A Rule of Thumb – Some Tips for Pre-Approval Communications Around Data Milestones

J0402542 When an investigational product is working its way down the clinical trial path, it is natural for a drug sponsor to want to communicate about its progress.  But when it comes to pre-approval communications, there are some caveats, particularly respecting press releases about  data milestones that makes the regulatory folks of companies press for the most conservative stance when considering what to say and how to say it.   There is good reason to be conservative.  While Warning Letters for pre-approval communications are somewhat rare, no one wants one. 

Let’s take into consideration the perspectives of the various parties – first that of the FDA, secondly that of the public and thirdly that of the drug sponsor. 

First of all, the FDA stake.  Quite reasonably, the agency does not want a drug sponsor to be creating undue excitement among patients by hinting that a drug is either safe or effective prior to the time that it has been examined by the FDA for both.  You should not make promises even if your trials appear to be very exciting.  It is not enough that drug data in clinical trials appear to be very good.   The data may be great, but if the methodology behind the statistical analysis is faulty, then what looks like safety and efficacy in clinical trials might be a mirage.  That is one of the reasons the agency guards against communications that either directly state or imply either safety or efficacy.

On the other hand, next let’s consider patients.  While they don’t want false hopes stoked, many disease-specific patient groups are highly interested in knowing and understanding what is going on in the pipeline, particularly where a life-threatening illness is involved.  That, too, is a reasonable interest. 

For the companies, especially start ups that are publicly traded, clinical trial developments are closely watched and assessed by analysts.  For many such companies, the clinical trial outcomes can be considered material for reporting purposes. 

The most common means of communication chosen to convey this information is through the publication in peer reviewed journals.  It may also involve the issuance of a press release by a company.  In the case of the latter, there are certain factors that should be kept in mind in order to avoid the stigma of a Warning Letter from the FDA.  This holds true whether or not the compound is coming on the market for the first time, or is being studied for a new indication.

  • DO state the facts, but stick to the facts only.
  • DO remember to state adverse events.
  • DO NOT embellish upon the facts. 
  • DO NOT draw conclusions from the facts.
  • DO NOT if at all possible, use adjectives to describe the facts.
  • DO NOT imply in any way that the compound being studied is anything but investigational.

If a compound has both a generic and assigned trade name, use of the trade name could be perceived as an attempt to imply that the drug has been approved. 

Remember, the best rule of thumb is to avoid any language that is descriptive, and stick only to language that is factual. 

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