What Impact does a Warning from the FDA have with Investors, Physicians, Patients?

It seems not a week goes by without a warning being issued from the FDA, so this looks to be a sign of the times, not to put anyone out of business, but to create an awareness.  This is transparency folks and the warnings will keep on coming, so get used to it.  Who knows, perhaps the competition could be next, as we really have no way or manner to predict until information is reported and evaluated.  It is a challenge too for Wall Street to feel the effects too of transparency with investors scattering forces on each announcement. 

There is good reason though for skeptics, as we have not been informed properly from some Pharma companies and some of this is just now coming down the pipeline as well, so the best we can hope for is the maximum efforts of Pharma to present both pros and cons initially without any ghostwriters with efforts to shove marketing in areas where it should not be just for the sake of a dollar.  Below is what has happened this week to Byetta.  At the rate we are going with additional information being made available, we could see substantial warnings on every drug that is out there someday, we already see side  effects to this could be the next level.

Personalized Medicine stands to take some of the guesswork out of the process to give some genomic clues ahead of time and thus the odds of extreme warnings may dissipate as more enters the picture up front, probably one good reason why the Office of Genomics creation just might be a good idea, to work hand in hand with the FDA and generate more intelligent information from the start.  More information relative to physician and patient involvement in the genomic education process can be found here.  Harvard also has an ongoing process in place to bring genomics education to the forefront, and then there is also the ongoing question of who's going to pay for this, as recently questioned with CMS trying to make a determination on the first of many tests coming to light, with Warfarin, as the first big testing ground, but groups in London have already passed that point.  

Until such time it appears we can watch funds and investors shift from one day to the next upon warnings and letters issued from the FDA and the roller coaster rides will continue.  BD

It did not matter that the FDA placed no blame for the pancreatitis on Byetta, the San Diego-based company's lead product for treating type 2 diabetes. The letter to physicians did not indicate that diabetics have an elevated risk of developing pancreatitis, whether on a drug or not.

Sitting in their La Jolla headquarters, Amylin executives could practically hear the thud from Wall Street as their shares dropped more than 13 percent.  Over the years, the company overcame setbacks at the FDA and a 1999 loss of its major financial partner, Johnson & Johnson.

“It's an impossible situation to be in,” Panetta said. “And it's beginning to show up now in the way these kinds of things are happening to companies like Amylin.  Bradbury and other Amylin executives have spent the past two weeks visiting physicians and making presentations at investor conferences to put the data in context and tout positive trial results on its once-weekly version of Byetta.

In the short term, he said, Amylin will feel more pressure from Byetta's competition from Januvia – more than it will from pancreatitis.

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