Friday, October 28, 2016

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 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.

Monday, October 24, 2016

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 (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:

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

  • Mr. Jeffrey Francer, 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, Ropes & Gray LLP
  • Ms. Coleen Klasmeier, Sidley Austin LLP
  • Mr. James Czaban, DLA Piper LLP (US)
  • Mr. Daniel Biank, DuVal & Associates, P.A.
  • Ms. Sandra Kalter, Medtronic PLC
  • Ms. Esther Carbon, RTI Surgical, 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
  • Ms. Susan Cantrell, Academy of Managed Care Pharmacy
  • Dr. Vikas Saini, The Lown Institute
  • Mrs. Suzanne Robotti, MedShadow
  • Mr. John Mack, Pharma Marketing News

Tuesday, October 04, 2016

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 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.

Friday, September 30, 2016

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 here.

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 "unretouched." It all depends on what you mean by "unretouched." Let me explain.

Monday, September 26, 2016

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?

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