OPINION: FDA Bureaucrats Are Hurting Patients — But Times May Be Changing


Mark Flatten Goldwater Institute
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Fear and overcaution at the U.S. Food and Drug Administration (FDA) are literally killing people.

FDA regulators fear that they might miss something and approve a drug that has unseen side effects. If that happens, they will be hauled in front of Congress and pilloried in the media. So in their quest for absolute certainty, FDA bureaucrats demand more studies, more tests and more time.

Adjusted for inflation, it cost about $100 million in the 1970s to get a new medication approved by the FDA. Today, it costs about $1.4 billion in out-of-pocket costs alone, and the entire process takes about 12-to-15 years.

As a result, new and beneficial treatments for conditions ranging from heart disease and cancer to Alzheimer’s and diabetes are not getting to doctors and patients. Instead, they are bottled up in the FDA’s regulatory labyrinth or discarded altogether because drug developers cannot meet the ever-evolving standards and spiraling cost of agency demands to prove the basic safety and effectiveness.

Look at aspirin: When drug companies sought permission to push its heart-health benefits in the 1980s based on overwhelming outside studies, the FDA stalled for five years. By the agency’s own math, that alone likely led to about a quarter-million deaths.

Even today, the FDA only concedes that aspirin can prevent another heart attack in patients who have already had one. It still refuses to allow drug manufacturers to tout its benefits in preventing a first heart attack. This runs counter to the conclusions reached by other health research and advocacy organizations, including the independent U.S. Preventive Services Task Force and the American Heart Association.

The public has largely taken to ignoring the FDA’s opinion when it comes to aspirin: A recent survey shows that more than half of Americans between the ages of 45 and 75 take a daily dose of aspirin, four out of five of them to prevent a first heart attack or stroke. Most do so on the advice of their doctors.

What the FDA’s overcaution leaves us with are more preventable deaths and more diseases that go untreated because of a regulatory system that emphasizes caution over innovation and statistical certainty over getting new and effective treatments to patients as quickly and efficiently as possible — which is the FDA’s core mission as defined in the law.

The consequence of this petrified bureaucracy is what critics call the “invisible graveyard.” It is filled with people who might have lived but died instead because the medicine that could have cured them is either stuck in the FDA’s regulatory system or abandoned altogether because there is little likelihood that it will ever recover its regulatory cost and become profitable.

The most obvious example of this is when people with terminal illnesses cannot access treatments still under testing and review by the FDA. But it also applies to chronic conditions like heart disease and diabetes, which continue to afflict millions of Americans in large part because the FDA is no rush to approve innovative new treatments, or because it makes no financial sense for drug companies to spend the time and money to find a cure.

So, what has this overcaution brought us?

It hasn’t made us any safer. The percentage of new drugs approved by the FDA and later withdrawn from the market has held remarkably steady for decades. About a third of all new drugs that are approved later have some type of safety issue that went undetected in clinical trials.

Nor has it encouraged innovation or lowered cost. Risk aversion by its very nature stifles innovation. And given the costs and time needed to secure FDA approval, many innovative and low-cost treatments that show promise are simply abandoned by drug developers for financial, rather than medical, reasons.

But there are signs that things might be changing.

There are several reform proposals percolating in Congress and in the states. One would remove current FDA restrictions on the ability of drug companies to communicate truthful and non-misleading information about their products to medical providers in a manner consistent with federal court rulings. Another would allow drugs approved by certain other countries, such as Canada and those in the European Union, to be available here.

Most significantly, in May, President Trump signed Right to Try legislation, which will make it easier for patients to access medications still undergoing clinical trials or awaiting final approval by the FDA. Beyond the lives that will be saved, Right to Try demonstrates a shift in thinking both by the public and the politicians.

It is a recognition that the quest for absolute statistical certainty can actually cost lives, and that life-and-death medical decisions about a person’s health are best made by patients and their doctors — not by risk-averse bureaucrats in Washington.

Mark Flatten is the national investigative reporter at the Goldwater Institute. He is the author of the new paper “Studied to Death: FDA Overcaution Brings Deadly Consequences.”

The views and opinions expressed in this commentary are those of the author and do not reflect the official position of The Daily Caller.