Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Industry Pundits Think Trump is Good for Pharma Advertising & Marketing. Duh!

Industry Pundits Think Trump is Good for Pharma Advertising & Marketing. Duh! | Pharmaguy's Insights Into Drug Industry News |

Donald Trump’s surprise presidential win has many industry executives taking a wait-and-see approach, including those in advertising. However, pharma company advertisers may not have as much to be wary about, according to industry executives interviewed by FiercePharma.


One key reason is the ongoing steady flow of FDA drug approvals, which means pharma companies will need to market and advertise at a similarly steady pace to get the word out about new drugs and indications.


“While pharmaceutical companies may have a wait-and-see approach in some areas, such as pending healthcare legislation, I just don’t see ad spending slowing,” Wendy Blackburn, executive VP at Intouch Solutions, told FiercePharma. On the contrary, "it’s likely safe to say the general consensus is that Trump’s election is a positive for this industry," she said, noting that "our clients’ product patent clocks are still ticking, and patients and professionals still need to know about treatment options.”


John Kamp, executive director at the Coalition for Healthcare Communication, agreed with Blackburn that the pace of FDA approvals at current “optimum efficiency” should continue and keep ad spending levels stable. Kamp added that while Trump has talked about reforming the FDA, he doesn’t anticipate significant changes there.


Bob Ehrlich, chairman-CEO of DTC Perspectives, said via email, “The only thing that would negatively affect spending is if Trump had Medicare negotiate directly on lowering drug prices." And while Ehrlich believes that's "certainly possible," he also thinks Trump will sympathize with pharma's position on the matter, which is that "price controls hurt innovation." Ehrlich figures that Trump will also probably appoint a less regulatory-minded FDA head, which "should speed up drug approvals."

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Pfizer-Allergan Merger Means Consolidation of Ad Agencies. And Less Advertising Spend?

Pfizer-Allergan Merger Means Consolidation of Ad Agencies. And Less Advertising Spend? | Pharmaguy's Insights Into Drug Industry News |

When Pfizer announced plans to acquire Allergan for $155 billion, the first questions to surface had to do with the feasibility of the deal. What are the tax implications? What would a combined Pfizer-Allergan look like? 

The deal not only creates the world's largest drugmaker but also one of the world's largest advertisers. Combined Pfizer and Allergan spent a total of $1.6 billion on advertising in 2014, according to Kantar Media.  

At stake are the fates of the drugmakers' massive brand budgets for drugs like Viagra, Celebrex, Botox and Juvederm, to name a few. There remains a lot of uncertainty about which agencies will be left outside looking in and which firms will be awarded potentially hundreds of millions of dollars in new billings when the dust clears, according to agency executives interviewed for this story.

An unnamed executive at an independent healthcare agency said the merger will likely lead to a consolidation of marketing agencies. “It's not a matter of if, but when,” he said. “They have to figure out how profound a disruption do they want?”

Pfizer is already the seventh largest advertiser in the US, according to Kantar Media data cited by The Wall Street Journal. Globally, in 2014 Pfizer spent $1.4 billion on advertising; Allergan spent $266 million; and Actavis, which acquired Allergan in November 2014 and took the drugmaker's name, spent $387 million, according to Kantar Media. In comparison, Procter & Gamble—the world's largest advertiser in 2014—spent $4.6 billion.

From January to June of this year, Pfizer spent $740 million while Allergan spent $144 million. Actavis spent $261 million in the same timeframe. 

The same agency executive noted, however, that it's unlikely any significant changes to the drugmakers' agency rosters prior to September 2016. The deal is expected to close by the end of next year. 

Pharma Guy's insight:

There is already talk that Brent Saunders -- Pfizer-Allergen CEO heir apparent -- is not keen on R&D spending (see here: He may be even less keen on advertising spending.

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Only 10% of Americans Would Pay Attention to Sexy Online Ads

Only 10% of Americans Would Pay Attention to Sexy Online Ads | Pharmaguy's Insights Into Drug Industry News |

The first annual Goo Online Advertising Survey of over 2,000 Americans aged 18 and older, conducted online by Harris Interactive on behalf of Goo Technologies is alarming. The survey reveal consumer behavior around the types of ads we see every day, found that fully 92% of Americans ignore at least one type of ad, including:

Ten percent of Americans even said they were more likely to pay attention to an online ad if it featured a sexy man or woman.

