The Right-To-Try Law is a federal legislation which allows terminally ill patients the opportunity to use experimental drugs that don’t yet have FDA approval. It’s controversial at best, but some patients feels like it’s their only option.
Of course, there are some regulations under this law. The policy says that the drug must have completed a phase 1 clinical trial successfully. The drug must also be working toward FDA approval. The FDA must be informed before one of these drugs is administered to a patient, however drug manufacturers do not need consent from the FDA. This law only requires the signature of a physician and the drugmaker for the patient to receive the requested drug.
41 states in the U.S. have implemented their own forms of this law in addition to the federal legislation. Advocates hope that it will allow patients in critical need the opportunity to receive treatment faster as it will let them slip past the “bureaucratic red tape.”
The very first patient just received treatment under this law that passed last November.
The first individual given a drug under this legislation was a Glioblastoma patient. They were given a new vaccine developed by the Epitopoietic Research Corp (ERC). This vaccine is based on extracted tumor cells which work to stimulate the body’s immune system. The hope is that the immune system will then begin to recognize and reject the cancerous cells in the body.
Last June ERC told the FDA it planned to provide the vaccine to a patient who didn’t qualify for their clinical trial (an ongoing Phase 2 study). In July, the FDA acknowledged the companies request. Finally, in November of 2018 the patient was given the treatment at the University of California, Irvine.
In addition to this U.S. patient, the ERC has provided 28 patients outside of the United States this treatment through various compassionate-use programs.
Critiques of Right-To-Try
Some people don’t believe this law is necessary because the FDA already grants patients access to unapproved treatments quite frequently. Under their compassionate-use policies, 99% of requests for access are approved.
Some are also afraid that it could cause exploitation of patients by corrupt companies.
However, others say that for those who don’t qualify for clinical trials, it could be their only alternative. There are many reasons a patient may not qualify for a trial including the type of medication they’re already taking, physical limitations, co-morbidities, or the progression of their disease.
You can read more about Right-To-Try and the ERCs work in Glioblastoma here.