
==== Front
J Law Biosci
J Law Biosci
jlb
Journal of Law and the Biosciences
2053-9711
Oxford University Press

39281965
10.1093/jlb/lsae019
lsae019
Essay
AcademicSubjects/SCI01050
Industry price guarantees for publicly funded medicines: learning from Project NextGen for pandemics and beyond
https://orcid.org/0000-0001-7813-9879
Lynch Holly Fernandez University of Pennsylvania, Perelman School of Medicine and Carey Law School, Philadelphia, PA, United States

Conti Rena M Boston University, Questrom School of Business, Boston, MA, United States

https://orcid.org/0000-0002-7899-3060
Contreras Jorge L University of Utah, SJ Quinney College of Law, Salt Lake City, UT, United States

Corresponding author. E-mail: lynchhf@pennmedicine.upenn.edu
Jul-Dec 2024
11 9 2024
11 9 2024
11 2 lsae01903 3 2024
10 7 2024
14 8 2024
© The Author(s) 2024. Published by Oxford University Press on behalf of Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School.
2024
https://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

Abstract

The affordability of publicly funded medicines has been a longstanding concern. In 2023, the Biden administration took several steps on this front, including incorporation of a price constraint in an agreement between the US Biomedical Advanced Research and Development Authority (BARDA) and Regeneron Pharmaceuticals, Inc. to develop a new COVID-19 monoclonal antibody. The agreement included a ‘Most Favored Nation’ (MFN) clause in which Regeneron agreed that the US commercial list price of certain products developed using BARDA funding would not exceed their retail price in comparable global markets. The Administration for Strategic Preparedness and Response (ASPR) included similar language in subsequent agreements, with a promise that this would become a new standard. Even beyond the preparedness context, government funders and purchasers might consider incorporating similar clauses in future contracts, especially given that the Regeneron agreement and its progeny have been praised as ‘groundbreaking.’ Yet a closer look reveals cause for skepticism. Regeneron’s MFN clause includes several loopholes related to covered purchasers and reference countries, prices, and conditions. We describe agreement terms that can make the difference between legally meaningful price constraints and mere window dressing. Our critical analysis offers important lessons for future efforts to improve the affordability of medical technology developed with public funds.
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pmcIn August 2023, Regeneron Pharmaceuticals, Inc. announced an agreement with the Biomedical Advanced Research and Development Authority (BARDA) to support development of a next-generation COVID-19 monoclonal antibody therapy for prevention of SARS-CoV-2.1 Part of the US Department of Health and Human Services (HHS) Project NextGen initiative, which aims to foster coordination across the government and private sector to advance the pipeline of innovative vaccines and therapeutics,2 the agreement funds up to 70% of Regeneron’s costs for certain clinical development activities, an estimated value of $326 million.3 This type of governmental support of private sector research and development (R&D) is itself unremarkable. In addition to medical countermeasures, including products to prevent or treat COVID-19,4 federal funds have directly contributed to all but two of the 356 drugs approved in the US from 2010 to 2019.5 What is remarkable, however, are the details of the Regeneron-BARDA deal, which disappointingly have been only partially released to the public, even a year later.

Shortly after the deal was announced, HHS revealed a contract clause that it described as ensuring that ‘if a new product is commercialized, its list price in the United States will be equal to or less than its retail price in comparable markets globally.’6 The clause was touted as ‘groundbreaking’ given that it appeared to use the government’s investment to influence a product’s list price from day one, in contrast to prior agreements for COVID-19 products that ensured only that the US government (and not necessarily other US purchasers) would pay as low a price as other governments or global purchasers.7 It also differed from typical National Institutes of Health (NIH) funding arrangements, in which government investment has not been tied to any constraint on price. The deal was praised even by skeptics like Senator Bernie Sanders, who called it a ‘positive step in the right direction’ and agreed to proceed with a hearing to confirm a new NIH director, which he had been opposing until the Biden administration delivered a plan to lower drug prices.8

Building on this momentum, the White House announced in December 2023 that the HHS Administration for Strategic Preparedness and Response (ASPR) ‘is making fair pricing a standard part of contract negotiations for medical products developed or purchased as part of its commitment to obtain the best value for the US taxpayer.’9 The press release noted that following the Regeneron deal, ASPR included ‘similar language’ in agreements with CastleVax, Codagenix, and Gritstone Bio, companies developing the first 3 vaccines under Project NextGen.10

