Wednesday, November 8, 2023

FDA Failures and How to Fix Them


Insulin is a hormone made by the pancreas that plays a vital role in all human metabolism.  Before insulin was discovered in 1922, people who developed diabetes died quickly.  A hundred years later, people still die quickly if they can’t obtain the hormone to inject. 

Henry I. Miller, the Glenn Swogger Distinguished Fellow at the American Council on Science and Health, has written an outstanding article on “The Tale of Human Insulin, FDA, and the Bureaucrat’s Mindset.”  He is an authority on the subject, having been “the medical reviewer and head of the [FDA] evaluation team” in 1982 for the first human insulin made by recombinant genetic engineering.  Prior to that, the only sources of insulin were pigs and cows.

Dr. Miller notes that Lilly, the manufacturer of the new insulin, submitted the application to the FDA in May 1982.  He writes:

“Based on my FDA team’s exhaustive review of Lilly’s data, obtained from pre-clinical animal testing and later in clinical trials involving thousands of people with diabetes, the FDA granted marketing approval for human insulin in October 1982. The review and approval took only five months when the agency’s average approval time for new drugs was 30.5 months.”  Dr. Miller notes that “bringing a new drug to market on average now takes, on average, 10-12 years and costs, on average, more than $2.5 billion.”

Dr. Miller was committed to an exhaustive but expeditious review of the new insulin because he was concerned about the death toll from diabetes, which, according to the CDC Mortality Database, was 34,600 in 1982. 

Compare that to the CDC-determined death toll of smoking, which is 480,000 souls per year.  The FDA has the authority to allow the sale of such revolutionary new technologies as e-cigarettes and vaping products, which are considered by respected authorities outside the U.S. to be no more than 5% as harmful as smoking.  Yet to date, the FDA Center for Tobacco Products has rejected market approval for the vast majority of vapes, approving only a few products that feature less popular tobacco flavors. 

I live in Kentucky, home of the bourbon industry, whose products contain the addictive ingredient alcohol.  Imagine if the FDA had regulatory authority over a product that reduced alcohol abuse, but it only approved bourbon-flavored versions.  Limiting through regulation the appeal of a proven remedy is clearly contrary to public health policy.  

Dr. Miller exposes other deficits in FDA-regulated biotech sectors, and he finishes with a universal truth:

“Regulators are supposed to abide by the ‘bargain’ that society has made with them: Civil servants are granted lifetime tenure and are protected from political pressure and retaliation, in return for which they are supposed to make decisions based solely on the public interest. But, often, they do not. 

“To get FDA-regulated products to those who need them, congressional oversight must emerge from hibernation and create a healthier, more constructive balance.”

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