Comments on FDA's Draft Guidance from CEI
The following is a letter sent from Arnie Fried to industry stakeholders. Competitive Enterprise Institute (CEI) has made comments on the FDA's draft "Risk Disclosure Guidance" and is requesting that these comments be disseminated to others in an effort to gain both awareness and additional support. Specifically, CEI "takes strong issue with FDA's failure to adopt a discrete policy in connection with risk disclosures in new media, such as the Internet.".
Click here to download the comments.
SUBJECT: FDA Draft Risk Disclosure Guidance--Request from Competitive Enterprise Institute for Support
DATE: August 20, 2009
Friends:
On behalf of the Competitive Enterprise Institute (CEI), I attach a copy of the public comments just filed by CEI in response to FDA's Draft "Guidance for Industry, Presenting Risk Information in Prescription Drug and Medical Device Promotion". In its comments, that I was privileged to help draft, CEI takes strong issue with FDA's failure to adopt a discrete policy in connection with risk disclosures in new media, such as the Internet.
CEI seeks additional support for the arguments advanced in its comments. CEI encourages you to endorse its comments in any comments you file, to attach a copy of the CEI comments to yours, and/or to support the positions advanced by CEI in your own comments in whatever other way you deem appropriate. THE COMMENT PERIOD ON THE DRAFT RISK DISCLOSURE GUIDANCE REMAINS OPEN UNTIL AUGUST 25, 2009.
Also, CEI requests that you disseminate its comments to others who may be supportive and to post these on your web sites or blogs in an effort to disseminate them broadly and thereby gain both awareness and additional support.
We are happy to answer any questions you may have. By all means, feel free to reach out to Gregory Conko, Senior Fellow at CEI ((202)331-2253), or to contact me with any questions, ideas, or concerns. Thank you for your consideration.
Arnie Friede
ARNIE FRIEDE
ARNOLD I. FRIEDE & ASSOCIATES
Office: 212.585-0411 Cell: 917.514.9166
Arnie@FriedeFDALaw.com
Admitted In: CA, CT, DC, MD