Excitement regarding these commitments is understandable, given the context. Consider that Moderna and Pfizer raised the US list prices of their COVID-19 vaccines by about 400% when they moved from federal distribution to the commercial market.11 Despite government investment of $1.7 billion in the Moderna vaccine, the company nonetheless refused to guarantee the US the lowest price.12 More broadly, US prescription drug prices are nearly twice those of other Organization for Economic Cooperation and Development (OECD) nations, even after adjusting for rebates and other discounts.13 Although US subsidization of innovative medicines for the rest of the world may encourage and sustain industry investment, there are also important downsides to this system. Most notably, Americans increasingly face challenges related to affording prescription drugs, even when they are insured. As a result, splitting pills or foregoing needed medicines are commonly reported behaviors.14 Addressing the price and affordability of medicines in the US is an important national priority.

Unfortunately, as a legal matter, the terms of the Regeneron deal and follow-on contracts are not as good for the American public as they have been made out to be. A closer look raises concerns about affordability of new COVID-19 interventions, even as infections persist, as well as other countermeasure products developed with ASPR collaboration. Given the strong praise these agreements have garnered, a deeper concern is that legally porous contract terms like these will be treated as models for future public-private partnerships, even beyond the unique circumstances of public health preparedness. While one consequence of such contractual terms could be to encourage greater private sector participation in government programs, they could also lower public and political pressure on the pharmaceutical industry without meaningfully lowering prices. With the goal of avoiding that outcome, we critically assess the Regeneron contract, limited to the excerpt that has been publicly shared, to highlight the multiple legal weak spots that could ultimately inhibit the government’s stated goals.

I. THE US GOVERNMENT AND HIGH PRICED MEDICINES

There have been many failed attempts to link the prices of medical products to public investment. In 1989, prompted by concern over the price of early HIV medicines, NIH inserted a ‘fair pricing clause’ into its standard cooperative research and development agreements requiring a ‘reasonable relationship between the pricing of a licensed product, the public investment in that product, and the health and safety needs of the public.’15 However, following industry opposition, as well as NIH concerns about the clause’s effectiveness, that approach was abandoned in 1995.16

Although it does not explicitly address fair pricing, the Bayh-Dole Act of 1980 authorizes a federal agency that funds private research to ‘march-in’ to require the grant recipient to license its patents to additional parties in order to ‘alleviate health and safety needs, which are not being reasonably satisfied’ or when a product’s benefits are not available to the American public on ‘reasonable terms.’17 March-in rights have never been exercised but, in December 2023, the National Institute of Standards and Technology (NIST) released a draft policy for public comment that would permit federal agencies to consider whether drug prices are ‘extreme, unjustified and exploitative’ when deciding whether to march in.18 NIST warned, however, of a ‘potential chilling effect’ on relationships with private industry,19 acknowledging industry arguments that this approach may impede innovation. Industry has also claimed that marching in on the basis of price exceeds the government’s statutory authority.20

An alternative approach to addressing pricey medicines builds on the federal government’s purchasing power rather than its research investment. For example, pricing provisions in the Inflation Reduction Act of 2022 (IRA) enable Medicare to negotiate payments for a subset of high-cost drugs after they have been marketed for several years.21 While significant, the IRA’s pricing provisions do not directly address high launch prices nor do they extend to all patients (although the possibility of being selected for price negotiation may alter industry decisions about launch price and Medicare negotiations may influence private payer behavior, resulting in broader impact). The IRA’s pricing provisions are also the subject of numerous pending industry lawsuits, which claim that the negotiation is coerced and the statutory scheme is unconstitutional, among other challenges.22

In contrast to these approaches, ex ante price negotiation between funding agencies and drug companies would be on stronger legal footing than use of march-in rights, given that the Bayh-Dole Act does not explicitly contemplate use of that provision to address pricing concerns, and would avoid many of the legal challenges raised about the IRA. In addition, by virtue of creating predictability and control for companies, ex ante negotiation may be less likely to inhibit innovation than more unilateral approaches to pricing that occur after medicines have been developed and approved. Indeed, the BARDA and ASPR deals are specifically intended to encourage and support innovation, although it is worth noting that companies unable to negotiate acceptable ex ante pricing terms may elect not to pursue the targeted R&D at all. While ex ante price negotiation offers important potential benefits, whether companies can be enticed into such negotiation outside certain exceptional cases, such as pandemic preparedness, and on terms that reasonably protect the public’s interests remain important questions.

