2018: Fitzpatrick Voted For Allowing Patients With Life-Threatening
Conditions Not Currently Part Of Drug Trials To Be Given Access To Those
Drugs Without Approval From The FDA. In May 2018, Fitzpatrick voted
for the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew
Bellina Right to Try Act of 2017. According to Congressional Quarterly,
"Passage of the bill that would allow patients with life-threatening
diseases or conditions who are not participating in clinical trials to
seek access to experimental and investigational drugs directly from a
drug manufacturer, without approval by the Food and Drug Administration.
It would require that in order for the patient to be eligible, the
patient must first try all approved treatment options and be unable to
participate in a clinical trial. Only drugs that have completed phase 1
clinical trials, that have not been approved or licensed for any use,
and that are currently under an active FDA application or are undergoing
clinical trials would be eligible for use under the bill's provisions."
The vote was on passage. The House passed the bill by a vote of 250 to
169. The bill was then sent to the president, who signed it into law.
[House Vote 214,
5/22/18; Congressional
Quarterly, 5/22/18; Congressional
Actions, S.
204]
- Democrats Were Opposed To The Bill Because The Legislation Was Not
Needed, Could Lead To Drug Shortages And Removing FDA Authority Over
The Approval Process Would Lead To Dangerous Outcomes For
Patients. According to Congressional Quarterly, "Opponents of the
bill, primarily Democrats, say it would not actually improve patient
access to investigational drugs, and that removing the FDA from the
approval process could prove dangerous to patients. The bill is
unneeded, they say, because the FDA's existing compassionate use
process already provides generous access with more than 99% of
requests being approved, while also providing important protections
to patients by allowing the FDA to modify treatment plans. They note
that in many states the patients who access drugs through state
right-to-try laws subsequently can't be insured for palliative or
hospice care, while others end up lacking insurance for lengthy
periods. They also point out that manufacturers only produce enough
drug for use in their planned clinical trials, and say that any
significant expansion of access to the drug outside of clinical
trials is unlikely because it could lead to shortages. Finally, they
say the Senate bill is even worse than the House-passed version
because it will allow a much wider range of patients to directly
seek access to the drugs, including those with chronic but not
life-threatening conditions." [Congressional Quarterly,
5/18/18]