Never mind Ebola, terrorists and school shootings.
What Americans should fear is… the FDA (U.S. Food and Drug Administration).
The FDA’s failure to approve life-saving drugs in a timely fashion is killing thousands, even tens of thousands, of Americans every year, critics charge.
Take just one example. An estimated 150,000 Americans have died or will die from idiopathic pulmonary fibrosis — a disease in which tissue deep in the lungs becomes thick and stiff, or scarred, making breathing difficult — because of the FDA’s four-year delay in the approval of the drug pirfenidone — a drug already approved and marketed in Europe (since 2011), Japan (2008), Canada (2012) and China.
That estimate comes from Dr. Henry I. Miller, a medical researcher, founding director of the FDA’s Office of Biotechnology, and 15-year member of the FDA.
That’s more Americans than were killed in any American war except the Civil War and World War II.
And pirfenidone is just one example among many others. The FDA’s slow approval of beta-blocking drugs in the 1970s may have led to the unnecessary deaths of up to 100,000 people, according to Sam Kazman, J.D., of the Competitive Enterprise Institute.
For many years the FDA prohibited aspirin makers from advertising the widely-accepted argument that aspirin could significantly reduce the risk of heart attack for some patients. According to economist Paul H. Rubin, “The FDA surely killed tens, and quite possibly hundreds, of thousands of Americans by this restriction alone.”
Indeed, says Reason magazine’s science correspondent Ronald Bailey, “the FDA’s increased obsession with safety may be killing more people than it saves. …After all, if it takes the FDA ten years to approve a drug that saves 20,000 lives per year that means that 200,000 people died in the meantime.”
The FDA’s approval process can take up to… 18 years. For people desperately fighting fatal illnesses, such long waits are death sentences.
Making things worse, the FDA’s review process is so expensive that,according to Yevgeniy Feyman of the Manhattan Institute: “The typical drug approval costs between $1.2 and $1.3 billion.”
According to Reason magazine’s Bailey, many drugs that could save lives are never introduced because of this cost.
In 2000, economist Daniel B. Klein of the Independent Institute wrote: “Because the FDA process is so expensive, so protracted, and so uncertain, thousands of untold drugs are never discovered or developed. It is impossible to estimate the suffering and death caused, but surely it greatly exceeds 50,000 premature deaths annually.”
Why is the FDA so agonizingly (literally) slow and expensive? Prior to 1962, the average time for FDA approval was just seven months. However, in 1962 Congress passed the Kefauver Harris Amendment, which added a new requirement of proof of effectiveness, in addition to the old standard of proof of safety, for approval of new drugs. Effectiveness is a far more difficult, and expensive, standard to meet.
Perhaps worst of all, the FDA typically doesn’t give even gravely ill patients the opportunity to choose promising treatments it has not approved. As journalist Kate Jenkins asks: “If you had a fatal disease and were told you only had one year to live, wouldn’t you prefer to be allowed to make your own choice?”
This article by Ronald Bailey gives a further look at this mess, and offers libertarian alternatives.
The Independent Institute offers an overview of the situtation and proposals for replacing the FDA.
And for a great movie that dramatizes this life-and-death struggle, see The Dallas Buyers Club starring Matthew McConaughey.