{"id":715,"date":"2026-06-27T07:38:29","date_gmt":"2026-06-27T07:38:29","guid":{"rendered":"https:\/\/urbaneconomynews.com\/?p=715"},"modified":"2026-06-27T07:38:29","modified_gmt":"2026-06-27T07:38:29","slug":"save-american-lives-and-prosperity-by-cutting-the-fda-bureaucracy","status":"publish","type":"post","link":"https:\/\/urbaneconomynews.com\/?p=715","title":{"rendered":"Save American Lives and Prosperity by Cutting the FDA Bureaucracy"},"content":{"rendered":"
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By statute, the approval process of the Food and Drug Administration (FDA) is to determine the safety and effectiveness of a new drug. If both requirements are met, the new drug is approved. The process usually takes roughly a decade.<\/p>\n

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Most people would reasonably assume the lengthy approval process is due to the need to prove a new drug is safe for use by patients. But the years-long lag between a drug\u2019s submission for approval and its arrival on the market often stems from the process of assessing its effectiveness.<\/p>\n

The easiest way to think about it is this: determining safety protects patients; determining effectiveness protects consumers. Safety cannot be compromised or rushed, and the FDA\u2019s efforts to ensure a drug \u201cdoes no harm\u201d are justified.<\/p>\n

But the FDA\u2019s outdated, overly bureaucratic review process to determine effectiveness can cause delays that detrimentally impact the health and finances of prospective patients in dire need of these drugs. For their sake, there is no time to waste in reducing the Byzantine bureaucratic obstacles that stand in the way of improving the quality and longevity of their lives.<\/p>\n

The case for reforming the FDA\u2019s cumbersome, costly process for determining a drug\u2019s effectiveness is forcefully made by Unleash Prosperity\u2019s recent report, . The authors argue that streamlining and otherwise reforming the FDA\u2019s lumbering bureaucracy to more swiftly assess a new drug\u2019s effectiveness by just one year<\/em> will generate up to $10 trillion in medical innovations and savings, potentially lower prescription drug costs, and speed the availability of medications for Americans, be they patients, consumers, or producers.<\/p>\n

As Tomas Philipson, an Unleash Prosperity economist and former acting chairman of the White House Council of Economic Advisers, told Fox News:<\/p>\n

It takes about a decade from start to finish to come through FDA. Most of that time is not spent on safety. Most of it time is spent on effectiveness trials. FDA is charged by Congress to enhance both safety and effectiveness of new drugs. People recognize the role of the government potentially ensuring safety and consumer protection, but it\u2019s a unique role that FDA has of ensuring effectiveness. Reforming FDA would have a big impact on drug affordability for patients because it would allow for far more competition between drugs that come out faster.<\/p>\n

Yet the FDA\u2019s bureaucratic delays regarding effectiveness not only jeopardize patients\u2019 health and savings\u2014at risk, too, is the future of American medical innovation.<\/p>\n

As the report asserts:<\/p>\n

[Reduced FDA delays will position US in a better position in regulatory competition internationally, in particular with adversaries such as China, where clinical trials are performed faster and cheaper. Early discovery-to-IND (investigational new drug) timelines are 50-70 percent faster than in the rest of the world . . . And the cost of clinical trials are 50-60 percent lower than in the United States.<\/p>\n

Those who endured COVID-19 and the concomitant lockdowns are painfully aware of how dangerous it is to outsource medical research to communist China, where appropriate health and safety standards for research are inadequate, if not sorely lacking.<\/p>\n

It is worth reemphasizing that Unleash Prosperity\u2019s recommendations for FDA reform will not weaken its safety approval process. Rather, they aim to reform the effectiveness approval process by bringing it into the 21st century. To that end, the report lists numerous commonsense recommendations, including:<\/p>\n

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