FDA Hears Results of Two Different Off-Label Surveys of Consumers at Recent Public Hearing
At the recent Part 15 FDA hearing on off-label promotion (seehere) results from two different consumer/patient surveys were presented. The first was presented by John Mack (i.e., me), Editor ofPharma Marketing News (PMN) and the second was presented by Dr. Doris Peter, Principal Investigator, Best Buy Drugs Project at Consumer Reports (CR).The PMN survey was administered byinVibe Research, which collects responses via automated, voice-response surveys. Fifty-on respondents were reached via a network of patient community partnerships. These included 40 patient advocates, 20 chronic condition patients (diabetes, fibromyalgi...
Source: Pharma Marketing Blog - November 11, 2016 Category: Pharmaceuticals Tags: Consumer Reports FDA off-label promotion Patient Advocacy Source Type: blogs
What is " Truthful and Non-misleading? " That is the Question FDA Must Answer to Allow Off-Label Communications by Pharma
Yesterday, I attended and presented atFDA ' s Public Hearing on drug company communications regarding unapproved uses of drugs. My presentation had to do with off-label promotion directed at consumers and patients (find ithere on Slideshare).Just a few takeaways.The phrase " truthful and non-misleading " was mentioned several times during the meeting, including by PhRMA (read "BIO #Pharma Industry Offers Its Own Set of Off-Label Communications Principles" ). But defining what is true and non-misleading is difficult as many presenters noted. Something can be truthful but also misleading as pointed out by Dr. Aaron Kesselhei...
Source: Pharma Marketing Blog - November 10, 2016 Category: Pharmaceuticals Tags: FDA off-label promotion Source Type: blogs
This Little Piggy... A New Pharma Nursery Rhyme
I attended the 10th Annual Digital Pharma East conference in Philadelphia last week. One of the highlights for me was the"after party" hosted by Intouch Solutions at the Reading Terminal Market.Intouch was celebrating the conclusion of its 2016 #ALLin program, which was yearlong cross-country campaign that involved traveling with a custom Airstream trailer and hosting"health hackathons." You can learn more about that inthis interview of Wendy Blackburn, Executive Vice President at Intouch Solutions, in which she also talks about her views on how digital devices such as wearables will transform the pharm...
Source: Pharma Marketing Blog - November 3, 2016 Category: Pharmaceuticals Tags: Drug prices Source Type: blogs
The Pharma Digital Health Accelerator Club
My friend Fard Johnmar, founder and president of Enspektos, recently identified a few issues facing the drug industry as it tries keep up with digital innovation in the health field:Pharmaceutical executives are flooded with digital health opportunities: Many startups and established companies are coming to drug firms with a range of innovations, from mobile health solutions to smart pills. Executives and leaders at these firms are having trouble triaging these innovations to determine which ones will meet key organizational, business and health goals. Companies are working hard to drive digital health innovation from...
Source: Pharma Marketing Blog - October 30, 2016 Category: Pharmaceuticals Tags: Digital Health Innovation Source Type: blogs
FDA Will Apply the " Uncanny Valley " Hypothesis to Test the " Eeriness " of Animated Characters in Drug Ads
AbbVie, Astrazeneca, Eli Lilly, GSK, Merck, Regeneron Pharmaceuticals, plus others have submitted comments to the FDA regarding its plans to research animated spokes-characters in DTC Drug Ads (see Federal RegisterDocket ID: FDA-2016-N-0538).Merck was not impressed: “While the proposed collection of information may be interesting to learn, it may not have practical utility for the general public and may be unnecessary for the proper performance of FDA's functions. ”Regeneron expressed a similar concern; i.e.,"the results from this study should not be used to guide or influence FDA's current thinking on the...
Source: Pharma Marketing Blog - October 28, 2016 Category: Pharmaceuticals Tags: Animation DTC Advertising FDA Study Source Type: blogs
Meet Me at FDA Public Hearing on Off-Label Promotion on November 9, 2016
I will be Speaking at FDA's Part 15 hearing on"Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products" on 9 November, 2016 (read"FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion").The purpose of this meeting is to obtain"input on issues" related to off-label product communications about by pharmaceutical and medical device companies (seehere). I will presenting the preliminary results of myDirect-to-Consumer Off-Label Promotion Survey in my allotted time of 8 minutes.Here's the list of speakers:Wednesday, 9 NovemberW...
Source: Pharma Marketing Blog - October 24, 2016 Category: Pharmaceuticals Tags: FDA off-label promotion Public Hearing Source Type: blogs
The Day Pharma Tchotchkes Died
Back in February, 2009, shortly after the Pharmaceutical Research and Manufacturers of America (PhRMA) imposed a voluntary ban on gifts to physicians (aka"tchotchkes"), I predicted that tchotchkes would become nostalgia items in the future, reminding pharmaceutical sales reps and physicians of the"good old days" (read"Viagra Boxers: An Example of Proto-Nostalgia tchotchke").I was reminded of this prediction by a recent article (here) in MM&M, which claimed:"These relics of the past have a certain value for those on the hunt. One eBay seller hopes to fetch $20 for a blue pill-shaped Vi...
Source: Pharma Marketing Blog - October 4, 2016 Category: Pharmaceuticals Tags: Ban Gifts to Physicians PhRMA Physician Sunshine Act tchotchkes Source Type: blogs
Kybella Double Chin TV Ad: Are the BEFORE & AFTER Photos REALLY Unretouched as Claimed?
Perhpas you've seen the recent TV ad ("Ancestors") for Allergan's Kybella, a new drug approved for the treatment of double chins (read"Pfizer May Own Your Penis, But Allergan, Maker of Botox& Kybella, Owns Your Face"). The ad claims that double chins may be inherited. You can view it on iSpot.tvhere.To prove the efficacy of Kybella, several screens are devoted to showing BEFORE and AFTER photos as in the following example:You clearly can see from these"unretouched photos" of an"Actual KYBELLA patient" that the double chin is gone.But are these photos really"unretouch...
