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Compliance In Focus
Posted by Elizabeth Zak on Mon, Apr 20, 2020

What’s New with the Right to Try Act?

Expanded AccessThe Right to Try Act (RTT) was signed into law on 30 March 2018. Since conception, the bill has been controversial and the focus of debate. The bill was introduced in order to help terminally ill patients access investigational treatments which may help them. The FDA already had a process to provide patients with immediate life threatening diseases or conditions with access to investigational medical products; this process is called Expanded Access or “compassionate use.” Supporters of RTT Act argue this pathway (Expanded Access) is difficult to navigate and many patients pass away before being able to receive access; thus, defeating the purpose of providing a pathway to access investigational treatments at all. One main difference between Expanded Access and the RTT is that under the RTT, FDA approval is not needed which usually speeds up the process.

If a patient is eligible for the RTT, the patient, patient representative, or physician must initiate a request with the drug manufacturer of the active clinical trial via a written letter. A database of clinical studies is accessible to anyone for free via clinicaltrials.gov. The drug manufacturer will deny or approve the request; per the law, manufacturers are not required to provide access to investigational treatments. If the drug manufacturer approves the request, arrangements will be made for the patient to access the treatment. Insurance companies and taxpayer funded healthcare programs (Medicare, Medicaid) may or may not cover the cost of investigational treatments. It is possible that the patient may have to pay for the investigational treatment out-of-pocket if it is not covered. Per the law, drug manufacturers cannot make a profit; however, manufacturers can re-coup the cost of providing treatment to the patient.

Who qualifies for investigational treatment under the RTT?

For an individual to qualify, they must meet the following criteria:

  • Been diagnosed with a life-threatening disease or condition
  • Exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (this must be certified by a physician who is in good standing with their licensing organization or board and who will not be compensated directly by the manufacturer for certifying)
  • And has provided, or their legally authorized representative has provided, written informed consent regarding the eligible investigational drug to the treating physician

Also, keep in mind that not all investigational drugs are eligible to be provided under RTT. A drug must meet the following criteria to be provided under RTT:

  • For which a Phase 1 clinical trial has been completed
  • That has not been approved or licensed by the FDA for any use
  • For which an application has been filed with the FDA or is under investigation in a clinical trial that is intended to form the primary basis of a claim of effectiveness in support of FDA approval and is the subject of an active investigational new drug application submitted to the FDA
  • Whose active development or production is ongoing, and that has not been discontinued by the manufacturer or placed on clinical hold by the FDA
 
What is so controversial about the RTT?

Critics of the RTT argue that the act is a deliberate side-step of the FDA and presents more harm than good to seriously ill patients. Some claim that with the act, any drug can be usable after just phase one of clinical trials. To clarify, there are three phases of clinical trials that a drug must go through prior to being submitted to the FDA for review and approval; the FDA also may mandate further testing after approval of the drug.

A few claims from advocates of the law directly from the righttotry.org website:

  • RTT is needed because dying people don’t have access to promising treatments once clinical trials are over, even if the drug was successful and will be approved.
  • RTT is needed because it takes too long for promising treatments to be approved.
  • RTT is needed because you shouldn’t have to ask the federal government to save your own life.

Advocates of the RTT purport the importance of individual freedom and critics of the act criticize the introduction of new risks to patients. What do you think of the act? If you or a loved one was faced with a terminal illness and you heard of a promising treatment that might help, what would you do? Take a look at some patient stories here and decide for yourself.
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photo credit: wuestenigel Access text on blackboard via photopin (license)

Topics: The Right to Try Act, RTT Act

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