2018: Schweikert 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, Schweikert 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]