Is FDA’s Credibility at Risk from Pandemic Actions?
Public health officials and former FDAers are expressing concern that by hastily allowing unproven coronavirus antibody tests on the market and by authorizing emergency use of hydroxychloroquine FDA is risking losing its hard-won credibility as the gold standard for world health agencies. An in-depth McClatchy News article says the agency has reversed course in recent days, demanding that companies that produce antibody tests prove their effectiveness and warning healthcare providers against using hydroxychloroquine for coronavirus patients.
“But career public health officials saw these early developments as warning signs that a greased regulatory framework put in place in the heat of an unprecedented crisis could become a slippery slope inflicting long-term damage on the agency’s credibility,” the article says. “As FDA uses emergency powers to fast-track antibody testing, drug treatments, and vaccine trials during the pandemic, circumventing regulations that have been honed for decades by public health officials, medical experts are asking if there is any going back.”
Former FDAer Regina Barrell told the news service that for the antibody tests, “the question of false positives and false negatives goes to the heart of why these regulations are needed. We were always considered the gold standard in the world for health agencies. If you passed FDA muster, you got a gold star. For the agency to be impacted negatively one way or another would be a tremendous detriment not just to our country but to the world.”
Public health officials are quoted as saying that since FDA has made many decisions under emergency authorities approved in 2004, the Trump administration has not relaxed FDA regulations in response to the crisis, which could have left the agency without a framework in place to restore pre-pandemic standards once the crisis ends.
“Obviously that was put in place to protect against backpedaling [and] ideally that’s the way things will be applied,” said Harvard professor Richard Frank, who was an HHS assistant secretary in the Obama administration. “But given that the devil is in implementation, how we go back to, in a sense, regular law, if you will, is going to be very important. We want to go back to a world that prioritizes evidence-based treatment.”
FDA commissioner Stephen Hahn told McClatchy the steps the agency has taken using its emergency authorities have been “based on a careful, science-based balancing of the risks and benefits of making unapproved medical products or unapproved uses of approved medical products available to combat the pandemic. The agency will continue to evolve its approaches both during and after this public health emergency with a focus on efficiently using the full breadth of our authorities to ensure the safety, quality, and supply of FDA-regulated products and provide the industries we regulate with the tools and flexibility to do the same.”
The article says that FDA officials including Hahn reject the notion that political pressures have interfered in the agency’s operations, maintaining that an urgent sense of public duty has motivated its work to quickly identify tools that can combat the pandemic.
While some public health experts worry that the agency will be pressured over approving a coronavirus vaccine, CBER director Peter Marks insisted that FDA would ensure that any vaccine that emerges “meets our high standards for safety and efficacy. Nobody’s looking to skip any of the parts of the development program to lead to a safe and effective vaccine. That said, in this particular crisis, we need to try to move very quickly to get there, working meticulously, because there is just so much at stake here.”
McClatchy says that career FDA officials expect that the internal debate over approving a coronavirus vaccine will be loud and rancorous, given the consequences for both the agency and the public.
“I can’t say that politics won’t try to push it through,” Barrell said. “But I think that if it does, there would be a lot of people screaming. It would be obvious that something’s going on. You’ll hear their voices that something’s not right.”