Joseph Declaration and Michigan LARA Exhibits (Exhibit 1 to Reply) — AAPS v. FDA

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ECF No. 13-1 in Association of American Physicians & Surgeons v. Food & Drug Administration, No. 1:20-cv-00493-RJJ-SJB, in the U.S. District Court for the Western District of Michigan, Southern Division, filed July 20, 2020 as Exhibit 1 to the plaintiff's combined reply in support of a preliminary injunction and opposition to the defendants' motion to dismiss. It is a declaration by Lawrence J. Joseph, counsel for the plaintiff, stating that he obtained two documents from the website of the Michigan Department of Licensing and Regulatory Affairs on July 20, 2020. Exhibit A is a March 24, 2020 letter to licensed prescribers and dispensers on prescribing hydroxychloroquine or chloroquine, citing Michigan Administrative Code, R 338.490(2). Exhibit B is a LARA notice about FDA guidance for emergency use of chloroquine phosphate and hydroxychloroquine sulfate.

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Exhibit 1 
Joseph Declaration 
Combined Reply in Support of Plaintiff’s Motion for a Preliminary Injunction and 
Opposition to Defendants’ Motion to Dismiss 
 
 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 13-1 filed 07/20/20   PageID.650   Page 1 of 7

1 
IN THE UNITED STATES DISTRICT COURT 
FOR THE WESTERN DISTRICT OF MICHIGAN 
SOUTHERN DIVISION 
ASSOCIATION OF AMERICAN  
PHYSICIANS & SURGEONS, 
Plaintiff, 
 v. 
FOOD & DRUG ADMINISTRATION; DR. 
STEPHEN M. HAHN, Commissioner of Food 
& Drugs, in his official capacity; 
BIOMEDICAL ADVANCED RESEARCH & 
DEVELOPMENT AUTHORITY; GARY L. 
DISBROW, Ph.D., Acting Director, 
Biomedical Advanced Research & 
Development Authority, in his official 
capacity; DEPARTMENT OF HEALTH & 
HUMAN SERVICES; and ALEX AZAR, 
Secretary of Health & Human Services, in his 
official capacity, 
 Defendants. 
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No. 1:20-cv-00493-RJJ-SJB 
Hon. Robert J. Jonker 
Mag. Sally J. Berens 
DECLARATION BY LAWRENCE J. JOSEPH 
I, Lawrence J. Joseph, hereby declare that: 
1. 
I am over the age of 21 years and competent to make this declaration 
pursuant to 28 U.S.C. § 1746. I have not been convicted of a felony or a crime of 
dishonesty. 
2. 
I am counsel for plaintiff Association of American Physicians & 
Surgeons (AAPS) in this action. 
3. 
In that capacity, I visited the website of the Michigan Department of 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 13-1 filed 07/20/20   PageID.651   Page 2 of 7

2
Licensing and Regulatory Affairs on July 20, 2020 at the following address: 
https://www.michigan.gov/documents/lara/Reminder_of_Appropriate_Prescribing_and_Dispensi
ng_3-24-2020_684869_7.pdf and downloaded the “Reminder” to Licensed Prescribers 
& Dispensers attached hereto as Exhibit A.
4.
In that capacity, I visited the website of the Michigan Department of
Licensing and Regulatory Affairs on July 20, 2020 at the following address: 
https://www.michigan.gov/lara/0,4601,7-154-11472-523663--,00.html
and 
printed 
the 
guidance entitled “FDA Guidance for Emergency Use of Chloroquine Phosphate 
and Hydroxychloroquine Sulfate” to portable document format, a true and correct 
copy of which is attached hereto as Exhibit B.
I declare under penalty of perjury that the foregoing is true and correct. Executed on 
this 20th day of July 2020.
Lawrence . Joseph
/s/ Lawrence . Joseph
Case 1:20-cv-00493-RJJ-SJB   ECF No. 13-1 filed 07/20/20   PageID.652   Page 3 of 7

Exhibit A 
 
 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 13-1 filed 07/20/20   PageID.653   Page 4 of 7

 
 