Pharma Guy's insight:

That sounds odd. Pfizer must disagree - it's new Viagra ad is almost as sexy as Victoria Secret ads (see Oh Yeah, Baby! Show Me More!... Viagra TV Ads Like This. But Don't Let My FDA See It!). Although I've seen the sexy woman Viagra banner ads on the Internet, he most impactful ad is the video ad shown on TV when OLDER American mend are likely to be watching. I bet much more than 10% of that demographic is likely to pay attention to sexy ads online or off!

What about physicians? The pharma industry was very successful selling their products to physicians and sexy female (and male) sales reps were key. See, for example, Sexy Reps Sell Rx Drugs

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Drug Industry Document Archive - Off-Label Marketing of Zyprexa

Drug Industry Document Archive - Off-Label Marketing of Zyprexa | Pharmaguy's Insights Into Drug Industry News |

The documents in this collection are a portion of those produced in a class action court case that alleged Eli Lilly withheld data on adverse effects such as weight gain and diabetes and participated in off-label marketing of the drug. The documents were first obtained and made public in 2006 by, expert consultant Dr. David Egilman, attorney Jim Gottstein, and journalists Philip Dawdy and Alex Berenson. After a legal battle over public access, the documents were un-sealed and allowed to remain in the public domain.  These documents highlight Lilly's marketing strategy of influencing key opinion leaders and its attempts to control the research, the scientific literature and regulatory product labeling to minimize information on adverse effects.

Pharma Guy's insight:

This database of documents is interesting, especially in light of FDA's new draft guidance on the distribution of off-label reprints. For more on that, read 

FDA Issues More Guidance Regarding Distribution of Reprints. Is It "Fair and Balanced?"
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Study: Pharmaceutical Online Advertising Has Highest Viewability Rates of Any Industry

Study: Pharmaceutical Online Advertising Has Highest Viewability Rates of Any Industry | Pharmaguy's Insights Into Drug Industry News |

Across a study of billions of pharmaceutical advertising impressions spanning over 15 brands, 51 percent of the ads were viewable*. Out of the ten industries comScore benchmarked, pharmaceutical advertising impressions had the highest viewability rates.

Also, this year's study shows that site visitation to a branded pharmaceutical site continues to provide sizeable lifts in both brand awareness and favorability. The most recent benchmarks show that site visitation influences both new patient starts and adherence or refills. For prospects, branded website visitation drove a 9.4-point lift above control in new patient starts compared to those in the control group, and there was a 14.7-point lift above control in prescription refill activity among patients who had recently visited a branded website.  

Pharma Guy's insight:

Given these data, how much money does pharma spend on online DTC advertising? There's no good data for that, especially with regard to sites.

When it comes to digital IQ, some brands are geniuses and some are feeble-minded idiots, according to the "L2 Digital IQ Index" for pharmaceutical brands, a first-of-its kind measurement of the digital competence of 51 pharma brands across eight therapeutic categories. For more on that, read this Pharma Marketing News article: Is Your Brand a Digital Genius or a Feeble-Minded Idiot?

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Has Gilead's Director of Regulatory Affairs Been Hiding Under a Rock Since 2009? Will He Be Fired or Praised?

Has Gilead's Director of Regulatory Affairs Been Hiding Under a Rock Since 2009? Will He Be Fired or Praised? | Pharmaguy's Insights Into Drug Industry News |

At the end of June, the FDA sent a Notice of Violation (NOV) letter to Naumann Chaudry, Director, Regulatory Affairs Advertising and Promotion at Gilead Sciences, citing a sponsored link on Google for VIREAD (you can find the letter here).

Unless Dr. Chaudry (he has a PharmD degree) has been hiding under a "regulatory rock" since 2009, it's difficult to imagine that he would have approved such an ad. Because as WE all know, FDA views such ads, which include the drug brand name AND indication but no fair balance safety information, as violative of the FD&C Act.

