Subject: Re: ldt - 60 day fda clock
From: "Eric Schwerin" <[email-masked]>
To: "John DeLoche" <[email-masked]>
Cc: "Hunter Biden" <[email-masked]>, "Rob Walker" <[email-masked]>, <[email-masked]>, "Devon Archer" <[email-masked]>, "William Lee" <[email-masked]>, "Neil Callahan" <[email-masked]>
Date: Thu, 31 Jul 2014 15:49:31 -0400

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]
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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