This all started at New Merck's R&D Day webcast last Tuesday, and continued at the Banc of America conference presentation made by Merck, a few days later, on Thursday.
Tonight, as Matt Herper, for Forbes, ably notes, if the FDA's increased disclosures initiative makes its way into the rule book intact, we will no longer be left to wonder what -- exactly -- is the holdup at FDA on putatively new drugs, like a Zetia® (ezetimibe) plus Lipitor® (atorvastatin) combo. Here's Matt's piece -- do go read it all:
. . . .Making the [FDA's] letters public will prevent companies from misleading investors about what went wrong, he wrote, but it will also prevent rumors that things are worst than they are. . . .
For instance, at Merck's recent analyst meeting some Wall Streeters wonder whether an FDA delay in approving a combination of Merck's Zetia and the soon-to-be-generic Lipitor reflects concerns on the FDA's part about Zetia. Merck says it comes down to manufacturing issues. In the future, there may not be any argument to have. . . .
Let us all hope so. [A private commenter points out that I have been too opaque, above. So -- for the record, I think such a pill isn't much of a meaningfully "new drug", at all -- and while Lipitor is a wonderful drug, there is little evidence to suggest that Zetia is doing anything to improve clinical outcomes. So, it would be reasonable to infer that FDA is taking a "wait and see" approach, until the results from IMPROVE-IT become known (that is Zocor® plus Zetia®, in the Merck-marketed combo pill called Vytorin®) -- as it is also a statin (simvastatin), plus ezetimibe. Could well be. And that could be 2014, or even beyond.]