Source: Pharma Marketing Blog - September 30, 2016 Category: Pharmaceuticals Tags: Allergan DTC Advertising Kybella TV Source Type: blogs
Pharma Has Funded Hilary to Tune of Nearly $1 Million This Cycle, But Supports Republicans Overall
According to the latest data from the Federal Election Commission released on Monday, September 12, 2016 (here), Hilary Clinton has received more than $990,000 in funds from the healthcare/pharma industry although the industry has donated nearly 50% more money to Republican presidential candidates than to Democratic candidates.Apparently, Trump doesn't need no stinkin' money from pharma, which only gave him about $95K. Does that mean that Trump will come out swinging harder at pharma during tonight's presidential debate than will Clinton?Read more » (Source: Pharma Marketing Blog)
Source: Pharma Marketing Blog - September 26, 2016 Category: Pharmaceuticals Tags: Donald Trump Hilary Clinton Lobbying Politics Source Type: blogs
Do Drug Ads Need to Scare Consumers to Motivate Them?
I was quoted in an AdAge story (see embedded summary at the end of this post) about the recent spate of scary drug ads seen on TV and in print. The title of the article -"Halloween Already? Big Pharma Marketers Try Terror Tactics to Scare Up Sales" - was bit over the top but, hey, that's how you sell content.The article quoted me as saying"a trend with companies, especially ones with injectable drugs and vaccines, which also have big price increases, is to scare people into buying their product or getting their vaccine." I have posted about that here on Pharma Marketing Blog ( read"Branded as W...
Source: Pharma Marketing Blog - September 16, 2016 Category: Pharmaceuticals Tags: DTC Advertising Fear Mongering GSK Scare Tactics Source Type: blogs
FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion
In what's been described as a"surprise move" (here) the FDA recently published a notice that it will hold a 2-day public hearing this November to obtain"input on issues" related to off-label product communications about by pharmaceutical and medical device companies. FDA defines off label use of drugs as,"Use for indication, dosage form, dose regimen, population or other use parameter not mentioned in the approved labeling."FDA's authority to prevent or even regulate off-label promotion by pharmaceutical companies is dwindling. After losing to Amarin in court ("FDA Deal with Amari...
Source: Pharma Marketing Blog - September 3, 2016 Category: Pharmaceuticals Tags: DTC Advertising FDA guidelines off-label promotion regulations Washington Legal Foundation Source Type: blogs
FDA Readies Itself for Direct-to-Consumer Off-Label Drug Promotion
In what's been described as a"surprise move" (here) the FDA recently published a notice that it will hold a 2-day public hearing this November to obtain"input on issues" related to off-label product communications about by pharmaceutical and medical device companies. FDA defines off label use of drugs as,"Use for indication, dosage form, dose regimen, population or other use parameter not mentioned in the approved labeling."FDA's authority to prevent or even regulate off-label promotion by pharmaceutical companies is dwindling. After losing to Amarin in court ("FDA Deal with Amari...
Source: Pharma Marketing Blog - September 3, 2016 Category: Pharmaceuticals Tags: DTC Advertising FDA guidelines off-label promotion regulations Washington Legal Foundation Source Type: blogs
Are We at the Saturation Point Viz-a-Viz Celebrity Pharma Endorsements?
I read with interest today's email missive from Bob Ehrlich, Chairman of DTC Perspectives. He was talking about the"Dry Eye DTC Battle" between Allergan's Restasis and the new kid on the bloc: Shire's Xiidra (two i's - get it? aka two"eyes").Ehrlich pointed out that Shire enlisting Jennifer Aniston is a"big get. Getting a movie star to promote the dry eye condition must have cost Shire a lot in talent fees," said Ehrlich."Obviously they think she is worth it. Her ad just went on air under the'myeyelove' title" (read"Jennifer Aniston is Shilling for Shire!...
Source: Pharma Marketing Blog - September 2, 2016 Category: Pharmaceuticals Tags: Allergan Celebrity Endorsement Dry Eyes Shire Source Type: blogs
Branded as Well As Unbranded Vaccine Ads Are the Scariest!
WhenSTATnews reporter Rebecca Robbins (@rebeccadrobbins) interviewed me about what's behind ominous unbranded"disease awareness" ads, I opined that if you ’re a drug maker, “you don’t want to attach a dark image to the brand — so you’re attaching this dark imagery to a medical condition instead,” which leaves room for a branded ad that shows “the bright side: that there’s this product that can save the day” (Read"#Pharma'Disease Awareness' Ads: Are They'Stealthy' Fear Mongering Set Pieces?").That"conventional wisdom" or"rule" -- if it is one -- o...
Source: Pharma Marketing Blog - August 31, 2016 Category: Pharmaceuticals Tags: Gardasil GSK HPV Meningitis B Pfizer Trumenba Vaccine Source Type: blogs
The Addyi Report Card: Crooked Valeant Fools FDA Again
Click on image for enlarged view or get PDFhere."Fool me once, shame on you; fool me twice, shame on me," should be FDA's response to a report card released by the National Women ’s Health Network advocacy group and shown here.FDA was first"fooled" into approving Addyi based on a dicey self-assessment questionnaire, which formed the basis for the drug's efficacy in clinical trials (read"The #Pharma-Developed Self-Assessment Questionnaire that Got Addyi Approved") and by"patient advocate" testimony (read"The Power of Patient Input: How FDA Learned to Love& Approve A...
Source: Pharma Marketing Blog - August 19, 2016 Category: Pharmaceuticals Tags: Addyi FDA REM Sprout Valeant Source Type: blogs
