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



Updated: 2017-02-22T11:31:28.213-05:00

 



Bob Ehrlich of DTC Perspectives Should Do Better Research & Fact Checking Before He Calls Out Media for "Misreporting" on DTC Off-Label Promotion

2017-02-17T10:22:16.520-05:00

I just received an email missive from Bob Ehrlich (@BobEhrlich_DTC), Chairman of DTC Perspectives, Inc., with the subject line "Media Misreporting Advertising Off-label Use."Ehrlich said "I was shocked to see media stories saying DTC may expand to cover off label use. What! This erroneous idea came from an FDA open meeting held 11/16 to discuss off label use based on court cases allowing drug companies the right to discuss them." WRONG!I first reported that the FDA was interested in hearing comments about off-label drug promotion to "patient and consumer audiences" back in September, 2016, after reading this in the Federal Register Notice (read "FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion" and find the notice here): "To what extent is it appropriate for firms to communicate information about unapproved uses of their approved/cleared medical products to patient and consumer audiences [my emphasis]? What disclosures and additional information would be needed to help ensure that a communication to lay audiences is truthful and non-misleading, given consumers' lack of medical training and expertise in critically evaluating this type of information?"Obviously, Ehrlich did not bother to read the notice and only reads Consumer Reports, which published results of a survey it did on the topic and reported at the hearing. Regarding that, Ehrlich said:"The lay press thinks that FDA might open the floodgates of off label use in DTC. A publication as reputable as Consumer Reports had a story 11/9/16 titled 'FDA Considers Allowing Drug Ads for Unapproved Treatments.' I am not sure why Consumer Reports made the leap from possibly loosening the regulations for discussions with doctors all the way to DTC. That story seemed to be picked up by many news organizations who said drug ads may increase because of off label uses."Yo! Bob! Consumer Reports may have got the idea from my blog post made two months BEFORE it published its story or maybe it did what a good news organization should do and actually read the FDA notice, which was pusblished in September, 2016.Ehrlich may also have confused this LA Times opinion piece with a news story that was published just last week: "Off-Label Direct-to-Consumer Drug Advertising 'Just Isn't Healthy'".Ehrlich closed with this:"I think the FDA will take years to study this issue and not do more than the courts push them to do. They are just figuring out how drug companies can use the Internet about 20 years late. They are worried consumers will get confused figuring out how to click on the fair balance. So, I do not think off label use is on their list of DTC to do projects, not for a decade or two."He may be right about the timeline, especially after Trump signed an executive order that calls for government agencies to pull two regulations for every new regulation they implement. The FDA may just "sit on its hands" and issue no new regulations for a good long while and that will NOT be good for the drug industry (read "FDA Regulation Cutting Will Impact Drug Approvals Too").[...]



Pharma CEOs Speak Out About Drug Prices

2017-02-17T07:02:46.807-05:00

Pharmaguy’s Selected List of Pharma CEOs’ Words of Wisdom Regarding Drug Prices, Jobs, and Taxes

CEOs include:
  • PHARMA BRO’ MARTIN SHKRELI
  • ALLERGAN CEO BRENT SAUNDERS
  • PFIZER CEO IAN READ
  • MYLAN CEO HEATHER BRESCH
  • MARATHON CEO JEFF ARONIN
  • LILLY CEO DAVID RICKS
  • REGENERON CEO LEONARD SCHLEIFER
  • NOVARTIS CEO JOESEPH JIMENEZ
  • ACORDIA CEO RON COHEN

src="//www.slideshare.net/slideshow/embed_code/key/MVmqQikipeQNS5" width="535" height="435" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" style="border:1px solid #CCC; border-width:1px; margin-bottom:5px; max-width: 100%;" allowfullscreen>



Pharma is Spending More on DTC Advertising But Its Effectiveness is Decreasing, Says New Survey

2017-02-13T09:59:27.338-05:00

“The DTC Attitudes, Behaviors, and Preferences Survey” conducted by Health Stories Project – Insights (HSPi) and published within the eyeforpharma Whitepaper “The Great DTC Shake-Up: Patient perspectives on direct-to-consumer advertising” in partnership with Health Perspectives Groups shows that as investment in DTC increases its effectiveness is decreasing. Only 22% of patients interviewed liked seeing advertisements for prescription drugs versus 52% in 1999.

What is more, says eyeforpharma, Pharma’s approach to DTC is "decoupling from patient needs causing patients to disengage from traditional tactics. Only 39% of patients interviewed thought that advertisements for prescription drugs helped them have better discussions with [their] doctor versus 62% in 1999."

"These worrying results," says the report, "show that pharma is not just failing to maximize the value from this increasingly expensive investment but that the current approach to DTC is actually undermining industry efforts to reposition itself as an industry focused on patient needs."

What are the reasons for this? Let's look at the data first.

Read more »



Who Is the Most “Fantastic” Person Trump Has in Mind to Lead the FDA?

2017-02-06T07:10:38.248-05:00

In a recent email, STAT: The Readout asked "Who's the next Mr. (or Ms.) Fantastic?":

"President Trump has a 'fantastic person' in mind to nominate as his new FDA commish. While we wait for his announcement, we're asking for your vote: Who is most likely to hear 'You’re Hired!?'"

5 candidates were put forward. It turns out that NONE is a woman.
  • Balaji Srinivasan, the long shot: This Silicon Valley darling may have expressed just a touch too much derision for the FDA on Twitter.

