2016. Pharma Marketing Network. All rights reserved.

The Year 2016 in Images

TM

2016. Pharma Marketing Network. All rights reserved.

“Judge, Jury and Executioner. Nice System.”

Said Bob Ehrlich, chair-man of DTC Perspectives, sarcastically about FDA’s enforcement actions against two drug firms for airing TV ads with “compelling, attention-grabbing distractions” that undermine communication of risks.http://sco.lt/5U3O2D

2016. Pharma Marketing Network. All rights reserved.

The FDA-Pharma-FDA “Revolving Door”

More than a quarter of the FDA employees who approved cancer and hematology drugs from 2001 through 2010 left the agency and now work or consult for pharmaceutical companies, according to research published by a prominent medical journal.

http://sco.lt/65y9Y1

Meanwhile, rumor has it that Dr. Scott Gottlieb, a partner at one of the world's largest venture capital funds and a former deputy commissioner at the FDA, is being considered by President-elect Donald Trump to run the agency.

http://sco.lt/7B5baT

2016. Pharma Marketing Network. All rights reserved.

Opioid Epidemic Getting Worse Due to FDA, Which Now Says It Will Change Its Ways

In 2015, FDA approved OxyContin for children without first convening an expert advisory panel. In 2016, under pressure from Congress, FDA required new safety warnings to be added to Rx opioid drug labels: http://sco.lt/7uZNGT

2016. Pharma Marketing Network. All rights reserved.

Will Califf, Nay, FDA Survive

Under Trump?For Trump, the FDA has for too long acted as a barrier to medical innovation. More here: http://sco.lt/50p8D3

As for Califf, the current FDA Commissioner, history tells us there is only one previous example when the incumbent commissioner has held onto his job after a change in president. More on that here: http://sco.lt/71n7YH

However, BIO President Greenwood Anticipating Worst-Case President Trump Scenario Urges “Don’t Blow [FDA] Up” More on that here: http://sco.lt/5eNDVp

2016. Pharma Marketing Network. All rights reserved.

Pharma Pushes Back Against FDA’s Proposed Study of Animation in TV DTC Ads

On February 23, 2016, FDA announced that it proposed to study "Animation in Direct-to-Consumer Advertising.” AbbVie, Astrazeneca, Eli Lilly, GSK, Merck, Regeneron Pharma-ceuticals submitted comments to the FDA regarding this study. The general consensus of the drug industry? This study has “no practical utility’ and “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.”

Perhaps the most interesting comments had to do with measuring the “eeriness” of certain animations.

http://bit.ly/pmn150502p

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FDA to Study If Oldsters Understand TV Drug Ads

The FDA wants to figure out just how well older Americans are able to comprehend the prescription drug ads they see on TV. The agency will test whether Americans 60 and older understand some of the more complex information presented in the commercials they see between network news and NFL football games. http://sco.lt/5OxfTl

2016. Pharma Marketing Network. All rights reserved.

TV DTC is Alive! But Ineffective!

Spending on DTC advertising in the U.S. totaled $5.2 billion in 2015 compared to $4.3 billion in 2014 - a 15% increase. Much of that is for TV ads. http://bit.ly/pmn150201p

At least one study, however, says TV DTC ads are 93% ineffective! http://sco.lt/7yGmWn

2016. Pharma Marketing Network. All rights reserved.

50 Celebrities Who Shilled for Pharma. Et Tu, Wonder Woman?MM&M’s semi-comprehensive list of past/present celebrity endorsements of pharma/healthcare products: http://sco.lt/60ZEpt This is a pretty lackluster list of celebrity names and the products they endorsed. For a much more entertaining and informative list, see my “Pharmaguy’s All-Time Favorite Drug Ad Celebrities” slide deck here: http://bit.ly/pgfavoritecelebs

2016. Pharma Marketing Network. All rights reserved.

DTC Moratorium Idea ResurrectedIn February, 2016, US Rep. Rosa DeLauro introduced a bill -- Responsibility in Drug Advertising Act -- calling for a three-year moratorium on advertising newly approved prescription drugs directly to consumers. http://sco.lt/7xoaXZ This is not the first time a DTC moratorium was suggested. Back in 2008, the Institute of Medicine issued a report recommending a 2-year moratorium on DTC for new drugs. http://bit.ly/IOMmoratorium

