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55 Years?!

Some days, all I can do is shake my head in disbelief. Listen to this…

This past summer, shortly after the FDA (U.S. Food & Drug Administration) approved the Pfizer vaccine for children aged 16+, a group of about 30 medical and public health professionals wanted to examine the data and documentation submitted to the FDA concerning this decision.

That doesn’t seem unreasonable, does it? These are qualified experts from places like Yale, Brown University, UCLA, and other institutions who are actually trying to provide some insight and assurances for segments of the general public who are skeptical of vaccines. So they filed a very common request with the FDA under the Freedom of Information Act requesting those documents.

You’d think the FDA would welcome that level of external scrutiny and quickly comply with that request. Well, not so fast.

The FDA refused to expedite their request for this vaccine data, so the group of experts took the FDA to court. And get this: with a straight face, the lawyers representing the FDA have asked the court to allow until the year 2076 for the FDA to fully release those documents. Fifty-five years from now!

As Joe Biden would say, C’mon, man!

To be fair, there are lot of pages in this request – over 329K in fact. However, virtually all of those are electronic. The FDA does have some responsibility to protect Pfizer’s trade secrets, which means some of that information needs to be redacted. But 55 years to fulfill this FOIA request? Really?!

Anyway, I just filed legislation along with Rep. Thomas Massie (R-KY) to require the FDA to expedite all records requests concerning the emergency use of, or licensing of, a COVID–19 vaccine. Under this legislation, the FDA would be given 100 days to release data to the public. They can hire additional staff, enlist the help of pharmaceutical company's attorneys – whatever it takes.

After all, the FDA managed to consider all 329,000 pages of data and grant emergency approval of the Pfizer vaccine within just 108 days. So it’s hard to rationalize why it now needs 55 years to release that information to outside experts.

This should hopefully get quick, bipartisan traction. We’ll see.