Select patients are now able to seek non-FDA approved experimental drugs and treatments. President Trump signed the bill May 30 stating it would provide terminally ill patients with the “hope of finding something.”
The “compassionate use” program enacted by the FDA already grants access to experimental drugs after the patient has applied; the FDA commissioner Scott Gottlieb said that approximately 99 percent of requests are approved annually. This “right to try” legislation would completely bypass the program.
Terms and conditions do apply. Before pursuing the experimental treatment, the patient must have exercised all other options and treatments and drug companies are not obligated to allow access if the drug makers have concerns of their own.
The drug does not have to be FDA approved but it must have gone through the phase I clinical trial, which determines its safety but not effectiveness. The FDA can also ignore deaths outside a clinical trial according to the Washington Examiner.
Trump highlighted that the new Senate bill enables drug companies to collect information on how a new drug actually works and the degree to which it is effective.
In an article published last week, CNBC called the bill “controversial,” in light of critics who believe the bill “undermines the FDA’s authority to regulate drugs and could leave patients vulnerable to medicines that might not work or may even be harmful.”
Drug companies are still skeptical when it comes to providing patients with a product outside of clinical trial.
For more information on the role of drug companies in this bill, visit the Washington Examiner.
Read USA Today for more reporting on the “right to try” legislation.