Sarah Owermohle, Politico: March 20, 2020.
President Donald Trump said he will “slash red tape like nobody has even done it before” in a bid to get unapproved coronavirus treatments to patients faster and identify effective drugs.
The president said Thursday he directed the Food and Drug Administration to “eliminate out-of-date rules and bureaucracy so this can go forward fast” — but he did not offer any details. Instead, Trump and top health officials highlighted steps the government has taken in recent weeks to launch clinical trials of potential coronavirus treatments.
Trump’s remarks came one day after he teased that an “exciting FDA announcement” was on the way — news that reportedly caught some in the health agency by surprise as they scrambled to finalize details, said three HHS officials.
Food and Drug Administration Commissioner Stephen Hahn appeared to downplay the president’s optimism about speeding up access to three drugs in particular. “What’s important is not to provide falsehood but provide hope,” Hahn said.
“We need to make sure the sea of new treatments will get the right drug to the right patients, at the right dosage, at the right time,” he added. “That’s why it is important we have our professionals looking at these therapeutics in development.”
Trump suggested certainprograms that the administration could use to get experimental drugs to people quickly outside of clinical trials. One such route, known as “Right to Try,” was established by a 2018 law that Trump and Vice President Mike Pence supported to help people who are seriously ill and have no other treatment options.
“What we’re talking about today is beyond Right to Try,” Trump said, adding that the law “has been a tremendous success.”
But outside researchers were quick to sound the alarm.
“Wow, that is bad advice from President Trump,” said Diana Zuckerman, a drug safety expert at the National Center for Health Research. “Lives can be saved if red tape is cut in terms of making tests, respirators, and hospital beds more available. Making untested antivirals available is not a good strategy.”
The Right to Try program allows patients to appeal directly to drugmakers to use medicines that are still being developed and tested. Bioethicists and drug policy experts argue there are other ways to help people access experimental medicine — like the FDA’s compassionate use route, also name checked by the president — and that Right to Try fuels false hope, while making it difficult to collect data on how well the drugs work.
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