It’s past time for Congress to reconsider propriety of FDA ‘user fees’

FDA-Logo-300x167Members of Congress, as usual, are racing to meet a deadline: This time, to determine the funding for the federal Food and Drug Administration, an agency with some of the most consequential responsibilities affecting Americans’ health.

In their furious political and financial machinations, though, lawmakers aren’t asking the tough, critical question about the FDA’s leading revenue source:

Is it a good idea for Big Pharma and medical device makers to pay most of the cost to run the nation’s watchdog of these giant, wealthy industries?

Here is the philosophical and practical quandary of the running congressional acceptance of the idea that any industry, much less one with the huge effects on regular folks’ lives, should pay for its federal oversight — and huge sway over how it is regulated, as the New York Times reported:

“Every five years, top officials of the Food and Drug Administration go behind closed doors to negotiate the terms of its core budget — about $3 billion this year. But the FDA is not at the table with members of Congress or with White House officials. Instead, it’s in dozens of meetings with representatives of the giant pharmaceutical companies whose products the agency regulatesThe negotiations are a piece of the ‘user fee’ program in which drug, device, and biotech companies make payments to the agency partly to seek product approvals. The fees have soared since the program’s inception three decades ago and now make up nearly half of the FDA’s budget and finance 6,500 jobs at the agency. The pharmaceutical industry funding alone has become so dominant that last year it accounted for three-quarters — or $1.1 billion — of the agency’s drug division budget.”

Proponents, including conservative Republicans, say it is fiscal common sense for rich pharmaceutical and device-making companies to cover the cost of vital, rigorous, medical-scientific reviews of prescription drugs and components put in and on people’s bodies before these are allowed on the market. Patients who want drugs that might help them with urgent, debilitating, and even lethal conditions (think historic HIV) have pressed for the fee-based system as an incentive to get the oft-plodding FDA to act.

At the same time, critics have pointed out that, sure, the FDA may be approving more drugs and doing so at a faster pace, this is not a positive outcome in itself. Too many of the drugs the FDA approves so quickly represent, at best, incremental improvement in the quality or length of patients’ lives. Too many drugs get approved now based on new, different standards, under which regulators, for example, consider “surrogate endpoints” — whether a tumor shrinks, or certain symptoms get better, but not whether the disease diminishes, or patients live better or longer.

Prescription drug prices are soaring without relief, particularly with rising numbers of cancer meds that bankrupt patients and their families but aren’t significantly improving outcomes, and the agency keeps bungling key aspects of its oversight of medications (think Aduhelm, the budget-busting drug targeted at Alzheimer’s and approved based on sketchy data). The FDA also has taken huge, merited criticism for all but waving ahead too many medical devices, many of which skip scrutiny before getting on U.S. markets because they are “boot-strapped” in regulator approval as being close enough to existing and allowed products.

Although the nation has decades of experience dating to the Reagan presidency in increasing reliance of FDA user fees, the action in the current congressional reauthorization of this revenue source is focused on an array of collateral, health-related issues, the New York Times reported:

“In recent weeks, the user fee bill in Congress became snagged by added provisions, including over an effort to speed approval of generic drugs that could cut into the big companies’ profits and make the drugs less expensive for consumers and insurers. A key Republican senator and the major pharmaceutical lobby opposed that provision. Versions of the bills in the House and Senate also included a raft of extra proposals that would require annual inspections of infant formula makers and increase oversight of cosmetics, diagnostic tests, dietary supplements, and food packaging. Those measures may not survive final haggling over reauthorizing the program in Congress, where the drug and device industries spend hundreds of millions on lobbying and campaign contributions.”

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 by bankrupting and dangerous drugs. Too many patients struggle these days to access and afford safe, efficient, and excellent health care. This has become an ordeal with the skyrocketing cost, complexity, and uncertainty of treatments and prescription medications.

Patients, as well as doctors and hospitals, can’t possibly keep up with all the information they must know about the quality, safety, efficiency, affordability, and usefulness of the galaxy of prescription medications and medical devices that inundate the nation’s markets — the richest and most alluring on the planet.

We need talented, smart, experienced, and committed public-minded medical scientists to serve in demanding roles at the FDA and other federal agencies to safeguard us, our medical treatment, and the prescription drugs and medical devices we so rely on now.

It is eyebrow-raising, at least when it comes to cost consideration, that lawmakers persist in re-upping the FDA user-fee scheme considering the sums under discussion with the agency and its toal budget ($6.5 billion) and especially the “core” sums for its work on drugs (~$3 billion).

That sounds like quite the chunk of change, and maybe conservatives are right in recouping some part of it from the industry via fees. Still, consider that Congress just dropped $8.5 billion — far more than the FDA’s total ’22 budget — — on 85 F-35 jets, spending that Rep. Adam Smith, D-Wash., the House Armed Services Committee chairman, has described as a “rathole” expense.

The FDA should not have so much as the whiff of conflicts of interest, ethics issues, or the odiousness of being an industry-captive, toothless watchdog. The cozy relationships that develop between the industry, and the revolving-door between Big Pharma and the FDA can be simply shameful. Alas, when an industry funds and dickers ferociously with its watchdog, reputations — and possibly reality, too — head south, fast. As Dr. Janet Woodcock, a former acting FDA chief, and Suzanne Junod, an agency historian, have written of the long-tortured path of user fees::

“The provision of industry fees to FDA has undermined public trust in the agency, which is perceived by some as having lost independence and credibility as a result of accepting industry money.”

We have much work to do to ensure that the FDA plays its highest, best role in safeguarding the health and well-being of the American public.

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