The Right to Try Act and What It Means for Myeloma Patients
The new Right to Try Act was signed into law on May 30, 2018. This act builds on the foundation of the governments Expanded Access programs, that we previously wrote about here. Previously, if a patient with a terminal illness was seeking an experimental treatment under the Expanded Access program, their doctor was required to initiate a request for the treatment. The request needed several different approvals, first from the pharmaceutical company manufacturing the drug, then from the FDA, and finally from the investigational review board (IRB) of the institution where they would be receiving it. This process was tedious and time consuming, especially for terminally ill patients, and very busy physicians.
The Right to Try Act removes the need for IRB and FDA Approval, making the process much more straightforward for physicians and their patients requesting experimental treatments. There are still some limitations with Right to Try - pharmaceutical companies cannot be required to provide their treatments to patients, and some pharmaceutical companies, even if they approve the request, may pass along the cost of manufacturing and shipping the drug to the patient - although Right to Try prevents them from profiting of the request. Additionally, the cost of receiving the therapy may not be covered by private insurances, Medicare or Medicaid. In order to be eligible for consideration under the Right to Try Act, patients and investigational drugs must meet certain criteria.
An eligible patient is a patient who has:
- 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
An eligible investigational drug is an investigational drug:
- 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
With this law being passed so recently, details about how to use the Right to Try Act are sometimes hard to find. You can always call us at SparkCures (888) 828-2206, and we will be happy to help you find the answers you need.