Big shakeups under way in much-criticized U.S. health agencies

DawnOConnellASPR-150x150califf-150x150While most regular folks wouldn’t give a hill of beans about the organization of bureaucracies in Washington, D.C., frustrated taxpayers should be taking note of seismic rumblings about restructurings that are shaking some of the biggest, most powerful, and influential federal health agencies.

Biden Administration officials, in one of their notable moves, have announced that responses to pandemics and other public health crises will be led now by a separate, independent division within the sprawling Health and Human Services agency.

While officials hastened to say that the 1,000-person Office of the Assistant Secretary for Preparedness and Response, or ASPR, will work hand-in-glove with the federal Centers for Disease Control and Prevention, the CDC clearly is taking its lumps for the shambolic course it took, starting in the previous administration, in dealing with the coronavirus pandemic.

The CDC already has announced its own “rethink” of its mission and operations.

Over at the Federal Food and Drug Administration, its new chief announced that he has invited the Reagan-Udall Foundation to conduct a “comprehensive evaluation” of the agency’s much-criticized food and tobacco programs. The foundation was created by Congress as a nonprofit, the group says, to work with the agency “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”

Dr. Robert Califf, the recently confirmed head of the FDA (shown above, left), explained his decision to tap an outside group to scrutinize agency operations after defending them in public hearings:

“[T]he agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations, prompting me to take a closer look at how we do business.”

Food and tobacco regulators under fire

Two FDA areas of oversight have created seeming nonstop nightmares for the agency’s leadership — the tobacco and food regulators.

The food experts, of course, already are under internal investigation over the problems that have erupted over the safety, affordability, and supply of baby formula. But two separate, deep digs by media organizations — Politico and ProPublica — assailed the federal government’s lax, ineffective, bureaucratic, redundant, and costly efforts to safeguard the nation’s food supplies.

The Washington Post quoted Califf in discussing the agency’s challenges in this area:

“On food, Califf said experts will scrutinize the Center for Food Safety and Applied Nutrition and related offices. While the food supply is safe, he said, ‘the program has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain.’ Califf said ‘fundamental questions about the structure, function, funding and leadership need to be addressed’ about the agency’s food efforts. He said food-inspection activities also need to be reviewed, given challenges caused by the coronavirus pandemic.”

For point of reference, this is what Politico reported of its examination of the FDA food oversight:

“This is not your run-of-the-mill slow-churning Washington bureaucracy. FDA’s food division is so slow, it’s practically in its own league. For this story, Politico spoke with more than 50 people, including current and former FDA officials, consumer advocates and industry leaders … There is a remarkable level of consensus that the agency is simply not working. Current and former officials and industry professionals used terms like ridiculous, impossible, broken, byzantine, and a joke to describe the state of food regulation at FDA.”

Politico also reported this:

“This government dysfunction has a real impact on people’s lives. The CDC estimates that more than 128,000 people are hospitalized and 3,000 people die from foodborne illnesses each year – a toll that has not lessened after a sweeping update to food safety a decade ago.”

As for the FDA experts on tobacco and nicotine oversight, they have found themselves plunged into a relentless regulatory morass dating to the previous administration and the agency’s bungled handling of e-cigarettes and vaping. New-age purveyors of nicotine raced ahead of the FDA repeatedly, critics say, hooking an entire generation with unhealthy habits when the agency tinkered with the idea that vaping could be an almost magical alternative to proven, deadly, and debilitating cigarette smoking.

Instead, the agency allowed the vaping fad to explode, despite plodding and ineffective FDA efforts to curb sales of candy-flavored, nicotine super-charged e-cigarette pods and liquids.

The agency, after dealing with a crisis that saw dozens of young people hospitalized with lung injuries due to vaping (likely with illicit products), infuriated critics by approving an e-cigarette — purportedly as a safer alternative to smoking.

The FDA, in recent days, had ordered makers of e-cigarettes and vaping products to produce voluminous, rigorous data to show the safety and benefits of their wares. Based on a giant filing from one of the agency’s nemeses, the FDA banned Juul products, saying they had not proved their safety and benefit. The agency, in a flummoxing turnabout, lifted its ban — purportedly temporarily and while the company appealed the FDA decision in the courts.

