It is hard to overstate the importance of a letter like the one below, to a drug like Vytorin’s market prospects. In essence, the FDA is requiring Schering to say that the drug is less effective than alternative drugs. Now, by FDA rule, that copy change must be made within 90 days of the letter (or earlier, if Schering stocks-out of an item) — so, ALL the ad copy must be changed over, by April 24, 2008 — just about two weeks from tonight. This is an image of the actual letter — it was signed, digitally, by an FDA lawyer, Joan Hankin, on January 23, 2008 — at 3:39:39 PM — precisely. This is the actual letter Reps. Dingell and Stupak referred to, this evening.
What have Schering-Plough, and Merck been doing since then, to comply with this FDA letter? And, for how long had the Joint Veture partners been discussing this concept with FDA, prior to the actual issuance of the below letter? [There is an e-mailed summary, reflecting a meeting in which Joan Hankin participated, several days prior to her letter, where the action itmes included changing Vytorin ad copy. Wow.]
This is likely to get uglier before it gets prettier. As ever, click each to enlarge: