FDA will keep bumbling until Biden and Becerra at least name agency’s chief

becerra-150x150biden-150x150With the Biden Administration battling the coronavirus pandemic and Democrats in the throes of determining what could be big spending for major changes in the U.S. health care system, even the president’s biggest supporters are baffled why he still hasn’t nominated a commissioner to head the federal Food and Drug Administration.

The FDA, entrusted to safeguard the safety and quality of the nation’s prescription drugs, medical devices, and foodstuffs, has a huge lift in the best of times.

In the Biden administration’s 10 months, the agency — demoralized and banged up, big time, by the Trump Administration and its politicization of health matters across the board — has found itself in a relentless crossfire in areas in which the 18,000-employee organization holds sway.

The controversies have become sadly familiar:

A less than great record with Covid testing and vaccines

The public, of course, has zeroed in on FDA oversight of coronavirus testing and vaccines during the pandemic. Critics have assailed the agency for moving far too slowly to secure and evaluate the heavy-duty data and expert information needed to assure Americans about the safety, effectiveness, and dosage for life changing and saving vaccines and tests.

While agency officials have insisted they will be governed by the best available facts, evidence, and science, the FDA has taken unceasing heat — over whether Trump and his people bullied regulators to give swift emergency authorization for the vaccines to their timetable. Then was the agency too slow to permanently green-light the shots as safe and effective? This occurred after billions of people around the globe had gotten jabbed, with relatively few bad side effects.

Critics prodded the agency for not moving fast enough to allow young folks 12 and older to get the shots on an emergency basis. Advocates want the FDA to approve vaccines faster for kids ages 6-12.

FDA officials got crosswise with the White House over the president’s plan for widespread vaccine boosters — with senior leaders quitting and taking umbrage that Biden had stepped into their area of expertise. They accused the United States of failing to share vaccines, so more developing and poor countries could get first shots to their people before Americans got boosters. The agency and the Centers for Disease Control and Prevention since have approved a seemingly more constrained booster plan.

Outrage with OK for Alzheimer’s drug, based on sketchy data

In the meantime, the agency outraged medical scientists, specialists, academic medical centers, big hospitals, and insurers with its sudden reverse and, initially, broad approval for a prescription medication targeted at Alzheimer’s disease. The agency had to back-pedal and try to seal a regulatory opening it created when it let the drug, which had been tested only in early cases of the disease, on the market for use with all Alzheimer’s patients.

The FDA overruled its own elite, independent experts to approve Biogen’s Aduhelm medication, with an array of experts citing not only the sketchy evidence of the drug’s effectiveness but also the high cost its maker set for its use and the significant side-effects it carries — including brain swelling and hemorrhaging. FDA approval of Aduhelm potentially put taxpayers on the hook for billions of dollars of new and, foes said, unjustified spending, though doubters — specialists, hospitals, and even a major federal health care provider (the Department of Veterans Affairs) — lined up against the drug so emphatically that its once-sizable forecast revenues have amounted to little. Critics blasted the cozy relationship that Biogen developed with FDA regulators of its drug, with the acting agency chief calling for an investigation of the matter by an inspector general.

Punting on big decision on e-cigarettes and vaping

Agency regulators have infuriated another sizable constituency — those who use or oppose e-cigarettes and vaping, as well as longtime anti-smoking crusaders.

Activists raced to federal courts more than a year ago to force the FDA to evaluate and announce whether e-cigarettes and vaping products provided real benefits to Americans’ health, purportedly by providing a less risky way to get a nicotine kick and to break the addiction of burned tobacco in cigarettes, pipes, cigars, and the like. The court heard the FDA describe the extensive, rigorous research that makers would need to supply for the agency to allow vaping products, including e-cigarettes, to stay on the markets.

A federal judge said OK and ordered the FDA into action, telling the agency it had until Sept. 9 to rule.

The agency busted that deadline, saying it needed more time to weigh millions of maker and vendor applications. The FDA asserted on the deadline date that it had exercised its authority and would ban millions of vaping products, many of them from mom-and-pop operations that lacked the resources to provide the agency with the hefty data and studies needed.

Though the agency said, defensively, that it had acted on 93% of submissions, the FDA punted and failed to do its job, critics said. They were outraged that regulators called for more time to decide the fates of the biggest companies in the business, including e-cigarette maker Juul, which controls just under half the market.

It is unclear when the FDA will finish its mandated oversight and if or when activists will return to court to try to get the federal judge to decide how he will get the agency to follow his order.

‘Flabbergasted’ at lack even of rumors

Dr. John Whyte, chief medical officer of WebMD and former FDA official, told the Kaiser Health News service that Biden’s failure to nominate a permanent agency head is confounding:

“People are just flabbergasted. We don’t even have rumors of viable candidates.”

Earlier this summer, Anna K. Abram, a former FDA deputy commissioner who is now a senior adviser with Akin Gump, a law firm, told the New York Times that it was difficult then to understand the delay in getting respected, long-term leadership for one of the nation’s most influential health agency:

“I find it a little perplexing. You get a grace period, but now it’s starting to get into a window of ‘What is the plan for the FDA?’ because it’s such a vitally important agency. Priorities may change depending on who is at the helm.”

Washington, D.C., insiders long have identified top contenders for FDA commissioner, with acting chief Dr. Janet Woodcock, an agency veteran of three decades, dimming as a contender — both because critics say she is too amenable to Big Pharma and has not dazzled in her time at the top. KHN reported this:

“Biden officials reportedly considered multiple potential candidates throughout the spring, including Woodcock; former top FDA official and Maryland health secretary Joshua Sharfstein; former FDA official Michelle McMurry-Heath; and Scripps Research Translational Institute director Dr. Eric Topol (who confirmed to KHN he wasn’t interested).”

Well, OK, there is a lot going on — including Democratic proposals to spend trillions of dollars over a decade to improve Americans’ health, including with efforts to lower prescription drug costs and to boost support for home and childcare — and would it not benefit from having an FDA chief be helping with it all?

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, effective, and excellent medical care. This has become an ordeal due to the soaring complexity, uncertainty, and costs of treatments and prescription medications, too many of which turn out to be dangerous drugs.

The U.S. health care system has become so big, difficult, and daunting that ordinary folks need all the help they can get in wrangling with it, including knowing they have a top-notch, well-functioning federal agency protecting their prescription drugs, medical devices, and what they eat and drink every day. As the president himself would say, “C’mon, man.” Biden and Xavier Becerra, the head of the sprawling Health and Human Services agency, need to get cracking, and together they must send the U.S. Senate a superb candidate to be the nation’s next FDA commissioner.

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