Legislation introduced by U.S. Sen. Ron Johnson (R-WI) would prevent the federal government from superseding state “right to try” laws, making it easier for terminally ill patients in certain states to obtain experimental treatments and devices.
In states that have passed right to try laws—28 since 2014—the Trickett Wendler Right to Try Act of 2016 would prohibit the federal government from restricting the possession, use, “production, manufacture, distribution, prescribing, or dispensing of an experimental drug, biological product, or device” intended for treating terminally ill patients who have no other medical recourse.
The act also would eliminate the liability of developers and prescribers of such experimental treatments and forbid federal agencies, including the U.S. Food and Drug Administration (FDA), to “delay or otherwise adversely impact review or approval” of a treatment based on patient outcomes.
Senate Bill 2912 is named after Trickett Wendler, a woman from Waukesha, Wisconsin who was diagnosed with amyotrophic lateral sclerosis (ALS) and died on March 18, 2015. The bill expands on legislation introduced in the U.S. House of Representatives by Rep. Matt Salmon (R-Arizona) in July 2015.
State Law vs. Federal Regulations
As Health Care News reported in February, right to try laws do not supersede federal law but instead tell companies they have a state’s permission, upon a patient’s request, to grant access to drugs still undergoing clinical testing. Current federal law discourages companies from doing so, because FDA may object to the dispensation of a drug that falls outside of its guidelines and may respond by denying approval of that company’s drug or taking other enforcement action.
Starlee Coleman, a senior policy advisor at the Goldwater Institute, says a federal right to try law would reduce developers’ and physicians’ fears of being targeted by FDA for making experimental treatments available to patients.
“With the House and Senate legislation that would prevent federal interference with right to try laws, we think more doctors and drug companies will be willing to work with patients to use the [state] laws,” Coleman said. “We know some people are already being treated, but we have also heard that some don’t want to get in the FDA’s crosshairs. This legislation takes away any fear they have in using the law to help a dying person.”
The Trickett Wendler Right to Try Act would render state right to try laws a viable legal defense for experimental drug developers and prescribing physicians to prevent retribution by FDA.
“While states have clear legal authority to protect the right of patients to try to save their lives by accessing promising treatments under these laws, Sen. Johnson’s bill formally recognizes that right and sends a clear message that the federal government won’t interfere,” Coleman said. “This is a really important step in the process because states can pass the laws, but people are too afraid to use them because the federal government could shut them down. This bill helps address that.”
FDA’s Obsolete ‘Heavy Hand’
The current FDA approval process takes 10–15 years for new drugs, Goldwater Institute reported in February 2016.
Bart Madden, author of Free to Choose Medicine, says medical innovation and digital technology have far outpaced FDA’s obsolete regulations.
“The status quo FDA regulatory structure has been obsoleted by the fast pace of medical innovation, the rise of big data analytics, and the internet,” Madden said. “We need freedom for early access to the most innovative new medical treatments that are far superior to existing FDA-approved treatments.”
FDA’s regulations supposedly aim to ensure safe and effective treatments for the average patient, but cutting-edge medicines are increasingly customized to treat specific individual needs, Madden says.
“The FDA says that we need their heavy hand to regulate access to new drugs in order to ensure that these medical treatments are ‘safe and effective,'” Madden said. “Safety and effectiveness for the average patient lose meaning as new treatments are fine-tuned to address the specific genetic makeup of the patient and further refined with biomarkers to pinpoint a customized treatment.”
Madden says the responsibility of protecting patients’ freedom to obtain lifesaving treatments from FDA encumbrances rests with lawmakers and, by extension, voters.
“Freedom to make an informed choice about the medical treatment that you and your doctor believe offers the best chance for improved health, or even the saving of your life, is a freedom that we should demand from politicians who seek our votes,” Madden said. “Let’s not forget that politicians work for us, and they are responsible for how the FDA operates.”
Josh Thomas ([email protected]) writes from Toledo, Ohio.
Internet Info:
S. 2912: Trickett Wendler Right to Try Act of 2016, U.S. Senate, May 10, 2016: https://heartland.org/publications-resources/publications/s-204-trickett-wendler-right-to-try-act-of-2017?source=policybot
H.R. 3012: Right to Try Act of 2015, U.S. House of Representatives, July 9, 2015:
Image via Thinkstock
