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Posted On: 11/06/2021 8:46:11 PM
Post# of 148870
I am posting this for the non Reddit people.
PBio31
"Trying to post for the seventh time!
Received final response to my FOI request regrading the LL statement issued by FDA!
FDA provided the following information regarding the LL statement they had issued in May . If you recall, my initial request had over 10 questions related to this statement and FDA told me that it will take over 18 months to get the answers. However, if I reduced the number of questions to 3, then they could provide the information within 21 days. I agreed to their recommendations and reduced the questions accordingly. They did charge me $69 for this request!
I have included a few comments in the following response. I have also removed the names of the individuals to prevent any harassment.
Question: The name(s) of the person who authorized issuance of the “Statement on Leronlimab” that was posted on an FDA web site on or around May 17, 2021 [hereinafter the “Statement”]:
Response: Former Chief Scientist, Office of the Chief Scientist
Comments: According to the FDA website, Chief Scientist is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. I am still not sure what motivated this person to issue this statement. This person recently stepped down from this position and is moving to another division.
Question: The name(s) of the person who reviewed the Statement:
Response: Within CDER, the Statement was cleared by the following people:
Within the Office of New Drugs, the Statement was cleared by:
1. Associate Director for Policy (Acting) in the Office of New Drug Policy;
a. Comments: This person was also the author of this statement!
2. Director of the Office of Infectious Diseases. As part of this clearance, the Statement also was reviewed by a division director, deputy division director, a clinical team leader, and a clinical reviewer within this division.
3. Director of the Office of New Drugs
a. Comments: Before coming to FDA, he served as Vice President for late-stage development, diabetes, and endocrinology at Merck Research Laboratories. He also served as Vice President, head of metabolism development at Janssen.
4. A review of the Statement for technical accuracy was also conducted by the Office of Translational Sciences, including a biostatistics division director, a biostatistics team lead, and a biostatistician.
5. Within the Office of Communications, the Statement was cleared by Office Director. As part of this clearance, the Statement also was reviewed by the division director and a health communications specialist.
6. Within the Office of Regulatory Policy, the Statement was cleared by Office Deputy Director. As part of this clearance, the Statement also was reviewed by a senior regulatory counsel.
7. Within the office of the Center Director, the Statement was cleared by Center Director. As part of this clearance, the Statement also was reviewed by a Deputy Center Director and a Senior Advisor.
8. Within the Office of the Commissioner the Statement was reviewed by the following people:
a. Office of Chief Counsel cleared the Statement for OCC. It also was reviewed by other attorneys in the office prior to clearance.
b. Immediate Office of the Commissioner Acting Chief of Staff, reviewed the Statement for the Immediate Office of the Commissioner.
c. Office of the Chief Scientist cleared the Statement for the Office of the Chief Scientist
Question: The name(s) of the person who authored the Statement:
Response: Associate Director for Policy (Acting) in the Office of New Drug Policy – primary author who consulted and coordinated with all of the individuals within CDER referred to in the response to question 2 above.
Comments:
I had a mixed feeling when I received the above information: I was happy that the statement had gone through several departments for review/approval and by very professional people with good experience. However, I was unhappy that I still could not get the main reason behind the issuance of the statement and why only selected data was included in the statement even when it was reviewed for technical accuracy etc. I would appreciate feedback from this board regarding the above information– only constructive comments please."
PBio31
"Trying to post for the seventh time!
Received final response to my FOI request regrading the LL statement issued by FDA!
FDA provided the following information regarding the LL statement they had issued in May . If you recall, my initial request had over 10 questions related to this statement and FDA told me that it will take over 18 months to get the answers. However, if I reduced the number of questions to 3, then they could provide the information within 21 days. I agreed to their recommendations and reduced the questions accordingly. They did charge me $69 for this request!
I have included a few comments in the following response. I have also removed the names of the individuals to prevent any harassment.
Question: The name(s) of the person who authorized issuance of the “Statement on Leronlimab” that was posted on an FDA web site on or around May 17, 2021 [hereinafter the “Statement”]:
Response: Former Chief Scientist, Office of the Chief Scientist
Comments: According to the FDA website, Chief Scientist is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. I am still not sure what motivated this person to issue this statement. This person recently stepped down from this position and is moving to another division.
Question: The name(s) of the person who reviewed the Statement:
Response: Within CDER, the Statement was cleared by the following people:
Within the Office of New Drugs, the Statement was cleared by:
1. Associate Director for Policy (Acting) in the Office of New Drug Policy;
a. Comments: This person was also the author of this statement!
2. Director of the Office of Infectious Diseases. As part of this clearance, the Statement also was reviewed by a division director, deputy division director, a clinical team leader, and a clinical reviewer within this division.
3. Director of the Office of New Drugs
a. Comments: Before coming to FDA, he served as Vice President for late-stage development, diabetes, and endocrinology at Merck Research Laboratories. He also served as Vice President, head of metabolism development at Janssen.
4. A review of the Statement for technical accuracy was also conducted by the Office of Translational Sciences, including a biostatistics division director, a biostatistics team lead, and a biostatistician.
5. Within the Office of Communications, the Statement was cleared by Office Director. As part of this clearance, the Statement also was reviewed by the division director and a health communications specialist.
6. Within the Office of Regulatory Policy, the Statement was cleared by Office Deputy Director. As part of this clearance, the Statement also was reviewed by a senior regulatory counsel.
7. Within the office of the Center Director, the Statement was cleared by Center Director. As part of this clearance, the Statement also was reviewed by a Deputy Center Director and a Senior Advisor.
8. Within the Office of the Commissioner the Statement was reviewed by the following people:
a. Office of Chief Counsel cleared the Statement for OCC. It also was reviewed by other attorneys in the office prior to clearance.
b. Immediate Office of the Commissioner Acting Chief of Staff, reviewed the Statement for the Immediate Office of the Commissioner.
c. Office of the Chief Scientist cleared the Statement for the Office of the Chief Scientist
Question: The name(s) of the person who authored the Statement:
Response: Associate Director for Policy (Acting) in the Office of New Drug Policy – primary author who consulted and coordinated with all of the individuals within CDER referred to in the response to question 2 above.
Comments:
I had a mixed feeling when I received the above information: I was happy that the statement had gone through several departments for review/approval and by very professional people with good experience. However, I was unhappy that I still could not get the main reason behind the issuance of the statement and why only selected data was included in the statement even when it was reviewed for technical accuracy etc. I would appreciate feedback from this board regarding the above information– only constructive comments please."
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