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Consumers Miss Risk Info in DTC Ads, Says Eye-Tracking

Study

A recent study found that, while about 80 percent of those viewing risk information for a fictitious allergy drug claimed to have read at least half or more of the warnings, an eye-tracking tool found they actually read little to none of the cautionary material on a product website. http://sco.lt/7WY049 Meanwhile, FDA may believe TV direct-to-consumer drug ads overstate risks: http://sco.lt/4t338z

2016. Pharma Marketing Network. All rights reserved.

The Dark World of Disease Awareness Ads

Lately many disease awareness ads have taken a distinctly dark approach and, in some cases, placed blame on parents and grandparents. "A trend with companies, especially ones with injectable drugs and vaccines, which also have big price increases, is to scare people into buying their product or getting their vaccine," said Pharmaguy. http://bit.ly/pmn150403p

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“Desperate Turds” Print Ad

Yep! It's a view of turds (Scheisse) trapped inside an A-hole! The tagline -- along with a photo of a Dulcolax Laxative package -- is expressed in a turd's thought balloon: “Only you can set them free.” http://sco.lt/6kUpKD

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Pharma on Social Media Gets FDA’s Attention

In March, 2016, Mark Senak, author of EyeOnFDA blog, perused his FDA warning letter data base and found six OPDP letters involving social media: 3 involved YouTube, 2 involved Facebook, and 1 involved Instagram. It is perhaps notable that no violations occurred involving Twitter. http://sco.lt/7Q3khN Perhaps FDA is holding off on Twitter until it studies whether links can be sufficient means of presenting risk information about drugs in advertising on social media platforms, such as Twitter, where character space is limited. http://sco.lt/5DbIqf

2016. Pharma Marketing Network. All rights reserved.

What’s Pharma Doing on Pinterest?

Pharmaguy’s Review of the Pinterest Accounts of the TOP 20 Pharma Companies (based on 2015 U.S. sales). Note: Only 8 of the 20 actually have Pinterest accounts. http://bit.ly/pharmapinterest

2016. Pharma Marketing Network. All rights reserved.

Flowchart: How Pharma Can Handle Every Type of Comment on Social Media

For most -- not all -- pharma companies, engaging people via social media is a problem, which I have often written about. Actually, it's several problems: (1) regulatory issues, (2) side effect reporting issues, (3) off-label promotion issues, but, most importantly, IMHO, (4) resource issues. Therefore, most -- not all -- pharma companies have a simplified flowchart for dealing with positive, negative or neutral comments on social media, which probably looks like this one. http://sco.lt/9DBnjF

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Pharma Must Digitize to be “Great Again”

Accenture analysis revealed that digitization will be fueling almost one-third of the growth and an estimated 40 percent of the profitability in the pharmaceutical market by 2020. For those that partially digitize, their business models can drive improved profitability by as much as 27 percent. But, the true prize will go to those who become “digital all-rounders” and build new business models that address new markets.http://sco.lt/4m5MLR

2016. Pharma Marketing Network. All rights reserved.

Over the years Pharmaguy has had the pleasure of meeting and working with many very smart, talented, and interesting people in the pharmaceutical industry and especially drug industry digital “pioneers” who have lead the way in the use of social media, digital, and/or mobile for marketing, research, patient support, or corporate communications purposes.

A segment that has not received enough attention from Pharmaguy and others is pharma women pioneers, digital or otherwise.

http://bit.ly/dswpharma

2016. Pharma Marketing Network. All rights reserved.

Digital Health #FAIL!

http://sco.lt/5SvY01 http://sco.lt/7VF9H7

2016. Pharma Marketing Network. All rights reserved.

Consumers On Their Own When It Comes to Wearable

Device & Data Security

Wireless-enabled medical devices are increasingly common. For some patients, this means that their hearts are, quite literally, connected to the Internet of Things. For others, mobile medical apps and wearable products are collecting personal health data that may be inadequately protected. More: http://sco.lt/5Fr41R Could this be the reason why 2016 has not been a great year for the consumer wearables market and the future doesn’t look bright? More: http://sco.lt/6eaNbV

2016. Pharma Marketing Network. All rights reserved.

Patients Turn Up Heat on FDAA report published by PricewaterhouseCoopers’s Health Research Institute reveals that the FDA, which developed the Patient-Focused Drug Development program in 2012 to better engage with patients, has held 21 disease-specific meetings to gain insight from them. http://sco.lt/5la6qn While FDA is dabbling with patient engagement strategies, on the flip side, patient advocacy groups are getting involved in the regulatory space. Read, for example, “How a #pharma Funded ‘Grassroots’ Patient Advocacy Campaign Changed FDA's Approval Process”: http://sco.lt/4tqlbF.

