Thursday, September 6, 2007

FDA shuts down company for illegally marketing their product as a drug....nice

Well, this is exactly what it is designed to do, grats to the FDA. From here:

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Brian Manookian, owner of Melanocorp, Inc. in Hendersonville, Tenn. for the illegal sale and marketing of the product Melanotan II, which is not FDA-approved, on Melanocorp's Web site.

The website is currently a blank page. Luckily we have the internet wayback machine.

The FDA letter is here. A great read. Essentially, they got nailed for saying their product was a drug, but more than that, by saying it was a NEW drug. Looking through the archive above, you can see they claimed it worked when it was "not generally recognized as safe and effective for its labeled uses"(fda words, great phrase).
But the FDA letter is worth a read more because it is so harsh, and they clearly dont believe the company have any valid claims, and have any chance of recovering.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations . Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you no longer manufacture or market Melanotan II, your response should so indicate, including the reasons, and the date on which you ceased production.
That bold part is my favorite. they're saying, "If this letter caused you to shut down, let us know". The height of FDA bureaucratic arrogance, however, and frankly hilarious to me, is the very last paragraph in the letter, which I feel is kind of like "ok buddy, nice try. If you want to make a real drug, you can learn all about that online at this website or write to these kind folks and they'll answer your questions":
A description of the new drug approval process can be found on FDA's internet website at http://www.fda . ,gov/cder/rep-ulatory/anplications/default htm . Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857 .


Melanotan - afamelanotide said...

There's an interesting article that since been published by Wired that's related to the topic of your entry here:

Suntan Drug Greenlighted for Trials

melanotan - afamelanotide

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melanotan - afamelanotide said...

melanotan-1 (afamelanotide / Scenesse) has been approved in Italy to treat sufferers of EPP:

more info: melanotan-1 Scenesse