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A "Must Read" Blog for Insiders. --Wall Street Journal      "...often-entertaining, always informative..." --MedAdNews



Updated: 2017-08-19T14:34:15.815-04:00

 



PhRMA May Be Shooting Itself in the Foot by Criticizing FDA DTC Studies

2017-08-17T07:19:50.739-04:00

As reported by RAPS (here), the Pharmaceutical Research and Manufacturers of America (PhRMA) is "harshly criticizing the US Food and Drug Administration's (FDA) research focused on prescription drug advertising and promotion and calling for a clearer vision on how this research protects public health."

"FDA has proposed to undertake projects in a variety of disparate topics without articulating a clear, overarching research agenda or adequate rationales on how the proposed research related to the goal of further protecting public health. Within the last year, the Agency has increased such efforts at an exponential pace," Kelly Goldberg, PhRMA vice president and senior counsel for biopharmaceutical regulation, and Ryan Kaat, senior director of law, wrote in comments published 11 August on an FDA notice.

"PhRMA has long sought to ease FDA's rules on advertising and promotion particularly as FDA last November held a meeting to consider the off-label promotion of drugs with some regulations," noted RAPS. Some FDA officials at that meeting, however, questioned industry's arguments and motives for loosening regulations on off-label promotions (read “Ex-FDA Commish Califf Says #Pharma Needs a Code of Ethics to Prevent ‘Misleading’ Off-Label Marketing”).

But now, PhRMA is taking FDA to task for proposing new studies "seemingly without fully appreciating its own previous research" and some proposed studies "are often unnecessary in light of existing data."

PhRMA also takes exception to FDA research on "obscure topics," such as "Spousal Influence on Consumer Understanding of and Response to Direct-to-Consumer Prescription Drug Advertisements" (read “Does Your Spouse Influence Your DTC Viewing Experience?”) to "Animation in Direct-to-Consumer Advertising." (read “FDA Will Apply the ‘Uncanny Valley’ Hypothesis to Test the "Eeriness" of Animated Characters in Drug Ads”). See my SlideShare presentation ("Gallery of FDA Studies of DTC Advertising") embedded at the end of this post.

But PhRMA may be "shooting itself in the foot" by criticizing FDA.

Read more »



"Fake Advertising": Allergan Should Be Red in the Face for Using "Before & After" Images in Rhofade & Kybella Ads

2017-08-08T06:35:45.404-04:00


Allergan is again resorting to side-by-side "before and after” images in a drug ad to prove that Rhofade - its new drug for the treatment of redness of the face, aka rosacea - works. This is the same technique the company used  to promote Kybella for double chin syndrome.

In the Kybella case, I analyzed the figures and suspected foul play; i.e., the after image was just a retouched version of the before image. That ad, however, claimed they were “unretouched photos” (read "Kybella Double Chin TV Ad: Are the BEFORE & AFTER Photos REALLY Unretouched as Claimed?").

Despite some anonymous commentator to my Kybella blog post claiming he/she “worked on this campaign and I saw first hand that not one photo in the treatment area was retouched,” I don’t buy it.

But I will point out that the photos in this ad for Rhofade are definitely not retouched versions of the same photo. The ad, however, says “Illustration only.” Which means this is not a real case study of a real person’s response to the drug.

Perhaps that commentator to my Kybella post learned from my blog to be more careful about using fake before-and-after imagery.

Whatever! Allergan is again practicing misleading and/or false advertising, IMHO!

Read more »



Is FDA Too Slow to Approve New Drugs?

2017-07-05T08:58:13.026-04:00

Back in March, 2017, President Trump "called on the Food and Drug Administration to speed the approval of drugs to treat life-threatening diseases, deriding the agency’s current process as 'slow and burdensome'”(here).

According to Dr. Michael Carome, Director, Public Citizen’s Health Research Group, president Trump’s claims that the U.S. Food and Drug Administration’s approval process for medical products is “slow and burdensome” and “keeps too many advances … from reaching those in need,” reflect complete ignorance about the FDA’s current regulatory schemes for ensuring that medications and medical devices are safe and effective (here).

In an analysis published in The BMJ last week, Thomas Marciniak, a retired team leader within FDA's Division of Cardiovascular and Renal Products, and Victor Serebruany, a professor at Johns Hopkins University, attempt to debunk some of these claims, reports RAPS (here).

