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The hottest market for drug or device development is : brain growth for governments worldwide.
Unfortunately this largely untapped market looks like it will remain so...forever!
Here is the latest proof that determines this urgent clinical need:
>FDA spokesman Brad Swezey said in response, "As a matter of policy, we can't acknowledge whether any company is or is not the subject of an ongoing investigation."<
Why does this seemingly innocent policy bother me? Well for starters, apart from being an engineer in the field that FDA breathes down, I am, fundamentally a consumer. I am glad they went ahead and "siezed" a product that they had already "banned" from sales before I could dunk it by the pound to grow giant eyelashes, a lifelong wierd dream of mine.
But, what seems like a cliched protest from a hithero unknown Jan Marini Skin Research, Inc, did raise a few red flags(lifted verbatim from the Reuters Article):
1. Jan Marini, the company's president and chief executive, said the product at issue had been in its warehouse since September 2006, when California public health authorities "embargoed" it at FDA request.
2. The company added in a statement it had offered to destroy the product, "but the FDA recently informed JMSR that it preferred to seize the product so that it could issue a press release announcing the seizure."
3. "We have been unfairly singled out," Marini said in a telephone interview. "Other companies use the same ingredient and we're not aware of any action that has been taken against them."
And, going back to the very beginning of this post,
4. FDA spokesman Brad Swezey said in response, "As a matter of policy, we can't acknowledge whether any company is or is not the subject of an ongoing investigation."
Here is why all these 4 statements mother me....
1. Okay, September 2006 subtracted from October (I am sure it took the FDA two weeks to prepare for a one page, cryptic, zero value press release) 2007 equals 1 year and a month. Why on Earth did it take the FDA 13 months to make some sort of a final decision, however small its incremental value was? Is this the average, lower end or higher end of the timeline for the (in)activity of FDA? Will we ever be blessed with the opportunity to find out what happens in Wonderland that takes them soo long to arrive at simple endpoints?
2. "so that it could issue a press release announcing the seizure." In all fairness, I don't know if this is true, but this is what got quoted on the company's behalf on the Reuter's Article, and I didn't see the FDA protest this statement anywhere. So have we been treated to a classic dog and pony show? Moreover, what irks me is why do they need to "seize" these products? How much money was spent into this "seizure"? Why would it be harder to let the company destroy the product on its own?
3. This is what ticks me off the most. Maybe the company was wrong in making and marketing this product, but not only did the FDA hold them in a state of limbo for over a year, they won't even reveal if other companies do make products with the same chemical "bimatoprost" or similar eyelash products are under investigation. Why is that so? It almost makes one think that JMSR is being singled out! This may very well not be the case, but 4, the statement by an FDA spokesman makes one very suspicious...
4. This is a "company friendly" policy that just seems to be wrong in every possible way, except that it probably thrills the companies under investigation. While we all would love for the stock prices of healthcare companies to perform as well as all other companies, we love living and not getting killed by devices and pharmaceuticals even more. This seems to be one of the worst policies a government agencies could have.
It also means the FDA is uncomfortable with the appropriateness of its own investigations. It seems to indicate they don't trust themselves. And, it is definitely not a good starting point. If at all Congress is interested in changing the way devices and drugs are developed and delivered to customers, this little "policy" needs to be wringed out of the FDA's day to day activities....
In effect, points 1 - 4 and my doubts relating to this issue seem to leave open some holes that would challenge the ozone layer's own holes in terms of graveness, urgency and the ability of the FDA to act as an effective policing agency..
If you have it in you, you may choose to shock yourself more, relating to the regulation of devices here:
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