Trump Sought to Expand Virus Drug Tests Over FDA Objections Plan would have expanded use of investigational drugs for coronavirus; FDA officials said plan would pose risks to patients By Thomas M. Burton
https://www.wsj.com/articles/trump-sought-to-expand-virus-drug-tests-over-fda-objections-11584545251
WASHINGTON—The White House considered issuing an executive order greatly expanding the use of investigational drugs against the new coronavirus, but met with objections from Food and Drug Administration scientists who warned it could pose unneeded risks to patients, according to a senior government official.
The idea to expand testing of drugs and other medical therapies was strongly opposed by the FDA’s senior scientists this week, the official said, and represented the most notable conflict between the FDA and the White House in recent memory.
Asked about The Wall Street Journal’s report at a press briefing Wednesday, President Trump replied that he hadn’t seen the article, but added: “We are making a lot of progress with therapeutics.”
Mr. Trump told reporters that his administration is expanding access to tests for the virus, and later said there would be a news conference Thursday involving the FDA.
Mr. Trump said he is also invoking the Defense Production Act to get more medical supplies like protective masks and hospital gowns in greater supply. Many hospitals are saying that th ey are already running short of such protective products that could protect doctors and nurses who are treating patients who are sick with the coronavirus.
Also at the press briefing, Mr. Trump said the current experience of getting tested with a nasal swab—which he said he has done recently— “is not very nice to do, I can tell you that.” He said there is a test in the works in which a patient can do the swab on himself or herself, potentially making the experience more pleasant.
Dr. Deborah Birx, the administration’s top-ranking coronavirus doctor, said at the briefing that there are indications that millennial Americans have a disproportionately large number of cases.
The draft order to expand testing was entitled Executive Order to Save Lives.
It would have allowed any drug molecule or cell therapy with evidence of safety to begin Phase 1 testing for patients infected with the Covid-19 coronavirus disease.
Normally, the FDA is involved in any such process to decide whether there are enough safety data to warrant going ahead with research. The draft order doesn’t spell out what “evidence of safety” means precisely, though it said any drug should have completed unspecified human safety studies.
Cell therapies, which are a newer and often controversial form of treatment, could raise their own problems. While the FDA has encouraged scientific study of cell therapies, it has also undertaken legal action against cell therapy centers that it has regarded as selling sham treatments to patients.
The order would have allowed such research to proceed if it has a scientific review and endorsement by a panel consisting of a scientist, a hospital administrator, a doctor and a person with regulatory-affairs expertise who has present-day dealings with the FDA.
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Write to Thomas M. Burton at tom.burton@wsj.com
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