Sunday, January 15, 2017

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

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.

Thursday, January 12, 2017

Top Pharma Companies on Facebook

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.


Further reading:

Monday, January 09, 2017

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

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...

Thursday, December 29, 2016

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

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.

Wednesday, December 28, 2016

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

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.

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