Pharma Industry News Update: 6 September 2016

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’s authority to prevent or even regulate off-label promotion by pharmaceutical companies is dwindling. After losing to Amarin in court (“FDA Deal with Amarin: Does It Mean More or Less Off-Label Promotion?“), FDA suffered another setback when it settled a case with Pacira Pharmaceuticals (here).

If a pharma company has a 1st Amendment right to promote off-label to physicians, it also has the right to do the same with consumers and FDA’s notice alludes to this possibility.
More here…
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Are We at the Saturation Point Viz-a-Viz Celebrity Pharma Endorsements?

There’s a “Dry Eye DTC Battle” going on between Allergan’s Restasis and the new kid on the bloc: Shire’s Xiidra (two i’s – get it? aka two “eyes”).

DTC Perspectives Chairman Bob Ehrlich said Jennifer Aniston was a “big get’ for Shire. “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!“).

Ehrlich noted that Aniston is getting “lots of commercial endorsements these days. She is touting skin care brand Aveeno and plugging the comforts of Emirate Airways. I am sure Shire considered whether we are at a Jennifer saturation point. My feeling is we can take a couple more campaigns before she gets overused.”

My view is that celebs are being overused by pharma marketers these days. Why? Find out here…

Also read: “Pharma Has No Defense Against Viral Social Media Reactions, Especially from Celebs

Apple’s Move to Tighten Health App Rules Could Have Bigger Impact than FDA

A couple of months ago, the U.S. Food and Drug Administration acted to shore up criteria for digital health companies with final guidance articulating the difference between the “low-risk” digital health apps and devices for general health management and those apps and devices that needed FDA 510(k) clearance (read “FDA declines to scrutinize claims by ‘low risk’ mhealth apps, devices. What’s the takeaway?“).

Now Apple has set down some rules for digital health companies aspiring to use the technology giant’s iOS network.

One rule: Apps that encourage people to place their iPhones under a mattress or pillow while charging (such as those that monitor sleep) will no longer be allowed.

Find more rules here…

We’re Putting Him in Charge of Pharma Marketing