The Bioshield Act, along with the laws that later modified it, was not intended as a carte blanche. For instance, an E.U.A. can only be granted during a declared public health or national security emergency, and is supposed to be used only for products that have no adequate, approved or available alternatives. But the F.D.A. was granted wide discretion to decide whether a product ought to be made available to the public. By law, the agency can grant E.U.A.s to products that “may be effective,” whose “known and potential benefits” outweigh “the known and potential risks.” It is up to the agency, however, to determine what those criteria mean.
“It was deliberately a quite flexible kind of standard,” said Dr. Jesse Goodman, the director of the Center on Medical Product Access, Safety and Stewardship at Georgetown, and the F.D.A.’s chief scientist from 2009 to 2014. E.U.A.s are intended to be evaluated on a case-by-case basis; the F.D.A. might tolerate more risk for a drug designed to treat a disease with a high mortality rate, such as Ebola, than for a vaccine that would be given to healthy people to stop a disease like Covid-19, Mr. Goodman said.
But, he added, E.U.A.s were not meant as a substitute for traditional approvals: “The intent originally was that ultimately you should be collecting data and moving these products toward approval,” even after the emergency authorization was granted.
However, it can be difficult to fully enroll a product in clinical trials after it has received an E.U.A., Dr. Goodman said, because clinical trials typically impose more stringent requirements on patients than an E.U.A. would. “Now we have tens of thousands of people getting convalescent plasma” — a Covid-19 treatment that was granted an E.U.A. in August — “and we still don’t know whether it works,” he said.
Another potential hazard of emergency authorization became apparent not long after the Bioshield Act was signed into law, when the F.D.A. granted its first E.U.A., at the request of the Defense Department, for the use of an anthrax vaccine, in 2005. That authorization suggested to some people, including Chris Shays, then a Republican congressman from Connecticut, that the E.U.A. process provided an avenue for political interference. The apparent urgency “appears to be the product of preventable legal and regulatory failures,” Mr. Shays wrote in a letter to the Secretary of Health and Human Services, “rather than any validated external threat.”
The actions of the Trump administration during the Covid pandemic have renewed these concerns. In May, Rick Bright, the former head of the Biomedical Advanced Research and Development Authority, alleged in a whistle-blower complaint that he had arranged an E.U.A. request for hydroxychloroquine and chloroquine as a “compromise position” to head off pressure by administration officials to make the drugs available under a less-restrictive protocol known as “expanded access.”
In late September, Mr. Trump said that he was considering blocking the F.D.A.’s vaccine E.U.A. guidelines, which made it unlikely that a vaccine would be authorized before the presidential election, because he saw them as “a political move more than anything else.” And Mr. Trump’s insistence, in the video he posted on Wednesday, that “we’ve got to get” an E.U.A. for the Regeneron antibodies “signed now” was an extraordinary intervention into a process that is usually left to career scientists at the F.D.A. (A few hours after Mr. Trump tweeted the video, Regeneron announced that it had officially applied for an E.U.A., although the company had previously suggested its intention to seek one.)