https://issuesinsights.com/2019/11/25/the
Academics and former agency heads have called for the Food and Drug Administration to become an independent agency, out from under the umbrella of the Department of Health and Human Services (HHS). Although the FDA has real problems, giving it more independence isn’t the solution.
The argument may sound compelling. “Partisan political interposition has grown increasingly worrisome” at the FDA, said three academics in an article in the journal Science. They continued: “As the sole arbiter standing between a new drug application and a potential public health calamity, the FDA can hardly afford to be buffeted by undue political interference,” and should, therefore, become an independent agency. A group of former heads of the agency made a similar recommendation in January.
Yet political meddling has been extremely rare in recent years, and the genuine calamities in which the FDA has been involved have been self-inflicted wounds that might have been avoided with more, not less, accountability and oversight.
The FDA is ubiquitous in Americans’ lives, regulating products that account for more than $1 trillion dollars annually — 25 cents of every consumer dollar. Its regulation provides some measure of reassurance and tangible benefits, to be sure, but it has massive costs, direct and indirect. For example, bringing a new drug to market costs, on average, more than $2.5 billion.
Regulation that is excessive actually costs lives, both directly by withholding life-saving products, and also by diverting societal resources to gratuitous regulatory compliance.