Nothing gets done unless marketing says so. Helping patients is just the gravy and absolutely not the primary objective…

Ergo, is it any wonder managed care facilities do not trust the approved drug - c’mon….

I swear there was one PBM that made the Mafia look like fair negotiators. Most were more subtle.

I recall one of the reasons 1st year promotional spend was so high was due to heavy sampling.

My recollection of accounting is getting fuzzy but I absolutely agree that every trial or study after the pivotal trials were determined by marketing. A lot of “happy” money was given out.

Not sure where the money ultimately came from, but there was never a trial, after the pivotal trials, not approved by marketing. I believe this applied to investigator initiated trials too. Protocols were scrutinized closely. I and the medical research manager had to lobby the SVP of Marketing and Sales to fund a direct comparative trial for our product versus the apparant market leader (fastest growth rate, but not yet highest share). We finally got approval, did the study, and compared favorably, but effort was about 9 months too late. If it hadn’t looked good, it would not have been published.

Ol Cranky is probably correct about the accounting, but at least in my experience, Marketing always called the shots in Phase III and beyond.

The estimates on expenses as a percent of sales are probably right. But, first year sales are pretty slow, and launch meeting and the initial blitz of printing, ads and frebies are pretty expensive. Second year marketing budgets are still pretty high (more convention spending than in year one to make up for the lack of a launch meeting), but sales are supposed to be much greater too.

Phase III-B trials are often in the marketing budget although managed by Medical Affairs. Is that your experience also? Phase IV is certainly is funded by marketing.

One major investment analyst told me her best estimate of marketing costs for the first year of launch is 50% of expected sales and then drops to 25% in year 2 post-launch.

My experience (which ended about a decade ago in Market Research) was that while the clinical trial expenses were not in the Marketing budget, a good portion of the researcher meetings (internal and external, needed or not) were carried by Marketing.

My prelaunch market research budget for a $250-300 million potential drug was about the same as my first year budget. The second year budget was less, but our Market Research budget rose again as we got into DTC advertising. This was a while back (early 90s).

Back then, external marketing - even if it was subtle - didn’t start too much before the phase III trials were over, and you had some idea of the direction the FDA would go. Certainly also there was the idea then that the medical professional segment got first priority over consumer directed promotion. Now apparently if you have a potentially promising prostate cancer drug, you begin consumer promotion at the same time as the Phase III trial. This way your “grassroots” supporters can put pressure on the FDA and their congressional representatives to grant approval if you can show even as much as “progression free survival.”