The U.S. Food & Drug Administration (FDA) is allowing pathologists to work from home while reviewing cases during the coronavirus pandemic.
Before the publication of the emergency guidance document in April, FDA regulators had not approved remote viewing, requiring pathologists to be physically present while working at clinical laboratories and hospitals.
The guidance remains in effect throughout the national public health emergency, first declared by President Donald Trump in March.
Regulatory guidance documents are generally not legally binding or enforceable, but they describe the agency’s suggestions and recommendations for governed entities.
The new rule is one of several deregulatory moves by the Trump administration in response to the COVID-19 crisis, intended to save money and reduce the risk of accidental exposure to COVID-19 among pathologists and laboratory technicians.
Says Streamlining Is Safe
The FDA’s relaxation of overly strict rules on clinic technicians proves government barriers to medical innovation can be lowered without sacrificing patients’ safety, says Jeff Stier, a senior fellow with the Taxpayers Protection Alliance and a policy advisor at The Heartland Institute, which publishes Health Care News.
“I’m pleased to see that the FDA is relaxing regulations to provide better access to care during the pandemic,” Stier said. “Critics of such moves often justify burdensome regulations by alleging that the rules are necessary for various technical reasons. But the FDA, by attaching strict technical requirements before permitting remote reading of scans, proves that deregulation can be implemented nationally. The only problem with the agency’s move is the temporary nature of it.”
Hidden Costs, Forgotten Lives
Government rules are often enacted and then forgotten by bureaucrats, just like the people who pay the costs of overregulation, says Linda Gorman, director of the Health Care Policy Center at the Independence Institute.
“Once regulations are imposed, there is little incentive to lift them, examine how they interact with one another, or question whether the pile that has built up over the years makes much sense,” Gorman said. “People killed by too much regulation are not as visible as people killed by too little regulation. Plus, health care regulation is an easy sell: we have to keep people safe, after all, and even if it would save only one life, never mind that everything is a tradeoff.”
Calls for More Deregulation
Gorman says it’s too easy for lawmakers and agency officials to overlook the costs of their edicts.
“They don’t think in terms of tradeoffs,” Gorman said. “Health care policy people, especially if they are academics or in government public health agencies, often have an overweening belief in the beneficial effects of government central planning when applied to health care. [The free-market economist Friedrich] Hayek is not required reading for a public health degree.”
Congress plays a vital role in getting government out of the way of health care innovation, Gorman says.
“Lawmakers can reduce regulation by passing laws that repeal it,” Gorman said. “They can reduce the need for regulation by giving patients more control over how health care money is spent. Quality of care, like everything else, is subject to tradeoffs. Optimal quality for you will differ from optimal quality for me.
“The role of government, if anything, might be to certify that people are doing what they say they are doing—the test works, the harms of the drugs are disclosed, and what is in the package is what the seller says is in the package.” Gorman said.
Costs ‘Not Just Economic’
Stier says the FDA should take the opportunity to cement the changes to rules governing remote pathology and look for more red tape to cut once the pandemic ends.
“I encourage the FDA to work with providers and device manufacturers to study the benefits of the increased access, together with any unintended consequences, so that the deregulatory move could become permanent if supported by the data,” Stier said. “The costs of unnecessary regulation are not just economic.”
Jesse Hathaway (firstname.lastname@example.org) is a policy advisor with The Heartland Institute.