Life Science Compliance Update

September 12, 2017

FDA Warns Cipher Over “Misleading” Marketing Materials

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The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent a warning letter to Cipher Pharmaceuticals over promotional materials for its combination immediate- and extended-release opioid tramadol hydrochloride, ConZip.

The warning letter, addressed to Cipher President and CEO Robert Tessarolo, states that marketing materials for ConZip directed at healthcare providers are “false or misleading” because they omit “important risk information” regarding the use of ConZip and because of other “material facts.”

The FDA said the promotional materials for ConZip make claims about its efficacy, such as "All Day Pain Relief," but fail to mention any of its risks, which include addiction and the potential for abuse and life-threatening respiratory depression.

The FDA also notes that the materials do not communicate any information about risks associated with use of the product. The letter states, "by omitting the risks associated with ConZip, including serious and potentially fatal risks, the detail aid fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug's safety, a concern heightened by the serious public health impacts of opioid addiction, abuse and misuse.”

The FDA also says the promotional materials leave out important parts of ConZip's indication, which specifies that the drug should be reserved for patients for whom alternative treatment options, such as nonopioid analgesics or immediate-release opioids, are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient pain relief.

In the letter, the FDA requested the company: (1) stop distributing the promotional materials, (2) provide the agency with a list of all other materials that make similar representations of the drug, and (3) develop a plan of action to disseminate "truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials,” on or before September 8, 2017.

The OPDP closed the letter by reminding the company,

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for ConZip comply with each applicable requirement of the FD&C Act and FDA implementing regulations. Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.

After sending eleven warning letters last year, the OPDP only issued two so far in 2017. That would continue a years-long trend of declining activity since 51 letters were sent to drug makers in 2010.

Last year's total of eleven letters was boosted by a late-year burst of six letters that came in the month of December, so 2017 may still wind up matching the number of letters issued in 2016. As we’ve discussed before, the continuing drop in warning letters to industry may reflect a change in focus for the FDA.

August 25, 2017

5th Annual Promotional Review Committee Compliance & Best Practices

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ExL Events is hosting the 5th Annual Promotional Review Committee Compliance & Best Practices conference on October 16–17, 2017 at the Wyndham Hamilton Park in Florham Park, NJ.

Promotional review professionals have been challenged by many new regulatory developments in the last four years, due to the rapid growth of social media as a marketing platform, the popularization of online regulatory submission, and the still-growing shockwaves from 1st Amendment court decisions about off-label communication. 

This year’s conference convenes industry experts from AbbVie, Allergan, Daiichi Sankyo, Eli Lilly, Leo Pharma, Pacira, Pfizer, Sanofi, Sunovion, and more. Speakers will provide all-new insights in response to audience requests on topics including proper outreach to managed markets, adaptive website review techniques, and ensuring promotional compliance with FDAMA 114. Attendees will come away with the skills to optimize their PRC roster, teamwork, and speed.

Featured Speakers:

  • Cynthia Akue,

Promotional Planner, ALLERGAN

  • Sergio Alegre,

Vice President, Global Compliance, VERTICAL PHARMACEUTICALS

  • Jill Charbonneau,

Director, Regulatory Affairs, AdProm, Product Launch and Labeling, MARATHON PHARMACEUTICALS

  • Masha Chestukhin,

Senior Manager, North America Compliance, SANOFI

  • Howard Dorfman,

Senior Corporate Counsel, EDGE THERAPEUTICS

  • David Jacobs,

Assistant General Counsel, Commercial Brands, DAIICHI SANKYO

  • Sameer Lal,

Senior Vice President, INDEGENE

  • Nellie Mamuya,

Quality and Compliance Manager, KEDRION BIOPHARMA

  • Anthony Molloy,

Vice President, Legal and Compliance, PACIRA PHARMACEUTICALS

  • Doreen Morgan,

Vice President, U.S. Regulatory Affairs, LEO PHARMA

  • Scott Morrison,

Global Biosimilars Medical Review Lead, PFIZER

  • Leslie North,

Vice President, Sales and Marketing, EAGLE PHARMACEUTICALS

  • Ana Rasack,

Regulatory Affairs Associate, HELSINN THERAPEUTICS

  • Josephine Secnik,

Director, Ad/Promo Regulatory Affairs, ELI LILLY

  • Keri Shugrue,

Senior Project Manager, Promotion Materials Compliance Manager, SUNOVION

  • Amy Van Sant,

Director, Regulatory Advertising and Promotion, JANSSEN

  • Gary Wieczorek,

Director, Regulatory Affairs, U.S. Ad/Promo, ABBVIE

To visit the conference website, please go to: www.exlevents.com/prc.

To register, please go to http://bit.ly/2u0sEbp and use Priority Code C897LSCU.

May 24, 2017

Improving Outcomes – Analyzing a Compliance Training Curriculum to Reduce Risk

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Life sciences compliance departments are under constant pressure to roll out updated and comprehensive training that addresses a growing milieu of subject matter, from off-label promotion, HIPAA, and data security, to antibribery laws around the globe. The rush to cover all the topics across all the potential audiences can lead to a convoluted curriculum, with gaps or redundancies in terms of which audiences receive what training. Building a curriculum that appropriately addresses the company’s unique risks is an important first step, but a regularly-scheduled analysis of all content, and audiences and delivery methods, is critical to ensure on-going effectiveness against risk.


In response to regulatory changes, compliance departments continually push out training focused on changing rules, regulations, and policies. Redundancies, misalignments, and occasionally, even gaps, emerge. This threatens the effectiveness of the curriculum. Regular, comprehensive analysis, with subsequent reconfiguration and realignment, is necessary to ensure that targeted training is being deployed to the appropriate audiences, at a frequency that maximizes engagement.


An effective, three-phase process begins with a comprehensive documentation of existing training content and components.

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