Unintended Pharmaceutical Regulatory State Implications of Operation Warp Speed

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Abstract

This paper will analyze the impact of the Operation Warp Speed Covid-19 program as a policy tool, in order to explain why its success on the front end of accelerated vaccine development has not been matched on the back end of manufacturing and distribution.

In May 2020, staring into the abyss of the Covid-19 pandemic with no tools to combat it and no end in sight, the US government initiated Operated Warp Speed, a public-private partnership to facilitate the rapid development, manufacturing, and distribution of Covid-19 treatments, particularly vaccines. Defying most predictions, effective vaccine candidates emerged within less than a year, and the first emergency use authorization was granted in December 2020 to Pfizer and Moderna Pharmaceuticals.

One of the key features of the Covid-19 vaccine rollout in the US has been the relatively short supply, forcing policymakers to prioritize certain categories of the population over most others. Although the vaccine first became available in December 2020, official estimates suggest that it will take until August 2021 for the vaccine to reach all segments of the US population due to supply bottlenecks.

As part of Operation Warp Speed’s public-private partnership, several pharmaceutical firms received over $1 billion each from the US government to facilitate research and development toward a Covid-19 vaccine, including at least one of the successful firms whose product has come to market. Yet contained within the language of these agreements between the US government and its pharmaceutical company partners is a prohibition against the US government invoking federal “march-in” authority under the Bayh-Dole Act of 1980, which would enable the US government to seize a pharmaceutical patent whose development benefited from public finance if there is a pressing public health need and the patent holder is unable or unwilling to make the finished product available in adequate quantities or at a reasonable price to meet the public demand. The pharmaceutical industry has long denied that the US government has such authority, and the US government has corroborated that interpretation by refusing to invoke this authority since its inception even though doing so may have been warranted.

Given that institutional history, this paper argues that Operation Warp Speed appears to have unintentionally undercut the previous legal positions held by the pharmaceutical industry and the US government regarding the legitimacy of march-in authority. This finding invites a reconsideration of federal march-in authority as a viable policy tool to combat Covid-19 vaccine shortages and in health care more broadly. It also invites a reappraisal of what constitutes a public good in health care and what claims should the public have in any public-private partnership.

Author

• Anthony D. Dell'Aera, Worcester State University