Anyone, such as Dr. Chaudry, who is a regulatory authority -- he's worked in a regulatory capacity for several pharma companies since 2004 -- should be aware of FDA's "received precedent" on this type of ad (i.e, 14 warning letters issued in April 2009).

VIREAD is associated with serious risks and includes a black box warning. To advertise such a drug without providing any mention of such risk is unconscionable.

But there are even more serious problems with this ad, that, IMHO, should get Dr. Chaudry in hot water with Gilead's CEO and perhaps fired!

Pharma Guy's insight:

What do you think? Should Dr. Chaudry be fired?

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Understanding the psychological blocks in medicine-taking: how pharma can help

Understanding the psychological blocks in medicine-taking: how pharma can help | Pharmaguy's Insights Into Drug Industry News |

Medicines adherence remains a massive problem for healthcare systems, the pharmaceutical industry and patients, leading to increased disease burden and personal risks. In this new white paper, Hannah Gagen looks beyond traditional approaches into the psychology behind adherence to understand the real challenges and solutions.

The major focus for the pharmaceutical industry is market access – making sure that novel medicines make it through the clinical and cost barriers to reach patients. But even once this has been surmounted a potentially bigger hurdle exists – adherence. Failing to take medicines as prescribed is expensive for healthcare systems and pharma, plus potentially damaging, or even life-threatening, for patients.

Despite numerous attempts to tackle non-adherence, it remains a significant challenge. But perhaps we are not looking at solutions the right way? Here, Hannah Gagen, from Boehringer Ingelheim, challenges traditional solutions and takes a more in-depth look at the psychological factors behind this problem and how they can inform new approaches that underpin a more collaborative resolution between doctors, patients and the pharmaceutical industry

Read this white paper from Boehringer Ingelheim to understand:

• Key definitions and metrics around medicines non-adherence

• Factors underlying intentional and non-intentional non-adherence

• Expert views on the psychology of adherence

• How pharma needs a new collaborative approach to tackling adherence

Pharma Guy's insight:

As Kevin Dolgin, president of French healthcare company Observia explains, there is still a long way for us to go. He points out that while patient adherence budgets have quadrupled over the past five years (to roughly $1 million on average per product per annum, according to US data), spending on traditional promotional channels are still 30 times higher, as shown in the figure above.

Check this out: 

The Adherence Problem: Are Patients Just Forgetful, or Are They Rebellious?
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DTC Makes My Job Harder, Says Doc

DTC Makes My Job Harder, Says Doc | Pharmaguy's Insights Into Drug Industry News |
Direct-to-consumer advertising is the biggest barrier to practicing medicine today, cardiologist Harmony Reynolds, MD, said in response to one of 10 questions MedPage Today is asking thought

1. What's the biggest barrier to practicing medicine today?

Direct-to-consumer advertising. These ads often frighten people about medication side effects without providing the right information about why a medication may be needed and why taking a small risk of side effects may be worthwhile. I don't think companies realize all of the effects these ads have. They make my job harder.

Pharma Guy's insight:

OK. One physician does not a consensus make. Her specialty is coronary artery disease and she seems to like prescribing high doses of statins. Ads for statins actually mention why they are needed and they don't overplay the risks, which are minimal.  So I am not sure why these DTC ads would be a barrier to Dr. Reynolds' practice of medicine.

In any case, drugs ads tend to understate the risks. About 40% of violations in drug ads cited by the FDA between 2004 and 2013 relate to "risk minimization." That's twice the percentage of violations relating to "overstated efficacy" (see chart here: Do TV DTC Ads Overstate Rx Drug Risks?).

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FDA requires more warnings on testosterone products

FDA requires more warnings on testosterone products | Pharmaguy's Insights Into Drug Industry News |

The U.S. Food and Drug Administration (FDA) is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins. Blood clots in the veins, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE). The risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products.

Because these clots occur in the veins, this new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products. We are currently evaluating the potential risk of these cardiovascular events, which are related to blood clots in the arteries and are described in the Drug Safety Communication posted on January 31, 2014.

Testosterone products are FDA-approved for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone for reasons such as genetic problems or chemotherapy.

Pharma Guy's insight:

In February, 2014, Public Citizen today called on the U.S. Food and Drug Administration (FDA) to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S. 


