Regulatory Open Forum

I have been asked to be the guest editor of a special edition of the DIA journal dedicated to examining the coexistence of state “Right To Try” laws and the FDA’s expanded access program. While I respect all of your opinions on what you may have to say on the topic, what I am most keenly interested in is a story that has not been told- that being an article from a manufacturer who has actually provided product under a state Right To Try law without going through FDA’s expanded access-- for them to tell their story on their thought process on why they made the decision to not go through FDA.

Overall, however, I am accepting a wide variety of viewpoints on this complicated issue thus your article can take a single stance on the issue or take on a multitude of viewpoints.  Please let me know if you can commit to sending me a draft by mid-June and if so, what is the general theme you intend to write about.

Thanks,

David

------------------------------
David Vulcano RAC
Responsible Executive for Clinical Research
Hospital Corporation of America (HCA)
Nashville TN
United States
------------------------------

As far as I know, no manufacturer has ever provided product under a state's right to try law, nor have physicians or patients shown much interest in receiving product under one of these laws:

http://www.modernhealthcare.com/article/20151017/MAGAZINE/310179969

------------------------------
Julie Omohundro, ex-RAC (US, EU), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 04-12-2016 19:10
From: David Vulcano
Subject: Article on coexistance of state Right To Try laws and FDA expanded access

I have been asked to be the guest editor of a special edition of the DIA journal dedicated to examining the coexistence of state “Right To Try” laws and the FDA’s expanded access program. While I respect all of your opinions on what you may have to say on the topic, what I am most keenly interested in is a story that has not been told- that being an article from a manufacturer who has actually provided product under a state Right To Try law without going through FDA’s expanded access-- for them to tell their story on their thought process on why they made the decision to not go through FDA.

Overall, however, I am accepting a wide variety of viewpoints on this complicated issue thus your article can take a single stance on the issue or take on a multitude of viewpoints.  Please let me know if you can commit to sending me a draft by mid-June and if so, what is the general theme you intend to write about.

Thanks,

David

------------------------------
David Vulcano RAC
Responsible Executive for Clinical Research
Hospital Corporation of America (HCA)
Nashville TN
United States
------------------------------