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What are “right-to-try” laws?

Posted Monday, February 12, 2018 by Tyler Goldberg-Hoss

Recently, in his State of the Union speech, President Trump voiced support for a pending federal “right-to-try” bill.

Currently, there are approximately 33 states that have enacted similar laws (Washington thus far as not), which remove legal obstacles for terminally ill patients to get treatments that have not yet been approved by the FDA. Many of the remaining states are also seeing legislative efforts to enact similar legislation.

For the terminally ill patient, when options for treatment have become quite limited, the argument seems quite simple. If I am already going to die with the treatment options currently approved, why shouldn’t I have the right to attempt to save my life with other possible treatments. While the treatment may not be approved yet – and it may never be approved – it gives me a chance I otherwise don’t have.

However, the issue is more complex than just that. First, some bills as written may be too broad, including more patients than just those with terminal illnesses. Second, under at least the proposed federal legislation, the right-to-try scheme would eliminate the FDA completely from the transaction, sot that doctors and patients work directly with drug makers.

This is important because without the FDA, there would be no regulatory body to protect patient safety, and the opportunity is there for drug makers motivated by profit to put patients at unnecessary risk of harm. When such drugs have not been approved for use, there is not a full understanding of what the drug may do. So patients are not going to be fully apprised of the possible risks of taking the drug, let alone the potential benefits. Terminal patients may thus become willing guinea pigs of the pharmaceutical industry.

Further, the FDA currently has its own way of allowing terminally ill patients to access drugs that have not yet been fully vetted. Through its Expanded Access program, most all terminally ill patients are approved for access to experimental drugs already. The application process was streamlined in 2015, and one can get expedited approval over the phone in cases of emergencies.

Certainly, anecdotal stories are powerful motivators for legislatures to support such laws. However, there are regulatory processes in place (at least currently) for a reason, and without them all patients are a risk of harm, even those with nothing to lose.

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