Post-marketing Studies and Communications

J0144824 Forgive me, but I am foregoing Weekly Roundup this week due to the very interesting development around post-marketing studies.  In any case, nothing too exciting happened, and we will include any developments in next week’s roundup.

In the meantime, the Boston Globe reports that the House has moved a bill that, although the purpose of which is appropriations, has been amended to require the FDA to begin requiring manufacturers of pharmaceutical products to post-marketing studies.  Stay tuned for more on that. 

However it reminds me to once again remind those in corporate pharma communications that you should already know exactly where your company stands its post-marketing studies track record and have your messaging built up already on that issue.  If you have not done an assessment of your company’s record and built up your messaging you are very much behind the curve.   This is called being pro-active. 

Many Democrats have promised that this issue is going to be pressed, along with many other reform initiatives.  If you haven’t noticed the polls lately, it appears that there are increasing chances of a shift in party emphasis in the coming elections.  That said, as the issue of post-marketing studies becomes more and more of a reality, it is inevitable that the individual track records of companies is going to come under scrutiny.  (You will notice in the left column, there is now a link under the FDA Resources by which you can access the FDA data base on this issue.)

There are other reasons for companies to be ready.  PhRMA was quoted in the Boston Globe article emphasizing how committed industry is to post-marketing surveillance without addressing the fact that a huge number of post-marketing commitments have not been met by that same industry.  Perhaps a quote from them did address it and simply wasn’t picked up, but talking around the issue doesn’t resolve the issue.  If this is going to be the PhRMA line, companies will need to do better. 

The FDA apparently was not available for comment. 

The lesson being here – whichever side of the issue your are on – poor communications will result in poor outcomes.  Right now, those pushing for reform definitely have the better messaging.

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