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A "Must Read" Blog for Insiders. --Wall Street Journal      "...often-entertaining, always informative..." --MedAdNews



Updated: 2017-01-17T21:53:35.625-05:00

 



Fact Checking Puzzling Criticisms of a "Puzzling" DTC Study Proposed by FDA

2017-01-15T09:48:36.682-05:00

I get periodic emails from Bob Ehrlich, Chairman of DTC Perspectives, Inc., giving his opinion on various direct-to-consumer (DTC) advertising issues.

Although I often do not agree with Ehrlich on many issues, I value his perspective and often respond to him via this blog (read, for example, "Are We at the Saturation Point Viz-a-Viz Celebrity Pharma Endorsements?"). We've even had a head-to-head podcast debate (listen to "Are Drug Marketers an Endangered Species?").

In a recent email missive, Ehrlich calls FDA’s recently proposed study of deception in DTC ads (read “Another FDA Study: Can HCPs and Consumers Recognize "Deceptive" Drug Website Promotions”) “the most puzzling FDA DTC study proposed to date.”

“I have problems with this proposed study on many fronts,” says Ehrlich. He also has at least ten questions about this study:

Questions:
  1. How are consumers supposed to know what is in the approved label to decide what is deceptive?
  2. So FDA will have consumers play detective like those games where you see two photographs slightly altered to spot the changes?
  3. Does FDA want consumers to be the vanguard of regulation and report claims they think are deceptive?
  4. Is FDA going to staff a hotline to receive consumer complaints?
  5. Consumers expect the claims in an ad to be vetted by FDA so what is the study goal in purposely putting in deceptive claims to see how misled is the consumer?
  6. What possible help could this study provide in future promotional guidances?
  7. A study that proves consumers can be deceived and might be unable to know they are being deceived proves what?
  8. Is FDA trying to prove consumers who do not know what is in the approved label can be easily fooled by rogue drug companies?
  9. If a drug makes deceptive efficacy claims, it is going to be more appealing to consumers. Hello, my new drug cures cancer. You interested?
  10. Is this deeper understanding using mock deceptive ads going to make FDA a better regulator?
I’d like to respond to some of these questions. But first, let me do some fact checking of statements Ehrlich makes.

Read more »



Top Pharma Companies on Facebook

2017-01-12T14:29:49.329-05:00

Back in August, 2011, Facebook opened up comments on ALL pharma pages, which meant that the pharmaceutical industry no longer was able to shut off comments on their product-related pages. Consequently, several companies decided to shut down their pages (read, for example, "Pharma Facebook Pages Being Phased Out" and "Janssen to Shut Down Psoriasis 360 FaceBook Page").

These days Facebook offers new opportunities and tools for the pharmaceutical industry to do promotions such as disease awareness campaigns (e.g., "Novartis, Queen Latifah, & American Heart Association Team Up on Facebook Live Broadcast") and ads that comply with FDA regulations (e.g. "Bayer's Betaseron Facebook Ad Uses a New Feature: Scrolling ISI" and "Will Drug Ads "Like" Facebook?").

Meanwhile, many top pharmaceutical companies have corporate Facebook pages. The following Slidehsare presentation is an analysis and review of Big Pharma Facebook pages.

allowfullscreen="" frameborder="0" height="435" marginheight="0" marginwidth="0" scrolling="no" src="//www.slideshare.net/slideshow/embed_code/key/Ae9yzYKdGDCqAl" style="border-width: 1px; border: 1px solid #ccc; margin-bottom: 5px; max-width: 100%;" width="535">

Further reading:



FDA Study is Designed to Justify a New BadAd Program for Consumers, IMHO

2017-01-09T10:30:36.851-05:00

The FDA plans to do two new studies supposedly to gauge the “ability of consumers and healthcare professionals (HCPs) to independently identify deceptive prescription drug promotion” (see the Federal Register Notice here).

A closer examination of the proposal, however, suggests that the real goal is to promote the Agency's BadAd program and open it up to consumers.

The Bad Ad Program is administered by the agency’s Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research. The program's goal is to help raise awareness among healthcare providers about misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.

There have been several cases where the FDA sent out warning letters based on notices it received from the BadAd program (read, for example, “OMG. Kim Kardashian Shills for Pharma! No Worry - No Side Effects!”).

According to a STATnews article, “Awareness [of the BadAd program] is low, however, according to a study published in 2015 in the Journal of Health Care Communications, which surveyed doctors, nurses and physician assistants who provide ambulatory care.

