Subject: Fwd: ldt - 60 day fda clock
From: "Eric Schwerin" <[email-masked]>
To: "Hunter Biden" <[email-masked]>
Date: Thu, 31 Jul 2014 16:22:18 -0400

Think about who we should recommend.   Does Boies’ DC office have any FDA regulatory expertise?  I think as part of the recommendation they may want to engage a law firm to handle any public comments they may choose to make the FDA.  

I think we can come up with a short list of lobbying/PR firms too.   

Eric D. Schwerin
Rosemont Seneca Partners, LLC
1010 Wisconsin Ave., NW
Suite 705
Washington, DC 20007
(202) 333-1880
[email-masked]
P Consider the environment before printing this email.

Begin forwarded message:

> From: Neil Callahan <[email-masked]>
> Subject: Re: ldt - 60 day fda clock
> Date: July 31, 2014 at 3:58:45 PM EDT
> To: Eric Schwerin <[email-masked]>
> Cc: John DeLoche <[email-masked]>, Hunter Biden <[email-masked]>, Rob Walker <[email-masked]>, "[email-masked]" <[email-masked]>, Devon Archer <[email-masked]>, William Lee <[email-masked]>, Neil Callahan <[email-masked]>
> 
> Agreed, they need to deploy capital to this part of their business as  a defensive move to protect the franchise.
> 
> Can we come up with a list of firms we'd recommend and the names of the principles we know?   John could serve this short list up to the company to action.
> 
> Also, as part of our value add, could we write an Opinion Memo that lays all this out with our recommendation?   I think this would show our work and head off Counsyl from saying "I thought you guys would do this work for us as part of your value add".
> 
> --------------------
> Neil Callahan
> Rosemont Seneca
> 917-945-9516
> 
> On Jul 31, 2014, at 3:49 PM, Eric Schwerin <[email-masked]> wrote:
> 
>> From my brief read on this the 60 day window is just FDA meeting is requirement to notify Congress 60 days before publishing a request for public comment in the Federal Register.  
>> 
>> Before any agency makes a new regulation or rule change they must publish it in the Federal Register and allow for a public comment period.  Very standard procedure.  Many times they need to notify Congress before doing so.
>> 
>> Once that request for public comment is published Counsyl can decide if it wants to make a comment or not.  Ultimately, it sounds like FDA is thinking of increasing regulations on LDT’s, which I am assuming is not ideal for Counsyl.  
>> 
>> I think this is a great data point to support our argument that Counsyl hire a firm or team in DC to work on public affairs/government relations/regulatory affairs and do so ASAP.  FDA regulations is a very technical area and they need to find the right firm(s) to help them with this and I don’t think should rely on an in house person.  Also, the decision on whether to comment publicly is something Counsyl should weigh as part of an overall public relations strategy as their comments will be out there for all to see.   And if they feel there is a potential regulation that will hamper their business they want to be up on the Hill now telling the Counsyl story and asking members to support their case with the FDA.
>> 
>> Hunter and Rob may have other thoughts.
>> 
>> Best,
>> 
>> Eric
>> 
>> 
>> 
>> Eric D. Schwerin
>> Rosemont Seneca Partners, LLC
>> 1010 Wisconsin Ave., NW
>> Suite 705
>> Washington, DC 20007
>> (202) 333-1880
>> [email-masked]
>> P Consider the environment before printing this email.
>> 
>> On Jul 31, 2014, at 2:27 PM, John DeLoche <[email-masked]> wrote:
>> 
>>> FYI. Let's discuss and form a plan on this. 
>>> 
>>> Sent from my iPhone
>>> 
>>> Begin forwarded message:
>>> 
>>>> From: Ramji Srinivasan <[email-masked]>
>>>> Date: July 31, 2014 at 1:43:12 PM EDT
>>>> To: John DeLoche <[email-masked]>
>>>> Subject: ldt - 60 day fda clock
>>>> 
>>>> John - see attached, let's plan to discuss as soon as possible.
>>>> 
>>>> The 60 day clock for notification to congress just started today.
>>>> 
>>>> http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm407321.htm
>>>> 
>>>> http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/UCM407409.pdf
>>>> 
>>>> http://blogs.fda.gov/fdavoice/index.php/2014/07/curbing-risk-not-medical-innovation-in-personalized-medicine/
>>>> 
>>>> -Ramji
>>