Just four months after President Trump asked the U.S. House of Representatives, in his State of the Union address, to make it a high priority to pass “right to try” legislation, a bill is now on his desk, ready for his signature. Bill HR 878 passed the U.S. Senate in 2017 by a unanimous vote.
The bill authorizes doctors to prescribe drugs that have cleared a Phase 1 trial, but which have yet to be tested in human clinical trials and therefore have not been approved by the FDA.
Similar legislation has already been passed in 38 states, largely due to the efforts of the libertarian-leaning Goldwater Institute. Despite the policy’s growing popularity, questions remain about the impact of the legislation.
Will It Help?
Policy analysts argue that the bill would accomplish very little for most patients while making it harder to get future drugs to get approved, which could do more harm than good for those who are not terminally ill. The legislation does give hope to some who suffer from conditions such as amyotrophic lateral sclerosis or ALS.
There’s also nothing in the legislation that makes it mandatory for pharmaceutical companies to provide these medications, nor for insurance companies to pay the drugs or for treatment of any harmful side effects which arise from their use. For this reason, experimental drugs can be hard to get and are extremely costly.
Drug companies have also expressed concern that allowing humans to use experimental drugs opens them up to lawsuits if use of the drug causes unforeseen side effects. The bill does provide some protections, but drug companies are likely to remain cautious as they see little upside.
Opponents of the measure also point to an already existing FDA program known as the “compassionate use act” which is meant to give patients access to experimental medications. The program allows patients to try experimental drugs after approval by a panel of FDA experts. So far, the FDA has approved 99% of requests made under the legislation, totaling more than 5,000. The new bill eliminates the FDA’s role, only slightly simplifying the process.
Under the bill, seriously ill patients will, indeed, finally be allowed to use marijuana, MDMA, and psilocybin. Marijuana meets the criteria of passing a Phase 1 trial because research on medical cannabis use by military veterans with PTSD is currently in Phase 2. Trials involving MDMA and psilocybin have undergone Phase 1 and 2 clinical trials.
Should President Trump sign the bill as expected, terminally ill patients who use medical cannabis will be protected from federal harassment.
This article by CN Editor Rick Schettino was originally written for and appeared on PotNetwork.com.