"This crude depiction ignores industry's contribution to the clock after clinical trials are completed but before the FDA receives the formal application," they write. "It may be possible to accelerate drug approvals in other ways, such as changing processes earlier in the development programme, before the end of the pivotal trials," they write, while cautioning that lowering FDA's standards to speed reviews "may prove costly for patients and healthcare budgets."

Of course, the real issue is how long it takes drug companies to come up with the evidence in order to submit an NDA (New Drug Application) to the FDA. Pharma has won the battle to get FDA turnaround times down to the bare minimum. It now has to turn to allowing drugs to be approved with less evidence. That's really what this is all about. FDA is just a convenient scapegoat, IMHO.

There is one solution to alleviating FDA’s “slow and burdensome” approval process and getting potentially life-saving drugs to patients.

Read more »



The Forgotten eHealth Code of Ethics

2017-06-27T08:33:39.329-04:00

Recently, I was sorry to see that the eHealth Code of Ethics, which I helped create back in 2000, was not included in the list of references to an article about trust and credibility of web-based health information. According to the Code, individuals need to be able to judge for themselves the quality of the health information they find on the Internet. Sites should disclose what sources the site or content provider has used, with references or links to those sources.

Any research or effort designed to improve the quality of health information on the Internet must build upon the work already done by the creators of the international eHealth Code of Ethics, which is as relevant today as it was back in 2000.

frameborder="no" height="166" scrolling="no" src="https://w.soundcloud.com/player/?url=https%3A//api.soundcloud.com/tracks/329529608&color=ff5500&auto_play=false&hide_related=false&show_comments=true&show_user=true&show_reposts=false" width="100%">

Click on "Read more >>" for the transcript of this podcast and for links to the code and other related information.

Read more »



Some PhRMA Board Member Opioid-Producing Companies are NOT Signatories to Its DTC Advertising Principles & Code on Interactions with Healthcare Professionals. Why Not?

2017-06-12T09:02:53.920-04:00


In December 2008, the PhRMA Board of Directors unanimously adopted measures to enhance the PhRMA Guiding Principles on Direct to Consumer Advertisements about PrescriptionMedicines. The revised Principles took effect March 2, 2009.

Despite the thundering unanimity of the PhRMA Board, several current board members are NOT signatories to the principles. Specifically, Allergan, Alexion, Alkermes, Teva, and UCB are not signatories even though the CEOs of these companies are current PhRMA board members!

Most disturbing to me is that opioid manufacturers and marketers Allergan, UCB, and Alkermes have not agreed to obey the DTC guidelines. In addition, Alkermes, which sells Zohydro, a powerful opioid (see here), is not a signatory to PhRMA's Code on Interactions with Healthcare Professionals

Alkermes also markets Vivitrol - an expensive drug approved by the FDA for treatment of opioid addiction (click "Read more >>" for background). The photo above shows a "reminder ad" for this drug on a NYC subway train. Technically, this ad does not violate DTC Principle 13, which prohibits such ads that do not disclose the drug's indication or side effects. That's because Principle 13 ONLY applies to TV ads!

Meanwhile, Alkermes specifically bypasses physicians and focuses on "a deft lobbying strategy that has targeted lawmakers and law enforcement officials."

Read more »



Funny, Witty, Snarky Pharmaguy Memes About Pharma

2017-06-05T06:58:16.619-04:00

The original, pre-internet definition of a meme is, “an element of a culture on system of behavior that may be considered to be passed from one individual to another by non-genetic means, especially imitation”.

Today, the “element of culture” is often an image or photo that has spread through social media or texting and which has been modified to include overlaid text. At least, that is how my son defines meme.

Over the years I have created numerous memes that I hope will be copied and passed on from one pharmaceutical marketer to another. This PowerPoint presentation includes many of my favorite memes and some insights on why I created them. Most of these memes have to be viewed in context of the news and events that inspired them. So for each one, I provide links back to the original social media post in which they appeared. Hopefully that will provide the necessary context.

Enjoy and feel free to spread them through your social media channels!

allowfullscreen="" frameborder="0" height="410" marginheight="0" marginwidth="0" scrolling="no" src="//www.slideshare.net/slideshow/embed_code/key/1Ct3fhwQVkTngi" style="border-width: 1px; border: 1px solid #ccc; margin-bottom: 5px; max-width: 100%;" width="500">



Defining "Patient Centricity"

2017-06-07T09:49:56.211-04:00

Patient Centricity used to be a buzzword in that it was often mentioned but seldom practiced by pharma companies.

