An EUA Fueled by Trump’s Treatment Sets Another Bad Precedence
(Thursday, October 8, 2020]​
Regeneron filed for an EUA for its antibody cocktail for COVID-19 within days of it being used to treat President Trump. While emergency use authorizations based on data from a few patients are not uncommon, the timing of this application and the immediate public authorization by the President creates an impression that Regeneron is trying to shortcut the regulatory process with political support. Political influence on regulatory decisions is always suspect. Product approvals should be driven by data and be unbiased. It is not uncommon for patients to strongly advocate for experimental treatments based on personal experiences, and patient advocates play a prominent strategic role in most new product development plans in recent years. Patient advocates are used in many ways; to better understand the target population preferences, to help with better clinical trial designs, to advocate a product directly with FDA, and to create a public image of the product in an effort to influence FDA’s decision regarding the market approval of a given product. A well-known example is that of Exondys where the manufacturer, Sarepta, very effectively used patient advocates to get approval despite lacking data. However, Exondys did go through the full regulatory process and its approval, although highly controversial, was driven by FDA’s drug chief, Janet Woodcock, who was strongly influenced by patient advocate and had no personal bias. In this case, it is very different. The patient advocate is Mr. Trump, the person whose entire brand is to take strong positions for things he supports, and he has the authority to overrule any objecting regulator in the country. On top, this is 3 weeks before an election where this approval could impact the outcome of the election. So, no matter what the outcome, the decision by FDA would look politically motivated. Manufacturers have the right to use any strategy to get their products approved by FDA, even if that strategy involves political influence. But political influence is a two-edged sword; it can backfire if the political environment changes. It used to be an after-thought, a back-up plan to fight, for disputes with the FDA when the manufacturers felt FDA reviewers were unfair. Using political influence for even relatively straight-forward decisions like emergency use authorization is a bad precedence.