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Jerome's avatar

There is unfortunately another twist to the PREP Act:

"If an act or omission by a manufacturer or distributor with respect to a covered countermeasure, which act or omission is alleged under subsection (e)(3)(A) to constitute willful misconduct, is subject to regulation by this chapter or by the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], such act or omission shall not constitute "willful misconduct" for purposes of subsection (d) if-

(i) neither the Secretary nor the Attorney General has initiated an enforcement action with respect to such act or omission; or

(ii) such an enforcement action has been initiated and the action has been terminated or finally resolved without a covered remedy."

Becasue Prizer, Moderna et al are subject to FDA regulation (under the Food, Drug and Cosmetic Act), this is a problem. If the Attorney General or HHS has not initiated an enforcement action on the same issues alleged as willful misconduct, it's not "willful misconduct." Of course tthey will never initate such an action. This clearly unconstitutional provision can (we hope) be overcome, but it is a huge hurdle.

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Steve Rooke's avatar

Joel Smalley just did a substack post on safe and effective and it's been an annoyance of mine for some months.

Stick to the basics and they have nowhere to hide and challenge the officials who supported it.

Statistics are always open to interpretation🥴

Safe and effective was a marketing slogan to push a product on people that had been manipulated by governments and state propaganda 🍻It was all a scam👍

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