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So-called "right-to-try" (RTT) laws aimed at improving terminally ill patients' access to investigational drugs lack adequate patient protections and do little to improve access, the American Society of Clinical Oncology (ASCO) asserted in a position statement.

Already on the books in 33 states, RTT laws do not remove any major barriers to access, might interfere with recent reforms that have streamlined access, and could cause "unintended harms," according to the statement.

While affirming the group's support for increased access to investigational treatments, ASCO officials expressed concern about proposed federal RTT legislation.

"ASCO supports access to investigational drugs outside of clinical trials, when adequate patient protections are in place," ASCO chief medical officer Richard L. Schilsky, MD, said in a statement. "We don't support right-to-try legislation, however, because these laws ignore key patient protections without actually improving patient access to investigational drugs outside of clinical trials."

In the statement, ASCO highlighted three reasons for its concern about RTT laws:

• Lack of an enforcement mechanism to compel drug manufacturers to provide investigational products
• Absence of legal obligations requiring insurers to pay for routine care associated with delivery of investigational treatment
• No independent review of investigational drugs' safety and efficacy

ASCO expressed support for the FDA's expanded-access program that provides a mechanism for patients to obtain investigational therapies outside a clinical trial. Recent changes to the program streamlined the application process. During 2016, the agency approved 99.5% of expanded-access requests and did so with a median approval time of 4 days for non-emergency cases, ASCO noted.

RTT laws have no mechanisms in place to minimize or eliminate delays in the application process. As an example, ASCO pointed out that applicants must determine a manufacturer's willingness to provide an investigational therapy. Providers and patients regularly reported difficulty locating contact information for requests, delays in manufacturers' responses, and denials.

ASCO supports additional improvements to existing mechanisms for expanded access, some of which were included in the 21st Century Cures Act.

"New policy initiatives should focus on increasing transparency among pharmaceutical manufacturers' expanded access policies, while ensuring that existing expanded access programs are timely and efficient for patients and their physicians," said Schilsky.

The complete ASCO position statement to the public.

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