The FDA Is Watching

The FDA Is Watching - Webinar CD/Transcript

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The FDA Is Watching: What Twitter, Tradeshows and TV Have in Common

The FDA’s focus on promotional activities is no longer limited to magazine and TV ads.

Now they're looking at websites, Twitter, journal articles, TV appearances, Facebook — and more.

It’s a brave new world for drug- and devicemakers. Are you ready for it?

There’s more: FDA officials have been seen walking the floors at medical meetings and industry trade shows, apparently on the lookout for improper promotional materials.

They’re poking around, checking the signage in your booth … carefully watching the promotional video messages you're showing … and listening to the physicians and other healthcare professionals you’ve paid to offer expertise or provide demos.

It's not much of a leap to begin to think that the FDA has probably created an electronic beehive of monitors and data to keep track of promotional activities of the drug and device markets.

Sound far-fetched?

Well, tell that to the drug company CEO who got slapped with a warning letter just days after making an appearance on CNBC. The warning letter said that comments the executive made on the television show constituted promotional speech and resulted in a misbranding of the company's product.

Many industry insiders have been shocked at the speed , detailed nature and the fact that the letter sent to the CEO was a warning letter rather than the typical untitled letter.

And all indications are that the FDA will continue this full-court press now — and in the future.

How can you and your organization defend yourselves?

Order the FDAnews webinar CD and transcript of The FDA Is Watching: What Twitter, Tradeshows and TV Have in Common. In this invaluable session, you will:

  • Explore some of the more unique and challenging promotional pitfalls you may encounter in 2014
  • Discuss activities the FDA may now consider promotional that they traditionally did not
  • Find out how the FDA’s recent enforcement actions should lead you to reconsider and possibly modify your current approach to policies and training for both promotional and corporate and media communications
  • Review checklists that can help you vet your own trade show promotions – so your employees are ready and prepared if and when the FDA visits your booth
  • Learn guidelines (and receive checklists) that will help you improve communications with the media and media-type outlets, including social media
  • Get new tools for developing a strong proactive legal strategy that will better protect your company by setting standards and safeguards to ensure claims are legally defensible
  • Find out how to conduct a “gap analysis” of your current compliance program, plus learn ways to train personnel so they understand what claims are legal and safe to make, identify when claims can become dangerous, and know the difference

Take action now to get a clear understanding of what the FDA expects, the best legal strategy to respond to FDA accusations, and the most effective way to develop a preventive plan in-house. Order your webinar CD and transcript today.

  • Legal counsel
  • Regulatory affairs
  • Compliance officers
  • Marketing and sales officers
  • Product managers
  • Advertising, marketing vendors

Meet Your Presenters

Timothy Ayers is a principal of Porzio, Bromberg & Newman in the Life Sciences Compliance, Commercialization and Regulatory Counseling Department. With a background as in-house counsel in the pharmaceutical/healthcare industry, he is familiar with the business challenges faced by members of corporate legal and compliance departments. As Vice President, Chief Compliance Officer for Dendreon Corporation from January 2012 through June 2013, Mr. Ayers created, developed and implemented a companywide compliance program in the United States and in Europe. Prior to that, he served as Associate General Counsel for pharmaceutical, biotech and other life sciences companies, where he established and implemented compliance programs and provided legal counsel in the areas of commercialization, research and development, global issues and corporate issues. Mr. Ayers counsels pharmaceutical, medical device and biotechnology companies on a variety of compliance-related issues, including healthcare fraud and abuse, FDA advertising and promotional law, FCPA, research and development/licensing, supply chain/distribution agreements, intellectual property, employment agreements and compliance investigations.

Mr. Ayers is also a vice president of Porzio Life Sciences, the firm’s subsidiary, which offers a range of marketing and sales compliance products and services to pharmaceutical, medical device and biotechnology companies.

Michelle Axelrod is a principal at Porzio, Bromberg & Newman. Drawing from her in-house experience, Ms. Axelrod offers valuable insights to Porzio, Bromberg & Newman clients on corporate dynamics and provides innovative ideas to support business goals while effectively protecting companies and reducing organizational risk.

Previously Assistant General Counsel at Sepracor, Inc., from 2004 through 2010, Ms. Axelrod successfully managed and supervised a team of attorneys and administrative personnel, supporting all commercial business units, including sales, marketing, commercial analytics, new products planning, contracting and pricing, institutional trade, managed markets, clinical research and medical affairs.  During that time, she acted as lead counsel on the development and/or commercialization of seven products.