In responding to the Coronavirus pandemic, President Trump’s leadership has spurred sweeping deregulation to promote medical innovation and protect patient access to the healthcare system. Nationwide, over 600 rules and regulations have been waived and suspended at all levels of government.

Senator Ted Cruz (R-Texas) has introduced two pieces of legislation that will build on this success by ensuring that Food and Drug Administration (FDA) rules and bureaucracy do not needlessly interfere with America’s Coronavirus response. 

Getting the FDA out of the way to better fight COVID-19 has already been one of Trump’s deregulatory priorities. The administration has enacted numerous reforms including:

  • Giving states the power to allow their laboratories to develop COVID-19 diagnostics and testing, waiving the requirement of labs pursuing Emergency Use Authorization from the FDA.
  • Loosening FDA requirements around distribution of newly-developed tests, allowing states to get tests into the hands of American patients as swiftly as possible.
  • Easing FDA rules to increase ventilator production.
  • Issuing several FDA emergency authorizations for COVID-19 diagnostic and antibody tests.

Cruz’s bills build on the Trump Administration’s deregulatory response to the Coronavirus pandemic.

S. 3545, the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020,” establishes a reciprocal marketing approval process for COVID-19 drugs, biological products, and medical devices. 

This bill allows the sale of COVID-19 in the United States that have not yet been approved by the FDA if the product has already been approved in other countries.

Product sponsors must meet several criteria in order to sell in the U.S., including:

  • The product has been approved to treat or prevent the spread of COVID-19 in another specified country. 
  • The FDA and specified countries have not rescinded support or approval because of safety or effectiveness concerns.
  • There is a public health or unmet medical need for the product.


In order to withdraw approval, the FDA must determine that the product is unsafe or ineffective in treating COVID-19, and has 30 days to make such a determination after receiving a request.

The FDA is notoriously slow at approving new drugs. On average, it takes 90.3 months for pharmaceuticals to go through the development and approval process, imposing immense R&D costs on manufacturers. In the middle of a global pandemic, we simply can’t afford to have the government slow things down more than they already do.

The pharmaceutical industry is working at an unprecedented pace to develop and bring a COVID-19 cure to market. Even though the U.S. is leading the way on developing a vaccine, S. 3545 will ensure that the FDA does not needlessly prevent Americans from accessing a Coronavirus cure or treatment if it has been approved in other countries. 

S. 3769, the “Right to Test Act,” would allow states to approve and distribute Coronavirus tests as long as the state or federal government has declared a public health emergency. This would empower states to bypass FDA approval and drastically ramp up our testing capacity. 

We already know what happens when Washington bureaucrats are in charge of developing and producing Coronavirus testing. The Center for Disease Control (CDC) took weeks to develop a Coronavirus test after the pandemic reached our borders, only to contaminate the first round of testing kits and completely botch the rollout.

Widely-available Coronavirus testing will be a central part of safely reopening the American economy. S. 3767 will ensure that the FDA doesn’t stand in the way of any American receiving a test as long as their state is under a public health emergency.

Ultimately, S. 3545 and S. 3769 will ensure that FDA bureaucracy does not stand in the way of any American receiving a Coronavirus test, cure, or preventative treatment.