6th Content Marketing for Life Science
6th Content Marketing for Life Sciences
6-7 December 2017 | Philadelphia, PA | Save 15% with discount code C920PMN

Monday, October 09, 2017

Is The End of Animated Characters in Drug Ads Neigh?

Merck has decided to dump its furry white vs black feline critters in its new direct-to-consumer advertising campaign for Belsomra saying that “the original ad served its purpose"; namely, breaking through the TV drug ad clutter to be noticed. Read the story below.

I have to ask if this is a trend now that each brand using mascots has already "broken through" AND the FDA is beginning to look more closely at the use of animated characters in ads (read "FDA Will Apply the 'Uncanny Valley' Hypothesis to Test the 'Eeriness' of Animated Characters in Drug Ads"). Or is it just Merck who got the jitters because those furry felines were particularly "eerie"?

Thursday, September 28, 2017

Does This Email Message from KVK Tech Violate FDA Regulations?

Today, I received an email message from KVK Tech - a generic drug manufacturer located in my my hometown of Newtown, PA - regarding a gift to Stanford's Department of Bariatric and Minimally Invasive Surgery (see below; ignore that the email has the wrong date on it - you can't expect a drug company to have good copy editors, can you?). It talks about obesity in the U.S.

At the end of the email, in the "About KVK Tech" section, it mentions that it manufactures and distributes Lomaira, which is a drug to treat obesity. Unfortunately, KVK Tech does not mention the Important Safety Information (ISI) whenever a drug company mention a brand name drug and its indication in the same communication.

I believe, therefore, that this email violates FDA regulations. I've passed this on via email to the FDA's BadAd program, which I am not sure still exists. Not being a healthcare professional, I don't have much standing with the FDA in any case.

So, what do you think? Violative or not?

Wednesday, September 27, 2017

Is FDA Most Science-Based and Less patient Centric Now that Gottlieb is in Charge?

Last October, FDA caved in to patients lobbying on behalf of Sarepta's Duchenne drug Exondys 51 despite the fact that there was little scientific evidence that it was effective (read "FDA Succumbs to Industry-Sponsored Patient Power & Accelerates Approval of Sarepta's Duchenne Drug").

Now, another company -- PTC Therapeutics -- is seeking approval for a competing drug and the FDA warned in a briefing document that it the company should not depend on the same tactics to get its drug approved. Will paid patient lobbyists sway FDA just like they did for Sarepta? Or is the FDA now more science-based that Gottlieb is in charge? For more, see story embedded below.

Friday, August 25, 2017

Specialty Brand Sales Excel Today, But What About Tomorrow?

@QuintilesIMS teamed up with #PharmaForce to provide a framework for product launch assessment. The following is an excerpt. Download the entire report here.

The chart below shows the total amount of revenue associated with launch brands in the year that they launch. "From 2000-2006," notes QuintilesIMS, "we see that somewhere between $3 billion and $5 billion were spent on launch brands in the first 12 months in which they were launched. These are your traditional, big primary care type of products."

Further quoting from the report:

"The launch figures dropped down in 2007-2010, and this is where you see launch brands generating somewhere around $2 billion and $3 billion. We call this the Dark Ages. Anyone in pharma during these years can recall thinking that the age of pharma is not what it used to be, if there would be any major launches, or if innovation was dried up.

"Then what we see are some of the biggest launches in the history of the pharmaceutical industry. The total spend on launches in a particular year in 2013 and 2014 is up to $15 billion and $20 billion. Payers are spending a lot more on launch brands. We can still see even in 2015 and 2016 that payers started to put more restriction in the process, but it’s still in that $8-billion-to-$10-billion range.

"The brands that are excelling during this timeframe are the oncology and specialty drugs. Specialty drugs would include hepatitis C, there are a lot of strong oncology drugs, and we also see some central nervous system drugs around multiple sclerosis and other types of diseases. We certainly see many specialty drugs coming into play here which are really driving that. The question becomes: As we start to see some of the trends drop down in 2015 and 2016, will the specialty drugs be able to maintain the influence they’ve had going forward?"

Download the entire report here and find out how to prepare for tomorrow's challenging launch landscape.

Thursday, August 17, 2017

PhRMA May Be Shooting Itself in the Foot by Criticizing FDA DTC Studies

As reported by RAPS (here), the Pharmaceutical Research and Manufacturers of America (PhRMA) is "harshly criticizing the US Food and Drug Administration's (FDA) research focused on prescription drug advertising and promotion and calling for a clearer vision on how this research protects public health."

"FDA has proposed to undertake projects in a variety of disparate topics without articulating a clear, overarching research agenda or adequate rationales on how the proposed research related to the goal of further protecting public health. Within the last year, the Agency has increased such efforts at an exponential pace," Kelly Goldberg, PhRMA vice president and senior counsel for biopharmaceutical regulation, and Ryan Kaat, senior director of law, wrote in comments published 11 August on an FDA notice.

"PhRMA has long sought to ease FDA's rules on advertising and promotion particularly as FDA last November held a meeting to consider the off-label promotion of drugs with some regulations," noted RAPS. Some FDA officials at that meeting, however, questioned industry's arguments and motives for loosening regulations on off-label promotions (read “Ex-FDA Commish Califf Says #Pharma Needs a Code of Ethics to Prevent ‘Misleading’ Off-Label Marketing”).

But now, PhRMA is taking FDA to task for proposing new studies "seemingly without fully appreciating its own previous research" and some proposed studies "are often unnecessary in light of existing data."

PhRMA also takes exception to FDA research on "obscure topics," such as "Spousal Influence on Consumer Understanding of and Response to Direct-to-Consumer Prescription Drug Advertisements" (read “Does Your Spouse Influence Your DTC Viewing Experience?”) to "Animation in Direct-to-Consumer Advertising." (read “FDA Will Apply the ‘Uncanny Valley’ Hypothesis to Test the "Eeriness" of Animated Characters in Drug Ads”). See my SlideShare presentation ("Gallery of FDA Studies of DTC Advertising") embedded at the end of this post.

But PhRMA may be "shooting itself in the foot" by criticizing FDA.

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