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Casey Mulligan: Making Prescription Drugs Expensive Again



As Biden supplants consumer experience with bureaucratic edicts, expect drug prices to rise. In 2018, prescription-drug prices fell for the first time in 46 years. They dropped even more in 2019 and 2020. Much of this break from the prior upward trend in prices was the result of additional competition unleashed by President Trump’s deregulatory agenda, which President Biden seeks to reverse.

How does Biden seek to do this? The federal government increases drug prices in two ways: by preventing manufacturers from entering the market and by requiring extant manufacturers to cease production.

By the time Trump came to office, Congress had long been exasperated that the Food and Drug Administration (FDA) had been so slow to approve new drugs and new manufacturers of old drugs; as Scott Gottlieb put it back in 2010, the “FDA [was] evading the law.” Meanwhile, the FDA complained that it did not have enough staff to follow the law as Congress had written it.

Trump appointed Gottlieb as his FDA commissioner to change that state of affairs. During Gottlieb’s 24-month tenure, the FDA approved hundreds more new drug manufacturers than it had in the prior 24 months. It also approved 16 biosimilars — generic versions of expensive vaccines, tissues, and other “biologic” treatments that are more complicated than a chemically synthesized molecule — after having approved just four in the previous 24 months. Trump’s next FDA commissioner, Stephen Hahn, of course, approved Covid-19 vaccines in record time.

Since 1962, the FDA’s mandate from Congress has been to certify that new drugs and medical devices are safe and effective. In 2006, without any new instructions from Congress, and despite its supposed staff shortage, the FDA decided that it would also target old drugs for certification and prohibit those drugs from U.S. markets until such approval was obtained. These drugs had been used by patients since before 1962, and perhaps even before the FDA existed.

Take intravenous vasopressin, which is used to support blood pressure in patients with septic shock (often a dangerous consequence of infections) and other conditions. The drug has been used for more than a century, during which time physicians and patients have accumulated a great deal of knowledge about its safety and efficacy. Under the FDA’s new “Unapproved Drugs Initiative,” however, Par Pharmaceutical was granted approval to manufacture the old drug, which the company did not invent but had been manufacturing and selling.

A Journal of the American Medical Association article explains what happened next: “On December 15, 2014, FDA instructed all other suppliers of unapproved intravenous vasopressin to stop manufacturing their products by January 30, 2015, leaving only Par with a marketed product. Subsequently, the average wholesale price of intravenous vasopressin increased from $4.27 to $138.40 per vial in November 2016, a 3141% increase.” Simply put, the FDA handed one manufacturer a complete monopoly on the intravenous-vasopressin market, and prices shot through the roof. This government-granted monopoly was not a reward for inventing a new drug, but merely for deferring to bureaucrats on one that was a century old.

Between 2006 and 2019, the FDA followed the same process for dozens of old drugs, most of which became radically more expensive. Trump sought to end the Unapproved Drugs Initiative (UDI) and allow manufacturers of old drugs to continue their business without FDA interference.

But when Biden took office, he wasted no time in reinstating the UDI and, thus, the FDA’s power to grant new monopolies on old drugs. Biden’s FDA, in a notice posted to the Federal Register announcing the UDI’s reinstatement, expressed its horror that it had not been consulted before Trump and his secretary of health and human services attempted to end the initiative. Conspicuously absent from the notice was any acknowledgement that physicians and patients might, with enough experience, be quite capable of evaluating a drug without assistance from bureaucrats. The notice did not acknowledge the harm done to consumers by government-granted drug-manufacturing monopolies, let alone quantify a commensurate benefit of such monopolies.

Of course, that’s because there is no commensurate public benefit. In other political contexts, Biden has grown fond of preaching about evil private-sector monopolies. He would better serve consumers by recognizing that monopolies are difficult, if not impossible, to maintain without the protection given to them by the government — and then working to rescind that protection wherever it has been given.

Casey B. Mulligan is a professor of economics at the University of Chicago’s Kenneth C. Griffin Department of Economics, and served as the chief economist of the White House Council of Economic Advisers in 2018–19. He is also the author of You’re Hired! Untold Successes and Failures of a Populist President, which details conflicts between President Trump and special interests.


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Posted: March 23, 2022 Wednesday 06:30 AM