Public Citizen Petitions FDA to Add a Black Box Warning to Low-T Drug Labeling

A pharma compliance executive -- who shall remain anonymous -- emailed me saying: "Great to know that OPDP got their [Twitter] guidance out in time to make clear that no testosterone manufacturer should be able to tweet about the new warning."

That brings up an interesting point. 

If a pharma company-- e.g., AbbVie, which markets Androgel -- wishes to tweet about this emerging risk, would the tweet be considered promotional by the FDA? For example, the tweet can mention the product name WITHOUT the indication and warn about this issue and link to more information (e.g., the FDA notice). At most, that tweet would be considered a "reminder" ad and would not be subject to the new guidelines published by OPDP.

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Fake patient story wins a real-life marketing award? Discuss

Fake patient story wins a real-life marketing award? Discuss | Pharmaguy's Insights Into Drug Industry News |

I'm not a doctor, but I play one on TV. That approach has put pharma in the doghouse before. But now, here's a new question. What about, "I'm not a patient, but I play one in a promo campaign for doctors"?

As the Pharma Marketing Blog reports, one of the few industry campaigns to snap up a gold Lion at the Lions Health ad festival this week was an Australian effort from McCann Health. Subject: Johnson & Johnson's  anti-inflammatory drug Simponi. Approach: patient storytelling, a big buzz-phrase these days in pharma advertising.

Thing is, the patient whose story features in the Simponi "Cate" campaign wasn't real. The story was a well-crafted visual narrative designed to show how easy it is for rheumatoid arthritis sufferers to dose themselves--something that's not pleasant for users of some RA therapies. And to illustrate how well it works, of course.

McCann described the video campaign--formed from hundreds of photographs--as a depiction of a month in the life of "a Simponi patient, Cate Jackson." Among those hundreds of pics, only one featured Cate injecting herself with Simponi, as a visual representation of how quick and simple it is. But as the Pharma Marketing Blog points out, there's a straightforward, discreet disclaimer at the end of that video. "This patient story is fictional. A model was used in the photographs."

Full disclosure. But is that enough? If drugmakers plan to rely on "patient stories" to illustrate various advantages of their products, do the stories need to be nonfiction--real, not imagined? Or can a visual metaphor like McCann's campaign, with its one actual treatment-specific shot, be perfectly valid if the patient doesn't exist?

No doubt a story would be more convincing if it is true, and we can envision drugmakers discrediting any fake narrative floated by a competitor. That's a PR problem in the making. But given all that DTC history of fake patients, one could make a case for "typical patient" stories. Either way, it sounds like a conundrum drugmakers need to address up front rather than risk being blindsided by criticism.

Ironically enough, a real patient's narrative picked up a Lion in Cannes this week, the blog post notes. But it was a bronze, not a gold.

Pharma Guy's insight:

Oh yes, there's a need to discuss this! I've pointed to this problem a number of times in the past. "Nobody Knows You're a Fake Patient on the Internet!" and "Alice, 35, is Not a Real Ambien CR Patient."

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Cannes Lions Health 2014: Is pharma advertising so bad it has no big winner?

Cannes Lions Health 2014: Is pharma advertising so bad it has no big winner? | Pharmaguy's Insights Into Drug Industry News |

Cannes Lions Health 2014 festival was supposed to be the world’s first contest of creativity in healthcare and pharma advertising. Made by advertising agencies and for advertising agencies, Lions Health could not find a grand prix winner in Cannes this year. Does it prove lack of creativity, or rather that the whole concept of advertising in the healthcare industry is wrong?

No grand prix of Cannes Lions Health 2014 was awarded.

Pharma Guy's insight:

The whole concept seems "A bit weird" to the authors at K-message. 

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When Meth Was Medicine: Big Pharma Amphetamine Ads from the Days of Better Living Through Chemistry

When Meth Was Medicine: Big Pharma Amphetamine Ads from the Days of Better Living Through Chemistry | Pharmaguy's Insights Into Drug Industry News |

Hey, gals of 1940! Looking for a new way to stay slim? Drug companies were looking for markets beyond stuffy nose sufferers for their new wonder drug in the1930s, and by the time of this 1940 ad, they found one: "This magic powder does more than disperse unwanted fat, it purifies and enriches the blood, tones up the entire system and makes you feel better in health in every way," the ad copy entices. But wait, there's more! "It even gives you the energy to carry on working throughout the night."


