Warning Letter Summary for First Quarter 2006

J0386036 After the end of each quarter, I would like to make it a point to review the FDA Warning Letters issued from DDMAC and describe the nature of the letters and the violations.  The point will be (i) to highlight trends by the agency in this regard, and (ii) provide insights to communications professionals regarding the many varied kinds of actions that trip the Warning Letter wire.

For these purposes, then, the only warning letters I look at will be those coming from DDMAC, which is a part of the Center for Drug Evaluation and Research (CDER).   We will not examine other types of Warning Letters issued by DDMAC, nor those issued by the larger FDA. 

General Profile of Warning Letters of First Quarter – A total of six letters were issued by DDMAC during the first quarter.  The products were broad-ranging in nature and the violations primarily limited to either an overstatement of efficacy or a minimization of risk.  However, the range of vehicles addressed in the letters was quite wide and included sales aids, journal ads, electronic billboards, Web site information and videos. 

Important Specific Learnings from Warning Letters of First Quarter

  • One of the products that was the subject of a letter was not even on the market – it had been withdrawn due to safety reasons.  Do not assume your promotional materials are not important, even if you are not selling the product.
  • Vague characterizations of effect, such as "rapid" or "easy" – or statements of opinion by physicians that put the product in a singular light – when presented without defining context (is rapid five minutes, or is rapid an hour?) can be construed by the agency as an overstatement of effect.
  • If the Package Insert states a risk, the promotional material needs to include it – not a tough one.
  • A claim of superiority that is based on meta-analyses, titration trials, open-label uncontrolled trials or not comparing head to head with a drug using that drug’s maximum allowed dosage, can be perceived as an invalid claim. 
  • If there is a serious risk, especially during pregnancy associated with use, do not attempt to refer physicians to the PI for more information, or minimize the mention of the risk within the text of the communication. 
  • If the risk is characterized by certain parameters in a boxed warning (e.g. 2-12 fold increase in risk of cancer) do not attempt to re-characterize that warning with different language.  Follow the boxed warning literally. 
  • By presenting unique characteristics of a product packaged together as a sales inducement that in any way suggests that this collection of benefits sets the product apart from competitors in a way that is more appealing could be considered suggestive of a claim of superiority, according to one letter. 
  • Language used to describe a product’s use as "routine" or inviting patients to make its use part of a weekly pattern can be construed to be broadening the indication to long-term use; if that is done, there must be studies to demonstrate long-term use is safe and effective.  Use only language that pertains to the studies from the PI of the product.

In the future, at the column to the left, under "Resources by Me" I will be inserting a link to the summary of Warning Letters for the year.  Good luck!

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