By Stuart Singer and John D. Graham
Currently, there are “no FDA-approved drugs specifically for the treatment of patients with COVID-19,” per the Centers for Disease Control and Prevention. There is also no vaccine. But there are antiviral drugs that show promise in tests and actual use. Food and Drug Administration emergency use powers should be exercised to fast-track the approval and use of these drugs. Confidence in accelerated approval will facilitate greater speed in their manufacture, which can and should be assured by the federal government through use of the Defense Production Act.
Leading scientists have predicted dire short-term public health impacts from the spread of the coronavirus, and the resulting COVID-19 disease. The president has said holding U.S. deaths under 100,000 would reflect good efforts. Other estimates are far higher. A reasonable weighing of risks and benefits shows that quick testing, approval and distribution of promising drugs could save hundreds of thousands of lives and help to mitigate the current medical care crisis.
As of March 20, at least 17 different drugs are in various states of development and clinical trials as potential treatments for COVID-19. These include Gilead’s Remdesivir, which seeks to interrupt the coronavirus’ ability to replicate and is subject to various clinical tests. Roche’s Actemra was approved in China for use of treatment of severe complications related to the coronavirus. And beginning March 24, New York started a clinical study of hydroxychloroquine and azithromycin, which showed promise in a small French study.
The Issue of Time
The problem is the proposed time frame for expedited FDA approval of promising antiviral drugs. FDA Commissioner Stephen Hahn on March 19 spoke of the responsibility to ensure products are safe and effective, and that the FDA “wants to do that in the setting of a large pragmatic clinical trial.” Such trials, even if accelerated, take months to perform and assess, time we do not have. Aside from existing antiviral medicines that are available now, but that require efficacy testing, the process for new drug approval requires months for clinical trials and assessment of the results. Regular FDA approval takes up to two and a half years, priority review takes six months and even fast-track approvals are 60 days after submission of data.
And after trials, manufacturing could take additional months. Credit Suisse’s pharmaceutical team estimated that building stocks of legacy drugs and new drug candidates would take months. In a recent Newsweek piece, Adam Piore reported that Christos Kyratsous, Regeneron’s vice president for research, “says it will take about four months to go from picking the most potent antibodies to producing enough cells to provide the tens of thousands of liters of medicine needed to make the drug widely available to those suffering from COVID-19 in the U.S.”
There is an alternative, involving three discrete but related legal steps.
Emergency Use Authorization
First, the FDA has authority under Section 564 of the Food, Drug and Cosmetic Act to give emergency use authorization for the production and use of antiviral drugs that show promise in combating the coronavirus.
The FDA has already exercised this authority with respect to protective equipment and testing kits for the coronavirus and should do so for drugs that have shown efficacy and have a record of safe use at appropriate dosing. On March 29, the FDA issued a limited emergency use authorization for chloroquine in treating COVID-19. The FDA can also use this authority for approval of new drugs, if clinical use or smaller-scale trials show efficacy and safety. The same emergency use authority is possible for vaccines that show promise.
Reciprocal Use
Second, Congress should within a few days pass emergency legislation to allow for the reciprocal use in the United States of drugs that receive approval in other countries. Sen. Ted Cruz, R-Texas, has introduced legislation toward that end. To address public concern about the trustworthiness of China, FDA should perform a special review of the safety and efficacy of any new drug permitted into the U.S. only because of use in China.
The Defense Production Act
Third, the president should exercise his emergency powers under the Defense Production Act, which he has already invoked, to take steps to accelerate manufacture and distribution of the drugs receiving emergency or reciprocal approval, so that they are available for actual patient use throughout the country in a matter of weeks, not six months or longer.
The act allows for entering government contracts to prioritize production of such drugs—as well as masks, protective gear and ventilators—over all else. The language of the act allows this because the uncontrolled spread of the virus certainly undermines national security. The act also allows for federal government loans and loan guarantees for manufacturers.
Taking action now is required so that the manufacturing and distribution of antiviral drugs, and later vaccines, starts occurring now.
Without an organized process where the federal government is seen to be urgently taking these steps, doctors and patients will simply reach out to get prescriptions for whichever drugs that are available for off-label use, thereby making them scarcer for other patients who need them.
Under our proposal, we recognize that some patients will be treated with drugs that are not effective. We believe that the risks of not waiting for multiple-month clinical trials are easily outweighed by the benefits of saving lives, and avoiding a catastrophic overloading of the health care system.
Our existing regulatory policy is not built to deal with a pandemic. The structured and careful process for approval of new drugs through clinical trials and staged approval will result in far too limited treatments for the hundreds of thousands or millions of Americans who could be infected over the next several months. Every minute counts. Moving quickly on the three recommendations we’ve outlined above has the potential to save thousands of lives—but the FDA and Congress must act immediately.
Reprinted with permission from the April 1, 2020, edition of the National Law Journal © 2020 ALM Media Properties, LLC. All rights reserved. Further duplication without permission is prohibited. ALMReprints.com – 877-257-3382 - [email protected].