QDIS Blog

Being a Flonase user for a couple of years now and having recently changed insurance, I’ve been keeping my eyes open with regard to the generic Flonase being brought to the market by Par Laboratories. Flonase is one of those blockbuster drugs (annual sales last year of $1.2 billion) and keeping the generic off the market for even one day would mean $3.29 million in sales, so it’s no wonder GlaxoSmithKline (GSK) tried to prevent it.

Parr and Roxane both started to ship the product on Feb 23 one day after the FDA ruled for their ANDA, but stopped when the US District Court in Maryland issued a temporary restraining order. They resumed shipments on March 7 after the court ruled against GSK and it looks like GSK will not challenge this further.

Mongabay.com has a good timeline of news articles regarding Flonase (fluticasone propionate).

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In preparing for a talk recently about the FDA and drug development, I looked at the timeline for FDA Commissioners over the last nine years (since David Kessler). Ends up that for six of the last nine years or 66% of the time the FDA was without someone to head up the agency. Just look at the FDA’s own website: Jane Henney served from 1/17/99 - 1/19/2001 two days past two years; Mark McCellan served from 11/14/2002 - 3/26/2004 or just a little more than 16 months, and then Lester Crawford served from 7/18/2005 - 9/23/2005 or just a few days over 2 months. So in the last 108 months (9 years), there has been someone heading up the FDA for only 42 months or 39.2% of the time. Now having spent 14 years in the industry, I know there have been acting commissioners but my point is, can someone in the acting position truly make a difference, lobby congress and set a culture and view of the future?

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