By Michelle McMurry-Heath
January 20, 2021 at 5:00 am ET
President Donald Trump seems determined to undermine our public health institutions.
His outgoing administration just released several rules that will hobble nonpartisan civil servants at numerous health-related agencies, including the Food and Drug Administration. These deeply misguided measures will endanger American patients.
The first change comes from the Department of Health and Human Services. In November, HHS Secretary Alex Azar proposed a “sunset order” requiring that regulations be reviewed and re-approved every 10 years — or else eliminated. Supposedly, this would streamline excessive regulations, but in practice, it would create other problems.
Federal rules are, in fact, already supposed to be reviewed every decade to see if they need revisions. The law on this isn’t widely followed by government agencies, which is a problem. But the answer isn’t to abolish unreviewed rules, regardless of their other merits. HHS regulations affect researchers, medical professionals and patients all over the country. They include measures on everything from safeguarding medical supplies to protecting study participants. Letting rules expire arbitrarily will put people at risk.
Trump administration officials have also proposed new red tape for regulatory guidance documents. Currently, agencies publish these documents to establish their official interpretations of new legislation. Under the proposal, both HHS and the Office of Management and Budget would have new powers to approve or reject any “significant” guidance documents, which could mean just about any of those published by the FDA.
Like the sunset order, this statute is ostensibly designed to simplify federal rule-making, but it will slow down and potentially jeopardize public health work.
Finally, the White House wants to create a new employment category for civil servants called “Schedule F.” Staffers with this status would be stripped of the protections traditionally afforded to public-sector workers, so that they could be fired at will.
Thousands of civil servants would be shackled with the new Schedule F designation. The OMB estimates that fully 9 in 10 of its own employees — about 425 people — would be converted to the new tier. It’s an explicit effort to put civil servants, who traditionally stay outside the political fray, under the thumb of political appointees.
Dr. Anthony Fauci demonstrates the value of career civil servants. For decades, he has run the National Institute of Allergy and Infectious Diseases, where he has played a critical role in combating COVID-19 as well as the AIDS epidemic.
There are thousands of other hard-working civil servants like him — they’re just less famous. Under Schedule F, they could be purged for purely partisan ends. The fear of being fired will surely keep many employees from speaking their minds on issues that affect millions of American patients. The National Treasury Employees Union is currently suing the Trump administration on Schedule F in the D.C. district court.
Streamlining regulations and ensuring civil service accountability are worthy goals. But achieving them requires a scalpel, not the club Trump is swinging on his way out the door.
The Biden administration has several options for reversing these misguided rules. It could issue its own executive orders to freeze the “sunset order,” and reverse the Schedule F order. Or, if it has enough support in the Senate, the government could invoke the Congressional Review Act, which was designed to prevent disastrous regulatory changes. Preventing our public health agencies from being hamstrung in the middle of a pandemic should be a top priority.
Michelle McMurry-Heath, M.D., Ph.D., is the president and CEO of the Biotechnology Innovation Organization.
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