Where Do You Stand on Phase IV Studies?

J0315598 Last week, there were reports that the FDA came out with its annual report on how drug companies are faring with respect to keeping their post-marketing study commitments.  The report card was not so hot. 

A whopping 65% of the studies were listed as pending.  Only 14% of the studies were submitted.  The FDA Web site contains the ability to conduct a search on how companies are doing.  Sooner or later, some reporter is going to get the idea to do one so that companies can be compared.  Where do you stand on the list?  It would be a good idea for corporate communications teams to have an answer to that question and to also be able to characterize what the company is doing to be on track. 

It would also be a very good idea for industry to start shaping this story.  If there are problems in getting these trials off the ground and completed, that message should be getting out there.  Right now, the only thing shaping public opinion on this is the story that industry has failed to meet its obligations. 

Legislation has been introduced to give the FDA more authority in this regard.  This report will almost certainly give impetus to that effort.

For those wanting to get cracking on this, the FDA also released a guidance for industry on Phase IV studies. 

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