OFFICIALS LEGISLATION INTEREST GROUPS PUBLIC STATEMENTS COMMITTEES VETOES

Letter to Janet Woodcock, Acting Commissioner of the US Food and Drug Administration - Gibbs Presses FDA on Vaccine FOIA Timeline

Letter

By: Bob Gibbs
By: Bob Gibbs
Date: Jan. 10, 2022
Location: Washington, DC
Issues: Health and Health Care Legal

Dear Acting Commissioner Woodcock,

I write to inquire about the U.S. Food and Drug Administration's (FDA) recent proposal to release
data pertaining to the approval of the Pfizer/BioNTech coronavirus vaccine over the course of over
55 years.

In August 2021, a Freedom of Information Act (FOIA) request was filed by the nonprofit group
Public Health and Medical Professionals for Transparency (PHMPT) seeking all documents and
data the FDA has on the Pfizer vaccine, including clinical trial data, correspondence between the
FDA, BioNTech, and Pfizer, and information on side effects. After refusing to expedite the request,
PHMPT sued, and in November, the FDA requested releasing the information over the course of
55 years. On January 6, 2022, a federal judge in Texas ruled the FDA must release 55,000 pages
of documents per month, resulting in the full release of information by the end of 2022.

The original timeline requested by the FDA was absolutely unacceptable and highlights the FDA's
constant inability to meet the 20-day FOIA response deadline set by Congress. According to the
most recent Department of Health and Human Services (HHS) FOIA report, there were over 2,800
backlogged requests at the end of FY 2020. This, in conjunction with the FDA's consistent
overuse of redactions in the public health documents it does release, has led to a lack of
transparency and public trust in the FDA. Information on life-saving medical treatments like the
Pfizer Covid-19 vaccine must be released with limited redactions so the public has confidence in
FDA decisions.

I therefore respectfully ask you to respond to the following questions:

* Will the FDA commit to following the court order of releasing 55,000 pages of documents
per month?

* Will the FDA commit to making limited redactions to the released documents?

* Does the FDA have a plan to increase transparency surrounding its approval process?


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