“The notice for the newest studies suggested the agency may consider creating such a program to prompt consumers to also report deceptive ads.”

I was quoted in the article, saying “It’s possible the Bad Ad program doesn’t go far enough and the FDA is looking to crowd source in order to use the power of consumers to help monitor industry advertising...It smells like they’re trying to gather data to decide whether to create another program.”

Here's why I think that is the goal of the FDA...

Read more »



Pharmaguy's Top Five 2017 New Year's Resolutions for the Pharma Industry

2016-12-29T10:20:08.202-05:00

As is my tradition – as well as the tradition for many other editors/pundits – it’s time for me to tell pharma what I’d like to see included in its list of 2017 New Year's Resolutions.

Last year I noted that 2015 wasn’t an especially good year considering that “the media and politicians have found a face for evil pharma and rising drug prices: Martin Shkreli!” (here).

It’s déjà vu all over again! Only this time many more evil pharma faces have come forward including the CEO of Mylan, aka “Pharma Sis” (read “Mylan ‘Gamed the System’ and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid”), and top executives at “Crooked Valeant” (read “More Top Executives Flee Sinking Crooked Valeant Ship with $ Millions in Bonuses In Tow”).


Before getting to this year's resolutions, let's see if the industry followed any of the resolutions I suggested for 2016.

Read more »



FDA's Last Licks for 2016: Issues SIX (6) Enforcement Letters in December, So Far!

2016-12-29T12:42:30.941-05:00

(image)
Click on image for enlarged view.
Just when you thought the FDA was finished issuing Warning and Untitled letters for 2016, it issued 2 more - both Untitled letters - last week, bringing the total issued in December to 6! The grand total to date is 11 letters, including 3 Warning letters.

I suspect FDA is responding to critical posts such as the one I wrote on 8 December 2016 citing a total of only 8 letters up until that date. A week later I had to update that (here) when the total reached 9 letters for 2016. I characterized that as a "slight uptick" in enforcement compared to 2015 when FDA also issued 9 total letters because there was one more Warning letter (3) in 2016 than in 2015.

That additional warning letter involved the promotion of a surgical irrigation solution promoted via email to healthcare professionals, which I don't put in the same category as warning letters involving drugs that are ingested by consumers. I would also note that 2 of the untitled letters were severely criticized for arbitrarily citing a trivial issue (read, for example, "'Judge, Jury and Executioner. Nice System,' says Bob Ehrlich Sarcastically About Recent FDA Enforcement Actions").

The two additional letters also do not have the same level of importance as letters typically issued by the FDA. Read on to learn why.

Read more »



Images Tell the Story of Pharma in 2016

2016-12-27T11:20:05.161-05:00

Yes, 2016 was a lousy year for many people and even for the drug industry, but for different reasons. I've already reviewed data from 2016 that document some good news for pharma (see "Charts & Graphs Tell the Story of Pharma in 2016").

Another way to look at 2016 is through images. Some of my favorite images from 2016 are collected in the Slideshare presentation embedded below. Click on "Read more" to access a clickable list of references.

allowfullscreen="" frameborder="0" height="410" marginheight="0" marginwidth="0" scrolling="no" src="//www.slideshare.net/slideshow/embed_code/key/FIET1ZbZ21WlWR" style="border-width: 1px; border: 1px solid #ccc; margin-bottom: 5px; max-width: 100%;" width="500">

Read more »



Can This Work for Pharma? The Continual Quest of Creative Advertisers

2016-12-22T06:32:46.751-05:00

In terms of creepiness, this campaign has nothing over some creepy pharma campaigns I've seen (see, for example, my "Gallery of Scary Pharma Industry Advertising").

According to the Creative Director who submitted this example to PM360, Australia’s Transport Accident Commission’s "visually and emotionally jarring approach to the problem of connecting with the public about road safety was unique and inspiring. Rather than educate people on the tragedy of auto-related deaths with a metaphor or visual of a mangled person, they reframed the problem by looking broader and closer, and by thinking younger."

But these and other "fresh [creative] ideas" are not really new to pharma or they just won't work for pharma. Let's examine each one.

Read more »



FDA Compliant Diclegis Instagram Promo by (Good) Emily Maynard Johnson Can't Compete with (Bad) Kim Kardashian's Violative Post

2016-11-30T12:21:04.355-05:00

About 22 weeks ago, Emily Maynard Johnson, who appeared on ABC's The Bachelor and The Bachelorette, posted the following Diclegis promotion to her Instagram account:


I assume you've noticed that all the ISI (Important Safety Information) and side effects are mentioned either through links or, more importantly, within the post itself (you have to scroll down to see it).