A lot of progress has been made in the past years to achieve patient centricity, but not all drug companies have had much success. Unfortunately, that has had a negative impact on the industry’s reputation.

Timothy White, Head of Global Customer Interaction Management at Lundbeck, once said people on the commercial side of the pharma business have an “unhealthy obsession with ‘buzzwords’.”

Worse than that, noted White, marketers cannot articulate the usefulness of the buzzwords they use.

Two years ago I compiled a list of “Buzzwords” used by pharmaceutical marketers. Patient Centricity was one of them (read "Pharma Buzzwords Heard During a Conference").

In a recent podcast (listen here) I pointed out how patient centricity has paid off in a big way for the drug industry when it comes to marshaling patients in support of speeding the approval with the FDA, which, by law, must include the patient perspective in the drug approval process.

But pharma still struggles to achieve patient centricity. Rich Myer, author of World of DTC Marketing Blog, reported recently that according to IMS a majority of pharma companies have attempted patient-centric initiatives but only a third have reported any success. Only 4% reported a high degree of success and nearly 60% of pharma professionals said there is no consistent definition of patient centricity in their organization (read "Why Does #Pharma Have Problems With Achieving Patient Centricity Success?").

To be successful at patient centricity, the drug industry must first define what they mean by the term. Astrazeneca has taken the first step to doing that.

Read more »



Pharma's Reputation Depends on Who You Ask

2017-06-01T12:12:43.468-04:00

Depending on who you ask, the drug industry's reputation is at an all-time low (read, for example, "Pharma’s Rep Among Patient Groups Sinks to Near Historical Lows") or an all-time high!

For example, if you determine the reputation of a pharma company measured by "the general public who are somewhat or very familiar with the company," then that company's reputation is likely to score much higher than if you asked the general public whose "familiarity" with the company is not a factor.

According to Reputation Institute's annual Global Pharma RepTrak®, which uses the former protocol, the reputation of the pharmaceutical industry is "improving and is now at a strong level with the general public (see the story embedded at the end of this post by clicking on "Read more >>"). I emphasized "general public" because this is misleading - further on in the press release you can see that what they measured are the attitudes of only a segment of the general public - those who are familiar with the companies.

In any case, here's the ranking of the top 10 companies according to Reputation Institute:


Read more »



FDA Has Many Hurdles to Overcome in its Effort to Stem the Current Opioid Addiction Epidemic it Helped to Create

2017-05-27T09:51:13.121-04:00

The FDA has made many efforts to deal with the current opioid addiction crisis. The latest is the establishment of a "Opioid Policy Steering Committee." Some of these efforts may have been compromised by the influence of patient advocacy groups sponsored by drug companies that produce and market opioids. Such groups have gotten a seat on FDA panels. So, one has to wonder who will be named to the new steering committee.

Listen to podcast below: frameborder="no" height="166" scrolling="no" src="https://w.soundcloud.com/player/?url=https%3A//api.soundcloud.com/tracks/324479125&color=ff5500&auto_play=false&hide_related=false&show_comments=true&show_user=true&show_reposts=false" width="100%">

Read the transcript, which includes links to more information, below.

Read more »



PhRMA Gets Religion & Purges Low Hanging Fruit

2017-05-10T08:56:20.925-04:00

PhRMA, the pharmaceutical industry's primary lobbying group, announced changes to its membership structure that purged 22 companies of their membership or associate membership status.

Now, to be a member of PhRMA, you have to spend at least $200 million per year spent on research and research expenditures must equal to at least 10% of global sales (click on "Read more >>" below for details).

Back in January, John LaMattina (@John_LaMattina) former president of Pfizer Global R&D, writing in Forbes, suggested that big pharma companies secede from PhRMA.

"I cannot help but wonder if the interests of the big companies would be better served if they split from PhRMA," said LaMattina. “The formation of a new association would go a long way to create a separate identity for the truly big pharma companies. CEOs like Ken Frazier will readily be able to point out to the world who big pharma really is. It would also bring accountability to the industry and demonstrate its commitment to not just being successful–but also doing good.”

