Healthcare’s Bad Business with FDA Changes

Guest post by Edgar Wilson.

Edgar Wilson

President Trump’s promises to reform and deregulate the FDA seem doomed to do the opposite of what they were intended to do.

His track record on other issues notwithstanding, Trump might be excused for not knowing that American medicine is a bizarro-world where the good intentions of outsiders and insiders alike transmogrify into destruction, disruption, and bureaucratic chaos.

Big Business That Depends on Regulation

In a world where insurance wasn’t a prerequisite for accessing almost any care, and the free market actually was the primary force in driving patient and provider behaviors, broad strokes deregulation might work.

But in America’s healthcare system, “access” isn’t access. Rather, having a payer on board who will cover drugs, treatment, and providers is “access.” Simply knowing that a new wonder-drug exists doesn’t help people who need it. Steamrolling the FDA so that drugmakers can offer the drug on the open market, it should come as no surprise, also helps no one in particular. Because payers–insurers–look to the FDA for evidence of a drug’s value and clinical efficacy (rather than, say, patients desperate for a cure or drugmakers looking to cash in), disrupting the approval process serves also to disrupt payer confidence.

In other words, without the FDA’s lengthy, cumbersome, and expensive approval process, payers will be shy to cover new drugs–and thereby enable patients to access them. Drugmakers, by extension, would rather not face the uncertainty of what payers, providers, and patients might decide to do with new drugs absent the structured system of insurers taking their cues from the FDA, and thereby driving the behavior of the rest of the system.

To be fair, the FDA and its system for testing and approving new medications and devices has flaws. An overreliance on drugmakers’ own data, rather than independent research, sometimes leads to a lack of rigor and poor follow-up allowing unsafe drugs and devices to slip through to market only to be proven faulty by consumers, rather than regulators. A lack of clarity in its labeling requirements creates onerous demands on manufacturers and retailers, yet provides little to no benefit to the very consumers it is supposed to help protect and inform. There is no shortage of ways in which the FDA and its operations could be improved.

But Trump’s approach to the FDA treats the organization like a Gordian knot — something more easily cut through than carefully managed — with predictably mixed and messy results. He isn’t entirely wrong that there are problems to be solved, but his approach also isn’t graceful or nuanced. More than that, though, it makes the mistake so ubiquitous in business and leadership today, of relying too much on generously vague terms like “innovation” and the amorphous power of “science” at large to provide cures not just for injury and illness, but all of society’s woes.

When Will Science Save Us

In a tech-obsessed period of American life, the instinct–apparently shared from the Trump White House on down through to developers and plenty of consumers and patients–is to rely more on automation and digital systems like EHRs to facilitate the spread of knowledge, best practices, and to capture performance and quality metrics. But overcoming both the imperfections of the FDA as well as the habits of practicing clinicians may still fall to the humans of the medical profession, rather than to their tools and tech.

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