[From STATnews] Srinivasan, for his part, has claimed the FDA creates “catastrophes” to increase its funding and that drug development takes too long. “Drug development prior to FDA shows that modern regimen is not necessary for safe innovation,” he tweeted. He also suggested in a tweet that “Yelp for drugs would do a better job." Ref: “Trump ‘Putin-ative’ Candidate for FDA Leader Would Have Converted Agency to ‘Yelp for Drugs’.”

UPDATE: Srinivasan is no longer a candidate for FDA Commissioner, reports STATnews. "Washingtonians know that before one’s name is floated as a candidate to run a federal agency, it’s imperative to delete one’s nasty tweets about said agency.”

Read more »



DTC Drug Ads Are Effective, But Confusing to Patients Say Physicians

2017-01-26T08:40:40.677-05:00

(image) Results from a new "microsurvey" (N = 319) performed by InCrowd, a provider of real-time market intelligence to the life sciences and healthcare firms, reveal "perhaps surprising" U.S. healthcare provider (HCP) perceptions on the efficacy of direct-to-consumer (DTC) ads. Specifically, HCPs say DTC drug ads drove patients to asks three times as many questions today than they did 5 years ago, but 87% observed patient confusion with ads.

This sounds impressive, but looking at the data, HCPs say they receive only 6 questions about DTC drug ads per week from patients vs. 2 times per week 5 years ago. It just may be that HCPs are more aware of DTC ads today than they were 5 years ago and that is influencing their perception of the number of questions they receive from patients specifically about these ads.

The "confusion" results are more interesting.

A majority of HCPs surveyed (65%) said that patients do not generally understand the information provided by the pharmaceutical companies in advertisements, and nearly 87% of HCPs observed some level of confusion with the ads. 43% said that “some of my patients” can understand or interpret them, 41% said that “few” patients understand the ads, and 3% said that “none of my patients” can understand the ads.

The increased physician awareness of DTC ads and the patient confusion that they cause may explain why 35% of physicians surveyed said DTC ads should be banned when asked what they would do to change pharma's DTC campaigns. 31% said the ads should provide additional information, and 17% said they should "simplify" the message. Only a paltry 3% said they would include cost information (see chart).

That only 7% of HCPs said they would like to see side effects explained is surprising considering the results of another survey.

Read more »



PhRMA Should Have Listened to THIS "Guy in a Hoodie"

2017-01-26T07:12:21.920-05:00

Back in December, 2015, year I suggested that the pharmaceutical industry put some distance between it a "Pharma Bro" Martin Shkreli. I said (here):

"Frankly, I'm getting tired of it all. Shkreli had his 15 minutes of fame. Let's move on. It's time for the pharma industry to get its 15 minutes of fame by doing something substantial to distance itself from the likes of Shrkreli."

But, I added a caveat:

"The mainstream drug industry cannot distance itself from 'wolves' like Shkreli merely through better corporate communications."

Unfortunately, the drug industry (aka The Pharmaceutical Research and Manufacturers of America aka PhRMA) did not listen to me and unleashed a TV ad that "cast Shkreli as a scoundrel in a hoodie who does not represent an industry of angels wearing white lab coats" (read "PhRMA Pissed That They Get No Respect, Lashes Out at Martin Shkreli, Gets Less Respect in Return!").

Yep, they should have listened to this guy in a hoodie - I just received my Brooklyn Tech hoodie in the mail. I'm proud to wear it too! I put the dark glasses on just to mess with you.

Any way, read on to learn more about what I recommended and view PhRMA's unfortunate TV ad that aside from casting some guy in a hoodie as a scoundrel also paints a dark image of medical researchers (keep an eye out for the dark image of a scientist peering through a microscope).

Read more »



Pfizer's New Viagra TV Ad Has a Unique Mobile "Call to Action"

2017-01-19T14:31:13.630-05:00

As reported by FiercePharma (here), Pfizer’s new TV commercial for Viagra, which encourages patients to text a keyword from their mobile phones to receive special discounts, appears to be "a first" for pharma Marketing.

I decided to have some fun with a few stills from the ad:





Does FDA Guidance About Pharma Communications with Payors Open a Path to Off-Label Discussions?

2017-01-18T11:10:29.015-05:00

At the November, 2016, FDA public hearing on off-label promotion, representatives of the drug industry made a case for allowing companies to inform payers of off-label uses of their products.

Payers “play such a gatekeeping role with respect to patients,” said Kellie Combs, an attorney for Ropes & Gray, who testified at the hearing on behalf of the Medical Information Working Group. “There's a real interest in getting information to payers as soon as possible.”

In addition, certain types of data, like demonstrating a drug's use in subpopulations and sharing pharmacoeconomic data, are examples of information that do not meet the FDA's criteria but are still valuable to payers, said Dr. Sandra Milligan, SVP of global regulatory affairs and clinical safety at Merck (see MM&M report here).

At the time, I asked “Will FDA Open a Path to Off-Label Promotion from Pharma to Payers & Not Patients or Providers?” (op cit). It appears that the path is now opening up, at least for drug companies to communicate “health care economic information” (HCEI) regarding their prescription drugs to payors. This opening is laid out in new draft guidance form the FDA titled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers” (find it here).

Here are some excerpts from this guidance…

Read more »



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 »