Jazz Pharmaceuticals’ (JAZZ) FDA Warning Letter and its Implications
I have to admit, I only briefly reported on this when it happened about a month ago, but I was surprised to find out when I spoke with a couple of investors who were long time followers of the company that they hadn’t heard about it.
On July 6, 2010, the FDA issued Jazz Pharmaceuticals a warning letter (found here) that warned the company about its marketing practices for their Extended Release Capsules Luvox. The FDA noted that Jazz’s patient brochure is “false or misleading because it omits and minimizes important risk information associated with Luvox CR and overstates the efficacy of Luvox CR.”
Warning letters are common in the pharmaceutical industry, but they shouldn’t be taken lightly. Companies don’t ordinarily disclose that they received them because they tend to shine a bad light on the company. The company that receives a warning letter from the FDA can also claim that they are not a material event and therefore aren’t required to report them to investors. A review of Jazz Pharmaceuticals EDGARS filings reveals that they too had not reported this warning letter (filing history here). Yet, I would argue that warning letters are highly relevant to investors, here’s why.
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GC,
Appreciate if you can do an analysis on the upcoming advisory panel for JZP-6.