Tuesday, August 10, 2010

Off-Label, Online: Know What the FDA expects before Internet Promotion Guidance is Released

Add a new item to your web promotion compliance checklist: website color schemes.

Seriously?

On April 21, FDA issued a warning letter citing, among other defects, "similar color schemes (including a distinct orange), design layouts and other presentation elements" between two disease state websites and the company's website for their prescription drug.

A month later, a DDMAC letter cited a web video's "audio and visual elements" fading out before risk information was presented.

The FDA is planning to provide guidance on Internet-based promotion - but you can't go offline while waiting for them to do so. So how can you focus your compliance efforts where they will do the most good, especially when FDA's enforcement targets include website colors and online video editing techniques?

In this 90 minute webinar, regulatory partner Alan Minsk will sharpen the often blurred line between acceptable communication and violative promotion online. He'll highlight the targets FDA is currently focused on, and point out compliance danger zones, from sponsoring educational websites to monitoring and responding to social media discussions. Alan will also discuss what the near future holds for online promotion enforcement.

After this program, you will know:

Your responsibilities for policing user generated content. Do you have to moderate message boards and delete posts? Are you responsible for statements made on our websites by people you don’t pay?
When an adverse event described online is reportable, the information you must collect, and the efforts you should make to track that information down.
The elements of disease awareness websites that draw DDMAC attention, and where to draw the line on linking to content from your drug website and other websites.
Do you really need an SOP for audio and visual cues? How can you know what video editing techniques will draw DDMAC scrutiny?
There isn't really (and never was) a "One Click Rule", how you can structure and run text ads on search engines and be in compliance.
"Same as the old boss" - superiority claims, risk minimization, and other classic promotional defects that are frequently cited in online-focused enforcement letters.

Alan will also answer your team's questions in the Q&A session.

Who should attend...

Sales executives, directors, managers, and detailers
Marketers and copywriters
Compliance and regulatory affairs professionals
General, corporate, outside counsel
Pharma and Medical Device executives

For one low price, you and your entire team from one location can take part in this fast-paced, insightful webinar. Best of all, you'll be able to connect personally with our panelists when we open up the phone lines for live Q & A.

SPEAKER

Alan Minsk
Partner and Practice Leader
Arnall Golden Gregory LLP

Alan Minsk is a Partner and Practice Leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP. He advises pharmaceutical and medical device companies on all legal and regulatory matters relating to the FDA and DEA. He counsels, speaks and writes on a wide variety of FDA - related issues, including regulatory strategy and lifecycle management, FDA enforcement, market exclusivity, FDA inspections, corporate compliance, promotion and advertising, product liability, imports and exports, and clinical trial issues. He also conducts in-house training on a wide variety of FDA and fraud and abuse-related topics.

Alan serves on several editorial boards, has been published in numerous professional journals, and is a frequent speaker at industry events. He earned his J.D. from Georgetown University.

Webinar Details

DATE: Tuesday, August 10, 2010
TIME: 1:00 PM ET • 11:00 AM MT • 10:00 AM PT
DURATION: 90 Minutes

Benefits

What does registration get me?

One (1) phone line, for you alone, or around which to gather your team(s). Toll-free in the U.S. only.
One (1) password to a website on which you'll be taken through the presenters' slides as they speak to them.
An interactive Q&A round with speakers by phone and electronic submission.
The insight you've come to expect and respect from Elsevier Business Intelligence and our guest speakers.

What are the unique benefits of a webinar?

Convenience—and lower cost. Your entire team can listen in one room. No travel required!
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REGISTRATION

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