Preemption debate heats up

FDA makes their decisions to release products for market on the basis of data submitted by the manufacturers. FDA does not have the ability to do this research due to the number of products being researched at any one time. They rely on the HONESTY and HIGH QUALITY RESEARCH of the companies.This data is reviewed by a panel of experts not employed by FDA. FDA usually accepts this review, however, they do not have to. Sometime times they reject the experts and require more data. Their have been occasions where companies have deliberately withheld data only to be found out later. Companies have a huge investment, consequently, they have been known to "take a chance" and put one over on FDA. Eventually they will get caught but the income derived until then usually covers the expense of research.

Companies are responsible for the data they present to FDA. When a drug is approved and widely used it is possible new information develops on a large scale that was not obvious in small scale research studies. FDA can not be responsible for data NOT reported. Someone has to be responsible, therefore, the company must answer as it was their data that was presented. I hope FDA has lawyers smart enough to present this in a manner that allows the judge to recognize where the responsibility lies.