The Food and Drug Administration’s test approval process resulted in an avoidable and costly delay in getting test kits for COVID-19 infection out to the public, which impeded an effective response to the pandemic by more than a month.
Eventually, the FDA permitted states to independently approve tests for use within their borders even if the tests had not yet received FDA approval. This temporary emergency action allowed several states that were hard-hit by the pandemic to rapidly ramp up testing. In some instances, states imported tests of proven quality that had been used in other countries. The devolution of authority to the states—50 “laboratories of democracy”—should remain in effect. The pre-pandemic federal monopoly on approving tests was never needed.
Congress should consider granting states the authority to approve drugs and other devices that may be marketed within their borders, independent of FDA approval, even when no public health emergency exists.
The Pfizer/BioNTech, Moderna, and Johnson & Johnson COVID-19 vaccines were developed and granted emergency approval in record time. The first messenger RNA vaccines became available less than a year after the pandemic reached North America. According to a report from the World Economic Forum, a vaccine takes an average of 10 years and $500 million to be developed and approved.
The FDA fast-tracked approval of COVID-19 vaccines as well as therapeutics under the Coronavirus Treatment Acceleration Program (CTAP). Under CTAP, the FDA grants emergency use authorization, if the benefits outweigh the risks, to vaccines that have already completed Phase 1 trials that demonstrate safety and Phase 2 trials that demonstrate safety and efficacy, but have not yet completed Phase 3 (long‐term protection) trials. Therapeutics such as remdesivir, Paxlovid, and molnupiravir have similarly been fast-tracked.
Policymakers should learn from this. Fast‐tracking drug and vaccine approvals should become the rule, not the exception. Better yet, patients should be able to choose between drugs and vaccines that are FDA‐approved and those approved by other “trusted” countries’ regulatory agencies. Patients should even be allowed access to therapeutics approved by independent third‐party certifiers if the label clearly states how and from whom the drug received certification. And as coronavirus cases mounted, the FDA should have sought to ameliorate the shortage of test kits by authorizing the use of tests already being used in similar countries.
Congress should pass legislation granting patients access to drugs and medical devices (including tests) already approved in similar countries. This already exists among the European Union states plus Iceland, Liechtenstein, and Norway. In July 2019, Sen. Ted Cruz (R‑TX) introduced S. 2161, the Reciprocity Ensures Streamlined Use of Lifesaving Treatment (RESULT) Act, which would allow the marketing of drugs approved in certain countries but not yet approved by the FDA, if “there is an unmet need.” It granted the FDA authority to block such drugs if the agency determined they were not safe and efficacious. Unfortunately, that provision, along with the “unmet need” requirement, undermined the goals of the proposed legislation. The bill failed to advance out of the Senate Committee on Health, Education, Labor and Pensions.