Terminally ill patients in Maryland will gain new treatment options if state lawmakers pass a bipartisan pair of bills that would recognize individuals’ “right to try” experimental medications the federal Food and Drug Administration (FDA) has not fully approved.
If passed, the Right to Try Act would allow companies to grant patients access to drugs, biological products, or medical devices that have passed the first phase of FDA testing but are still being investigated in clinical trials. Right to try laws do not supersede federal law. Instead, they tell companies they have a state’s permission, upon a patient’s request, to grant access to drugs still undergoing clinical testing. Whether companies will do that remains up in the air, because FDA may object to the dispensation of a drug that falls outside of its guidelines and may respond by withholding approval of that company’s drug.
Twenty-four states have adopted right to try laws, as of February 2016.
The Senate version of the Maryland bill defines an “eligible patient” as an individual who has received a terminal diagnosis, considered all other treatment options currently approved by FDA, consents to the experimental treatment, and obtains a doctor’s recommendation for the treatment.
Hearings on Senate Bill 63 and House Bill 56 began on January 28, and the legislation has received bipartisan sponsorship from state Sen. Bryan Simonaire (R-Anne Arundel County) and state Del. Karen Lewis Young (D-Franklin County).
‘For Hope of a Cure’
Simonaire says the bill offers hope to the hopeless.
“Right to try legislation gives hope to those that are terminally ill and have no hope,” Simonaire said. “These patients are at the end of their road and out of options. Time is their enemy, as they cannot wait years for the full and complete approval from the FDA. They literally have no hope, no FDA alternative drug, and are looking for a cure.”
The goal of Maryland’s right to try bill is to lengthen and improve lives by freeing desperate patients to seek cures while they still can, Simonaire says.
“Right to try does not guarantee a cure, but merely the opportunity for a patient to make an informed decision to try an experimental drug that has been through the safety clinical trials but [has] not gone through the long process of final FDA approval, which could take over a decade,” Simonaire said.
Legislative action on the Right to Try Act ought to transcend partisan controversy, says Marc Kilmer, a senior fellow of the Maryland Public Policy Institute.
“I think right to try legislation makes a lot of sense,” Kilmer said. “Allowing terminally ill patients to access medication which may help them should be uncontroversial. That is why we see this legislation have support from both Democrats and Republicans in the General Assembly.”
Simonaire says patients, not lawmakers, should get the last word.
“This is not ‘right to a cure,’ but ‘right to a try,'” Simonaire said. “The final decision rests with the patient.”
The Maryland General Assembly will consider the legislation in its current session, which ends April 11.
Michael McGrady ([email protected]) writes from Colorado Springs, Colorado.
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