II. THE REGENERON-BARDA PRICING COMMITMENT

Against this backdrop, the Regeneron-BARDA pricing clause sounds promising and perhaps it was the best deal the government could strike. Under closer inspection, however, the deal is less beneficial to the public than it may appear given the presence of terms that are unduly favorable to Regeneron and, presumably, to the additional vaccine developers that have made similar agreements. This is critical because, as a matter of contract law, non-ambiguous contractual terms will be interpreted according to their plain meaning, not necessarily as intended (or hoped) by one of the parties. As a result, developers will be held only to the specific language of their contracts, even if this language frustrates the government’s goals of reasonable pricing.

The provision announced by HHS represents a familiar contractual approach known as a ‘Most-Favored Nation’ (MFN) clause.23 Borrowing nomenclature from the field of international relations, these clauses assure a buyer that it will not be treated worse than any other buyer, while helping sellers resist individual buyers’ demands for discounts. Other MFN clauses exist for medicines in the domestic market, such as Medicaid’s best price24 and 340B discounts,25 which respectively require companies to give Medicaid programs the best price among nearly all purchasers and to provide medicines used in the outpatient setting to covered entities at reduced prices. These provisions guarantee state Medicaid programs and qualified safety net providers affordable prices,26 and in turn assure companies of sales to these entities. However, they also have some unintended consequences. For example, they allow companies to charge some purchasers higher prices for the same products. In addition, the expansion of entities eligible for low prices may cause companies to seek ways to limit their use.27 Although MFN clauses can be a helpful legal tool and have been used in other health care contexts, companies sometimes act to mitigate their effect when viewed as a threat to business interests.

Problematically, the full Regeneron contract has not been published, nor have the contracts with the other Project NextGen vaccine developers. However, the excerpt that has been released contains several exclusions that substantially reduce the likelihood that prices will be meaningfully constrained. Moreover, it is unlikely that undisclosed contract language will mitigate these loopholes, as presumably the government would have been eager to publicize those if present. The published excerpt of the Regeneron MFN clause states as follows (with the bracketed redaction in the original):

‘If Regeneron commercializes a product in the United States for prevention of SARS-CoV-2 comprised solely of a COVID-19 therapeutic for which BARDA invests [a minimum amount or more] under this Agreement, then, subject to applicable law, the list price (at wholesale acquisition cost) for commercial sales of such product in the United States following full licensure of the product, shall be substantially equivalent to or less than the approved price for commercial sales in High Income Countries outside of the United States; provided that such sales are comparable sales taking place within the same time period. Regeneron is permitted to take into account all relevant factors in determining whether sales are comparable sales, including volume commitments, timing of purchase and supply, the terms and conditions of purchase and supply, market conditions and epidemiology of SARS-CoV-2.’

One important limitation of this language is specific to the pandemic context: the pricing constraint only applies ‘following full licensure of the product.’ This means that products receiving an emergency use authorization (EUA) would not be covered until the US Food and Drug Administration (FDA) transitions them to traditional marketing approval. Notably, despite the expiration in May 2023 of the COVID-19 public health emergency declared under the Public Health Service Act, FDA’s declaration allowing new COVID-19 EUAs remains intact as of August 2024.28

The next concern is that the pricing constraint covers only the list price ‘for commercial sales’ in the US, meaning sales to commercial (private) payers. This is important, given that prior COVID-19 price constraints negotiated by the government were not extended to private payers. However, this clause seems to exclude non-commercial purchasers, i.e., the government, meaning that Medicare, state Medicaid plans, and federal and state employee plans may not benefit from the lower price and may have to negotiate separate agreements. Relatedly, because the reference price is linked exclusively to commercial sales outside the US, both the US government and other US payers may pay a price higher than other governments.

