This November, Arizona voters will have an opportunity to decide if Proposition 303 called “The Right to Try” should become law in Arizona. It is important to understand what this proposed law does and does not do.
What is Proposition 303?
The official short title for Proposition 303 reads as follows: (Source)
“ Use Of Investigational Drugs, Biological Products And Devices A CONCURRENT RESOLUTION ENACTING AND ORDERING THE SUBMISSION TO THE PEOPLE OF A MEASURE RELATING TO THE USE OF INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS AND DEVICES.”
The full ballot summary reads as follows:
“ ALLOWS A MANUFACTURER TO MAKE AVAILABLE TO AN ELIGIBLE TERMINALLY ILL PATIENT, A DRUG, BIOLOGICAL PRODUCT OR DEVICE THAT HAS SUCCESSFULLY COMPLETED PHASE ONE OF A CLINICAL TRIAL BUT HAS NOT BEEN APPROVED FOR GENERAL USE BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION.
A “yes” vote shall have the effect of allowing a manufacturer to make available an investigational drug, biological product or device to an eligible terminally ill patient. It exempts a physician from regulatory action based solely on the physician’s recommendation of the drug, product or device to the eligible terminally ill patient and classifies, as a class 1 misdemeanor, any attempt by a state official, employee or agent to block access of the investigational drug, biological product or device to an eligible terminally ill patient.
A “no” vote shall have the effect of retaining the current law regarding the availability of an investigational drug, biological product or device that has not been approved for general use by the United States Food and Drug Administration.
To see the full text of Proposition 303, click here. As election time nears, discussions on Proposition 303 will begin to be heard across the airwaves and on social media. Here is a recent example that aired on 3TV’s Policy Unplugged:
In the interview above, Gibson McKay of Sherpa Public Affairs speaks out in support of passing Prop.303 and Joan Koerber-Walker of the Arizona Bioindustry Association explains why Prop. 303 would give terminally ill patients “the right to try” but does not provide a way for them to succeed at the state level. By sending terminally ill patients down a dead end pathway, time is wasted that could have been used to help the patient be successful under the current FDA process.
What is the current FDA process? In short it flows like this:
- The patient’s physician determines the patient has no comparable or satisfactory alternative therapy AND identifies a possible alternate therapy that is currently in a clinical trial. Click here to see the phases of the clinical trial process.
- The patient’s physician contacts the clinical trial sponsor (sponsor) to determine if the patient meets the eligibility requirements as specified in the clinical trial and can be included in it.
- If the patient does not qualify for the clinical trail AND, if after conferring with the sponsor, the physician and the sponsor agree that it is in the best interests of the patient, AND the sponsor confirms that they are willing and able to provide the investigational drug to the patient; then
- the treating physician or the drug’s sponsor submits an IND application, an outline of the patient’s medical history, a proposed treatment plan, and a commitment to obtain informed consent from the patient and Institutional Review Board (IRB) approval following the single patient IND process.
- The FDA determines there is sufficient evidence of safety and effectiveness to support the use of the investigational drug; AND
- the FDA determines that provision of the investigational drug will not interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval that would make the drug or therapy available for all the patients that need it.
According to the Wall Street Journal
“In the fiscal year ended last October, the agency [FDA] approved 863 requests, or 99 percent of all cases reviewed, according to FDA data. And one-third of those were approved on an emergency basis. In fact, the agency has approved 99 percent of all requests since October 2009. On average, 932 requests were endorsed annually since then.”
Why does Proposition 303 create false hope and waste the precious time of terminally ill patients?
According to the Goldwater Institute, Proposition 303:
allows a patient to access investigational medications that have passed basic safety tests without interference by the government when the following conditions are met:
- The patient has been diagnosed with a terminal disease;
- the patient has considered all available treatment options;
- the patient’s doctor has recommended that the investigational drug, device, or biological product represents the patient’s best chance at survival;
- the patient or the patient’s guardian has provided informed consent;and
- the sponsoring company chooses to make the investigational drug available to patients outside the clinical trial.
In addition, Proposition 303 states that under Arizona Law, the sponsor, the physician, and the healthcare institution can not be held liable for providing the investigational drug, device, or biological product(collectively, “therapy”). The challenge that Prop. 303 creates is that while it provides protection under Arizona law, the sponsor, the physician, and the healthcare institution are bound by federal laws and regulations. Providing protections under Arizona law does not solve the problem or give them the ability to provide the therapy to the patient. Should action be brought against the sponsor, the physician,and/or the healthcare institution in a federal court, they would lose. This is not a case like medical marijuana where federal agencies elected to look the other way and not bring suit. In a federal court, the judge must follow federal law and federal law provides for the use of the FDA approved processes. Even if the patient were able to successfully obtain the therapy, other issues then arise.
- Prop. 303 has no provision that outlines who pays for the therapy or for the associated healthcare costs of treatment and/or side effects and specifically states that the sponsor, the healthcare providers, and the insurance companies do not have to bear these costs.
- Terminally ill patients electing to go out side the federally approved process could lose their coverage for hospice care
- Prop. 303 has no mention of the role of the IRB thus eliminating a necessary safeguard for patients.
- Prop. 303 does provide for record keeping on patient outcomes. Should an adverse patient outcome occur, it could delay or even halt the approval process underway that upon approval would benefit many patients.
So what does Prop. 303 really do?
- It sends a message that the clinical trial and drug approval needs to move faster. This is a message that all the parties already have. Solutions are being worked on by the people closest to it and who know it best: industry, patient groups, the FDA, the NIH, Congress, and the health care community.
- It tells terminally ill patients and their families that they have the right to try and an option to go down a state pathway. Unfortunately that pathway is a dead end. It wastes time that could be spent following the established federal pathway where they have some hope for success.
- It creates loop-holes that can open the door for abuse by individuals or organizations who are not bound by safeguards put in place to protect patients at their most vulnerable time.
- It gives rise to a host of ethical issues on how access decisions can be made fairly and equitably.
Proposition 303 as written, would give patients the ability to try to gain access to investigational therapies outside of the FDA process here in Arizona BUT it does not create a way for them to successfully obtain the therapies or receive treatment from the very organizations best able to help them.
The people who make up our life science and healthcare communities dedicate their lives to helping patients and use their experience and talents to work for the best possible outcome for every patient. These are the people who through their efforts create true HOPE for patients.
Prop. 303 unfortunately creates a false hope for terminally ill patients and at its worst creates situations where they potentially will waste what is most precious…their time.
Learn more about the clinical trials process: