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President Donald Trump signed legislation Wednesday that will give terminally ill patients the "right to try" experimental treatments not approved by the Food and Drug Administration, although observers say the cooperation of drug companies and affordability issues could limit the law's real-world application.
What Happened
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Under the new law, terminally ill patients who are ineligible for clinical trials and have exhausted all treatment options will now be allowed to test experimental therapies not yet approved by the FDA. The “right to try” legislation supports use of drug candidates that have cleared Phase 1 trials and encompasses life-threatening conditions many drugmakers are targeting, such as amyotrophic lateral sclerosis and Alzheimer’s disease.
Why It’s Important
In providing a workaround for the FDA’s long and arduous trial processes, the law accelerates the time it takes for patients to access a new formula and may make it easier for clinical-stage pharmaceuticals developing orphan drugs to test their products.
Notably, companies are not obliged to grant any patient requests for investigational drugs.
Many may forgo the right in order to protect limited molecule supply; prevent lawsuits over inefficacy or adverse side effects; or to keep clinical data from being marred by unwanted outcomes in uncontrolled settings. Negative results could alert the FDA and delay official approval of drug candidates.
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While company cooperation remains a barrier, so does affordability. Patients may find the financial burden, unsupported by insurance plans, too significant to attempt treatment.
In all, some analysts argue the new legislation will have little impact on the availability of experimental drugs, as 38 states have already passed similar measures and the FDA has a “compassionate use” program in place to approve access for desperate patients. Other critics say it will stunt the FDA’s procedures protecting public health.
What’s Next
At the time that the law was passed, Trump said voluntary price decreases from pharma companies were imminent.
Due to the additional variables in the biotech space, it's unclear whether the marginal midday gains in the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ:IBB) and SPDR S&P Biotech (ETF) (NYSE:XBI) could be attributed to the “right to try” law or the threat of price pops.
Related Links:
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Trump Strikes At PBMs, Insurers, Drugmakers With Plans To Lower Consumer Prices
White House photo by D. Myles Cullen.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.