Another key limitation is that the clause allows pricing based on Regeneron’s determination of ‘comparable sales’ in high income countries (HICs), accounting for a variety of factors such as ‘volume commitments.’ Although the published language does not define HICs, the World Bank groups countries into four income categories, with 83 deemed HICs in 2024.29 Given the size of the US population, even large HICs such as Japan, Germany, France, UK, Italy, and South Korea are unlikely to have COVID-19 case counts or demand near US levels. Yet Regeneron’s pricing commitment does not extend to the World Bank’s ‘upper-middle income’ category, which includes large countries such as China, Indonesia, and Brazil. Thus, if Regeneron contracts to sell 10 million doses in Germany at $25 per dose, it could still sell 20 million doses in the US at $100 per dose, as these likely would not be considered comparable volume commitments; yet if Regeneron sells 20 million doses in China at $10 per dose, it can again sell 20 million doses in the US at $100 per dose, as China is not a country that may be considered for comparison under the agreement. Because there is not likely to be any HIC with total volume requirements comparable to those of the US, and other large economies are excluded, the MFN status extended to the US is likely to be legally toothless.

Accounting instead for proportionate volume sales and broadening the range of reference countries would make the MFN clause stronger, although the effect of such proposed changes is not entirely predictable. For example, while expanding the clause to ‘upper middle income’ countries would likely result in lower prices for US consumers without significantly affecting product distribution abroad, it is also possible that a company might avoid or discontinue sales in countries where the maximum supportable price would result in a contractually-required US price decrease exceeding the profit earned from sales in those countries.30 Although this is unlikely, it would be problematic to impede distribution of beneficial medicines abroad, demonstrating the complexity and potential ripple effects of MFN agreements.

Apart from the limited selection of reference countries, the clause also permits Regeneron to consider factors such as ‘market conditions’ and ‘epidemiology’ when deciding whether a US price adjustment is required. As a result, if the company reduces its prices to remain competitive with rivals in other markets (or in light of the maximum supportable local price, as noted above), it need not reduce prices in the US. Similarly, if the spread of disease is faster or slower in reference countries, resulting in price reductions due either to high volume or low demand, the company is not legally required to adjust US prices. Other broad language allows Regeneron to consider ‘the terms and conditions of purchase and supply’ in a reference country. Because no two deals are the same, there will invariably be differences in these terms and conditions, whether arising from regulatory compliance, quality guarantees, timing, shipment, indemnification, liability, and many other common terms. Consequently, Regeneron and other companies with similar clauses will have numerous legal justifications for refusing to lower US commercial list prices while still technically abiding by the terms of the agreement.

III. ARE THE PROJECT NEXTGEN DEALS WORSE THAN NOTHING?

The federal government, politicians, and others have touted the Regeneron agreement as a victory in the march toward more defensible drug pricing and a model for the future. Given the concerns just described, however, especially when taken cumulatively, it is reasonable to question whether these deals will in fact promote affordable COVID-19 drugs – or other medical products, should the language be adopted more broadly. Although government negotiators likely intended to show some positive movement on pricing to advance political goals, it is important to acknowledge how weak legal parameters could backfire by lowering pressure on both the pharmaceutical industry and the government to do better. In this way, the deals as struck may be worse than excluding such a pricing clause altogether.

Our concerns are not meant to suggest that Regeneron or other companies lack genuine interest ‘in ensuring enduring and equitable access to therapeutics developed under public-private partnerships for all Americans’31 or that they would necessarily take advantage of legal loopholes. The problem is that a company could easily evade the announced intent of these MFN clauses and the government would have little legal recourse. When a dispute arises, courts will interpret contractual terms between sophisticated parties strictly, notwithstanding good intentions and wishful thinking. Moreover, an MFN clause is only as good as the government’s willingness to enforce it in court should prices remain unreasonable. A different administration or different political circumstances could make enforcement efforts less likely than they were when a contract was initially signed.

One partial response to these concerns is greater transparency. Complex contractual terms cannot be reduced to a few politically expedient talking points shared via press release or cherry-picked excerpts. The public must be allowed to analyze government contract terms in their full context to ensure that the public interest is being served. This is especially true when similar language may be adopted as part of standard government contract negotiations going forward.32 Here, for example, it would be helpful for the public to know the minimum amount of government investment that will trigger the negotiated price constraint. The lower that amount, the less concerning the weak contractual provisions allowing enforcement of that price constraint might be (at least on the grounds that public investment should be matched with affordability and access).

