Study Request Received
Today we received a request from one of our customers for assistance in responding to a particular letter they received from the U.S. Department of Health and Human Services, Office of Inspector General. We have assisted customers during audits in the past, but never seen a letter request like this one. Our customer was nice enough to allow us to share the contents of the letter for educational purposes.
On the Email (we have removed any disclosing information)
******Begin Email******
Dear XXXXX,
This email is to notify you that the U.S. Department of Health and Human Services, Office of Inspector General is conducting a study on early implementation of product tracing requirements outlined by the Drug Supply Chain Security Act (DSCSA).
For this study, we plan to collect documents from and interview a sample of wholesale distributors. Your company has been selected for inclusion in our study. Please send requested documents to XXXX by XXXXXX. An OIG staff member will contact you shortly to schedule an interview. See the attached letter for further details.
If you would like to designate a different contact for the survey, please reply with the name, title, email address, and telephone number of the preferred contact by XXXXXXX.
Thank you for your assistance.
Best,
XXXX
******End Email******
Attached to the email was a official letter with the official letterhead of the U.S. Department of Health and Human Services, Office of Inspector General.
*****Begin Attached Letter*****
To XXXXXXXX:
The U.S. Department of Health and Human Services, Office of Inspector General is conducting a study on early implementation of product tracing requirements outlined by the Drug Supply Chain Security Act (DSCSA).
The purpose of this study is to describe the variety of ways in which wholesale drug distributors are meeting requirements as detailed in the DSCSA §582(c)(1) and by guidance published by the Food and Drug Administration (FDA) in November 2014 governing product tracing. We plan to issue a public report that will summarize obstacles and best practices to wholesale distributor implementation at a general level. The report may also include recommendations to the FDA about ways to improve program operations to assist with implementation (e.g., clarify product tracing guidance, provide technical assistance, etc.).
For the study, we are interviewing a sample of wholesale drug distributors about their product tracing practices. Your organization was selected to participate in the study, and we are requesting the following.
- An hour long interview—to take place between XXXXXX
- Examples of traceability documents (i.e., transaction information, transaction history, transaction
statement, direct purchasing statement) for two product transactions from XXXXXXX - Standard operating procedures for product tracing processes, if available.
An OIG staff member will contact you shortly to schedule the interview and answer any questions you may have. Please send traceability documents and standard operating procedures to Phil Sung at the e-mail below by XXXXXXX. If you have any questions or need additional information at this time, please contact XXXXX at XXXXXX or XXXXXX. If you would like to designate a different contact for the survey, please reply with the name, title, email address, and telephone number of the preferred contact by XXXXXXX.
Thank you for your time and cooperation.
******End of attached Letter******
A few points:
1.The government is really looking for industry feedback. They are reaching out to different pharmaceutical companies. If this is mandatory or not, is yet to be seen. Rejecting it could send a message that your company is not prepared.
This statement really outlines the purpose of the study.
“We plan to issue a public report that will summarize obstacles and best practices to wholesale distributor implementation at a general level. The report may also include recommendations to the FDA about ways to improve program operations to assist with implementation (e.g., clarify product tracing guidance, provide technical assistance, etc.).”
2.“For the study, we are interviewing a sample of wholesale drug distributors about their product tracing practices. Your organization was selected to participate in the study”
By the sound of it, more wholesalers will probably be selected.
Interesting outline of what is required for the study:
- An hour long interview—to take place between XXXXXX
- Examples of traceability documents (i.e., transaction information, transaction history, transaction
statement, direct purchasing statement) for two product transactions from XXXXXXX - Standard operating procedures for product tracing processes, if available.
If you haven’t created a Standard Operating Procedure (SOP) for product tracing read our post about it here. We also include a free SOP template.
Finally, we will be assisting our customer during this interview and documentation process. If possible, I will post an aftermath of how it went.