The original methamphetamine. The substance that many today disparage as the worst drug ever kept housewives slim in the 1950s and 1960s. Manufactured by Burroughs Welcome, it sold in the millions, but sold as an injectable liquid, it gave rise to a Bay Area speed shooting scene, followed by a state-level ban, followed in turn by the first illict meth labs--in California in 1962 and 1963!

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"Ask Your Doctor" in DTC Ads: Effective or Not Effective?

"Ask Your Doctor" in DTC Ads: Effective or Not Effective? | Pharmaguy's Insights Into Drug Industry News |

This month’s Kaiser Health Tracking Poll finds that the affordability of prescription drugs continues to be at the top of the public’s priority list for the President and Congress.

Of interest to pharma marketers:

A large majority of Americans (82 percent) report seeing or hearing prescription drug advertisements, and 3 in 10 (28 percent) say they have talked with a doctor about the specific medicine they saw advertised. After talking to a doctor about a drug they saw, 15 percent of the public says the doctor recommended changes in their behavior or lifestyle, 14 percent say the doctor recommended a different prescription drug, 12 percent say they were given the drug they asked about, and 11 percent were instead recommended an over-the-counter option.

About half of the public (51 percent) say they think that prescription drug advertising is mostly a good thing, while 4 in 10 (39 percent) say the opposite. Regardless of whether they think drug advertisements are good or bad, the public seems to find them only moderately informative. Half (50 percent) say drug advertisements do a good or excellent job of telling consumers which condition or disease the drug is designed to treat. Over 4 in 10 say the advertisements do at least a good job telling consumers about the potential benefits (47 percent) and potential side effects they might experience (44 percent). About a quarter (24 percent) say the advertisements do at least a good job of informing consumers of how effective the drug is in treating a specific condition compared to other treatments. Just 11 percent say the ads are good or excellent at informing the public of the typical cost of the drug, while 20 percent say they do a fair job and a majority (65 percent) say they do a poor job.

More here...

Pharma Guy's insight:

Looking more closely at the numbers: Only 3 out of 100 Americans who have seen drug DTC ads get the drug they asked about. About 4 out of 100 get a competing drug. You tell me if DTC advertising is effective or not, based on this information.

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Benefits of Celebrity Drug Ads Do Not Justify the Cost

Benefits of Celebrity Drug Ads Do Not Justify the Cost | Pharmaguy's Insights Into Drug Industry News |
Do ads in which celebrities discuss specific diseases – but not specific medicines - really influence consumer behavior toward prescription drugs? Although well-known personalities may lend some credibility and prompt consumers to pay closer attention to the messages, a recent study suggests that such advertising does not really make much of a difference when it comes to seeking a medicine.
Pharma Guy's insight:

The authors of the study, which you can find here, conclude that such ads are not worth the cost -- something I blogged about months ago (although I was talking about branded ads) - read 

Pharma: Your Brand Celebrity Spokespersons Are Worthless!

Authors conclusion:

"While consumers paid more attention to the celebrity-containing ads and viewed them as more credible, this did not translate into significant effects on the outcome dependent variables of consumer attitudes toward the ad and company, behavioral intentions and information search behavior. As previous literature has suggested, level of disease state involvement was a significant predictor of respondent outcomes. Overall, pharmaceutical manufacturers might want to re-evaluate using a celebrity endorser in disease-specific ads, as this research shows the benefits/outcomes may not justify the cost."

But brand managers hobnobbing with the glitterati? Priceless!

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Big Pharma Pushes for Off-Label Promotion

Big Pharma Pushes for Off-Label Promotion | Pharmaguy's Insights Into Drug Industry News |

Should a pharmaceutical sales rep be allowed to tell a doctor that Topamax, a drug approved to treat seizures and prevent migraine headaches, might also help combat alcohol dependence? Or suggest the epilepsy drug Neurontin could also help treat bipolar disorders or insomnia? Or offer data showing that any number of other drugs could have uses beyond those listed on their labels?

