a memorandum of understanding (MOU) with the Bill & Melinda Gates Foundation.
Under the MOU, the two entities agreed to share information to “facilitate the development of innovative products, including medical countermeasures,” such as diagnostics, vaccines, and therapeutics to combat disease transmission during a pandemic.
The FDA has MOUs with many academic and non-profit organisations, but few have as much to gain as Bill Gates, who has invested billions into pandemic countermeasures.
Experts are concerned the Gates Foundation could have undue influence over the FDA’s regulatory decisions of these countermeasures.
David Gortler, an ex-senior adviser to the FDA commissioner between 2019 and 2021, says he is “suspicious” of the MOU.
“If the Gates Foundation establishes an MOU with a regulator on a product they want to develop, it seems like it would be a conflict of interest. What if every other drug company did the exact same thing as the Gates Foundation?” he says.
Gortler, now a fellow at the Ethics and Public Policy Center in Washington, DC, explained that normally, meetings between developers and regulators are supposed to be an official part of the public record and subject to Freedom of Information Act requests.
“However, an MOU such as this can circumvent the usual requirements for the transparency of official communications,” says Gortler. “This way their communications can be kept secret.”
David Bell, a former medical officer for the World Health Organisation (WHO) who now works as a public health physician and biotech consultant, agrees that the MOU has potential to corrupt the regulatory process.
“The narrative is that philanthropic foundations can only be good, because they’re making vaccines and saving thousands of lives, so we need to cut the red tape and help the FDA get stuff done quickly otherwise children will die,” says Bell. “But in reality, it has potential to corrupt the whole system.”
Bell adds, “Speaking generally, close relationships between regulators and developers raise inevitable risks that shortcuts and favours will breakdown the rigorousness of the product review, putting the public at risk.”
The FDA has been roundly criticised for its “revolving door.” Ten of the past 11 FDA commissioners left the agency and secured roles with pharmaceutical companies they once regulated.