I’ve always said that pharmaceutical companies that are truly looking at improving their image (and heading off further regulations) with the public, should do better at completing agreed upon post-marketing studies. A recent article shows that 71% of agreed upon post-marketing studies (899 studies) have not yet even been started.
Prescription Drugs | Prescription Drug Makers Have Not Begun Many Pending Post-Market Studies on Newly Approved Drugs, FDA Says - Kaisernetwork.org:
Here is the latest numbers for 2006 from the FDA: Postmarketing Study Commitments 2006 [HTML] [PDF ]
These are studies that pharmaceutical companies agree to as a condition for approval of the drug. The problem is, the FDA has no authority to do anything if companies do not comply. Their only true recourse is to withdrawal approval but that is something they have never done for failure to complete post-marketig studies. It isn’t something I would recommend either as it would hurt too many patients who may truly need a specific drug.
Some in the industry complain that it is hard to recruit patients for some drugs. That may very well be the case, but that doesn’t mean they should not even start trials. It means it may take longer to get them completed. However, that reasoning does not address the extremely high percentage of studies that have not even been started! Also, if there will be a problem getting patients for these studies, then the companies should discuss that with the FDA at the approval and agree to start them but state that it will likely take longer to complete them. It would be interesting to try and determine how many drugs pharmaceutical companies make this sort of claim for and look at how many prescriptions are written for those drugs. One of the problems is, someone in a phase IV study (aka post-marketing studies) will not be generating revenue for the company.
At the heart is the fact that these studies tend to be large and costly and in most cases, the companies will not be achieving anything substantial from them (i.e. a competitive or marketing advantage). They are mainly studies to give the FDA better confidence in the safety of the drug. Therefore, from a strictly business perspective (ignoring safety), it makes sense to put off these trials as long as possible since they are costly and are not likely to bring any benefit for the companies. Also, if there are no consequences than why do them? I would argue that sort of mentality is very shortsighted and not including the potential costs of later legal problems if the drug should have some unintended consequences (i.e. Vioxx).
Also, if this sort of trend continues, there will certainly be more power given to the FDA. I have always found it interesting that the EPA can fine companies in order to protect the environment (and the potential human consequences) but the FDA has no such power to fine companies for failing to complete required pot-marketing studies that have a larger potential to do harm.
Fro another view see Opinion | Delayed FDA Post-Marketing Study Statistics ‘Misrepresented,’ Opinion Piece Says - Kaisernetwork.org
Other Resources (note: some are from 2005)
FDA says too many drug studies delayed - Boston.com
FDA Accused of Dropping the Ball on Post-Marketing Studies of Fast Track Drugs - CME Teaching Brief® - MedPage Today
FDA To Drug Firms: You Promised, Where Are The Post-Marketing Studies? - CBS News
Postmarketing Study Commitments Database (FDA website)
Postmarketing Study Commitments: Introduction (FDA website)
Technorati Tags: FDA, post-marketing studies, phase IV studies
Email Ed Vawter
Related Posts:
Senate Bill Would Allow FDA to Fine Companies for Not Completing Post-marketing StudiesSenate to Debate Big Pharma Deals with GenericsContract Pharmas Report on Pharma and BiotechDrug Development Cost to Soar?!Amercans less confident in FDA
Bookmark it with:
| 
del.icio.us
| 
Digg it
| 
Furl
| 
Simpy
| 
Spurl
| 
My Yahoo!
|
