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ASCO Supports FDA's Expanded Access Program, Wary of Right to Try

Surabhi Dangi-Garimella, PhD
The American Society of Clinical Oncology (ASCO) has released a statement raising serious concerns about right to try, while strongly supporting the FDAs expanded access program.
Thirty-three states in the United States have passed a right-to-try (RTT) law, which bypasses the FDA to provide access to phase 1 drugs for patients who are terminally ill. However, the American Society of Clinical Oncology (ASCO) has released a statement raising serious concerns about RTT while strongly supporting the FDA’s expanded access program.
 
In a position statement released today, ASCO said these measures lack adequate patient protections and do not remove any of the major barriers patients face in accessing investigational drugs outside of clinical trials.
 
“ASCO supports access to investigational drugs outside of clinical trials when adequate patient protections are in place,” said ASCO Chief Medical Officer Richard L. Schilsky, MD, FACP, FASCO. “We don't support right to try legislation, however, because these laws ignore key patient protections without actually improving patient access to investigational drugs outside of clinical trials.”
 
Also called “compassionate use,” the expanded access program allows use of investigational drugs, yet to be FDA approved, outside of a clinical trial, when a patient may not be eligible to participate in an ongoing trial. For a patient to qualify for expanded access, the FDA has laid out the following requirements:
  • The patient and a licensed physician are both willing to participate
  • The patient’s physician determines that there is no comparable or satisfactory therapy available to diagnose, monitor, or treat the patient’s disease or condition
  • That the probable risk to the person from the investigational product is not greater than the probable risk from the disease or condition
  • The FDA determines that there is sufficient evidence of the safety and effectiveness of the investigational product to support its use in the particular circumstance
  • The FDA determines that providing the investigational product will not interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval
  • The sponsor, the clinical investigator, or the patient’s physician in the case of a single patient expanded access request, submits a clinical protocol that is consistent with the FDA’s statute and applicable regulations for investigational new drugs (INDs) or investigational device exemption applications describing the use of the investigational product
  • The patient is unable to obtain the investigational drug under another IND or to participate in a clinical trial


 
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