In regular places, when alarms blare and it becomes clear that a big, important something is broken and threatens folks’ well-being, those with common sense race to make needed fixes. Washington, D.C., is different. And members of Congress, the White House, and top federal bureaucrats already may be dodging a desperately needed reckoning for the Food and Drug Administration.
This health watchdog is taking body blows about two of its biggest responsibilities — ensuring the safety, effectiveness, and affordability of prescription drugs, and its oversight of these same qualities with the nation’s food supplies.
The agency finds itself jamming the brakes on its hotly contested efforts to hurry prescription drugs onto public markets. And an independent foundation, which is often supports the agency and its work, has ripped the operations of its multiple food regulatory programs, calling them ineffective and lacking needed leadership and direction.
A long, poor history on reforming food regulation
These twin shots at the FDA hardly come as a surprise. Critics have assailed the agency for failing to protect its most important constituents — we, the taxpaying public — for some time now, with broadsides slamming two of the eponymous FDA functions, protecting people from dangerous drugs and risky food. The major revamp that policy experts say is most demanded, however, has about as much a chance of occurring any time soon as cancer getting cured overnight.
The FDA, an abundant number of experts in medicine, health, and lawmaking agree, should be busted up and reconfigured, perhaps with oversight of food and nutrition put into a new agency. It would end and absorb responsibilities not only in the current FDA but also those that have ended up over the years in the U.S. Agriculture Department. Meantime, the safeguarding of prescription drugs, medical devices, and intoxicants — including tobacco, marijuana, psychedelics, and more — would be the responsibility of a significant, full-blown drug agency. Both new agencies could be part of the sprawling Health and Human Services department.
As the Pulitzer Prize-winning investigative news site ProPublica reported recently of the many proposals for a single, unified federal regulator of food:
“Over the last 25 years, three presidents — Bill Clinton, Barack Obama, and Donald Trump — have proposed unifying the food safety system, but none of them have made it a political priority. The Clinton administration, for example, released its plan on his last day in office. Since 1970, the nonpartisan investigative arm of Congress now known as the Government Accountability Office has issued 16 reports documenting the dysfunction of our food safety system.
“But the GAO’s repeated calls to create a single agency have gone unheeded. Congress has held more than two dozen hearings where the idea was raised, often prompted by one of those damning GAO reports or by news of a deadly outbreak somewhere in the country. And over the last two decades, legislators have introduced 10 bills that proposed creating a single agency. But none of them stood a chance. The congressional committees that oversee various arms of the food safety system have shown little appetite for giving up power — as some would have to do if the bureaucracy were consolidated into a single agency. So, the country remains saddled with a system that prohibits meat safety inspectors from regulating farms, that makes cheese pizza the purview of one agency and pepperoni pizza the responsibility of another, and that can’t ban raw poultry tainted with dangerous strains of salmonella — unless it’s in pet food.”
A new call to action
Still, as the Washington Post reported, FDA Commissioner Robert M. Califf added to multiple reviews of years past by asking the respected Reagan-Udall Foundation for the FDA to take a careful, thorough, and friendly but independent scrutiny of the agency’s food regulation. The newspaper reported this of the foundation and its published study:
“An outside group that was asked to examine problems at the Food and Drug Administration in the wake of an infant formula crisis this year offered a scathing indictment of the agency’s structure and culture and recommended major restructuring, including possibly breaking up the agency so that oversight of the food system gets more attention. The FDA has long been accused of giving its food program short shrift, and it came under fire from members of Congress and others for not heading off a formula shortage that left many parents scrambling to feed their infants. The response to the formula crisis was hampered by flaws in the leadership structure and poor communication within an agency that seemed to be in a state of ‘constant turmoil,’ according to the report from the [foundation] … The report recommends several options for fixing the agency, which is housed within the Department of Health and Human Services and is responsible for overseeing aspects of the nation’s food system, as well as tobacco products, and pharmaceutical drugs.
“The task force’s first, most sweeping suggestion was to create separate food and drug administrations within HHS, which would require approval from Congress. The task force acknowledged this was ‘thinking big’ and would be a longer-term solution to remedying problems but said the benefit would be elevating the visibility of each side and separating their budgets. Other, less ambitious options included separating the food and drug arms but keeping them within a single agency, as well as creating a new deputy commissioner position with authority for overseeing food.”