An even better response would be for the government to insist on robust MFN language of the kind that has withstood legal scrutiny in court, rather than allowing the multiple opt-outs evidenced in the Regeneron contract. The relevant clause could be improved to read as follows:

‘If [company] commercializes a COVID-19 therapeutic product in the United States for which BARDA invests [a minimum amount or more] under this Agreement, then, subject to applicable law, the list price (at wholesale acquisition cost) for all sales of such product in the United States shall be no higher than the price charged by [company] for sales of such product in any other High Income or Upper Middle Income country (as defined by the World Bank) within the same calendar year.’

This language eliminates broad company discretion to decide whether or not to charge higher prices for drugs in the US. Unless they in fact intend to charge higher prices, companies receiving substantial government investment should be willing to agree to clear contractual restraints without an abundance of dilutive and discretionary wording. Refusal to do so also speaks volumes.

In addition to recent policy interventions directed at drug pricing, such as the IRA and efforts around march-in rights, the federal government should continue to push for fair pricing clauses in its contracts, both when supporting public investment in research and when purchasing drugs. To ensure maximum impact in future efforts, policymakers should seek to improve on the Project NextGen deals. Doing so will avoid the need for public reliance on a company’s goodwill over its contractually binding promises.

Footnotes

1 Regeneron Pharmaceuticals, Regeneron Announces Agreement with BARDA Supporting Development of Next-Generation Antibody Therapy for COVID-19 Prevention, Aug. 22, 2023, https://investor.regeneron.com/news-releases/news-release-details/regeneron-announces-agreement-barda-supporting-development-next/.

2 Administration for Strategic Preparedness & Response, Project NextGen, https://aspr.hhs.gov/NextGen/Pages/Default.aspx.

3 Regeneron Pharmaceuticals, supra note 1.

4 Susan Athey et al., The Economic Case for Federal Investment in COVID-19 Vaccines and Therapeutics Remains Strong, Brookings (2022), https://www.brookings.edu/articles/the-economic-case-for-federal-investment-in-covid-19-vaccines-and-therapeutics-remains-strong/; Ruchir Agarwal & Patrick Gaulé, What Drives Innovation? Lessons from COVID-19 R&D, IMF Working Paper (2021), https://www.imf.org/en/Publications/WP/Issues/2021/02/20/What-Drives-Innovation-Lessons-from-COVID-19-R-D-50096; Richard G. Frank, Leslie Dach & Nicole Lurie, It Was The Government That Produced COVID-19 Vaccine Success,  Health Affairs Forefront (May 14, 2021), https://perma.cc/K6AU-44X9.

5 Ekaterina Galkina Cleary et al., Comparison of Research Spending on New Drug Approvals by the National Institutes of Health vs the Pharmaceutical Industry, 2010–2019, 4 JAMA Health Forum e230511 (2023).

6 US Department of Health and Human Services, HHS Announces Details of Partnership with Regeneron to Develop Life-Saving Monoclonal Antibodies (2023), https://www.hhs.gov/about/news/2023/09/08/hhs-announces-details-partnership-regeneron-develop-life-saving-monoclonal-antibodies.html.

7 Rachel Cohrs, In New Regeneron Deal for Covid Drug, White House Imposes Price Limits for First Time, STAT (Sep. 13, 2023), https://www.statnews.com/2023/09/13/covid-regeneron-white-house-price-limits/.

8 Bernie Sanders, Sanders Statement on HHS Contract with Regeneron for Reasonable Pricing of COVID-19 Treatment (2023), https://www.sanders.senate.gov/press-releases/news-sanders-statement-on-hhs-contract-with-regeneron-for-reasonable-pricing-of-covid-19-treatment/.

9 The White House Press Office, FACT SHEET: Biden-Harris Administration Announces Dozens of Pharma Companies Raised Prices Faster than Inflation, Triggering Medicare Rebates (2023), https://www.whitehouse.gov/briefing-room/statements-releases/2023/12/14/fact-sheet-biden-harris-administration-announces-dozens-of-pharma-companies-raised-prices-faster-than-inflation-triggering-medicare-rebates/.

