While it is too early to assess the performance of the U.S. medical system’s coronavirus response as a whole, public sector performance has been disappointing. The CDC’s testing failure and its early refusal to partner with the private sector have been well-documented. But the bureaucratic approach to health care regulation has deep-seated problems. Failures are attributed to inadequate budgets, but more funding creates more regulations, more programs, and less focus. Regulations proliferate, health care costs increase, and agencies stop doing their jobs.
The tale of the N95 mask shortage brings some of these problems into focus. First approved in 2007, the masks protect wearers from airborne particles. Three regulatory agencies control their marketing and use. The National Institute for Occupational Safety and Health approves masks for industrial users who follow OSHA approved guidelines, while health care facility masks need additional FDA approval. Foam nose pieces and elastic bands might degrade over time, compromising fit, so N95s come with an expiration date.
In 2017, FDA agreed to accept the National Institute for Occupational Safety and Health filtration tests, confining its oversight to allergic response and fluid and flame resistance tests. It responded to the N95 mask shortage with a March “Nonbinding Recommendation” on its “thinking” in which it says it might look the other way if health care facilities use National Institute for Occupational Safety and Health approved N95 masks that are not FDA approved. In normal times, hospital administrators and tort lawyers are perfectly capable of discriminating between situations when National Institute for Occupational Safety and Health masks are adequate substitutes for FDA masks. Why the FDA requires an emergency to realize this remains a mystery.
In 2016, FDA contracted with Battelle Memorial Institute to determine whether existing hydrogen peroxide vapor decontamination systems could make 3M’s disposable N95 masks reusable. The results were good. Battelle built a machine capable of decontaminating 80,000 masks a day. It did not have FDA approval until March 29, when the FDA granted emergency approval after calls from Ohio’s governor. The approval unaccountably limited Battelle to just 10,000 masks a day. Gov. Mike DeWine denounced the FDA’s decision as “nothing short of reckless.” “Free us, let us go do it!,” he said. He called President Donald Trump. Hours later, the FDA upped the limit to 80,000 masks a day.
Some health bureaucrats have failed to do their jobs. In 1999, Congress created a National Pharmaceutical Stockpile. In 2003, it expanded to include essential medical supplies, including N95 masks. Now named the Strategic National Stockpile, its job is to properly store supplies and rotate stock. CDC controlled it until Oct. 1, 2018.
As its budget more than doubled from 1999 to 2019, CDC lost its focus on U.S. disease control. It spent money on everything from the Global Health Security Agenda to violence prevention programs. It decided that rotating mask stocks was “expensive.” On Feb. 28, it announced that out-of-date masks were OK if they passed visual inspection. In March, the Stockpile shipped expired N95 masks to the states. According to CDC, “in the face of emergency the expired masks would provide better protection than surgical masks or improvised mouth and nose covers.”
In the private sector, 3M has been refining its N95 surge production capacity since the 2002-03 SARS epidemic. It activated surge production in January, doubling its global production of N95 masks in two months.
Unlike 3M, the government bureaucracies that once helped defeat polio and yellow fever are now too obese to even maintain warehouse stockpiles. Taxpayers need to put them on a diet before they crush the private sector that everyone’s health depends on.
Linda Gorman is director of the Health Care Policy Center at the Independence Institute in Denver.
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