello, Jordan McLinn and Matthew Bellina
Right to Try Act of 2017. 1 The law amends
the Federal Food, Drug, and Cosmetic Act
to allow more direct access to investigational
drugs for patients with terminal illnesses who
have exhausted available treatment options
and who do not qualify for a clinical trial.
The action put a federal stamp of approval
on similar “Right to Try” laws that had been
passed in 41 states. 2 Under the Right to Try
Act of 2017, eligible patients can appeal di-
rectly to a drug manufacturer for access to an
investigational drug that has completed one
phase I clinical trial – bypassing the U.S. Food
and Drug Administration’s (FDA’s) expanded-
access program. If the company grants the re-
quest, the patient provides informed consent
before the product is used. 3
However, the action did not quell debate
about the ethics and jurisdiction of giving
terminally ill patients access to investigational
drugs. The American Society of Hematology
(ASH) has not yet taken a position on the
legislation. While patient safety was the first
and foremost concern for members involved
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ASH Clinical News
in committee discussions about this issue,
the membership remained divided on how
this legislation would affect patients. Oth-
ers have not remained neutral, though, with
ethicists, physicians, and medical