The news that four big pharma companies have agreed to a six month moratorium for new brand DTC is not earth shattering. The four, Pfizer, Schering-Plough, Merck and J&J, had all been recently called to testify before the Dingell/Stupak committee regarding DTC for Lipitor, Vytorin, Zetia and Procrit respectively.

The Congressmen had asked for a two year moratorium on new products to allow for potential safety issues to emerge. The four drug companies agreed to the six month number. Pfizer had previously announced six months, and Bristol Myers said they would wait a year.

I have previously written that I think anything up to year is a fair waiting period for a new class of drug, but no more than one year is a reasonable period to expect a drug company to delay ads. There are unforeseen safety issues that can emerge with a wide scale launch of a new class of drug. A voluntary moratorium should be negotiated for each drug launch where FDA is concerned about safety issues.

So the agreement by the four companies is going to likely spread to all drug companies and may become the PhRMA standard as a minimum. My guess is that eventually a year will be the negotiated voluntary standard given that Dingell/Shupak wanted two years. Is a year a burden to drug companies anxious to launch DTC? Most want to give their detail forces a six month window to establish physician awareness and trial before launching consumer programs. So is the additional six months a problem? That depends on a number of factors such as remaining patent life, novelty of the drug, category penetration, and expected formulary presence. Drugs that expect immediate benefits from DTC will not want to wait.

I want to emphasize that I think a long moratorium is not really needed for additional drugs in existing classes with years of experience. The public safety issues are real in new classes of drugs where clinical studies did not test more than a few thousand people.

The six month moratorium from the four is a concession to Congressional attention. It will not likely satisfy those who want to ensure more restrictions on DTC advertising. That is why I believe that individual new classes of drugs will voluntarily extend that period in negotiations with FDA for approval. The advertising industry will vigorously fight any mandatory moratorium periods but will concede that voluntary negotiations are acceptable. The fear of accepting mandatory waiting periods is that it is a slippery slope that could eventually lead to longer and longer moratorium periods. On first amendment grounds it seems that Congress recognizes it will not succeed in creating mandatory waiting periods.

This entry was posted on Friday, June 20th, 2008 at 6:16 am and is filed under Uncategorized. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.