Editor’s Note: Dr. Stephen M. Hahn was sworn in as the 24th Commissioner of Food and Drugs on December 17, 2019. Hahn is a physician, scientist and health care leader with an extensive background in patient care, academic research and executive leadership. Prior to joining the FDA, Hahn served as the chief medical executive at The University of Texas MD Anderson Cancer Center. The opinions expressed in this commentary are his own. View more opinion articles at CNN.
With the spread of the coronavirus around the world, America’s health care system faces its greatest challenge in decades. In response to this national emergency, President Donald Trump is utilizing the authority and resources of the federal government to protect the American people. President Trump has empowered the FDA to provide flexibility to those in the private sector who are stepping up by manufacturing critical medical products and distributing food supplies.
I am proud to lead the US Food and Drug Administration, which plays an indispensable role in the American health care system and in our country’s response to the coronavirus pandemic. We work every day to ensure the safety and effectiveness of drugs, vaccine and medical devices that the American people use to stay healthy. Our oversight of medical products facilitates America’s dynamic and innovative medical research and development, which has changed our country and our world for the better.
In the fight against the coronavirus, the FDA is providing maximum flexibility across all of our regulatory areas to reduce red tape while still maintaining our gold standard for safety and effectiveness. The FDA does not develop tests – that’s up to the private sector and other federal government partners, such as the Centers for Disease Control and Prevention.
In a public health emergency, we have tools that Congress granted us to help us review tests quickly. And during this emergency, what we have done is offer different pathways to bring these tests to market so they are available to patients.
We are quickly authorizing the tests that developers send us – most in 24 hours, including Abbott’s test, which can deliver results in minutes. We are reviewing these applications around the clock and more than 230 test developers have chosen this pathway to date. We’ve also issued a policy offering flexible processes, meaning more than 110 labs and test developers across the country did not have to wait for the FDA to review their tests before patient testing – they only needed to confirm the tests work.
Relaxing the regulatory requirements has led to an exponential growth in the availability of tests across the country. According to data from the Department of Health and Human Services, 18.5 million tests have been distributed to date.
And we’re not just focused on increasing the quantity of tests but ensuring the quality. Inaccurate test results during a pandemic are especially dangerous. I can assure every American that we are working to ensure that the tests are accurate and that our policies strike the right balance of scientific oversight while expediting testing availability. We issued a warning about consumers using at-home test kits, which we have not authorized due to concerns about accuracy, which may keep some patients from seeking the care they need.
We’re also working to streamline our processes for coronavirus vaccines and therapeutic treatment. In nearly record time, a potential coronavirus vaccine has already begun a Phase 1 clinical trial. If there are strong data to demonstrate the safety and efficacy of a vaccine, I am committed to reviewing it as quickly possible.
There are also ways we can help with the development of medicines to get treatments to patients quickly, such as through clinical trials of new drugs or facilitating the availability of drugs, such as chloroquine, that are already approved for other uses. While clinical trials are ongoing to assess the benefits of both new and existing drugs for treatment of Covid-19, doctors may prescribe medicines approved for other uses right now for their patients with Covid-19 when they judge that it could help their patients. It should be noted that no one should be taking these drugs without the supervision of a doctor, as they are still in the testing phases for Covid-19 and their safety and efficacy in this regard is still being determined.
We’re also actively monitoring the medical supply chain and doing what we can to mitigate any shortages. To prevent a shortage of hand sanitizer, for example, we issued a policy for new sources of alcohol-based hand sanitizer to come to the market. We have also been aggressively working with partners to identify and mitigate shortages of personal protective equipment by granting authorizations for alternative sources for masks, gowns and gloves. We are relaxing red tape to allow non-traditional manufacturers to produce much-needed supplies such as personal protective equipment and ventilator parts.
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We are also working to minimize disruptions in the food supply chain as grocery stores face unprecedented demand.
The American people can be assured that we will take many other meaningful measures in the weeks ahead. Under President Donald Trump, the FDA will continue to take strong action to protect the American people.
