SUMMARY – IOWA RIGHT TO TREAT LEGISLATION
Heartland Impact Supports a YES Vote on this Legislation
WHAT THIS BILL DOES
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.
OPPOSITION TO BILL
Opponents of Right to Try/Right to Treat legislation are generally not opposed to individualized therapies and treatments, but against cutting the FDA out of the approval process. Opposition to Right to Try legislation sited the FDA’s existing program, Expanded Access, as a safer alternative to Right to Try. Opponents were concerned that Right to Try would not have the same safety boundaries as Expanded Access, or that realistic expectations would not be set with patients. Right to Try addressed those concerns and was enacted on the national level.
Right to Treat patients would not qualify for most Expanded Access requests because their condition is not immediately life threatening. Additionally, safety and patient expectation concerns are directly addressed in HF225.
HF225 constructs the framework of consent around important patient protections. The patient and doctor must agree and demonstrate that:
- A list of FDA approved treatments that are currently approved to the patient’s condition.
- Attestation that these are unlikely to prolong the patient’s life.
- An understanding of the range of outcomes expected using the investigational therapy (“best and worst possible outcomes”).
WHY THIS BILL SHOULD PASS
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.
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:
- A list of FDA approved treatments that are currently approved to the patient’s condition.
- Attestation that these are unlikely to prolong the patient’s life.
- An understanding of the range of outcomes expected using the investigational therapy (“best and worst possible outcomes”).
This bill will allow patients in Iowa to work with their doctors to achieve a better quality of life. These patients should have the opportunity to work with their doctors to try everything they can to live the best life possible. HF225 would give them that opportunity.
HOW MUCH THIS COSTS
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.
Heartland Impact 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 Cameron Sholty, at csholty@heartlandimpact.org or 312/377- 4000.
OTHER REASOURCES
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.
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)
