Sen. Ron Johnson (R-WI) has introduced legislation that would make it easier for terminally ill patients to use experimental drugs and medical devices, by preventing the U.S. Food and Drug Administration (FDA) from superseding state right-to-try laws.
The Trickett Wendler Right to Try Act of 2017 would “authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law,” the bill states.
If the bill becomes law, terminally ill patients and their doctors in the 33 states with right-to-try laws, as well as manufacturers of experimental drugs, will be able to try drugs not yet approved by FDA, without fear of recrimination.
Playing Politics with Patients
Satya Thallam, chief economist for the U.S. Senate Committee on Homeland Security and Governmental Affairs, says the Trickett Wendler Act has a better chance of becoming law under the administration of President Donald Trump than it did under the Obama administration.
“We believe there has always been a powerful moral case for this legislation but are heartened that the current vice president enthusiastically signed a state right-to-try law as governor and then publicly supported taking the idea to Washington, DC,” Thallam said.
Devon Herrick, a health economist and senior fellow at the National Center for Policy Analysis, says the 2016 bill was stopped for political reasons unrelated to the specifics of the legislation.
“It is well-known [Sen.] Harry Reid blocked Sen. Johnson’s legislation for political reasons,” Herrick said. “Johnson was in a tough reelection campaign with a well-known Democrat, Russ Feingold. Senate Democrats were also angry that Senate Republicans were blocking confirmation of Merrick Garland, President Obama’s Supreme Court nominee.”
Risky Business
Even if the bill passes, drug companies may decide making their experimental drugs available is not worth jeopardizing their chances of obtaining FDA approval, Herrick says.
“I fear that right to try is mostly a symbolic gesture,” Herrick said. “There is fear among drug makers that bad press or unfortunate outcomes could harm the approval process. Dying patients could pose risks but no reward.”
FDA’s stringent, lengthy, and expensive approval process negates incentives for drug manufacturers to make their treatments available, Herrick says.
“The problem is that within the current structure at the FDA, drug makers who are in the final stages of seeking approval for an experimental drug have little reason to participate and make their drugs available for compassionate use,” Herrick said.
FDA Reform
Deregulating the clinical trial process would encourage more drug manufacturers to offer treatments awaiting full FDA approval, Herrick says.
“If the approval process is changed such that anyone taking an experimental drug can have their experiences added to the aggregate data, then more drug makers would be jumping at the chance to include those who want one last chance at life,” Herrick said.
President Donald Trump would probably sign legislation to accelerate FDA’s drug-approval process and reduce its regulatory footprint, Herrick says.
“President Trump has signaled he favors faster access to drugs for life-threatening conditions. I expect him to sign any legislation that makes it to his desk,” Herrick said.
Jordan Finney ([email protected]) writes from Boise, Idaho.
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