Following up on yesterdays forecast of issues for 2005, Melissa David in The Street.com has a good article about how the Merck Mess Shows FDA’s Flaws. The key takeaway is that the FDA has been fast-tracking drugs that aren’t really break-through, and approving them while the data is still being gathered. It seems likely both that the approval process will slow and that there’ll be much greater requirement for post-market surveillance. Meanwhile FDA renegade and now superstar David Graham has upped his estimate of the number of deaths from Vioxx from 28,000 up to between 88,000 and 139,000–if and when The Lancet publishes that number you can be assured that the trial lawyers will use it.

Secondly, the US pharmacopoeia is out with its list of drugs that Medicare ought to cover under the new Part D. This is a screaming big deal because it lumps several drugs that are in different competitive groups in the market in the same therapeutic class. For example, the biphosphonates Fosamax and Actonel are lumped in with two other drugs in the anti-osteoporosis class. So potentially an aggressive PBM may try to push its patients away from them onto an older and cheaper drug. Expect plenty more politics about this, but in a system where the government is making the rules, it’s rules like these that make and lose fortunes.

Finally, John Mack of the Pharma Marketing list serve and Pharma Marketing News has entered the murky world of blogging with his Pharma Marketing Blog. Welcome John.