For decades, the answer overwhelmingly has been no. The Justice Department has aggressively pursued companies that run afoul of rules against such “off-label” marketing — racking up billions of dollars in settlements. And the Food and Drug Administration has held firm to the idea that sales pitches generally should not include information on uses not approved by the agency.

But in the long-running conflict between federal regulators and drugmakers over how companies promote their drugs for unapproved uses, the landscape could be shifting, if only in subtle ways, and the outcome could affect doctors and patients alike.

Prompted in part by recent federal court decisions, the FDA is reviewing its rules on what kind of data drug companies should be allowed to distribute to doctors regarding off-label uses, as well as how they should respond to unsolicited questions from physicians about those uses. Its goal is to issue new guidelines by the end of the year.

Critics of the current rules say allowing pharmaceutical companies, which know the most about their drugs, to share more information about off-label uses would lead to better-informed physicians and ultimately benefit patients. Others are skeptical, saying the industry could exploit even a minor loosening of the restrictions to hype drugs for unapproved uses, exposing patients to ineffective and potentially harmful treatments.

Pharma Guy's insight:

Some industry officials say the FDA has been slow to adjust to the reality of those court rulings.

“They were in denial,” said John Kamp, executive director of the Coalition for Healthcare Communication, which represents drug marketing agencies and medical publishers. “If doctors can talk to each other and major researchers can talk about off-label uses, the drug’s manufacturer should be able to talk about those uses, too.. . . If something is true and can be said by one party, it can be said by all other parties.”

 Aaron Kesselheim, a Harvard Medical School professor who has studied off-label promotion, asks: Who gets to decide what qualifies as “truthful” information when it comes to sharing data about unapproved drug uses?

What do you think? SURVEY: Distribution of Off-Label Reprints by Pharma: Are FDA's New Revised "Rules" Too Limiting?

Pharma Marketing Blog post: 

WLF to FDA Regarding Distribution of Off-Label Reprints: See You in Court!
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Did FDA Avoid the "Social Media Guidance Cliff"?

Did FDA Avoid the "Social Media Guidance Cliff"? | Pharmaguy's Insights Into Drug Industry News |

Section 1121 of the Prescription Drug User Fee Act (PDUFA) states: "Not later than 2 years after the date of enactment [signed into law on 9-July-2012], FDA shall issue guidance describing FDA policy regarding Internet promotion, including social media, of medical products regulated by FDA" (see here). 

I call this the "Social Media Guidance Cliff."

Pharma Guy's insight:

Well, today is exactly two years after PDUFA V was signed into law. While FDA has issued a few social media guidance documents, it still has one more to go: Use of Links

FDA's "Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2014," which was published in January 2014, promised that it would publish that guidance sometime in 2014 (see here).

Section 1121 was not specific as to how many social media guidances FDA should issue before toddy's deadline. So I guess FDA is off the hook as far as complying with section 1121 is concerned.

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Omega3 drugs Recruit Pawn Stars & Fish for DTC Campaigns

Omega3 drugs Recruit Pawn Stars & Fish for DTC Campaigns | Pharmaguy's Insights Into Drug Industry News |
Celebrity endorsement, copay cards and online edutainment are some of the ways marketers are dueling for attention in the prescription omega3 space.

Amarin is poised to announce a celebrity tie-in with cable-TV star Rick Harrison (host of the showPawn Stars) as part of an integrated campaign to boost awareness of its one-year-old Vascepa brand. And AstraZeneca, whose prescription omega-3 drug Epanova is a relative newcomer, recently launched an unbranded, digital edutainment effort. 

Amarin's partnership with Harrison, who was diagnosed with the condition, works the correlation between knowing trig-treatment facts and not being hoodwinked in his own pawn shop.

“If I hadn't checked with my doctor, I would have made the mistake many make, thinking dietary supplement omega-3s are actually over-the-counter drugs,” Harrison says in a video on the related site, adding that Pawn Stars teaches that “knowing what's valuable and authentic is important to success.” 

Meanwhile, in a campaign that takes its cue from the aquatic theme of DTC advertising done by GlaxoSmithKline's Lovaza—but also departs from it—AZ posted three videos as part of an unbranded consumer effort called “Take it From a Fish.” The videos, dubbed “Love,” “Diet” and “Tri,” take the viewer into the seafood section of the grocery store as two talking fish carry on a casual conversation about healthy eating habits.

