INSIGHT REPORT
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mdi
Consultants
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Can Monica breathe new life into the FDA?
What the Presidents
Impeachment can mean to the FDA and the Regulated Industries.
"What a way to get your attention" you may say. Maybe I just want to impress you by jumping on this impeachment hype to make me look like a sharp Washington insider. Youve got to be kidding! Anyone who wants to look like a Washington insider now-a-days must be out of their mind or is some poor soul who has cheated on a spouse and is looking for the next WIWHCBDNCP (Washington insiders who have cheated but did not commit perjury) meeting. No, this isnt what I had in mind. What I was alluding to was the fact that if the America public, which is pretty fickle, decides that they had enough of this hot air and bipartisan rhetoric from their elected officials, they will do what happens on some rare instances .they will vote the BUMS out. This may turn out to actually become one of those rare events. With all the mud slinging partisanship, and the fact that the Republicans have had the majority in Congress for almost 8 years, when the next congressional election arrives in the year 2000 there is a good chance for major changes in the Congressional makeup. How does this change bode for the FDA and its regulated industries? For the FDA it could only be a good sign, which I am sorry to say means that for the regulated industries - especially the medical device industry - it could be a very abrupt wake up call. As most people have determined, over the past years, a Republican congress is pro-industry and a Democratic congress is pro-consumer. A change in congressional make up, giving the democrats the majority, could mean that the FDAMA and all that reduced regulatory posture that the agency has been politically forced to incorporate and accept, can all be thrown out the window. The change could mean rebuilding the agency, making it stronger, tougher and into the "take no enemies" FDA of the early 90s. Will the FDA be able to retake all that has been given away in the last 8 years? That will need to be seen. If the industry can show that the reduced regulatory structure did not reduce public safety, then maybe industry can show cause why the FDA should maintain their loose grip on the industry. But if some catastrophe occurs between now and that time, you can be assured that the new democratic congress will make consumer safety a major issue and put the FDA back in the drivers seat. We all have our own opinion on whether the President should or should not be tried by the Senate; or, even if he is guilty or not now that he has been impeached. But we need to be concerned as to the effect that this trial will have on the country as the legislature drags the President through this process. Will the country be paralyzed? Will the social security problem be addressed? Will your 401(k) valuation be shrunk if the stock market takes a hit because of this presidential crisis? But the more important picture may be 2 years away. So, as we all watch as this unbelievable series of events unfolding before us, Perhaps you should not be as concerned about whether the President is found guilty or not but concerned about what this process will have on the future of the FDA and the industries it regulates.
Believe me the year 2000 is not to far away.
The Next Insight "Warning Letter or No Warning Letter?" that is the question.
If you have any comments
on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS
that you feel would be of value to other companies, we would be pleased to hear from you
and to discuss them with you and if you allow, we would even put them up on this site for
others to learn from. |
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