FDA has responded to my questions on a Manufacturing Facility Inspections FOIA—It's not Good News...
You've got to have lots of $$$$$s to pay for their work...
Subscribers may remember this potential bit of good news I reported recently:
I had been told by FOIA staff that the document I had submitted would be passed on to Quality staff at the Center for Biologics Evaluation and Research (CBER)
This is the reply that came in earlier today:
Good Morning,
I have received the subject FOIA request for the following:
“This FOI relates to the following Inspection at FEI Number 1222181, Wyeth BioPharma Division of Wyeth Pharmaceuticals: Inspection End Date: 09/19/2023 Inspection ID: 1218069 Product Type: Biologics Classification: VAI I wish to know what the voluntary action comprised and would like sight of the inspection report, if that were possible. Was there a further FDA inspection (biologics) to confirm that remediation activities in the VAI had been carried out satisfactorily? In relation to the inspection below: Inspection End Date: 04/28/2017 Inspection ID: 1020234 Product Type: Biologics Classification: VAI I wish to know what the voluntary action comprised and would like sight of the inspection report, if that were possible. Was there a further FDA inspection (biologics) to confirm that remediation activities in the VAI had been carried out satisfactorily? I would also like to know if there was a pre-approval inspection carried out at the Wyeth facility prior to the EUA for the Pfizer/BioNTech drug substance in the SARS-Cov-2 sterile injectables? If so, I wish to have sight of the inspection report.”
After reviewing your request, it appears that you are posing questions about a specific inspection topic. DIDP can provide specific records requested; however, we do not answer questions regarding specific inspectional topics. We are requesting that you reword/resubmit a new FOIA request listing the specific records that you are seeking.
Please note, if you are still interested in the 2 Establishment Inspection Reports for the dates listed in this request, a prepayment will be required, due to the number of pages included in these reports, and the search/review time required. We can discuss that more once we receive your new FOIA request with the records you are seeking.
Once you concur, this FOIA request will be withdrawn. Feel free to submit a new FOIA request including the specific records you are seeking.
Thank you and I look forward to your response.
Sincerely,
Cara Minelli
Government Information Specialist
Freedom Of Information Act Branch I
Division of Information Disclosure Policy (DIDP)
Office of Partnerships (OP)
Office of Regulatory Affairs (ORA)
U.S. Food & Drug Administration (FDA)
What does this mean?
It means that I will not be able to put my case to the people in charge of quality and facility inspections for biologic products at FDA CBER. I was initially told that would be the case.
Not only that, but if I want details of the two inspections I originally asked for, I will need to make a pre-payment. That’s going to be thousands of dollars that I don’t have. In have not worked for 4 years, other than what I raise from my 126 paid subscribers here (mega thanks to you).
This decision is despite the fact that the document I submitted raises serious concerns, based on published FDA inspector’s observations in Form 483s, indicating lack of control over quality. I made it clear that this was of the utmost urgency given the risk to consumer safety.
What happens next?
Well, in the light of the comment above, repeated below, this is as far as it can go:
Please note, if you are still interested in the 2 Establishment Inspection Reports for the dates listed in this request, a prepayment will be required, due to the number of pages included in these reports, and the search/review time required. We can discuss that more once we receive your new FOIA request with the records you are seeking.
I do find it odd that they charge for all FOIA enquiries, especially when these reports already exist. The time is in redacting the contents to make them as incomprehensible as the can.
Anyway, stay with me, we’ve got this!!!
H.
The one USAtty whose firm is highly successful with FOiA requests to CDC and FDA is Aaron Siri. You may want to run your issue past Del Bigtree at the Highwire to see what he thinks.
Welcome to the FOIA club 'F#ck Off Idiot Amateur.'