Pharma Guy's insight:

Doesn't Harrison often ask his dad about "what's valuable and authentic" on the Pawn Stars show?

As far as I am concerned, these Rx drugs are "me-too" versions of existing over-the-counter dietary supplements, no  matter what Harrison might say about Vascepa

Read my take on the comments made by Harrison: 

Did Pawn Star Rick Harrison Ask His Daddy About the Value of Vascepa Omega-3 Fish Oil?
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FDA's Social Media Guidances Provide Little That's New, Says Coalition for Healthcare Communication

Indeed, at the Drug Information Association Annual Meeting held last week in San Diego, Abrams noted that he expected minimal use of space-limited media because of the agency’s requirements on risk information. Cooke wrote that OPDP’s call for risk information that includes the most serious risks associated with the product, as well as all boxed warnings, makes it “difficult to imagine a product that has fatal or life-threatening risk, contraindications or boxed warnings that could be contained within the space-limited context of a Tweet, which has a 140-character limitation.” For example, he cited one product’s boxed warning, which alone contains 692 characters.

This approach “would limit the availability of space-limited communications to the small subset of prescription products whose risk and benefit information” meet the agency’s requirements, Cooke said, adding that the framework set forth by the draft guidance “seems more amenable to the participation of products with limited risks and short benefit statements.” He told the Coalition that the agency “could have suggested some approved abbreviations to help companies meet the requirements in a limited space – such as using ‘risks incl death’ instead of ‘risks include’ and listing all possible inclusions –but it chose not to.”

In an e-mail to Bloomberg BNA June 17, James N. Czaban, chairman of the FDA Practice Group at Wiley Rein LLP, said that the risk/benefit guidance “is actually very limited in scope” because it does not address many other types of online activity. He also told BNA that “The idea that FDA would allow a black box warning to be condensed for use in the format of Google Sitelinks or even Twitter is quite surprising given existing promotional limitations on black box products, and the length and seriousness of such warnings for many drugs,” Czaban told BNA. “Will any company risk such an approach from a liability perspective, even if it could meet the space limitations?”

Czaban said that “the bottom line is that FDA’s guidance leaves many questions unanswered, and its examples are of limited utility.”

Pharma Guy's insight:

Here's how I believe pharma can create a compliant tweet INCLUDES a 692-character boxed warning: A Type of Rx Drug Tweet FDA Did Not Consider in its Recent Guidance

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It’s Time to Turn Off TV Doctors

It’s Time to Turn Off TV Doctors | Pharmaguy's Insights Into Drug Industry News |
From shady business deals to the lust for fame, television doctors are among the last people we should trust when it comes to health advice.

Though many of television doctors’ pedigrees are, in fact, impressive, it doesn’t exclude them from succumbing to the power trip that is the cult of celebrity.

The most recent example is Dr. Mehmet Oz, whose shilling of various ineffective weight loss supplements ultimately landed him in a congressional hearing that has cost him a fast-vanishing reputation. For Congress to call upon Dr. Oz is to essentially ask that a publicist be present and willing to issue a statement for green coffee.

Lucky for us, Oz somehow has a conscience and basic understanding of how the law works, forcing him to come clean. He further shamed the empire he’s built with statements made on the record against the exact things he’d been uttering on television. It’s a testament to the fever dream haze of celebrity that Dr. Oz’s defense lies squarely in the ability to prop up his audience, even through pseudoscience. To say that Oz is using a white lie to better the public would be letting him off too easy, however.

Pharma Guy's insight:

Remember, Dr. Jarvik, the erstwhile "real" physician that Pfizer hired to recommend Lipitor in its TV ads back in 2007? Since he was outed as an unlicensed physician (read the story here), the drug industry has been reluctant to use real physicians in TV drug ads (the exception is that Restasis doctor, the sight of whom drives me to flip the channel). 

There are, however, fake doctors portrayed by unknown actors in drug commercials and there used to be famous TV doctors -- e.g., Dr. Geiger played by Mandy Patinkin -- starring in TV drug ads. Haven't seen any of those lately.

