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More assertions by President Donald Trump about the Right to Try Act, a lack of regulations, and the emergence of startup companies that aim to profit from the 2018 law have sparked concerns from bioethicists and patient advocates more than a year after the law was enacted.
Trump has been promoting the law as saving patients' lives, yet the White House has declined to provide specific evidence to support the claim.
The Right to Try Act was adopted by Congress in May 2018. It permits critically ill U.S. patients to seek experimental treatments without going through the Food and Drug Administration's expanded-access program, also known as compassionate use, which has been in place for decades. The FDA said it grants about 99% of the compassionate-use requests it receives.
Trump and some lawmakers have insisted the FDA was not approving compassionate-use requests quickly enough and pushed to get the Right to Try law adopted as an additional option for patients.
Critics have said the real intent of the Right to Try Act was to weaken the FDA and have raised concerns that desperately ill patients could be exposed to "snake oil" salesmen peddling false hopes.
Adding to the confusion in recent days are two startups looking to profit from the administration’s law — both of which are named Beacon of Hope CRO, and both located in the same county in Florida.
"I'm not sure there is anything nefarious about all of this," bioethicist Jeremy Snyder of Simon Fraser University said of the two companies. "It is just strange and opaque. When we're dealing with clinical trials, expanded access, and real people with real illnesses who are desperately hoping for better health, however, transparency is needed."
STORY: 'Right to Try' twin startups, Trump's claims stir confusion, bioethicists say
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