Critics have underscored the importance of major, fundamental change in the FDA, arguing that more must be done the proverbial re-arranging of deck chairs on a sinking ship:
“Food safety experts have long complained that the agency’s food oversight arm has been chronically understaffed and underfunded. Those problems, critics say, have been exacerbated by poor communication between its centers. More broadly, experts say, the agency has prioritized the drug and medicine side, frequently drawing leaders with medical backgrounds and without food industry knowledge.”
Scott Faber, a food safety expert with the Environmental Working Group, told the newspaper this:
“’What’s clear is that the [FDA’s] cultural and structural failures are contributing to communication, organizational, and risk management failures that are making our food less safe. Any of the structural reform options proposed by this task force would make the current system better, provided the Congress follows through on the needed resources.’”
When the agency food programs prove to be so dysfunctional, Americans suffer, the New York Times reported:
“Congressional lawmakers and others have long called for strengthening the authority and influence of the agency’s food division, given the effects of foods like added sugar and salt on deadly chronic diseases and the toll of food-borne illnesses that account for an estimated 128,000 U.S. hospitalizations and 3,000 deaths each year. The report followed years of complaints that the food unit was toothless, a criticism that was amplified by what critics viewed as the agency’s plodding and disorganized response to reports of infant illness and death and unsanitary conditions at the Abbott Nutrition infant formula plant in Michigan. The agency’s shutdown of the factory in February aggravated an infant formula shortage that left parents scrambling to feed their babies for months earlier this year.”
Slowing down speeded-up drug approvals
As for the agency’s oversight of vital medications, the Wall Street Journal and the Associated Press both reported that the FDA is reversing its speedy approval of prescription drugs promoted as having preliminary but promising results.
This program, pushed by Big Pharma, lawmakers friendly to the drug industry, and patients and advocacy groups enamored with potential treatments for difficult or rare conditions, has drawn increasing fire.
That’s partly because drug makers have dragged their feet in conducting required, additional studies after their products get on the market to show they work, news articles say. Makers have proved reluctant to pull drugs that don’t show results. Big Pharma also has pressed for FDA expedited approval for medications that offer higher costs but only incremental patient benefit.
Regulators took a major drubbing, though, when they raced to approve a drug targeted for Alzheimer’s care — advancing the medication with dubious cooperation with its maker and over the objection of the FDA’s own, independent, expert advisors. That drug headed to market with a whopping price tag and with howls from specialists in the field, major academic medical centers and big hospitals, insurers, the Department of Veterans Affairs, and, ultimately, officials at the Centers for Medicare and Medicaid.
The FDA is still dealing with the fury surrounding its inability for years now to pull the drug Makena off the market, even though follow-up studies show the medication does not help prevent preterm births as it was promoted to do.
This has led to changes in the FDA approach to its long-standing expedited drug approval program, as the Wall Street Journal found:
“The Food and Drug Administration is taking a harder line on its program that fast-tracks drug approvals based on preliminary evidence, spurring GSK PLC, Roche Holdings AG, and other drug makers to remake plans for their drugs or pull them from the market … In recent weeks, the agency has taken action, prodding GSK to withdraw a blood-cancer drug after it failed a follow-up trial and announcing that Viatris Inc. stopped selling a burn treatment because the company never finished its confirmatory study. Meantime, the FDA told ImmunoGen Inc. and ADC Therapeutics SA, which have been developing cancer drugs, that it wouldn’t grant the speedy approval until they had begun follow-up studies, the companies said. ‘The message from the agency is we want to see, you know, meaningful progress on your confirmatory study,’ said ImmunoGen Chief Executive Mark Enyedy.”
Can we say, it’s about time?
In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them and their loved ones by dangerous drugs and by defective and dangerous products, including various goods that we eat and drink.
Regular folks can’t possibly sort through the soaring complexity of claims and products pushed on to markets by Big Pharma and Big Food. Doctors, hospitals, and medical researchers also rely on federal regulators to help them sort through the uncertainty surrounding issues of safety, access, affordability, effectiveness, and excellence with prescription medications. This is also true of these qualities, as well as the nutritiousness of U.S. food supplies.
While taxpayers shovel huge sums into federal oversight, investigations by news organizations have shown little or poor progress in safeguarding the public — either with drugs or food. This is unacceptable and we have much work to do to improve the FDA, not with tiny tweaks or half measures but with aggressive action that puts teeth back into a watchdog of the public’s well-being.