Wholly Owned – Riiiight…

I’m no fan of el Presidente Bush, as anyone who reads my blog will know.  That being said, I wholeheartedly disagree with the assessment, repeated here, that the FDA has been “a wholly owned subsidiary of the pharmaceutical industry”.

Research has been done that has shown that FDA approvals rates are actually falling, especially in the wake of the COX-2 market withdrawls (VIOXX, Celebrex) in 2004.  Pharma companies are increasingly finding it easier to get new products approved in Europe and other countries around the world but not in the US.  Within Merck’s product suite, several products, including Arcoxia and ER niacin/laropiprant, cannot make it through the FDA without significant additional investment in research studies.  The reality has been that the FDA has become significantly more conservative in its approach to approving new drugs under the Bush administration, not less.