 
STATE OF MICHIGAN 
 
GRETCHEN WHITMER 
GOVERNOR 
DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS 
LANSING 
ORLENE HAWKS 
DIRECTOR 
 
 
BUREAU OF PROFESSIONAL LICENSING 
611 W. OTTAWA • P.O. BOX 30670 • LANSING, MICHIGAN 48909 
www.michigan.gov/bpl • 517-241-0199 
LARA is an equal opportunity employer/program 
March 24, 2020 
 
 
TO:  Licensed Prescribers & Dispensers 
 
RE:  Reminder of Appropriate Prescribing and Dispensing  
 
 
Dear Licensed Prescribers and Dispensers: 
 
The Department of Licensing and Regulatory Affairs has received multiple allegations of 
Michigan physicians inappropriately prescribing hydroxychloroquine or chloroquine to 
themselves, family, friends, and/or coworkers without a legitimate medical purpose.  
 
Prescribing hydroxychloroquine or chloroquine without further proof of efficacy for treating 
COVID-19 or with the intent to stockpile the drug may create a shortage for patients with lupus, 
rheumatoid arthritis, or other ailments for which chloroquine and hydroxychloroquine are proven 
treatments.  Reports of this conduct will be evaluated and may be further investigated for 
administrative action.  Prescribing any kind of prescription must also be associated with medical 
documentation showing proof of the medical necessity and medical condition for which the 
patient is being treated.  Again, these are drugs that have not been proven scientifically or 
medically to treat COVID-19. 
 
Michigan pharmacists may see an increased volume of prescriptions for hydroxychloroquine 
and chloroquine and should take special care to evaluate the prescriptions’ legitimacy. Pursuant 
to Michigan Administrative Code, R 338.490(2), a pharmacist shall not fill a prescription if the 
pharmacist believes the prescription will be used for other than legitimate medical purposes or if 
the prescription could cause harm to a patient. 
 
It is also important to be mindful that licensed health professionals are required to report 
inappropriate prescribing practices.  LARA appreciates all licensed health professionals for their 
service and cooperation in assuring compliance in acting responsibly while continuing to provide 
the best possible care for Michigan’s citizens during this unprecedented and very challenging 
time. 
 
To stay up to date on the latest information regarding the COVID-19 pandemic please go to 
www.michigan.gov/Coronavirus and the CDC site at www.CDC.gov. 
 
Sincerely, 
 
Deb Gagliardi, Director 
Bureau of Professional Licensing   
                                                                      
Forrest Pasanski, Director 
Enforcement Division 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 13-1 filed 07/20/20   PageID.654   Page 5 of 7

Exhibit B 
 
 
Case 1:20-cv-00493-RJJ-SJB   ECF No. 13-1 filed 07/20/20   PageID.655   Page 6 of 7

7/20/2020
LARA - FDA Guidance for Emergency Use of Chloroquine Phosphate and Hydroxychloroquine Sulfate
https://www.michigan.gov/lara/0,4601,7-154-11472-523663--,00.html
1/1
LARA /  LARA NEWS RELEASES
FDA Guidance for Emergency Use of Chloroquine
Phosphate and Hydroxychloroquine Sulfate
Dear Licensed Prescribers and Dispensers:
This communication is being provided to inform you of a recent guidance that has been issued
by the US Food & Drug Administration (FDA) for emergency use of chloroquine phosphate and
hydroxychloroquine sulfate, as described in the Scope of Authorization section of the FDA letter
(Section II) for the treatment of COVID-19. 
LARA appreciates the essential role of our prescribers and dispensers and recognizes their
ability to make proper clinical decisions including following responsible prescribing and
dispensing practices.  LARA thanks all of the dedicated licensed health professionals and others
who continue to provide the best possible care for Michigan’s citizens during this state of
emergency. 
Debra Gagliardi
Director, Bureau of Professional Licensing
COPYRIGHT 2020 STATE OF MICHIGAN
OFFICIAL WEBSITE OF MICHIGAN.GOV
DEPARTMENT OF
LICENSING AND REGULATORY AFFAIRS

Administrative Rules
LARA FOIA Process
MICHIGAN.GOV HOME
ADA
MICHIGAN NEWS
POLICIES
Case 1:20-cv-00493-RJJ-SJB   ECF No. 13-1 filed 07/20/20   PageID.656   Page 7 of 7

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