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Regulatory failings are leadership failings

Back in January, as soon as genetic information about the virus that causes COVID-19 became available, University of Washington virologist Alex Greninger threw himself into the task of designing a test for it.

He soon had one ready but needed permission from the Food and Drug Administration before using it on patients.

He completed a detailed application and emailed it to the FDA.

Which informed him that his application was incomplete. As reported by Julia Ioffe in GQ, “It turned out that in addition to electronically filing it, he also had to print it out and mail a physical copy along with a copy burned onto a CD or saved to a thumb drive.”

Back in 2000, when thumb drives were introduced, the FDA’s requirement was cutting edge. In those long-ago days, email applications couldn’t handle large attachments.

But requiring paper copies and thumb drives in 2020 was pure bureaucratic inertia.

Because the pointless hassle was endured by applicants, not the FDA, the agency hadn’t bothered to modernize its rules. Consequently, even as

the disease began its exponential growth, the test application process had to wait until FedEx transported media no one needed across the country.

On the east coast, the University of Virginia Medical Center lost two crucial weeks in March trying to get approval for its own housemade test.

UVA’s scientists were stymied at every turn by proliferating regulatory obstacles put in place by the FDA and the Centers for Disease Control and Prevention. The director of the lab, Melinda Poulter, told Reuters, “It felt like a constant uphill battle with people throwing rocks at you from the top of the hill.”

Those weeks lost to the uphill slog delayed the medical center’s response to the pandemic. A recent headline on the medical news website STAT asked, “How many needless COVID-19 deaths were caused by delays in responding?”

STAT’s answer: “Most of them.”

You can replace “most” with “some” or even “a handful” and the upshot is the same: in this crisis, bureaucratic obstructionism cost lives.

This isn’t to blame the front-line employees of the FDA. Their job is to enforce regulations as directed by their bosses. We want our government workers to be incentivized by the wish to keep their job rather than the hope of getting something in return for favors done. The duty of front-line government workers is to follow directions.

The FDA was unyieldingly rigid with respect to swab tests for the presence of the virus.

But it swung to the opposite extreme when it came to the distribution of blood tests for antibodies. The presence of antibodies indicates a person was infected in the past. That’s pretty important information for anyone, and especially for the elderly or immunocompromised, and those who live or work with them. Inaccurate results can be downright dangerous.

With regard to antibody tests, the FDA relaxed its ordinary procedures to a truly irresponsible degree. By April, according to the Washington Post, it had allowed no fewer than 90 tests to be sold in the United States, most of which it had never reviewed for accuracy.

FDA Commissioner Stephen Hahn told the Post that “people should be very cautious” about relying on the unreviewed tests. “Meanwhile,” the paper added, “the unreviewed tests remain on the market.” Imagine if cancer screening tests were sold the same way.

Hahn’s unhelpful words of warning came in mid-April. The following month, the agency moved to stop the marketing of 22 tests already on the market.

In June it acted against three manufacturers of “adulterated or misbranded” tests. But the quick-buck artists responsible for all those faulty tests were in business only due to the FDA’s initial laxity.

The antibody test debacle shows why regulation is essential to our modern society. The free market cannot work its magic when consumers lack the technical knowledge necessary to make an informed choice between products, or when sellers actively deceive them. When the stakes are high, we need a responsible gatekeeper to enforce minimum standards.

In one sense, the two regulatory failures described here fall at opposite poles, overversus under-regulation.

But in a broader sense, there was only one failure: leadership. An agency’s front-line workers are responsible for processes.

But responsibility for outcomes lies with the agency’s leaders, the political appointees such as Hahn.

Those at the top decide when to relax enforcement and when to insist on strictness.

They can order regular reviews to eliminate regulations that frustrate the agency’s mission and strengthen those that advance it. Leadership means ensuring that the agency’s processes serve its mission. The lack of leadership at our federal public health agencies is an ongoing national tragedy.

Joel Jacobsen is an author who in 2015 retired from a 29-year legal career. If there are topics you would like to see covered in future columns, please write him at legal.column.tips@gmail.com.

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