In 2018, President Trump signed Right to Try legislation, which allows terminally ill and untreatable patients with the right to try medicines that are deemed safe, but have not yet gained final approval from the FDA. This year, states are taking the next step to allow more patients access to more potential treatments. While Right to Try only helps patients who are likely to die from their disease, Right to Treat legislation offers hope to those who suffer from an incurable and untreatable condition that is not necessarily fatal. The millions of patients who suffer profoundly from chronic conditions or injuries are due at least as much compassion as those who have a fatal diagnosis.
States should reduce regulations that restrict access to investigational treatments for patients who live with untreatable, painful, and debilitating conditions. These patients should be able to try a medication or course of treatment that has been proven to be safe without the burden of demonstrating to the government that they are at death’s door, or that the drug is provably effective in alleviating their specific condition. Right to Try legislation neither requires, nor prevents, insurance coverage of investigatory drugs. Right to Treat laws should follow that rule.
Doctors should be able to rely on their medical judgement in determining what is in the best interest of the patients. They should be allowed to prescribe medications with broader latitude than currently allowed by the FDA and importantly, not have second thoughts about prescribing a medication that could cause an action against their license by individuals motivated by financial or political interests.
In Texas, a bill that would protect the doctor-patient relationship and offer hope for patients who suffer from untreatable, nonlethal conditions is being considered. Senate Bill 773 takes up where Right to Try left off, in expanding access to investigational treatments to patients who are not terminally ill, but suffer significant pain or functional impairment from an incurable “severe and chronic” condition that cannot be treated with an approved FDA drug.
SB 773 would allow the commissioner of State Health Services the authority to define “severe and chronic diseases” and conditions that would allow a candidate to take part in an investigational treatment program.
The bill requires informed consent and signed documentation that the patient’s physician, “in consultation with the patient, considers all other treatment options the United States Food and Drug Administration has currently approved and determines those treatment options are unavailable or unlikely to provide relief for the significant impairment or severe pain associated with the patient’s severe chronic disease.”
Moreover, the legislation would offer protection from action against a physician’s license. “The Texas Medical Board may not revoke, fail to renew, suspend, or take any action against a physicians license” according to the proposed law, “based solely on the physician’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device provided that the recommendations meet the medical standard of care and the requirements of this chapter.”
To date, the health care industry has cautiously embraced Right to Try. A 2019 GAO report found that 23 out of 29 drugmakers surveyed had information publicly available on their websites that said, “they would consider individual requests for access” from patients, though most said they would also require regulators to review the request. Since Right to Try was passed, FDA’s traditional Expanded Use program has more than doubled the total number of approved medications for use.
Before Right to Try, desperate patients would have no choice but to wait in line at the FDA for an expanded use waiver, which excludes 97 percent of people from clinical trials. Bioethicist Arthur Caplan explains that the number of patients represented in these data reflect only a fraction of those who have run out of options, noting: “the FDA data do not represent the total number of patient requests: requests declined by either the drug’s manufacturer or the patient’s physician would not be reported to the FDA.” Caplan also notes that, “Additionally, the FDA may approve programs, such as expanded access programs (EAPs) through which multiple patients may access an experimental drug. The FDA would record this as one decision.”
State legislators passed Right to Try legislation in 38 states before it was signed into federal law. Federal Right to Treat legislation, proposed by Sen. Ron Johnson (R-WI) is very likely years away from passage. That legislation—like Right to Try—will be propelled and shaped by legislation passed in multiple states. That effort is clearly benefitting patients through the Right to Try pathway, as well as expediting approvals within FDA. What’s more, families are reaching out to their state representatives and senators to demand a Right to Try bill to help even more suffering victims of insidious disease. Legislators are again responding to their constituents and asking that more patients be allowed access to investigational treatments as a last option for hope through Right to Treat bills like Texas Senate Bill 773.
The following documents examine the expansion of approved investigational drugs and the opposition to FDA reform.
The Right to Try Medicine https://heartland.org/opinion/the-right-to-try-medicine/ Daniel Sutter, of the Heartland Institute explains the need for Right to Try federal legislation, and the benefits it offers. Daniel Sutter: “Right to try is worth celebrating. The principle is that we should get to make decisions about our health care. Further reforms letting Americans decide how to treat our life-threatening and everyday ailments will, I think, make us wealthier, healthier, and happier.”
Federal Right to Treat Legislation introduced by Sen Ron Johnson https://www.ronjohnson.senate.gov/2022/2/sen-johnson-introduces-legislation-to-reaffirm-doctor-s-right-to-treat-patients-without-interference-from-federal-health-agencies Sen. Johnson: “The pandemic exposed the fact that many doctors no longer call the shots when it comes to treating patients, the COVID Cartel does. The COVID Cartel includes the Biden Administration, federal health agencies, Big PHARMA, mainstream media, and Big Tech. The Right to Treat Act would ensure that federal health agencies return to their proper functions of gathering and providing public health data and regulating drug safety – not telling doctors how to practice medicine.”
Should Patients in Need Be Given Access to Experimental Drugs? https://www.tandfonline.com/doi/full/10.1517/14656566.2015.1046837 Arthur Caplan, PhD. Caplan: “Patient advocates, the FDA, pharmaceutical trade groups, and state and national legislators in the US are all currently weighing in on patient access to experimental drugs, and new guidelines and rules are being introduced. In this editorial, we discuss the impulse to rescue individual patients facing dire diseases and underscore the ethical questions that such rescue efforts raise.”
The Need for FDA Reform, Four Models https://www.mercatus.org/research/policy-briefs/need-fda-reform-four-models Adam Thierer and Michael Wilt of the Marcatus center make the case that it is time to rein in the powers of the overreaching FDA.
Nothing in this Research & Commentary is intended to influence the passage of legislation, and it does not necessarily represent the views of The Heartland Institute. For further information on this and other topics, visit the Budget & Tax News website, The Heartland Institute’s website, and PolicyBot, Heartland’s free online research database.
The Heartland Institute can send an expert to your state to testify or brief your caucus, host an event in your state, or send you further information on a topic. Please don’t hesitate to contact us if we can be of assistance! If you have any questions or comments, contact Heartland’s government relations team at [email protected] or 312/377-4000.
