Interesting question - I would say as long as the applications were NOT approved, that information should remain confidential. Although some practices are a little different in the US, I think we can learn a lot about a two your inquiry by the European Union Ombudsman on EMA procedures which may be perceived as presenting a bias.
One specific point of discussion is Scientific Advice provided - it was a two main point inquiry:
1. Separation of those staff that provided scientific advise from those that will eventually review the application - public could conceive a bias of reviewers that were involved early in the final application (which is indeed very unlikely since the application review team is larger etc). This was based on an unnamed companies press release that that interacted with the EMA and there was some positive support (we see that in the US, but it's not appropriate in the EU).
2. Public release of the reviewer names involved in scientific advice to allow for public scrutiny. - This is kind of similar to your interview situation, although of course that was not public.
The inquiry was resolved by the EMA agreeing to try as best as possible to use different marketing authorization reviewers with a maximum of one of the Rapporteurs having been involved in Scientific Advice also providing input on the authorization application - and the EMA needs to justify that too.
The second point - Scientific Advice Rapporteurs will be made available with the EPAR AFTER the product is approved. That decision, I believe would fit your situation also.
A public consultation and workshop was part of the entire process and the opinion field was split in two:
Academic Researchers and Non-Government organizations: Wanted more transparency, wanted names early and no overlap to be able to provide scrutiny.
Medical product sponsors and regulatory agencies: Processes are fine, no changes needed and be careful with company confidential information.
The Ombudsman decision is here:
https://www.ombudsman.europa.eu/en/decision/en/116683 - original inquiry should be there two. The EMA response and agreement are on the EMA website.
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Kirsten Messmer RAC
Principal Regulatory Affairs Specialist
Garner NC
United States
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Original Message:
Sent: 20-Dec-2019 12:43
From: Anonymous Member
Subject: Ask Me Anything Session: Regulatory Intelligence and Policy
This message was posted by a user wishing to remain anonymous
I need some advice on stating who I worked with on a project at FDA.. I recently applied for a position and the Sr VP has asked who I interacted with on my IDEs and PMAs/pre-subs. They are looking for people with lot of FDA interaction experience. IMO, those names and titles might be available via the FOI release of some documents; however, since those discussions are confidential I do not believe it would appropriate or ethical to divulge the names of the lead, technical or clinical reviewers and branch chief i interacted with while managing the submissions. I can only state i was the Official Correspondent for the file and i can list the titles (branch chief, technical reviewer, lead reviewer, statistician) of those who i interacted with on these long term projects. If you can provide recommendations or FDA reason for not disclosing this information I would appreciate it..I have never been asked this before and I wonder if its because the individual is a R&D representative and historically most RD representatives have an lack of understanding of FDA requirements and ask regulatory counterparts off the wall questions or have extreme demands. Thank you
Original Message:
Sent: 11-Dec-2019 12:59
From: Emily Stamm
Subject: Ask Me Anything Session: Regulatory Intelligence and Policy
Hi Members,
Recently, RAPS released it's quarterly article series focusing on global best practices in regulatory intelligence (RI) and policy. Today, we have three experts, Kirsten Messmer, Matt Medlin, and Meredith Brown-Tuttle, who will be discussing the article series and available to answer your questions in real time.
Please use this thread to ask the experts your questions.
Can't wait to read the discussions!
Best,
Emily
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Emily Stamm
Community Manager
Regulatory Affairs Professionals Society®
regex@raps.org
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