Pennsylvania will become the 31st state to allow drug and medical device manufacturers to offer terminally ill patients drugs, devices, and procedures not yet approved by the U.S. Food and Drug Administration (FDA), if House Bill 1104, the Right-to-Try Act, becomes law.
HB 1104, sponsored by Robert Godshall (R-Hatfield), advanced to the Senate after the House approved it 182–0, with 20 representatives abstaining, on June 16.
The bill would authorize drug manufacturers and physicians to help eligible patients obtain experimental treatments. State right to try laws do not supersede federal law, which discourages drug companies from dispensing investigational drugs still undergoing clinical testing in compliance with FDA’s lengthy approval process.
Approval of the Trickett Wendler Right to Try Act, currently before Congress, would give manufacturers, prescribers, and users of investigational treatments authorized by state right to try laws protection against federal recrimination.
Immunity and Eligibility
Citing a long FDA approval process for which “patients who have a terminal illness do not have the luxury of waiting,” HB 1104 would permit manufacturers to make investigational medical products and devices available to eligible patients under state law.
The bill also would provide civil and criminal immunity under state law to physicians who prescribe such treatments in good faith and would prohibit the state boards of medicine and osteopathic medicine from stripping physicians of their licenses based solely on their prescription of an investigational drug or treatment for an eligible patient.
To be eligible under the bill, patients must have received a terminal diagnosis from a physician, contemplated using FDA-approved treatments, and been unable to participate in or rejected from a clinical trial within 100 miles of the patient’s home. Patients must give written, informed consent to the treatment, which must be recommended by their physician.
The Pennsylvania legislature is scheduled to adjourn on November 30. Bills not passed by then will not carry over into 2017.
‘Patients Deserve More Control’
Elizabeth Stelle, director of policy analysis at the Commonwealth Foundation, says using investigational treatments is a right all patients, not just the terminally ill, should be free to exercise.
“Allowing a few patients the freedom to try experimental medications is certainly a game-changer for them and their families, but all patients deserve more control over their healthcare,” Stelle said.
Starlee Coleman, vice president for communications at the Goldwater Institute, says HB 1104 protects Pennsylvania patients’ basic rights from government interference.
“Right to Try is aimed at maximizing one of the most fundamental freedoms Americans have: the right to try to save our own life,” Coleman said. “When people are at the end of the line with no treatment options and are unable to enroll in a clinical trial, the government needs to remove obstacles that prevent medical professionals from providing the care they are trained to give.”
Nationwide Bipartisan Support
Lawmakers of both major parties see right to try laws as commonsense health care policy, Coleman says.
“Right to Try has now been adopted in 30 states with overwhelming bipartisan support,” Coleman said. “In two-thirds of the states where Right to Try has been adopted, it has passed with unanimous, bipartisan support. So, there really isn’t much opposition to the laws.”
Stelle says the biggest obstacle to the bill is Pennsylvania’s ongoing budget battle.
“In the short term the greatest challenge is momentum,” Stelle said. “The legislature will be focused on the state budget through the end of June and possibly into the summer. Last year the budget battle lasted nine months.”
Stories Saving Lives
Sharing with legislators the stories of real patients in need of experimental drugs, devices, or procedures is vital to persuading lawmakers to adopt right to try laws, Stelle says.
“The key to passing right-to-try in other states was storytelling,” Stelle said. “If lawmakers are confronted with a real-life case of a dying Pennsylvania patient, they’re more likely to act.”
Coleman says constituents should speak out to persuade legislators to pass the bill.
“When lawmakers hear from their constituents who are dying and just want the glimmer of hope that this law provides, it’s hard for them to say no,” Coleman said. “We hear over and over again from patients that this isn’t a ‘right to a cure,’ it’s a ‘right to try.’ And that’s all dying people are asking for—just another option to try.”
Luke Ferree ([email protected]) writes from New York, New York.
Matthew Glans, “Pennsylvania Considers the Right-to-Try for Terminally Ill Patients,” Research & Commentary, The Heartland Institute, June 20, 2016: https://heartland.org/publications-resources/publications/research–commentary-pennsylvania-considers-the-right-to-try-for-terminally-ill-patientshttps://heartland.org/publications-resources/publications/research–commentary-pennsylvania-considers-the-right-to-try-for-terminally-ill-patients
“‘Right to Try’ States Map, The Heartland Institute, June 22, 2016: https://heartland.org/publications-resources/publications/right-to-try-states-maphttps://heartland.org/publications-resources/publications/right-to-try-states-map
Josh Thomas, “Federal ‘Right to Try’ Act Would Help States Bypass FDA to Treat Terminally Ill,” Health Care News, The Heartland Institute, July 2016: https://heartland.org/news-opinion/news/federal-right-to-try-act-would-help-states-bypass-fda-to-treat-terminally-illhttps://heartland.org/news-opinion/news/federal-right-to-try-act-would-help-states-bypass-fda-to-treat-terminally-ill
S. 2912: Trickett Wendler Right to Try Act of 2016, U.S. Senate, May 10, 2016: https://heartland.org/publications-resources/publications/s-2912-trickett-wendler-right-to-try-act-of-2016https://heartland.org/publications-resources/publications/s-2912-trickett-wendler-right-to-try-act-of-2016
Mark Flatten, “Dead on Arrival: Federal ‘Compassionate Use’ Leaves Little Hope for Dying Patients,” Goldwater Institute, February 24, 2016: https://heartland.org/policy-documents/dead-arrival-federal-compassionate-use-leaves-little-hope-dying-patients-right-try
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