A Texas Senate bill would expand the state’s “right to try” law to a wider range of patients.
State Sen. Tan Parker (R-Flower Mound) introduced SB 773, which would allow unapproved treatments for those with severe chronic disease, on February 6. The state’s current law, enacted in 2015, allows terminally ill patients to access medications and treatments that have not yet been approved by the Food and Drug Administration (FDA).
Access for Chronically Ill
SB 773 defines “severe chronic disease” as “a condition, injury, or illness that requires medical attention and entails significant functional impairment or severe pain that limits a person’s activities of daily life.”
Texas’ current law was put into place after the Trump administration expanded a provision in the Food, Drug, and Cosmetic Act to allow access to experimental drugs after receiving express FDA approval. Since 2015, 78 terminally ill patients in Texas received experimental treatments not approved by the FDA.
SB 773 would prohibit anyone working for the state to block a patient’s access to an investigational treatment. Without such a provision, federal authorities could take aggressive action against entities giving unapproved treatments, such as withholding federal funding. The bill would prohibit the state from revoking a medical license or issuing sanctions against a professional using experimental treatments with patient consent.
Right to Decide
Allowing the doctor and patient to determine treatment options is the key to the bill, says Matt Dean, a senior fellow in health care policy outreach at The Heartland Institution, which co-publishes Health Care News.
“The attestation and consent piece of the bill is critical,” said Dean. “Patients need to know that they have been offered and tried the standard of care in the treatment of their problem. When the doctor and patient have tried everything that is commonly available, they should not have to win the lottery to become part of a clinical trial. Having doctors who can push for more answers than the FDA has provided is key for people with rare conditions.”
Medical professions appreciate the freedom, says Dean.
“We need smart, ethical people with common sense to want to be doctors,” said Dean. “Without that, we turn to cookie-cutter medicine or artificial intelligence algorithms to determine our treatment course.”
Should Bill Go Further?
The role of the FDA should be limited to determining that medications are safe—not safe and effective—says Dan Sutter, an affiliated senior scholar at the Mercatus Center at George Mason University and a professor of economics at Troy University.
“I believe in the right of Americans to access drugs to treat their conditions,” said Sutter. “I would like to see this right not interfered with by the law.”
With few exceptions, federal law prohibits the use of treatments that have not been shown to be effective in clinical trials, says Sutter.
“The primary interference is FDA regulation of effectiveness,” said Sutter. “Once drugs and medical devices are judged to be safe, they should be allowed on the market. Ultimately, patients in consultation with their doctor should decide if a treatment is effective enough to try on their condition.”
‘Should Be the Exception’
While the bill offers hope to chronically ill patients who are short on treatment options, potential pitfalls exist.
For example, some critics have expressed concern the law could potentially be applied to questionable gender procedures. Additionally, desperate patients could be vulnerable to bad actors. Dean says access to unapproved treatments should be subject to scrutiny.
“Unfortunately, there are snake oil providers who will always be there to sell false hope to suffering patients,” said Dean. “Real harm and death can come to people whose illness has pushed their desperation too far. Ultimately, these approved investigational treatments should be the exception and not the rule, and doctors should have the ability to stay within the contours of their comfort in providing good patient care.”
Prescriptionless Permission?
Sutter says he would take freedom to treat one step further.
“I would ideally like to see all drugs approved as safe – available without a prescription,” said Sutter. “Prescriptions from medical professionals would be used as a basis for insurance coverage. Insurance companies would largely then regulate evidence for effectiveness, as they would not want to pay for drugs that do not work. I see the Texas bill as a step in the right direction. The limitation to severe chronic disease is not ideal. However, this limited measure would still improve the current situation.”
The effort in Texas could have an impact beyond its borders, says Sutter.
“The best path to further deregulation would be for a bill like this to pass and work well in practice. This is the best path forward,” said Sutter. “Modest steps at deregulation would help demonstrate that increasing access improves the quality of care and life for patients.”
Controlled Substances Excluded
Parker’s bill specifically excludes cannabinoids as unapproved treatments authorized by the legislation, says Dean.
“No doctor should be pressured to prescribe a drug that has not been approved,” said Dean. “The use of controlled substances, such as THC and narcotics, is ripe for abuse and puts doctors in peril by providing a pathway for drug-seeking addicts to legally obtain marijuana and other potentially addictive and dangerous drugs not approved by FDA.”
The bill was referred to the Senate Committee on Health and Human Services, but no action was scheduled as of press time. The regular biennial session of the Texas Legislature ends May 29.
Kevin Stone (kevin.s.stone@gmail.com) writes from Arlington, Texas.