Perhaps to forestall such a secession or perhaps to appease president Trump -- who accused the drug industry of "getting away with murder" -- PhRMA ousted small pharma members who are shouldering most of the blame for drug price increases. Meanwhile, Pfizer -- the largest of the Big Pharma companies -- won't commit to keeping a lid on the prices IT charges for drugs (read "Ian Read – Bean Counter Pfizer CEO – Won’t Commit to Keep a Lid on Drug Price Increases").

Read more »



The Benefits and Risks of Limiting Pharma Sales Rep Access to Physicians

2017-05-05T11:11:17.197-04:00

Pharmaceutical sales representatives are faced with increasingly limited access to physicians as many academic medical centers and other healthcare centers adopt conflict of interest policies restricting detailing. This is another benefit versus risk challenge for physicians who need quick access to the latest information about novel drugs. Listen to podcast below:

frameborder="no" height="166" scrolling="no" src="https://w.soundcloud.com/player/?url=https%3A//api.soundcloud.com/tracks/320945014&color=ff5500&auto_play=false&hide_related=false&show_comments=true&show_user=true&show_reposts=false" width="100%">


Read the transcript, which includes charts, below.

Read more »



March for Science, Why I March

2017-04-24T10:50:44.265-04:00

John (PharmaGuy) Mackspeaking at the March for Science in Doylestown, PA.My name is John Mack and I live in Newtown.On Twitter I am known as PharmaGuy – that’s P-H-A-R-M-A, plus “Guy!” I PUBLISH a newsletter for the pharmaceutical industry. And I have a graduate degree in Biochemistry.Every day we benefit from medicines and vaccines created by scientists who work in pharmaceutical and government-funded research laboratories. We need to discover new drugs faster and defend efforts that make those drugs cheaper and more accessible to everyone. In doing so, however, we also need to defend the scientific methods the drug industry uses to prove that medicines WORK. A big part of that process is the Food and Drug Administration, which ensures that drugs are proven safe and effective through rigorous clinical trials.Today the Food and Drug Administration and other science-based agencies like the National Institutes of Health and the Environmental Protection Agency are under attack by the current administration, WHICH intends to increase SPENDING on the military and decrease SPENDING on these and other science-based agencies that help improve our lives. We should not have to sacrifice science for security.DEFUNDING science impacts us on a local level whether the issue is the quality of our air and water, fracking, opioid drug abuse, or the heroin epidemic. We need leaders who believe in data and scientific evidence to help solve these problems.More scientists must get involved in politics today just as Benjamin Franklin did during the American Revolutionary War.There is a war being fought today – a war against science. We must defend science in THIS war.Marching together is a good first step. But we must follow up by electing pro-science leaders and ensure that they rely on evidence, not beliefs, when making decisions about our health, our environment, and our general well-being.Thank you for listening and may Science be with you![...]



Speedy Drug Approval Versus Safe Drugs: Can We Have Both?

2017-04-19T13:33:29.978-04:00

More user fees paid to the FDA by the drug industry and the push for less rigorous scientific proof in clinical trials may lead to faster drug approvals, but also more deaths due to side effects. Where’s the balance between speed and safety?

For the last few years I have been tracking data from the FDA regarding how much money it collects from the drug industry in prescription drug user fees to see those payments influence more than just how quickly the FDA is able to approve new drugs for marketing.

One stark correlation I noted with the rise in user fees was the sharp drop in the number of warning letters the FDA sends out. I guess this is actually a negative correlation. Interesting...


But the fees seem to be working. In 1992 it took the FDA 19 months on average to approve new drug applications. Today, when user fees account for about 70% of FDA's budget for the review of new drug applications, it takes the FDA only 10 months to approve a drug for marketing (see here).

But what about drug safety, which is the other responsibility of the FDA?

Read more »



Making Sense of DTC Ad Spending

2017-05-18T16:12:24.600-04:00

About this time every year, I get data from Kantar Media and Nielsen regarding how much money the U.S. pharmaceutical industry spends on direct-to-consumer (DTC) advertising.

The data I’m most interested in are the total spend for the year and what portion of that is digital versus TV. But it can be difficult to ferret out that information from the two different sources, which often report different numbers.

Let’s look at the total spend first.

According to Nielsen numbers reported in the March 3 2017 issue of MM&M online, spending on direct-to-consumer pharmaceutical ads rose 9% to $5.6 billion in 2016 (read Direct-to-Consumer #Pharma Drug Ad Spending at an All-Time High).

