U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn recently gave a speech to the Alliance for a Stronger FDA. In it, he suggested that some of the changes forced on the agency by the COVID-19 pandemic are likely to become permanent.
U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn recently gave a speech to the Alliance for a Stronger FDA. In it, he suggested that some of the changes forced on the agency by the COVID-19 pandemic are likely to become permanent.
Worth noting, as Hahn does, he took on the role of Commissioner of the FDA in December 2019, and was quickly thrust into an emergency footing because of the pandemic. Prior to taking on the role, he was chief medical executive at MD Anderson Cancer Center.
“I certainly did not anticipate a public health emergency of this magnitude when I joined the agency. And I could not have imagined how significantly my new role would change and be shaped by this pandemic. I definitely could not have known that discussions about personal protective equipment (or PPE) or face masks or nasal swabs would be central to my work as Commissioner.”
Part of the challenge, he notes, is to maintain the high standards of the agency while in the middle of a crisis. To that end, “I pledged to myself and emphasized to my new colleagues at FDA that our decisions would always be rooted in science.”
That being said, the U.S. response to the pandemic has been highly criticized. An April 20 op-ed in the New England Journal of Medicine by Benjamin N. Rome and Jerry Avorn, physicians from the Program Oon Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, note, “The global pandemic has put pressure on clinicians and the Food and Drug Administration (FDA) to act swiftly to make medications available to patients. When very limited observational and anecdotal evidence raised the possibility that the antimalarial drugs chloroquine and hydroxychloroquine may have activity against SARS-CoV-2, President Donald Trump quickly began celebrating the promise of their widespread use, stating on national television that he had a ‘hunch’ that such therapy was effective and that the drugs could be a ‘game changer’ in addressing the pandemic.”
Shortly afterwards, they point out, the FDA, “still facing criticism that its delays in approving testing kits for the virus hindered prevention efforts” issued an Emergency Use Authorization (EUA) on March 28 that allowed chloroquine and hydroxychloroquine for use in COVID-19, as well as their addition to the federal stockpile. “Its issuance,” they write, “was widely yet incorrectly reported by Trump and others as meaning that the FDA had approved the drugs for this indication. The Centers for Disease Control and Prevention (CDC) went so far as to publish doses of chloroquine and hydroxychloroquine for use in patients with COVID-19, though it later removed them from its website.”
Hahn listed his actions to date, including working to maintain the safety of the country’s food supply, monitoring for signs of foodborne illness outbreaks; facilitated efforts to development diagnostic tests, treatments and vaccines; “have helped facilitate increases in our national testing capacity, having helped ensure continued access to necessary medical products, and have sought to prevent the sale of fraudulent products.”
“To be sure,” he adds, “there were bumps along the road, but today we have an adequate supply of the devices that have been in unprecedented high demand such as PPE, ventilators, and others.”
Yet, today, USA Today published an article on clinical testing in the U.S., writing, “For nine critical weeks during the pandemic, the agency exercised little of its power to decide which companies could sell blood tests aimed at detecting whether someone was previously infected. In that vacuum of oversight, USA Today—in the most thorough independent review to date—found a nascent industry with inexperienced or dubious companies jockeying to cash in.”
The FDA has rebounded. USA Today wrote, “Facing withering criticism, the FDA recently tightened its restrictions, requiring companies to submit data on their test’s accuracy and how it will be marketed. In recent days, about 30 tests have been dropped from the FDA list, some of them voluntarily.”
The FDA responded to the USA Today findings in a written statement, saying that it takes fraud seriously and “continually monitors and conducts surveillance for fraudulent and inappropriately marketed medical products, including tests.”
Scott Becker, chief executive officer of the Association of Public Health Laboratories, told USA Today that lab representatives were on a March conference call with the FDA where the agency describes its initial plans to allow almost anyone to sell antibody tests, saying, “You could see the train wreck coming.”
Hahn’s rebuttal in his speech was, “As you have seen reported, early in the crisis we provided regulatory flexibility for developers with validated tests as outlined in our policies because public health needs dictated that we do as much testing as possible. But as the process has matured, we have helped increase the number of authorized tests, and we have adapted some of our policies to best serve the public need.”
But aside from some self-defense efforts, the focus of Hahn’s speed was on the need for the FDA to adjust to the pandemic and now it’s time to determine if some of those changes should be made permanent. “I have instructed my staff to identify the lessons learned from this pandemic and what adjustments may be needed, not just to manage this or future emergencies, but to make FDA itself more efficient in carrying out our regulatory responsibilities.”
Some of that involves streamlining some of the processes in developing new treatments, evaluating how clinical trials are designed and conducted, and the use of expanded access to meet the needs of patients not eligible or unable to participate in randomized clinical trials.
“Many of the permanent changes that we will implement really represent an acceleration of where we were headed before,” Hahn stated. “For example, the concept of decentralized clinical trials, in which trial procedures are conducted near the patient’s home and through use of local health care providers or local laboratories has been discussed before, and laid the foundation for some of the trials for COVID-19 products.”
He also emphasized the use of real-world evidence (RWE) in COVID-19 trials as something that is likely to stick post-pandemic. That was something that was being built in the later period of the previous commissioner, Scott Gottlieb’s leadership.