You might like to read this: 

While Real Doctors Prescribe Placebos, Fake Docs on TV Prescribe Drugs Off-Label
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Thinking Outside the Tweet

Thinking Outside the Tweet | Pharmaguy's Insights Into Drug Industry News |

I couldn't sleep last night. For some reason I became obsessed with trying to figure out a way that pharma companies can create Rx branded tweets that satisfy FDA's recent "Industry Guidance for Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices."

Pharma Guy's insight:

"The draft guidance does not mention Tweets accompanied by images, which is perhaps a way to present ISI along with benefit information in the tweet itself," I said. "I have created a mock-up using Lipitor as an example."

Here's a screen shot of how this tweet would look on Twitter (would it pass muster with FDA? Tell me your opinion on Pharma Marketing Blog).

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The FDA Social Media Guidances May Not Change Anything: Senak Explains

The FDA Social Media Guidances May Not Change Anything: Senak Explains | Pharmaguy's Insights Into Drug Industry News |
After a five-year wait, the FDA this week released guidelines for how drug and device makers should deal with social media. One provides a blueprint for correcting misinformation on websites run by others, while the second guidance discusses the use of Twitter. We spoke with Mark Senak, a senior vice president and partner at the FleishmanHillard public relations firm that works closely with drug makers and who also writes the Eye On FDA blog, about what the guidances may – or may not - change.

Pharmalot: And what about the other guidance, which refers to using Twitter?

Senak: Using Twitter for specific product communications prior to the guidance was problematic because there were so many unknowns. But now it’s problematic because of what we know.

Pharmalot: What do you mean?

Senak: In general, the manufacturer must present risk information in the same venue as any discussion of a product. In characters placed in a limited venue, people didn’t know how to cram all of that into 140 characters, particularly after the banishment of a one-click rule in 2009, [my emphasis] when you couldn’t use a link to take you elsewhere to read the info.

So people avoided Twitter, because it wasn’t known how to satisfy requirements. Looking at the guidance and the example of how to develop a Tweet, it’s still so constricted that I think product-specific communication by Twitter is still problematic. Again, I think it’s a situation where not much has changed.

Pharma Guy's insight:

I take issue with Senak's statement that the "one-click rule" was "banished" by the FDA in 2009. He's referring to the famous 14 letters FDA sent to major drug companies on April 2, 2009 (read "Ramifications of FDA Regulatory Actions").

Here's what I wrote in November 2007 - nearly one and one-half years prior to when Senak says FDA "banished" the one-click rule (read: The "One-Click Rule": Rant or No Rant?):

The "one-click rule" is no rule at all and is merely a platitude online pharmaceutical marketers spout to trick us into believing that they obey "rules." Since I spend a lot of time documenting how pharma marketers violate this "rule" repeatedly, I thought I would write a comment to the authors of a document that advised pharma about the "rule." Here it is. You decide if it is a "rant" or not.

In the paper, the authors make frequent reference to the so-called "one-click rule" regarding access to fair balance information on the Internet.

If you search Google on "one-click rule FDA" you won't find any references to this rule that the FDA has made, but you will find my post "Girl from Google." (posted in November 2005).

That's because, in that post, I discuss how the so-called "one-click rule" was used to justify Google Adwords (aka, "BAdwords") that violate FDA guidelines -- these ads mention the brand name and indication, but do NOT include any fair balance as is required by FDA. (NOTE: THE FDA'S 14 LETTERS PRECISELY TARGETED THESE KINDS OF ADS IN APRIL, 2009, MORE THAN 2 YEARS AFTER I POINTED OUT THAT THESE ADS VIOLATED FDA REGULATIONS!).

One person from a pharmaceutical company, perhaps playing the devil's advocate, contended that these "BAdword" ads may pass muster with the FDA because the package insert or brief summary is "one or two clicks away." His argument was that without specific guidance from the FDA, no one knows what is correct in this case.

It is a shame that the FDA does not have any guidance for the industry as far as Internet advertising is concerned. This means that marketers can use lack of guidance as a defense for sneaking in ads that push the envelope. What are the chances that the FDA would ever notice (BUT THEY DID!). These ads are fleeting, here today, gone tomorrow!


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