Tuesday, April 10, 2018
According to the New York Times, late last month, the House of Representatives passed the right to try bill on their second attempt. House Passes Bill That Would Give Patients Access to Experimental Drugs explains that "[s]upporters said the bill would give dying patients a chance to obtain potentially helpful prescription drugs without waiting for the completion of clinical trials or going through a process established by the Food and Drug Administration to allow the use of “investigational drugs” outside clinical trials." There were supporters as well as opponents of the bill.
The House and Senate bills would establish a new pathway providing access to unapproved medicines for certain patients who had exhausted other treatment options. To qualify under the House bill, a patient would have to have some kind of terminal illness: a condition that is likely to cause death “within a matter of months” or “irreversible morbidity that is likely to lead to severely premature death.”
Nothing in the bill would require pharmaceutical companies to provide experimental drugs to patients who requested them. Drug manufacturers sometimes turn down requests because they have only a limited supply or they are concerned about legal and medical risks.]
To address such concerns, the legislation would shield drugmakers, doctors and hospitals from some of the legal risks of providing unapproved drugs to patients. Doctors and hospitals would generally be protected unless they engaged in gross negligence or willful, reckless or criminal misconduct.