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.
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’s submission for approval and its arrival on the market often stems from the process of assessing its effectiveness.
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’s efforts to ensure a drug “does no harm” are justified.
But the FDA’s outdated, overly bureaucratic review process to determine effectiveness can cause delays that detrimentally impact the health and finances of prospective patients in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.
The case for reforming the FDA’s cumbersome, costly process for determining a drug’s effectiveness is forcefully made by Unleash Prosperity’s recent report, . The authors argue that streamlining and otherwise reforming the FDA’s lumbering bureaucracy to more swiftly assess a new drug’s effectiveness by just one year 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.
As Tomas Philipson, an Unleash Prosperity economist and former acting chairman of the White House Council of Economic Advisers, told Fox News:
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’s 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.
Yet the FDA’s bureaucratic delays regarding effectiveness not only jeopardize patients’ health and savings—at risk, too, is the future of American medical innovation.
As the report asserts:
[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.
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.
It is worth reemphasizing that Unleash Prosperity’s 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:
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- Increased utilization of artificial intelligence (AI) in the pre- and post-approval processes.
- Establishment of a Cancer Warp Speed Office.
- Extension of Project Orbis-style concurrent review beyond oncology products to all serious and life-threatening conditions,
- Substitution of pre-market effectiveness approval with post-market approval of safe products through better incentivized post-market obligations on manufacturers.
- Amending the existing “right to try” regulations to enable more widespread use, building on the law passed during President Trump’s first term.
Being a doctor of laws, not of medicine, I sought a second opinion about reforming the FDA’s effectiveness approval process from an actual medical doctor of my acquaintance. Declaring the “case so easily made on so many fronts,” she further elaborated:
This is one of the major areas where government over-regulation not only makes life more expensive, it literally costs lives. The drug development pipeline is jammed up at FDA approval, because an anachronistic bureaucracy pretends the internet hasn’t been invented, let alone AI.
The good doctor remained optimistic about future advancements in medications, but there was a caveat. “We need to get government out of the way of the quantum leap in drug development that we have already begun in the private sector—notably in areas such as space, where drug development in low orbit is already taking place.”
And when it came to the prospects of Unleash Prosperity’s proposed reforms, she was blunt: “The FDA will oppose such recommendations, because they don’t want to lose their power, funding, and perks. But we simply cannot keep running the same old approval process with 1970s standards and personnel.”
This sounds like a prescription for the Trump administration and Congress to act. Because cutting the FDA bureaucracy is not merely a matter of dollars and cents; it is a matter of life and death.
Fortunately, President Trump, HHS Secretary Robert F. Kennedy Jr., and FDA Commissioner Marty Makary agree. The administration recently authorized a pilot program to speed up the process of determining a new drug’s effectiveness.
According to Unleash Prosperity’s hotline:
The FDA pilot program would shorten the time it takes from drug identification to first-in-human Phase 1 clinical trials; additionally, FDA is clarifying regulatory expectations for sponsors that could reduce early trial timelines by six to 12 months. FDA has also issued draft guidance clarifying that, in many cases, one high-quality late-stage clinical trial with confirmatory evidence will generally be sufficient to provide substantial evidence of effectiveness in support of a drug approval.
While a welcome step forward, this pilot program must be followed up with a more comprehensive implementation. To paraphrase Winston Churchill: this pilot program is not the end, it is not the beginning of the end, but it is, perhaps, the end of the beginning in cutting the federal health care bureaucracy to save American lives and prosperity.
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The Hon. Thaddeus G. McCotter (M.C., Ret.) served Michigan’s 11th Congressional district from 2003 to 2012. He served as Chair of the Republican House Policy Committee and as a member of the Financial Services, Joint Economic, Budget, Small Business, and International Relations Committees. Not a lobbyist, he is also a frequent public speaker and moderator for public policy seminars, and a cohost of The John Batchelor Show, among sundry media appearances.
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