2016. Pharma Marketing Network. All rights reserved.

21st Century Cures for Pharmaceutical

Marketing

In what Public Citizen described as an “Early Gift for the Pharmaceutical Industry,” the Senate in December passed the 21st Century Cures Act, which contains many provisions that also will pharma marketers by usher-ing in a new era of pharmaceutical marketing. http://sco.lt/4rDC65

2016. Pharma Marketing Network. All rights reserved.

OMG! Drug Side Effects (Almost) Killed Granny!

Side effects from medication are causing more older Americans to visit emergency rooms and leading to more hospitalizations, according to an analysis of ER data from 2005-2006 and 2013-2014.

An estimated four ER visits for adverse drug events occurred per 1,000 individuals annually. The rate of ER visits among older adults, aged 65 years and older, was 9.7 visits per 1,000 individuals compared with 3.1 visits per 1,000 individuals for those younger than 65 years.

An estimated 35 percent of ER visits for adverse drug events occurred among adults aged 65 years or older in 2013 and 2014 compared with nearly 26 percent in 2005 and 2006.

http://sco.lt/9KYwPB

2016. Pharma Marketing Network. All rights reserved.

FDA Drops Black Box Warning on Chantix

“As a result of our review of the large clinical trial, we are removing the Boxed Warning, FDA’s most prominent warning, for serious mental health side effects from the Chantix drug label,” said FDA.http://sco.lt/7v8v33 But Public Citizen is not happy & calls FDA decision a “dangerous precedent.http://sco.lt/792BY9

2016. Pharma Marketing Network. All rights reserved.

Anti-Vaccine Film Won't be Screened at Tribeca Festival

Facing a storm of criticism over its plan to show a documentary about the widely debunked link between vaccines and autism, the Tribeca Film Festival pulled the film from its schedule. http://sco.lt/56mI9h

2016. Pharma Marketing Network. All rights reserved.

Teva to PhRMA: “Can’t We All Just Get Along?”

“Yes we can!”, said PhRMA. When Teva requested membership in the branded Rx industry’s trade association, some members expressed alarm at the prospect and saw it as tantamount to allowing a spy into the fold.Shortly afterward, however, PhRMA welcomed five new member companies, including Teva. More here: http://sco.lt/7mDJir P.S. Teva is among 6 drug firms being sued by 20 states for price fixing! http://sco.lt/8zi729

2016. Pharma Marketing Network. All rights reserved.

When It Comes to Greed, Pharma & Insurers Are Two Sides of the Same Coin

The August 2016, issue of Consumer Reports featured an in-depth, multi-prong invest-igation into why Americans are facing rapidly escalating pre-scription drug prices…[it boils] to a single word: GREED.

The CR analysis suggests that high prices for generic and brand-name drugs stem in part from a battle over profit between mammoth industries—big pharma and insurance companies—with consumers caught in the middle.”

http://sco.lt/7iwo8P

2016. Pharma Marketing Network. All rights reserved.

“1bn Here We Come!” A Common Goal for Pharma CEOs

http://sco.lt/5vB1Yv http://bit.ly/ianpish

2016. Pharma Marketing Network. All rights reserved.

Valeant Fires, Then Rehires Xifaxan Sales Reps

In June, 2016, Valeant CEO Papa blamed “sales force disruption” for triggering Xifaxan’s poor performance to begin with. In December, when talks to sell its Salix unit to Takeda fell through, the company announced a “significant” GI sales force

expansion. But whether that expansion also will be “disruptive” or “productive” remains to be seen. http://sco.lt/5jbjQ9