This is in contrast to Kim Kardashian's Diclegis Instagram promotion that made news last year. That ad drew a prompt warning letter from the FDA to Duchesnay USA, which markets the drug, because the post did not mention nor did it link to any ISI or side effect information as required by FDA regulations (for more on that read "OMG. Kim Kardashian Shills for Pharma! No Worry - No Side Effects!" and "Celebrities + Social Media").

There are a couple of other important differences between these two celebrity Instagram endorsements/ads.

Read more »



The Evolution of the Written Word in the Social Media Information Age

2016-11-14T12:46:43.284-05:00

I started writing about the drug industry – specifically the commercial side of the industry – in 2002 with the publication of the first issue of Pharma Marketing News. At the dawn of the social media age in 2005, I started writing Pharma Marketing Blog and in 2008, I started tweeting.

By the end of 2016 I will have written over 4 million words, which is equivalent to eighty (80) average length non-fiction books! BTW, I also co-authored a book ("Socialize Your Patient Engagement Strategy").

Here is the breakdown of the current stats relating to my Internet publishing activities over the years:

Pharma Marketing News (started January 2002)
  • 639 articles 
  • Over 1.2 million words (1800 words per article
Pharma Marketing Blog (started January 2005)
  • 2393 posts
  • Over 2.3 million words (554 words per post)
 Pharmaguy on Twitter (started March 2008)
  • Over 26,000 tweets
  • Over 0.5 million words (21 words per tweet)
Do you see the trend?

Read more »



FDA Hears Results of Two Different Off-Label Surveys of Consumers at Recent Public Hearing

2016-11-20T09:17:23.468-05:00

At the recent Part 15 FDA hearing on off-label promotion (see here) results from two different consumer/patient surveys were presented. The first was presented by John Mack (i.e., me), Editor of Pharma 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 by inVibe 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, fibromyalgia, arthritis, CHF, etc.), and 9 caregivers.

The Consumer Reports survey was done by random-digit dialing so that the 1,011 survey respondents are "demographically and geographically representative of the U.S. population."

Thus, an important difference between these surveys is the first is patient & patient advocate specific whereas the second is generally consumer specific.

Let's compare the results of these two surveys.

Read more »



What is "Truthful and Non-misleading?" That is the Question FDA Must Answer to Allow Off-Label Communications by Pharma

2016-11-11T11:02:41.645-05:00

Yesterday, I attended and presented at FDA'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 it here 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") and the Washington Legal Foundation (WLF).

In its testimony (here), the WLF said:
"Starting in the late 1990s with the Washington Legal Foundation cases, courts have consistently upheld corporations’ and their representatives’ First Amendment rights to communicate truthfully and non-misleadingly about the effects of their products. Courts have held that such a right is not limited by FDA approval of the use that is under discussion. Rather, the limiting factor on a company’s speech is a classic First Amendment test: whether the communication is false or misleading. Therefore, the FDA may only restrict health care companies’ speech regarding both approved and off-label uses if it is untrue or misleading to the listener. This test is grounded in both the Constitution and sound public policy. Pharmaceutical and medical device companies and their representatives possess the same rights to free speech under the First Amendment as other individuals, and patient care is strengthened by increased access to truthful information and innovation regardless of its origins." 
But defining what is true and non-misleading is difficult as many presenters noted.

Read more »



This Little Piggy... A New Pharma Nursery Rhyme

2016-11-03T08:37:22.076-04:00

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 in this 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 pharmaceutical and healthcare industries.

While at the party, I saw an opportunity for a selfie with the Market's iconic pig statue.

This piggy's name is "Philbet," which was inspired by the market's Filbert Street location but with the f changed to ph as per local (i.e., the Phillie Phanatic) custom.

Other people photographed me with the pig including my friend Latizia Affinito (@laffinito) with whom I co-authored the book "Socialize Your Patient Engagement Strategy" (buy it on Amazon here).

At the time, I knew there was metaphor I could attach to the photo and the image shown here is what I came up with.

What's the basis of this metaphor?

Read more »



The Pharma Digital Health Accelerator Club

2016-10-30T10:31:40.720-04:00

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:
  1. 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. 