In the March 29 2017 issue of MM&M, a Nielsen chart showed the 2016 DTC spend to be $5.8 billion (see Will It Be Downhill from Here for DTC Advertising?).

A difference of $200 million is peanuts compared to the whole, but it’s just slightly more than what Pfizer spent promoting Xeljanz to consumers in 2016.

Now these Nielsen numbers apply only to what’s called “measured media,” which includes TV, magazines, newspapers, radio, outdoor, and Internet banner ads. It does NOT include websites, web videos, web audio, sponsored links, social media, mobile applications, and emails. It also does not include search engine marketing, which has been estimated to be 40% of the total pharma digital spend (consumer and physician).

Kantar Media generally reports slightly higher numbers. For 2016, Kantar Media estimates that total DTC spending was about $6.4 billion. But this number includes $515 million of “digital.”

I’m not exactly sure what Kantar considers “digital” versus what Nielsen does. I think it’s pretty obvious, however, that the pharma industry cannot be spending $515 million on banner ads alone. Perhaps Kantar’s number includes search engine marketing targeted to consumers. In any case, if that number is subtracted from the total, you get $5.9 billion, which is close to what Nielsen reported.

$5.8 billion, $5.9 billion, $6.4 billion. Whatever! The number is very high. It’s more important to look at trends and what portion of the total is allocated to different channels.

Read more »



A Drug By Any Other Name

2017-04-03T13:14:31.705-04:00

The naming of drugs has been described both as a science and an art, which is also true about marketing in general.

No matter what side of the brain is involved, there must be a reason why drug names are often ridiculed as being "absurd." The issue even made it to Saturday Night Live skit in which Oscar nominee Octavia Spencer sued Merck for naming dozens of drugs after members of her family ("Pharma Gets Drug Names from Octavia Spencer’s Phone Contact List").

Perhaps my reporting of that skit was the reason why my long-time friend, Jonathan Richman, founder and director of Dose Marketing in Cincinnati, posted a study he did of prescription drug names on LinkedIn. His post – titled “The Absurdity of Pharma Drug Names” – railed against the many drug names that are difficult to spell and pronounce. He questioned the validity of the “urban legend” that drugs are named this was to make them more memorable.

Read more »



PharmaGuy To Compete for Recognition at Cannes Lion Health Festival

2017-04-02T07:27:52.854-04:00

April 1, 2017: PharmaGuy is excited to announce that the organizers of the 2017 Cannes Lion Health Festival have chosen him as one of the finalists to compete for this year’s Old Pharma Lions Award!

Judges are seeking out the greatest generation of older, awe-inspiring pharma marketing communications pundits. This year’s competitors will put their snarkiness to the test on a brief set by UNIPHARM, the world’s leading organization working to revive the reputation of the endangered pharmaceutical industry (for more on that, read "Pharma Industry Reputation Hits 7-Year Low According to Harris Poll").

Participants will be challenged to write a series of blog posts or Tweets that ridicule the notion that pharma creative ad awards -- including the Old Pharma Lions Award -- have any value!

The talented winners will be invited to attend Lions Health in Cannes, where they will receive their awards during the official awards show in front of thousands of experts from across the pharma communications world.

Entry Criteria
  • You must be 50 years old or over!
  • You must have pissed outside the tent of elite advertising agencies for at least 15 years!
  • Your application needs to be written in English – we will, however, accept emojis
  • Competition entrants must work as individuals, never ever as a team!
  • Students are not allowed to enter the competition, even if you are over 50!
See last year's award winner below.

Read more »



Which is Bigger: Pharma Profits or R&D Spending?

2017-03-28T07:58:34.716-04:00

On Mar 27, 2017, Public Citizen came out with a report that claimed "Pharmaceutical Industry Profits Are Nearly Double R&D Costs in 2013, 2014 and 2015". The email announcing the report said “Even the inflated estimates of R&D reported by the industry are dwarfed by the industry’s profits, which, for the 20 largest pharmaceutical companies, jumped from $100.5 billion in 2014 to $123 billion in 2015.”

“Big Pharma says that high prices pay for R&D, but it turns out they pay almost twice as much for sky-high corporate profits,” said Robert Weissman, president of Public Citizen. “The pricing system is broken and needs fundamental change.”

Today, another email from Public Citizen notified me that the organization “discovered a methodological issue in our report on medication costs and industry R&D spending. We have withdrawn the report and will repost it later this week with corrected data.”