10 Id.

11 Beth Mole, US May Pay 3x More than EU for Moderna’s US-Funded COVID Shot, Ars Technica, Sep. 28, 2023, https://arstechnica.com/health/2023/09/us-may-pay-3x-more-than-eu-for-modernas-us-funded-covid-shot/.

12 Id.

13 Andrew W. Mulcahy et al., RAND: U.S. Prescription Drug Prices Are 2.5 Times Those in Other OECD Countries (2021), https://www.rand.org/pubs/research_briefs/RBA1296-1.html; T. Joseph Mattingly et al., 60 Years after Kefauver: Household income required to buy prescription drugs in the United States and abroad, 17(8) Res Social Adm Pharm 1489–95 (2021).

14 Laryssa Mykyta and Robin A. Cohen, Characteristics of Adults Aged 18–64 Who Did Not Take Medication as Prescribed to Reduce Costs: United States, 2021, CDC NCHS Data Brief, No. 470, June 2023, https://stacks.cdc.gov/view/cdc/127680.

15 Jorge L. Contreras, What Ever Happened to NIH’s ‘Fair Pricing’ Clause?, Bill of Health (Aug. 4, 2020), https://blog.petrieflom.law.harvard.edu/2020/08/04/nih-fair-pricing-drugs-covid19/.

16 Id.

17 Patent and Trademark Law Amendments Act, Pub. L. 96–517 (1980).

18 US Department of Commerce National Institute of Standards and Technology, Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (2023), https://www.federalregister.gov/documents/2023/12/08/2023-26930/request-for-information-regarding-the-draft-interagency-guidance-framework-for-considering-the.

19 Ed Silverman, Biden Proposal Targeting Pharma Patents Spurs Industry Fears, Consumer Doubts, STAT (2023), https://www.statnews.com/pharmalot/2023/12/07/biden-patents-medicines-prices-nih/.

20 Id.

21 Juliette Cubanski, Tricia Neuman & Meredith Freed, Explaining the Prescription Drug Provisions in the Inflation Reduction Act, Kaiser Family Foundation (Jan. 24, 2023), https://www.kff.org/medicare/issue-brief/explaining-the-prescription-drug-provisions-in-the-inflation-reduction-act/.

22 Congressional Research Service, Constitutional Challenges to the Medicare Drug Price Negotiation Program (2023), https://crsreports.congress.gov/product/pdf/R/R47682.

23 Jorge L. Contreras, Intellectual Property Licensing and Transactions: Theory and Practice 238–40 (2022).

24 Ramsey Baghdadi, Medicaid Best Price, Health Affairs (Aug. 10, 2017), https://www.healthaffairs.org/do/10.1377/hpb20171008.000173/full/.

25 The Commonwealth Fund, The Federal 340B Drug Pricing Program: What It Is, and Why It’s Facing Legal Challenges (2022), https://www.commonwealthfund.org/publications/explainer/2022/sep/federal-340b-drug-pricing-program-what-it-is-why-its-facing-legal-challenges.

26 David H. Howard et al., Pricing in the Market for Anticancer Drugs, 29(1) J Econ Persp 139–62 (2015); Rena M. Conti et al., Common Agent or Double Agent? Pharmacy Benefit Managers in the Prescription Drug Market, NBER Working Paper 28,866, 2022, https://www.nber.org/papers/w28866.

27 Timothy W. Levengood et al., Assessing the Impact of the 340B Drug Pricing Program: A Scoping Review of the Empirical, Peer-Reviewed Literature, 102(2) Milbank Quart 429–462 (2024).

28 US Food and Drug Administration, FAQs: What Happens to EUAs When a Public Health Emergency Ends?, (2023), https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/faqs-what-happens-euas-when-public-health-emergency-ends; US Food and Drug Administration, Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products (2024), https://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products.

29 World Bank Country and Lending Groups – World Bank Data Help Desk, https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups.

30 Thank you to the anonymous reviewer who raised this point.

31 US Department of Health and Human Services, supra note 6.

32 The White House Press Office, supra note 9.
