Are Political Considerations Behind the Expedited Approval of Pfizer’s Vaccine—Including a Lack of Public Participation?

Are Political Considerations Behind the Expedited Approval of Pfizer’s Vaccine—Including a Lack of Public Participation?

Transparency in the research, clinical trial, and regulatory approval process drives societal buy-in along with the ongoing continuous improvement of medicines and treatments. TrialSite was founded just at the end of 2018 with that premise in mind. Patient participation in research depends on greater awareness, trust, and engagement—important underlying foundations for advancing research. Federal government agencies such as the U.S. Food and Drug Administration (FDA) know this. That’s why the FDA initiated the “Transparency Initiative” back in 2009, a three-phased effort to improve transparency as reflected in the Transparency Initiative Task Force report. Transparency improvements are supported by agency-wide program performance and the FDA’s Advisory Committees. It is critical for transparency and, to some extent, overall Agency legitimacy is the concept of the FDA Advisory Committee. That is, groups of people representing various interests, including the public. Such committees typically include a “Chair, several members, plus a consumer, industry and sometimes a patient representative.” Such committees may also include additional experts with specialized kn...

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