2016. Pharma Marketing Network. All rights reserved.

More Top Executives Flee Sinking Crooked Valeant Ship with $ Millions in Bonuses In Tow

http://sco.lt/6Gm6Ph

2016. Pharma Marketing Network. All rights reserved.

LA Times Columnist Not Drinking Kool-Aid Served Up by

SaundersBrent Saunders, CEO of Allergan, is a hero because he won’t rip off customers any more. “While we have participated in this industry practice in the past, we will stop this practice going forward, Saunders said. Excuse me for not drinking the Kool-Aid, but how is this different from a schoolyard bully patting himself on the back for saying he won’t beat you up any more? http://sco.lt/72uFt3

2016. Pharma Marketing Network. All rights reserved.

Oh Snap! Regeneron CEO Schleifer Said What to Pfizer CEO Read?

http://sco.lt/8ZED0T

2016. Pharma Marketing Network. All rights reserved.

Pharma Sis, Mylan CEO, Hits Her EpiPen Marketing Target: Moms! Price Gouging Followed: http://sco.lt/5Iy70b

2016. Pharma Marketing Network. All rights reserved.

J & J Guilty Again! Ordered to Pay $1 Billion in Putative Damages, the Largest This Year

Johnson & Johnson was ordered by a Texas jury to pay more than $1 billion to patients who claimed the company hid flaws in its Pinnacle artificial hips. More about that here: http://sco.lt/5l207V Related Stories:• “America’s Most Admired

Lawbreaker”; http://sco.lt/7Gz2q9 • “How Gorsky Drove 46% - 66% of

Risperdal Sales for Off-Label Use”; http://sco.lt/7gkFl3

• “Giving J&J an Ethics Prize is Like Giving Strom Thurmond a Civil Rights Award”: http://sco.lt/6RqBRB

2016. Pharma Marketing Network. All rights reserved.

FDA May Soon Be Replaced by Judicial Off-Label Activism

“The courts are at the precipice of taking over a fundamental FDA function of calling balls and strikes in the drug market about what’s truthful and not misleading,” said Dr. Joshua Sharfstein, a former principal deputy commissioner at the FDA. http://sco.lt/7J3xyr

2016. Pharma Marketing Network. All rights reserved.

Pharma Sales Reps Would Be More “Helpful” If They Could Discuss Off-Label Drug Use

Pharmaceutical detailing by reps is an antiquated model and not very helpful, says KevinMD on his blog. “Reps are not allowed to talk about upcoming trials or discuss any off-label applications,” he says, which suggests that the only way that sales reps will regain their influence in today’s world is if they can talk to docs about upcoming trials and off-label applications of drugs. More about that here: http://sco.lt/5pE37p That may soon happen. Read more about FDA and off-label communications here: http://bit.ly/offlabelscooped

2016. Pharma Marketing Network. All rights reserved.

Pharma Focuses on Payers as Likely Starting Point for Off-label Drug Promotion

At a November, 2016, public hearing, drugmakers told the FDA that allowing them to share off-label information with payers would be a critical first step in redefining off-label regulations.

At the hearing, industry stakeholders agreed with concerns over supplying information not vetted by the FDA to consumers, who may not understand the limitations of the data, and doctors, who may not have the time in their busy days to determine what information is misleading. This leaves payers as a likely starting point for sharing off-label information.

http://sco.lt/5Vg4zx

2016. Pharma Marketing Network. All rights reserved.

Patients with Chronic Conditions Are OK With Off-Label Drug Promotion

In preparation for a public hearing on off-label promotion, FDA posed several questions for which it is seeking input. Among these were two questions regard-ing off-label promotion targeted to patient and consumer audiences. Results from three different surveys were presented at the hearing on November 9, 2016. Each survey addressed off-label direct-to-consumer (DTC) promotion of drugs by the pharmaceutical industry. One survey suggested some patients would welcome off-label DTC.http://bit.ly/pmn150501p

2016. Pharma Marketing Network. All rights reserved.

Off-Label Direct-to-Consumer Promotion

The FDA extended the comment period by to April 10, 2017, for submitting comments concerning “Manufacturer Commun-ications Regarding Unapproved Uses of Approved or Cleared Medical Products.” See the Federal Register notice: http://sco.lt/7UY48X

This gives me more time to collect responses to my survey, which solicits your opinion regarding possible changes in FDA guidance/regulations of off-label drug promotion to patient and consumer audiences. The results of this survey will be submitted to the docket. Please take 2 minutes to respond to this survey here: http://bit.ly/PPTofflabel

2016. Pharma Marketing Network. All rights reserved.

Wishing You a Happy New Year!