
WASHINGTON — The Senate on Thursday easily passed legislation that aims to help terminally ill patients access experimental treatments under so-called “right to try” laws.
The legislation, from Sen. Ron Johnson (R-Wis.), would keep the federal government, including the Food and Drug Administration, from interfering when a terminally ill patient seeks access to experimental treatments that haven’t yet received FDA approval, subject to several specific conditions. It is an updated version of a January bill Johnson reintroduced after making the issue a priority on the campaign trail last year.
As a practical matter it is impossible to prevent the data from Right to Try from negatively biasing future clinical trials. Anybody debating whether to enroll can submit an expedited FOIA request to find out how many folks have been treated and with what outcomes.
Another significant issue is that many of these drugs have failed controlled clinical trials but there is still a limited drug supply left that is ultimately destined for the the incinerator. To keep this drug around, ensure stability, then deal with all of the logistics to get in the hands of a few patients? Facing such strictures many companies will say no. It doesn’t make them bad people, just a business decision.