A vial of the measles, mumps, and rubella virus (MMR) vaccine at the International Community Health Services clinic in Seattle, Wash., March 20, 2019. (Lindsey Wasson/Reuters)

A few days ago, Tyler Cowen posted this at Marginal Revolution:

“In 1957, when flu swept through Hong Kong, Mr [Maurice] Hilleman identified the virus as a new form to which people had no natural immunity and passed on his findings to vaccine-makers. When the virus reached the United States a few months later 40m doses of vaccine were ready to limit its damage.” Here is more from The Economist, circa 2005, via Brian LaRocca.

So basically, when it comes to producing vaccines, we were much better and faster at responding to pandemics in 1957 than we are now. That’s not right, especially since creating vaccines should be much easier now than it was back then.

At the Mercatus Center, Eli Dourado, who is now at the Center for Growth and Opportunity at Utah State University, writes about the way the FDA is impeding this process, and what to do about i:

Unfortunately, the FDA approval process is not likely to result in a marketable vaccine until sometime next year. To resolve this mismatch in timelines, Congress should create an expedited process to allow patients, via a process of informed consent, to use vaccine candidates that have not yet completed the full FDA approval process. . . . “The traditional vaccine timeline is 15 to 20 years,” says Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative. Given the urgency of addressing the COVID-19 pandemic, the world is moving faster: For example, researchers have skipped the usual animal testing of Moderna’s mRNA vaccine candidate and have already begun human clinical trials in Seattle. Even so, experts say it will take between a year and 18 months to get an FDA-approved COVID-19 vaccine on the market. This means that even if society “flattens the curve” and gets some respite via warm summer weather, the population will still be unprotected in the fall, when colder weather could drive an increase in the COVID-19 contagion again.

As to what Congress should do, Dourado writes:

To make this possibility viable, Congress should instruct the FDA to publish vaccine trial data in real time. . . . In addition, Congress should extend liability protections to COVID-19 vaccine candidate manufacturers. Sections 300aa–22 and 300aa–23 of title 42 of the US Code provide some liability protection for vaccine manufacturers, but only for those products that have complied with all requirements of the Federal Food, Drug, and Cosmetic Act, including the requirement to have received an approval from FDA…. Finally, Congress will need to create the mechanism by which patients can opt to forgo the protections of vaccine approval based on informed consent. . . .

The whole thing is here.

The same problem exists in the development of drugs. At the Wall Street Journal, David Henderson and Charles Hopper report on how the FDA’s current process is dramatically decreasing the supply of life-saving drugs:

The federal government requires pharmaceutical companies to prove that their drugs are both safe and effective before putting them on the market. Before 1962, companies needed to prove only safety. While there is some appeal to this two-hurdle approach, evidence suggests that there is only a slight benefit and a tremendous cost . . . Further, the Kefauver-Harris Amendments dramatically increased the time and cost of getting new drugs approved. Evidence provided by University of Chicago economist Sam Peltzman suggests that the number of new drugs approved dropped by 60% in the decade following the law change. We have fewer ineffective drugs, but also far fewer effective ones than we could have had.

The whole thing is excellent.



Also, it is no secret that the government, and the FDA in particular, botched the coronavirus testing. For more on that, you can read this and this. This isn’t new, of course. Back in 2011, George Mason University’s Alex Tabarrok wrote about the role the FDA plays in the shortage of 246 drugs. Tabarrok writes today about how the FDA’s precautionary principle continues to affect us during this crisis.

It is time for us to learn and finally reform the FDA. This is a good point by Nobel Prize Economist, Vernon Smith, and Bartley Madden:

Today’s world of accelerating medical advancements is ushering in an age of personalized medicine in which patients’ unique genetic makeup and biomarkers will increasingly lead to customized therapies in which samples are inherently small. This calls for a fast-learning, adaptable FTCM environment for generating new data. In sharp contrast, the status quo FDA environment provides a yes/no approval decision based on statistical tests for an average patient, i.e., a one-size-fits-all drug approval process.