  2. Executives and leaders at these firms are having trouble triaging these innovations to determine which ones will meet key organizational, business and health goals.  

  3. Companies are working hard to drive digital health innovation from within: A number of firms have created internal innovation groups that are responsible for locating, developing and supporting the integration of digital health technologies into their operations. There is a special need for this work in developing countries like Brazil and China.
[Read: Can Pharma "Triage" All the Digital Innovation Ideas Coming Through Its Doors?]

Let's take a look at some innovations "flooding" the drug industry and how the industry is managing that flood.

Read more »



FDA Will Apply the "Uncanny Valley" Hypothesis to Test the "Eeriness" of Animated Characters in Drug Ads

2016-10-31T10:09:21.784-04:00

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 Register Docket 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 use of animation in DTC ads."

But FDA is sticking to its guns.

“On the contrary,” says FDA in response, “this particular study has the potential to directly influence policy in an area that we have no prior research on. Although one research study cannot answer all questions, we believe we have designed the study in such a way that we will be able to provide information on the issue of animation in DTC ads. Because there is no previous research of this kind, this will be an informative study that will help FDA develop guidance and policy in the future, should the research reveal a need to.”

Meanwhile, The Advertising Coalition, representing national trade associations whose members prepare and deliver advertising through television, newspapers, magazines, the Internet, whipped out its 1st Amendment gun: “[T]his study must be viewed through the lens of two Supreme Court rulings that explicitly protect Commercial Speech, including advertising. In particular, the FDA must be mindful of the Supreme Court's ruling in Zauderer v. Office of Disciplinary Counsel, which held a state regulation of an advertising illustration unconstitutional and subject to strict scrutiny.”

But the comments I found most interesting had to do with the "Uncanny Valley” Hypothesis and measuring the “eeriness” of certain animated ads.

Read more »



Meet Me at FDA Public Hearing on Off-Label Promotion on November 9, 2016

2016-10-31T12:22:49.650-04:00

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 (see here). I will presenting the preliminary results of my Direct-to-Consumer Off-Label Promotion Survey in my allotted time of 8 minutes.

Here's the list of speakers (updated 31 Oct 2016):

Wednesday, 9 November
Welcome and Administrative Announcements
Leslie Kux, Associate Commissioner for Policy
Opening Remarks
Dr. Robert Califf, Commissioner

  • Mr. Michael Labson, Covington & Burling LLP, on behalf of Pharmaceutical Research and Manufacturers of America (PhRMA)
  • Ms. E. Cartier Esham, Biotechnology Innovation Organization (BIO)
  • Ms. Khatereh Calleja, Advanced Medical Technology Association (AdvaMed)
  • Ms. Kellie Combs and Ms. Coleen Klasmeier, Medical Information Working Group (MIWG)
  • Mr. James Czaban, DLA Piper LLP (US)
  • Mr. Daniel Biank, DuVal & Associates, P.A.
  • Ms. Sandra Kalter, Medtronic PLC
  • Dr. Andrew Koenig, Pfizer Inc.
  • Ms. Danelle Miller,Roche Diagnostics
  • Dr. Sandra Milligan, Merck
  • Mrs. Penny Levin, Teva Pharmaceuticals
  • Dr. Edith Perez, Genentech
  • Mr. Frank Wilton, American Association of Tissue Banks (AATB)
  • Mr. Nicodemo Fiorentino, G&M Health, LLC
  • Ms. Zoe Dunn, Hale Advisors
  • Ms. Tracy Rockney, OneSource Regulatory
  • Dr. Samuel Nussbaum, Anthem, Inc.
  • Mr. Michael Hoak, Humana
  • Ms. Jennifer Graff, National Pharmaceutical Council
  • Dr. Soumi Saha, Academy of Managed Care Pharmacy
  • Dr. Vikas Saini, The Lown Institute
  • Mr. John Mack, Pharma Marketing News

Read more »



The Day Pharma Tchotchkes Died

2016-10-12T07:09:41.151-04:00

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 Viagra promotional clock that doubles as a business card holder, an item that was once a big weapon in the Pfizer sales rep's arsenal of freebies."

I think the Viagra jock strap/boxers would command much much more money on eBay!

In any case, the subtitle of the MM&M article ("The Day the Tchotchkes Died") inspired me to rewrite the lyrics of "American Pie" as "American Pharma Pie." I imagine a physician singing my version of the song. "Read More" to see the lyrics, which also touches upon the ramifications of the Payments to Physicians Sunshine Act.

Read more »