publication date: Apr. 14, 2017

ASCO says “right-to-try” laws don’t safeguard patients and fail to address problems in obtaining therapies

By Paul Goldberg

The American Society of Clinical Oncology said it opposes “right-to-try” laws that allow terminally ill patients to request access to investigational drugs directly from manufacturers, bypassing a layer of review, where FDA assesses the available data to review and benefits of the treatment on behalf of the patient.

Right-to-try laws have been passed in 33 states, and bills seeking to enact right-to-try on the national level recently surfaced in Congress. The House bill (H.R. 878) is posted here, and the identical Senate version (S. 204) here.

ASCO said right-to-try laws don’t offer sufficient protection to patients while also failing to address the principal obstacle patients face as they seek access to investigational drugs outside clinical trials: convincing the manufacturer to provide the investigational therapy outside clinical trials.

None of the right-to-try laws on the books today require drug companies to provide access to investigational drugs.

The congressional bills seek to require the federal government to “allow unrestricted manufacturing, distribution, prescribing, and dispensing of experimental drugs, biological products, and medical devices that are: (1) intended to treat a patient who has been diagnosed with a terminal illness, and (2) authorized by state law.”

The bills also state that the “outcome of manufacture, distribution, prescribing, dispensing, possession, or use of such a treatment may not be used by a federal agency to adversely impact review or approval of the treatment.”

To be dispensed in this manner, treatments have to have gone through phase I testing and “remain under investigation in a clinical trial … Continue reading ASCO says “right-to-try” laws don’t safeguard patients and fail to address problems in obtaining therapies

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