Unfortunately, I did NOT download the report, so I can only speculate as to the nature of the “methodological issue.”

But I can cite some research that says Public Citizen is wrong.

Read more »



The Context Problem Foils Pharma Online Advertising

2017-03-27T09:41:00.554-04:00

(image)
Click on image to enlarge.
Last week I came across an article about Johnson & Johnson and other pharma companies pulling their ads from Youtube because they appeared adjacent to hate speech, e.g.; an anti-Semitic clip claiming the existence of a “Jewish World Order” (see the back story embedded at the end of this post or click here).

In an official statement Johnson & Johnson said it paused all YouTube digital advertising globally “to ensure our product advertising does not appear on channels that promote offensive content. We take this matter very seriously and will continue to take every measure to ensure our brand advertising is consistent with our brand values.”

According to a Bloomberg article, "While Google’s tools can be incredibly sophisticated, allowing ads to follow users from site to site, the software hasn’t fully matched the human judgment necessary to protect brands from inadvertently funneling cash to causes their customers would find objectionable. The high number of intermediaries in digital advertising further complicates the problem. So Google’s announced fixes may not completely solve the challenge."

This problem, however is NOT limited to Google, YouTube, and Facebook. It's also a problem for pharma digital marketers looking to place ads in major online media channels.

A case in point is the Janssen ad embedded in a STATnews story about a immunotherapy "breakthrough" (see image at left).

What's the problem with this and can pharma companies do anything to place limits on digital ad placement by taking account of context?

Read more »



How Many Adverse Event Reports Are Submitted to the FDA? Whatever the Answer, It's at an All-Time High!

2017-03-20T14:08:33.617-04:00

I've been tracking the number of adverse event reports (AERs) submitted to the FDA over the years based on data supplied by the FDA here. The latest update of that data was made in November 2015 showing the number of AERs FDA received in the first quarter (Q1) of 2015.

If you assume that the submission rate seen in Q1 of 2015 remained constant throughout the year, you get the following trend chart based on FDA's summary data table:

(image)
Click on image for enlarged view.
According this analysis, about 2.25 million AERs were submitted by healthcare professionals (HCPs) and consumers in 2015. An analysis by the Milwaukee Journal Sentinel and MedPage Today, however, yields drastically different numbers.

Read more »






DTC Advertising in the Era of High Drug Prices

2017-03-13T07:40:36.994-04:00

TV and, to a lesser extent, print direct-to-consumer (DTC) drug ads have often been blamed for the high price of drugs. For example:

Pharma marketers are no doubt concerned that the current political atmosphere, in which both Republicans and Democrats are calling for lower drug prices, is having a negative effect on the effectiveness of their ads as consumers tune out the message (read, for example, “Pharma is Spending More on DTC Advertising But Its Effectiveness is Decreasing, Says New Survey”).

Bob Ehrlich, Chairman of DTC Perspectives, in a recent email titled "Times of Turmoil Ahead" expressed concern that DTC marketers may not adequately understand consumer sentiment viz-a-viz high drug prices:
"Most of us practicing the art and science of DTC have no control over political decisions on drug pricing and drug approval. That being said, it is imperative DTC marketers understand the popular sentiment consumers are exhibiting towards drug companies."
How does high drug prices affect the work product of DTC marketers and what does Ehrlich propose that DTC marketers do to address consumer concern regarding high drug prices?

Read more »



How to Make WebMD Great Again!

2017-03-03T07:51:47.408-05:00

World of DTC Marketing blog author and pharma marketing consultant Richard Meyer has some advice for WebMD, which may be looking for a buyer (read “’Same Amount of Eggs, More Baskets’ – Lesson Learned by WebMD re Pharma Digital Spending”).

WebMD needs pharma and medical device companies, but pharma doesn’t need WebMD,” says Meyer who has some suggestions about how to Make WebMD Great Again

“Even though WebMD is the top health portal on the web, turning traffic into revenue is hard to do as a lot of websites have found out,” says Meyer. “There are opportunities, but WebMD has to act fast.”

Here is what Meyer would do to rescue the brand:

Read more »



Is "Right to Try" a Good Idea?

2017-03-02T07:08:32.940-05:00

Last night, President Trump called on the FDA to speed the approval of drugs to treat life-threatening diseases, "deriding the agency’s current process as 'slow and burdensome'," according to this STATnews article.

