“Right to Treat” Iowa Bill Expands Right to Try Legislation

Published June 7, 2023

Suffering patients deserve more access to investigational treatments. In Iowa, HF225 would expand access to drugs and therapies that have not yet been completely approved by the FDA, but could help patients who have no other options. Iowans are currently restricted to limited expanded use of investigational drugs to only those patients who are near death.

In 2018, President Trump signed Right to Try legislation, which allows terminally ill and untreatable patients 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 investigational treatments to alleviate their suffering. While Right to Try only applies to patients who are going to likely die from their disease, Right to Treat legislation offers hope to those who suffer from an incurable and untreatable condition that is not immediately fatal. These patients who suffer profoundly from painful, crippling, but not life-threatening disease are due at least as much compassion as those who have a fatal diagnosis.

Patients shouldn’t have to wait for a winning lottery ticket to join a clinical trial. States should reduce regulations that restrict access to investigational treatments for those who live with untreatable, painful, and debilitating conditions. These patients should be able to try a medication that has been proven to be safe without the burden of demonstrating to the government that they are at death’s door.

While the FDA seeks to approve drugs and therapies for patient populations in the thousands or millions, cutting edge therapies and drugs are being created to treat a unique cancer in a single person. HF225 recognizes “Individualized investigational treatment” as “a drug, biological product, or device that is unique to and produced exclusively for use by an individual patient based on the individual patient’s own genetic profile.” “Individualized  investigational treatment” includes, but is not limited to, individualized gene therapy, antisense oligonucleotides, and individualized neoantigen vaccines. The FDA is unable to respond to this technology within its current approval process, and states like Iowa and others are recognizing that with Right to Treat legislation.

HF225 defines minimum parameters of informed consent to protect desperate and vulnerable patients from possible harm. The FDA’s recommendations for informed consent provide patient safety parameters that can be a starting point for Iowa and other states seeking to expand use through informed consent.

HF225 constructs the framework of consent around important patient protections. The patient and doctor must agree and demonstrate that:

  1. A list of FDA approved treatments that are currently approved to the patient’s condition.
  2. Attestation that these are unlikely to prolong the patient’s life.
  3. An understanding of the range of outcomes expected using the investigational therapy (“best and worst possible outcomes”).

Other states have provided additional protections. In Texas, Senate Bill 773 provides a more comprehensive approach to informed consent and patient protection, while extending additional  safeguards to the physician prescribing the treatment. Sec. 490.151 states that the Texas Medical Board, “may not revoke, suspend, or take any action against a physician’s license” if the action “is based solely on the physician’s recommendations to an eligible patient.”  

States should consider robust patient protections through informed consent, as well as protections for the prescriber against possible action against a medical license.

Right to Try legislation neither requires, nor prevents, insurance coverage of investigatory drugs. Right to Treat laws should follow that rule. Balancing the potential astronomical costs for investigational treatments with the potential benefits is a job for patients, industry, and government. States can provide leadership in taking the first steps.

The marketplace 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.

The following resources provide additional information on FDA reform:

What is Right to Try? https://righttotry.org/about-right-to-try/ The Goldwater Institute explains their pioneering work to expand patient choice for Americans.

Matt Dean 2022 Testimony on South Dakota House Bill 1228: Right to Treat

Matt Dean testifies on behalf of one first bills introduced to expand the ability of nonterminal  patients to access investigatory drugs.

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-agenc 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.” (May 22, 2015)

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 Mercatus center make the case that it is time to rein in the powers of the overreaching FDA. (September 14, 2016)

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