The Food and Drug Administration aims to let only safe and effective drugs reach the US market — but its turtle-speed approval process may be killing more patients than it protects.  

FDA regulations have made long delays in clearing medical products the agency’s norm.

As far back as 1980, the great economist Milton Friedman was pointing to the FDA as Exhibit A in America’s over-regulation problem. 

It can take a decade or more to clear new medicines through the FDA’s regulatory labyrinth, which requires companies to prove two things: that a drug is safe for patient use, and that it is an effective treatment for a particular ailment.  

The latter is the stumbling block.

Most of America’s health-care spending — the 85% of it spent on medical procedures or other care, not pharmaceuticals — involves no bureaucratic “help” to determine efficaciousness. 

Moreover, once the FDA approves a drug for one disease, doctors routinely prescribe it “off label,” without any government involvement, often finding that it’s effective for other ailments as well. 

So why can’t the private sector do the same in the first place, once a drug has passed FDA-regulated safety trials?

Why must American patients wait years, suffering with and even dying of potentially curable illnesses, while bureaucrats put treatments through the evidentiary wringer?

It costs $2 billion or more to bring each successful drug to market, given that about 90% of them must be abandoned during the lengthy FDA process.  

The government’s byzantine and unpredictable approval procedures thus divert billions of dollars of vital and scarce investment capital away from drugs that could cure cancer, heart disease, emphysema and other killer ailments.  

The two of us sometimes consult with drug companies to help them navigate the FDA maze — and we’ve seen many promising drugs bottled up by the bureaucracy.

One of them shows great potential in slowing the memory-loss progression of early-stage Alzheimer’s. There’s currently no similar treatment, but the FDA wants to hold it back for many more years of effectiveness trials. 

The FDA is currently considering a drug for ataxia, a rare neurological disease that often has agonizing effects. The drug has been studied for more than eight years and is totally safe.

But anecdotal evidence of its effectiveness from leading ataxia experts is not enough: The FDA is demanding lengthy and expensive additional studies to prove it. 

Why deny a ray of hope to suffering patients?   

Then there’s Zynquista, a promising new drug for patients with Type 1 diabetes.

It’s the only potential adjunct to insulin developed in over a century and is much less invasive — but the FDA has just called for yet another round of trials that could cost millions of dollars, denying today’s patients a chance to better manage their disease.   

President Donald Trump has been an enormous supporter of “right to try” orders, which allow patients with life-threatening conditions to use drugs that have been shown not to have dangerous side effects.

But strict FDA regulations have thwarted Trump’s effort: Insurance companies are reluctant to cover drugs that haven’t checked the agency’s efficacy boxes.

Instead, we need to relax or eliminate a 1962 law that required FDA to ensure effectiveness of drugs, not just their safety.      

We need an Operation Warp Speed for American pharmaceuticals.

During the COVID pandemic, all of America reaped the benefits of rapidly speeding a drug from idea to market.

Trump’s 2020 deregulatory effort opened much quicker pathways through the FDA, bringing the COVID vaccine to market in less than one year — a process that would have taken a decade or so under normal circumstances.

Why should the benefit of a streamlined FDA be applied to COVID and no other disease?

We urge the president to establish a permanent Operation Warp Speed for killer diseases like cancer, Alzheimer’s, diabetes, epilepsy, Parkinson’s and MS, among others.

Let’s expedite FDA safety trials for those treatments — no one wants unsafe drugs on the market — but allow the private sector a broader “right to try” to establish effectiveness far more quickly, as off-label usage has proven it can do.

Needless bureaucratic holdups are denying patients drugs that could add years to their lives and reduce their pain.  

We know that many patients would gladly take the risk — because trials are almost always oversubscribed by those who have no other choice but to die or suffer.  

Denying Americans such an option is unjust and inhumane.  

The choice of whether to take a drug for a killer condition should rest with patients, their families and their doctors — not faceless, detached government employees setting up one-size-fits-all policies.

Stephen Moore is a co-founder of Unleash Prosperity, where Tomas Philipson is a senior research fellow.