The House of Representatives is set to vote tomorrow on Trump-backed legislation that would give terminally ill patients the right to obtain potentially beneficial drugs that have not been fully cleared by the Food and Drug Administration (FDA).
The bill, a companion to legislation unanimously approved last year by the Senate, would let patients gain access to a drug that has gone through the first of three phases of clinical trials. The patient must be terminally ill and have no other options to qualify.
Manufacturers wouldn't be required to supply the drug to terminally ill patients, but the bill hopes to entice drugmakers to participate in the program.
How many times have you heard about dying patients having to go to other countries to seek potentially life-saving medications that have not yet been approved by the FDA? That always struck me as horrible. Why are they being denied these medications? Because they might not work, or might actually kill them? Hello...what does "terminally ill" mean?
Drugmakers reportedly are sometimes hesitant to provide a drug outside of a clinical trial to a terminally ill patient because if the patient dies, it could hurt the approval of the product by the Food and Drug Administration. However, experts have said patients who would use right-to-try likely would be sicker than patients in a clinical trial. The bill seeks to provide certainty to manufacturers on how the FDA will use patient outcomes when evaluating whether to approve the product.
However, this article in SLATE contends that the bill would do almost nothing because FDA since 2009 has granted patients access to experimental treatments when enrollment in clinical trials is impossible. Completing the necessary form takes 45 minutes, the article says, and the FDA will reply to emergency requests within 24 hours, with a 99 percent approval rate.
"So the problem with Trump's rallying cry for right-to-try is not that the people shouldn't have it, but that such a law already exists -- and if anything, the right-to-try bill would end up undermining patients' access to care rather than affording them viable alternatives," writes the article's author, Alex Barasch.
The article also states that patients who exercise their right to try before further studies have been completed may end up worse than before—and the use of such therapies "can render them ineligible for health insurance or hospice care when they need it most."
For some patients, the availability of such therapies could be a matter of life -- or at least extended life -- and death. Let's hope Congress gets it right.