Marketed Unapproved Drugs FDA to Take Immediate Enforcement Action at Any Time, Without Prior Notice

Held Oct. 27, 2011

As of September 19, 2011, all unapproved drugs introduced onto the market are subject to immediate enforcement action.

FDA’s new guidance on Marketed Unapproved Drugs is stronger than the 2006 crackdown that resulted in dozens of warning letters and consent decrees.

This time, there are six specific priorities for stepped-up enforcement — and enforcement action can occur at any time without prior notice and without regard to prior enforcement policies.

Could the FDA target you?  Here’s how to get ready. Fast.

The FDA’s six priorities for stepped-up enforcement of rules against the marketing of unapproved drugs include:

  • Drugs with potential safety risks
  • Drugs that lack evidence about effectiveness
  • Health fraud drugs
  • Drugs that present direct challenges to the new drug approval and OTC drug monograph systems
  • Unapproved new drugs that in any way violate the Federal Food, Drug and Cosmetic Act
  • Drugs that have been reformulated to evade an FDA enforcement action

Don’t risk severe new enforcement actions! Rely on this FDAnews webinar to get you and your entire team up to speed with what the FDA’s new guidance says, who it targets, and what steps you need to be taking now to troubleshoot your marketing and shore up compliance.

Bonus Resource for Attendees

Webinar leader Kurt Karst will provide all registrants with a marked-up copy of the Marketed Unapproved Drugs Compliance Policy Guide. In the document, he has highlighted sections that demand your attention and provided real-world tips on how to comply with the various requirements in these sections.

Register now, so when you hear from the FDA, you’ll already be at work with best practices and the know-how to align compliance with the new priorities, including:

  • New categories of marketed unapproved drugs created by amendments to the Federal Food, Drug and Cosmetic Act
  • New enforcement priorities set forth in the September 2011 guidance
  • New strategies for how best to apply the Special Circumstances – Newly Approved Product section included with the new guidance
  • New insights on how the FDA will prioritize enforcement actions and the real-world impact the 2006 and 2011 guidances are likely to have on both manufacturers and distributors
  • New perspective on the FDA’s enforcement methods and actions since the 2006 Compliance Policy Guide and how those Federal Register notices, warning letters, consent decrees and permanent injunctions will shape upcoming enforcement
  • New early-warning intelligence on what recent statements and activities reveal about what future enforcement initiatives the FDA might be planning
  • And more

A flexible fit for your busy schedule

Thiswebinar is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your office-in-home.

Of course, Kurt Karst will be on hand to answer all of your questions. Simply submit your questions via email, and you’ll have answers by the time the session ends.
Executives, regulatory affairs and compliance officers, sales and marketing personnel, R&D staff, auditors, corporate counsel, risk management specialists and QA/QC personnel will all benefit from taking part in this event. Best of all, everyone can do so at a cost that won’t break the budget.

You pay one single low registration fee per facility, regardless of how many participate. And every participant gets the FREE bonus: the highlighted version of the FDA’s September 2011 guidance annotated with practical tips for complying with each section.So spread the word to your team!

This webinar offers hands-on guidance of value to executives and personnel in drug and biologics companies as well as distributors, including:

  • Compliance officers
  • Consultants/service providers
  • Executive management
  • General/corporate counsel
  • Managers
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • R&D staff
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Sales/marketing personnel
  • Strategic planning and business development staff

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Kurt Karst, a director and attorney at Hyman, Phelps & McNamara, P.C., provides regulatory counseling to a wide variety of clients, including pharmaceutical and medical device manufacturers. He specializes in Hatch-Waxman patent and exclusivity, myriad drug development issues, pediatric testing, and orphan drugs. He previously worked as a lobbyist for F. Hoffmann-La Roche Inc. He has been published in numerous legal and industry journals, and is a primary author of the popular FDA Law Blog.  Kurt earned his J.D. from American University Washington College of Law.

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