HCQ lawsuit

Summary: The FDA cannot block usage of Hydroxychloroquine

[II]

B. Whether under the APA or pre-APA review, FDA’s actions were improper... 26

- 1. FDA acted arbitrarily and capriciously... 27

- 2. FDA exceeded its statutory authority... 29

- - a. FDA lacks statutory authority for its clinical-trial requirement... 30

- - b. FDA lacks statutory authority to limit off-label uses, based on perceived safety... 31

- 3. FDA’s actions are not in accordance with the law... 32

C. AAPS states a claim under the First and Fifth Amendments... 33

- 1. Defendants’ actions chill First Amendment rights... 33

- 2. Defendants violated the Due Process Clause’s Equal Protection component... 35

D. A court can grant relief – and especially interim relief – on claims outside the pleadings... 38

III.

AAPS is entitled to a preliminary injunction... 39

A. If this Court rejects FDA’s procedural defenses, this Court should grant interim relief because FDA has not otherwise disputed AAPS’s entitlement to that relief... 40

B. FDA’s interference with HCQ correlates with anti-life policies in other countries, contrary to President Trump’s position... 45