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What Type Meeting Are You? A B or C?

Wyndham shares fail to catch lift from earnings

SAN FRANCISCO (MarketWatch) — Wyndham Worldwide Corp. shares fell 4.5% to $25.44 early Wednesday, failing to catch a lift from mostly upbeat earnings. The trading volume was double its daily average with almost three hours to go before the close.

Twittering FDA – An Analysis of FDA’s Twittering Activity

Expect FDA Social Media Draft Guidance Before End of 2010

Let me make a prediction: FDA’s DDMAC will issue some version of draft guidance on the use of social medial for Rx drug/device promotion BEFORE the end of 2010. Just for the record, I tweeted about this last week (October 21, 2009; see here )

No FDA Regulations Would Be Like Driving on a Highway Without Speed Limits

My friend Jonathan Richman asks an interesting question on his blog: ” What If There Were No Rules in Pharma Marketing?

FDA’s Non-Guidance on Relating Risk Information is FDA’s Loss – Industry’s Opportunity

This week, the FDA issued a Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion .  It is more accurately referred to as a Non-Guidance.

Arnold Friede Blasts FDA’s Right to Define “Reasonable Man” Without External Input

Arnold Friede, Counsel to the law firm McDermott Will & Emery LLP, was my guest in yesterday’s live Pharma Marketing Talk Show/podcast (see ” Towards a Rational FDA Policy Addressing the Internet and Social Media “). At the end of that interview, Friede mentioned FDA guidance on presenting risk information in drug promotion that had just been released (see ” FDA Rules are NOT Media Agnostic “). Today, Friede sent me this note regarding that guidance: “It is true that FDA in the Draft Guidance officially adopts the ‘reasonable man’ standard for interpreting advertising and promotional claims.

FDA Rules are NOT Media Agnostic

FDA has just released a new draft guidance document: “Presenting Risk Information in Prescription Drug and Medical Device Promotion” (find the pdf file here ). I haven’t read the guidance yet, but according to a Reuters report, the guidance has some specific to TV ads: “Television ads for drugs and medical devices should avoid distracting images and music that can reduce viewers’ comprehension of potential side effects, U.S.

Distribution of Reprints: Another Example of FDA Flexing Its Enforcement Muscles

Recently, the FDA sent Sanofi-Aventis (SA) an untitled letter requesting that the company cease the distribution of a reprint from the Journal of Clinical Oncology , which describes a study comparing the efficacy of its breast cancer drug Taxotere to that of Bristol-Myers Squibb™s Taxol. Actually, FDA did not request that SA cease distribution of the reprint itself.

How to do Social Media Pharma Marketing without Getting Blown Up

That’s my re-interpretation of Josh Bernoff’s presentation “How to do a social application in life sciences without getting fired” at yesterday’s Social Pharmer Boston Unconference organized by @Shwen . Bernoff is the co-author of the book “groundswell – winning in a world transformed by social technologies” and is Vice President and Principal Analyst at Forrester Research