But as the Washington Post reported of the exasperated reaction by Sen. Richard J. Durbin (D-Ill.) on the Senate floor:

“Not two weeks after ordering Juul off the market, the FDA backtracked and halted its own decision.”

The rise of ASPR

The previous administration did itself, the nation, and federal regulators zero favors with its deadly, chaotic response to the coronavirus pandemic. But problems have persisted and have repeated themselves to a degree as the nation has struggled with challenges, for example, with a global monkeypox outbreak and continuing efforts to vaccinate Americans safely, widely, and effectively against the coronavirus.

The 13,000-member CDC has, with reason, taken a major share of the blame and a huge reputational hit for its role in safeguarding the public.

The agency already had quietly ceded some of its disease-fighting authority, dissolving its internal teams to battle the pandemic and returning key responsibilities to other parts of the federal government.

HHS has pushed further, media outlets have reported, creating the new division ASPR, headed by assistant secretary Dawn O’Connell (shown above), to deal with pandemics. The CDC will retain its medical-scientific expertise and authority in battling illnesses, as well as maintaining its long relationships with state and local authorities in dealing with major disease outbreaks, experts say.

But Biden officials explained that the new division was needed, in large measure, to respond to shortfalls in how the government contracts and purchases important medical and scientific materials and services. The new division, for example, will take responsibility for national emergency storehouses, including for personal protective gear.

The division, unlike the CDC, also will have the expertise and resources to negotiate with companies, for example, vaccine makers. Because of gaps in the way the government operated, many of the coronavirus vaccine deals, including determining major logistics issues like supply chains, were handled through the Pentagon, the New York Times reported.

The bureaucratic shifts have caused unease among experts, the Washington Post reported:

“ASPR was founded in 2006, in the wake of Hurricane Katrina and other disasters that taxed the nation’s emergency response. But the office, which operates out of the federal health department’s headquarters in D.C., has frequently come into conflict with the much larger CDC, which is based in Atlanta, employs about 13,000 people and has historically led the response to disease outbreaks, including Covid-19 … Federal watchdogs have also faulted the confusion between ASPR’s and the CDC’s responsibilities, saying that clashes undermined the pandemic response. The Government Accountability Office last year published its probe of one episode — a chaotic effort to return hundreds of Americans to the United States in the earliest days of the coronavirus outbreak — warning that infighting between ASPR and other agencies had led to safety breakdowns that put the evacuees, federal officials and even U.S. communities at risk.”

Not good. In my practice, I see not only the harms that patients suffer while seeking medical services, but also their struggles to access and afford safe, efficient, and excellent health care. This has become an ordeal due to the skyrocketing cost, complexity, and uncertainty of treatment and prescription medications, too many of which turn out to be dangerous drugs.

Patients, doctors, hospitals, insurers — indeed, all of us — need outstanding public servants with health, medical, and scientific expertise to be our trusted guardians and advocates, providing evidence-based recommendations on the best policies possible for our individual and collective well-being. The world has become so complex, uncertain, and interconnected that we cannot huddle in the dark or in tiny health havens while diseases and other threats to our wellness explode all around us.

Sadly, as federal regulators in recent times have fallen short in their oversight of risks to the public, anti-science, evidence-light critics have stepped into a void left by dawdling, do-nothing members of Congress to pass state and local laws that experts say will cause big problems in battling diseases in the future.

Sure, everyone who has spent time in corporate life knows well the jibes about reorgs and consultants (the camel is a horse assembled by committees and consultants), and the challenges of getting giant bureaucracies to change (elephants don’t dance).

But the federal health agencies’ problems have been writ large for the public during several bad years, and changes are needed. Creating new divisions? Bringing in independent outsiders for review? Hmm, whatever happened to congressional oversight? What great questions are dogged House and Senate staffers asking of the White House and the chiefs at HHS, FDA, and CDC? While Dr. Califf is at it, shouldn’t he also dig into the major flaws in FDA drug approval processes, including those just reported by NPR and affecting expedited processing of certain medications?

We have much work to do to ensure that the billions of dollars we taxpayers spend do hard, excellent work in ensuring the safety, accessibility, efficiency, and excellence of the nation’s health.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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