Issues & Insights

The FDA Is Blocking Game-Changing New Drugs For Kidney Disease

Imagine you’ve been diagnosed with chronic kidney disease, told by your physician that if it can’t be managed, you may eventually need a transplant or long-term dialysis. This scary situation is one faced by hundreds of thousands of Americans every year.

Chronic kidney disease (CKD) is an illness that affects an estimated 37 million people in the U.S. That’s more than one in seven adults across the country, or nearly the entire population of California. Despite this alarming statistic, investment in kidney disease research and therapies lags other sectors. We must redress that imbalance.

CKD is a serious condition that, if unaddressed, leads to organ failure. Without early interventions and disease management, CKD leads to an increased chance of heart disease, stroke, vascular disease, and even early death. Another serious, common complication – renal anemia – can cause debilitating symptoms that severely impact patients’ quality of life. Physicians and the millions of Americans living with CKD need more, and better, treatment options. 

While there have been increased efforts toward innovation in the kidney care community to provide new, effective treatments for patients, the U.S. Food and Drug Administration (FDA) has rejected most of the drugs for kidney disease that it has reviewed in recent years. Perhaps for that reason, nephrology has historically had one of the lowest rates of new drug applications submitted to the FDA, particularly when compared to other therapeutic areas like oncology and cardiology. 

Although the Department of Health and Human Services (HHS) has championed advancements in kidney care through initiatives like the public-private Kidney Innovation Accelerator (KidneyX), the FDA seems not to be onboard. By failing to approve drugs to treat patients with CKD and renal anemia, the FDA is out of step with the administration’s efforts to advance the development and access to cutting-edge treatments that have the potential to greatly improve patients’ lives and appear to have demonstrated a favorable risk-benefit profile.

The development of new kidney drugs such as vadadustat, one of a class of drugs called HIF-PHI, has given hope to the community that more options will be available to patients. Like other drugs in this new trailblazing class, it works by using the body’s innate oxygen sensing mechanism to stimulate red blood cell production, a great help to patients with anemia due to CKD.

Therapies like vadadustat would offer patients with renal anemia an alternative to the only approved treatments available, which are injected or infused through an IV in a dialysis or blood transfusion facility or clinical setting. For dialysis and non-dialysis patients alike, the option to take a daily pill instead of traveling to a center several times a week for treatment would be a game-changer.

However, although HIF-PHI drugs are currently approved for use in Europe, China, and Japan – the FDA has failed to approve them. Most recently, on March 29, the FDA denied approval of vadadustat (which is approved in Japan) for both dialysis-dependent and non-dialysis-dependent patients, the second time in the past eight months that it denied marketing approval for a drug of this class. As eminent nephrologist Jay Wish wrote about the FDA’s verdict, “[T]he decision by the FDA not to approve vadadustat for treatment of anemia in patients on dialysis was not transparent.” I would go further: I think the FDA was wrong.

As a last resort, blood transfusions may be given to treat renal anemia, but they can cause a condition called allosensitization, which results in longer waiting time for transplantation (because of decreased availability of compatible donors), increased risk of rejection, and poorer graft survival.

Such barriers to treatment affect more vulnerable populations, because CKD is more common in people aged 65 and older, in women, and in black and Hispanic adults. According to the Centers for Disease Control and Prevention (CDC), black Americans are three times more likely than non-Hispanic white Americans to develop kidney failure, and Hispanic Americans are also disproportionately affected. Underserved populations deserve access to innovative, effective care before it’s too late.

In summary, we desperately need new treatment options to improve the care, outcomes, and quality of life of CKD patients. The FDA should trust nephrologists and patients to use new therapies responsibly.

Henry I. Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. He was the founding director of the FDA’s Office of Biotechnology and a Research Associate at the NIH. Find links to his many articles at henrymillermd.org.

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1 comment

  • Maybe FDA has some other agendas in-play that remain best shrouded in opaqueness, for a variety of reasons. Not saying FDA is aligned with Klaus Schwab’s Davos World Economic Forum or Bill Gates and the need for population reduction (e.g. by withholding life-saving drugs approved in Japan & the EU). Would be easier to believe that the FDA occupies a detached-from-reality, Kafkaesque realm where a roulette wheel is spun and approvals happen only when a “double zero” hits. Perhaps we are wrongly assuming that health is the main interest of FDA, when the explanation may be monetary politics? In other words, the EU and Japan are making the correct decision based on health benefits (altruistic), whereas FDA is motivated by less altruistic internal politics and monetary considerations. What other explanation could explain the known facts?

    We must first ask: Are the EU and Japan more immune from monetary considerations in their kidney drug approval? In the USA, we have learned from the mandatory or forced consumption of “experimental” COVID vaxxes and prophylactics that the USA health agencies reap revenues and royalties amounting to nearly half of some agency budgets. Perhaps the kidney drug manufacturer is not paying licensing or royalty fees to USA health agencies? Furthermore, the kidney drug manufacturer may not be donating money to the research budgets of those influencing the FDA decision-making process. My understanding is that the drug in question is of Japanese origin, and not licensed from a branch of USA.gov. Also, if more people die a quicker death by keeping the drug off the market, USA.gov saves money via reduced public pension and social security payouts. Not saying this is so, just that in the absence of health-based rationales we have to look elsewhere in the bureaucratic haze for an explanation (or accept the hypothesis that FDA decisions are randomly generated).

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