One solution to alleviating FDA’s “slow and burdensome” approval process and getting potentially life-saving drugs to patients is "Right to Try" laws that would allow people with fatal illnesses to gain access to experimental medicines, even though they are not enrolled in a clinical trial. VP Pence and other lawmakers support this approach (see here).

“We should reform FDA so it is approving drugs after their sponsors have demonstrated safety and let people start using them at their own risk,” said Jim O’Neill, a managing director at Mithril Capital Management, a venture capital firm run by Peter Thiel, the billionaire Trump donor and transition team advisor and candidate for FDA Commissioner (see here). “Let’s prove efficacy after they’ve been legalized.”

I decided to ask my readers if they think this is a good idea or not and to also submit comments to support their views.

So far, I've received nearly 50 responses to my survey and more than 30 interesting comments, some of which I share with you here. I invite you to take the survey and give me your opinion as well.

Read more »



To Boost Sales, Gilead's Hep C Awareness Ad Focuses on Baby Boomers

2017-02-23T07:26:00.588-05:00

Direct-to-Consumer (DTC) drug ads are less and less effective according to several studies including the eyeforpharma Whitepaper “The Great DTC Shake-Up: Patient perspectives on direct-to-consumer advertising.”

One reason for this is a "negative reaction to the use of what could be perceived as 'scare tactics' or shock value to garner attention in a crowded media environment."

In that report, I was quoted as saying “scare tactics might be good for awareness.” Now, however, I'm beginning to rethink that, especially when disease awareness ads are scaring a large portion of the population to get tested for a medical condition they most likely do not have.  A case in point is a new Hepatitis C disease awareness ad by Gilead Sciences focused on "Baby Boomers."

Let's look at the numbers and do some math.

Read more »



Bob Ehrlich of DTC Perspectives Should Do Better Research & Fact Checking Before He Calls Out Media for "Misreporting" on DTC Off-Label Promotion

2017-02-17T10:22:16.520-05:00

I just received an email missive from Bob Ehrlich (@BobEhrlich_DTC), Chairman of DTC Perspectives, Inc., with the subject line "Media Misreporting Advertising Off-label Use."Ehrlich said "I was shocked to see media stories saying DTC may expand to cover off label use. What! This erroneous idea came from an FDA open meeting held 11/16 to discuss off label use based on court cases allowing drug companies the right to discuss them." WRONG!I first reported that the FDA was interested in hearing comments about off-label drug promotion to "patient and consumer audiences" back in September, 2016, after reading this in the Federal Register Notice (read "FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion" and find the notice here): "To what extent is it appropriate for firms to communicate information about unapproved uses of their approved/cleared medical products to patient and consumer audiences [my emphasis]? What disclosures and additional information would be needed to help ensure that a communication to lay audiences is truthful and non-misleading, given consumers' lack of medical training and expertise in critically evaluating this type of information?"Obviously, Ehrlich did not bother to read the notice and only reads Consumer Reports, which published results of a survey it did on the topic and reported at the hearing. Regarding that, Ehrlich said:"The lay press thinks that FDA might open the floodgates of off label use in DTC. A publication as reputable as Consumer Reports had a story 11/9/16 titled 'FDA Considers Allowing Drug Ads for Unapproved Treatments.' I am not sure why Consumer Reports made the leap from possibly loosening the regulations for discussions with doctors all the way to DTC. That story seemed to be picked up by many news organizations who said drug ads may increase because of off label uses."Yo! Bob! Consumer Reports may have got the idea from my blog post made two months BEFORE it published its story or maybe it did what a good news organization should do and actually read the FDA notice, which was pusblished in September, 2016.Ehrlich may also have confused this LA Times opinion piece with a news story that was published just last week: "Off-Label Direct-to-Consumer Drug Advertising 'Just Isn't Healthy'".Ehrlich closed with this:"I think the FDA will take years to study this issue and not do more than the courts push them to do. They are just figuring out how drug companies can use the Internet about 20 years late. They are worried consumers will get confused figuring out how to click on the fair balance. So, I do not think off label use is on their list of DTC to do projects, not for a decade or two."He may be right about the timeline, especially after Trump signed an executive order that calls for government agencies to pull two regulations for every new regulation they implement. The FDA may just "sit on its hands" and issue no new regulations for a good long while and that will NOT be good for the drug industry (read "FDA Regulation Cutting Will Impact Drug Approvals Too").[...]