The Food and Drug Administration (FDA) has been part of many conversations in 2020. To the great frustration of tens of millions, it has to approve COVID tests and arguably applies the wrong (from economic and health perspectives) standards in doing so. It is also tasked with approving COVID treatments and vaccines. Vaccine approvals came much quicker than experts expected, although IMO not quickly enough.With few exceptions, economists have “long been aware that the agency causes unnecessary deaths and suffering by” its “inexcusable delays in approval” (see esp. Klein and Tabarrok's collection). Judging from 74 years of Economic Reports of the President, the White House has not traditionally given this issue much attention. When the FDA does appear, the sentiment generally confirms
[email protected] (Casey B. Mulligan) considers the following as important: CEA, covid19, Health economics, President Trump, Regulation
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The Food and Drug Administration (FDA) has been part of many conversations in 2020. To the great frustration of tens of millions, it has to approve COVID tests and arguably applies the wrong (from economic and health perspectives) standards in doing so. It is also tasked with approving COVID treatments and vaccines. Vaccine approvals came much quicker than experts expected, although IMO not quickly enough.
With few exceptions, economists have “long been aware that the agency causes unnecessary deaths and suffering by” its “inexcusable delays in approval” (see esp. Klein and Tabarrok's collection). Judging from 74 years of Economic Reports of the President, the White House has not traditionally given this issue much attention. When the FDA does appear, the sentiment generally confirms that the approval delays are harmful and need reform.
Alan Greenspan's CEA was the first in 1975, when it included a paragraph about Sam Peltzman's famous study finding that the 1962 amendments were harming consumers. A sentence of the 1977 ERP lamented further FDA bans.
Ronald Reagan's ERPs gave the issue more attention, and more bluntly. "Screening agencies can dramatically affect the rate of innovation. A case in point is the Food and Drug Administration" it said in 1989, as part of a three-page section on the subject (pp. 218-20). A sentence in the 1987 ERP noted how badly FDA regulation was failing cost-benefit analysis: "the average cost per life saved varies across regulations from as little as $100,000 for NHTSA's 1967 steering column protection rule to $132 million for the Food and Drug Administration's 1979 ban on diethylstilbestrol (DES) in cattle feed." (p. 183)
Both Presidents Bush included a sentence on the issue (1993 and 2001). Consumer harms from FDA regulation was certainly top of mind for Mark McClellan, who was a member of the CEA at the beginning of the GW Bush administration until in late 2002 when he went on to head FDA.
Janet Yellen's CEA had a full chapter about regulation (Chapter 5 of 1998 ERP), especially climate change, which generally expressed the view that more federal regulation is needed. Interestingly, five pages of that chapter express some sympathy for the view that FDA has overregulated. It notes (p. 188) that FDA has been biased toward stopping "unsafe drugs that may cause injury or death" at the expense of "preventing sick people from getting more effective treatment." The bias is especially questionable, it says, in the context of a life-threatening illness.
The historical context may be especially relevant to understanding ERP 1998: Yellen's boss President Clinton was dealing with a Republican Congress led by Newt Gingrich. Both Republicans and AIDS advocates wanted to reduce FDA approval delays (the FDA review times for the AIDS treatments were still much longer than those under 2020's Operation WARP Speed), sponsoring the 1997 FDA Modernization Act that President Clinton signed. The FDA would ultimately, as Scott Gottlieb put it, “steadily disregard many of the law’s provisions.”
I see only two exceptions in the 74 ERPs. President Kennedy signed the Drug Efficacy Amendment that Peltman would later find to be so harmful. The 1963 ERP characterizes the amendment as "protecting public health."
The second exception is the Obama Administration. The 2012 ERP cites the FDA as a prototype of "a Smart Approach to Regulations."
By comparison to all previous administrations, President Trump's White House was arguably obsessed with FDA harms to medical innovation from the very beginning. FDA critic Scott Gottlieb was immediately appointed to head the FDA. The 2018 ERP had a full chapter about the health sector, half of which was about "Improving People’s Health through More Access to Medical Innovations" and "Encouraging Innovation, and Making It Affordable." The 2019 ERP (p. 18) cites FDA deregulation as one of the highlights of the year, and devotes twelve pages to how FDA reforms increased competition and reduced prescription drug prices. The same report also looks at the possible negative innovation effects of a proposed Federal ban on for-profit healthcare, which even Vox acknowledged as "a plausible downside."
The 2020 ERP updated the status of the FDA reforms in its chapter about deregulation, its chapter about healthcare, and its chapter about competition policy. It also cited the new Right to Try law, and regulatory barriers to treating chronic kidney disease. FDA barriers were part of the discussion we had with President Trump when he was signing the 2020 ERP (see the photo below). He clearly indicated to us that his experiences with FDA so far would be helping him remove still more barriers. (That promise was kept within weeks when Operation WARP Speed launched).
Citing a pandemic vaccine study finished in September 2019 (sic), page 193 of the 2020 ERP estimated that "the cost of delay in vaccine availability in the case of a pandemic is $41 billion per week." As White House senior staffer Joseph Grogan put it, the September CEA report was “was part of the intellectual foundation to the modernizing pandemic vaccine production executive order that [the White House] did along with Tony Fauci and NIH.”
[For context versus the current pandemic, note that the 2020 ERP went to the printer in early January 2020 and the writing stopped in early December 2019. In late March 2020, knowing about the COVID-19 pandemic, I estimated that vaccine delay would cost just the U.S. as much as $136 billion per week].