On May 19, 2020, as a result of the coronavirus or SARS-CoV-2, President Trump issued Executive Order (EO) 13924 to combat the economic consequences of the virus “with the same vigor and resourcefulness with which the fight against COVID-19 itself has been waged.”  He ordered that “agencies must continue to remove barriers to the greatest engine of economic prosperity the world has ever known: the innovation, initiative, and drive of the American people.”  He called on agencies to address the nation’s economic emergency by “rescinding, modifying, waiving, or providing exemptions from regulations and other requirements that may inhibit economic recovery, consistent with applicable law and with protection of the public health and safety, with national and homeland security, and with budgetary priorities and operational feasibility.”

Citizens Against Government Waste (CAGW) has discussed how the nation’s major healthcare regulatory agencies, like the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), have already taken numerous steps to lower barriers early in the COVID-19 crisis by allowing investigational new drug medications and medical devices, like COVID-19 test kits, to be used by physicians and laboratories quickly through emergency use authority (EUA). Healthcare delivery and payment policies were relaxed that permitted health professionals to practice medicine at the top of their license, allowed doctors to use telehealth to meet with Medicare beneficiaries, and authorized pharmacists to use test kits to discover whether a patient had been infected by the virus.

The May 19 EO is attempting to get agency heads to identify regulatory standards that may inhibit economic recovery and take appropriate action within current law either temporarily or permanently, and rescind, modify, waive, or exempt persons or entities from the regulations and relax enforcement whenever possible to promote job creation and economic growth.  According to the Trump administration, more than 600 deregulatory actions, like suspensions, waivers, and enforcement discretion, have had a significant impact in expediting and improving the response to the coronavirus.  The administration wants to determine which of these actions should be made permanent and will work with the states to change their laws that are standing in the way of easing burdensome restrictions.

Health professionals and policy experts agree that many of the deregulatory measures implemented in March, April, and May should be made permanent.  The most obvious candidate is telehealth, which has been utilized extensively by doctors and patients across the country and will likely never go back to how it was pre-COVID-19.  The President’s Council of Economic Advisers stated that, “beyond aiding the Administration’s COVID-19 response, telehealth has the potential to expand quality healthcare to individuals with limited access to physical services, including some rural Americans, those who are disabled, and elderly patients who have difficulty traveling.  Additionally, telehealth can cut overhead costs and reduce the overall time it takes to seek medical expertise for diagnoses and treatments.”

Personal delivery services for medications were also expanded.  CVS announced in early March that it would waive charges for home delivery of prescription medicines in order to enable people to stay safe at home.  In April, CVS announced it would use its community presence to test people in their facilities’ parking lots or at drive-through windows while maintaining strict safety standards.  This enabled patients to avoid a hospital emergency room and get tested for COVID-19.  Other pharmacies like Rite Aid, Publix, and Walgreens, are offering the same services for their customers.  It is likely that free delivery and testing for other illnesses will become commonplace going forward.

CMS Administrator Seema Verma was already leading in the deregulatory area with other actions undertaken prior to COVID-19 and has promised this will be a continued focus of the agency going forward.

There will be a major push as well for the FDA to speed up drug and medical device approvals beyond COVID-19.  Currently, there are three vaccines for COVID-19 that received an EUA from the FDA and have entered human clinical trials.  Moderna announced it would enter phase three for its vaccine in July and will be tested on 30,000 individuals.  This is unprecedented as it usually takes years for a vaccine to be developed.  Several other vaccines are in preclinical trials.

Other medications are moving equally as fast like Remdesivir, which is an antiviral currently under an EUA that has helped COVID-19 patients recover faster.  Other therapies, like utilizing blood plasma from people who recovered from COVID-19 to help people fight the disease, are being used in hospitals under an FDA-developed protocol.

Testing kits entered the market at lightning speed, which determine if a person has COVID-19 or had it and has developed antibodies and are being used extensively across the nation.

In response to the coronavirus, the FDA established the Coronavirus Treatment Acceleration Program (CTAP) to use “every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.”

Following the protocol and procedures developed in CTAP, it has been shown that the FDA can speed up drug and medical device approvals when it focuses on getting it done.  Once the pandemic is under control, it will be up to the FDA, working with pharmaceutical and medical device companies, scientists, and physicians, to review what worked well and what needs improvement.  Speeding up drug and device approvals will require the FDA to focus its resources on its core missions.  By doing so it will help to lower medical costs and get important life-saving products to patients quickly.

COVID-19 has caused an unprecedented healthcare and economic crisis for the United States.  The lessons learned from the response to the pandemic and the deregulatory actions taken by the federal government must be used to keep Americans healthy and help the economy recover both now and in the future.