These are my favorite images and posts that appeared in Pharma Marketing Blog in 2014 (see embedded slide deck below – you can also view this directly on slideshare here).
It was a very interesting year, especially since FDA finally released some long-awaited social media guidance for the pharma industry. 2014 was also notable for the proliferation of pharma mobile health apps, which is another emerging area that needs FDA guidance. FDA has said that the guidances it has issued so far do not include mobile. Finally, it was the year of high prices – for both branded and generic drugs.
See below for notes.
Slide 2: OH YEAH, BABY! SHOW ME MORE!… VIAGRA TV ADS LIKE THIS. BUT DON’T LET MY FDA SEE IT!
Wowie zowie! Is that a roll of dimes quarters in my pocket or am I just excited to see this new Viagra DTC TV ad that features what could be a MILF? I pity the man who can’t get an erection carousing with this woman in a beach resort or even watching her on TV lounging around the beach resort telling you that “plenty of guys” have “this issue”; i.e., getting and maintaining an erection. Posted October 1, 2014. More…
Slide 3: ANALYSIS OF FDA’S DRAFT GUIDANCE RELATING TO POSTMARKETING SUBMISSION OF INTERACTIVE PROMOTIONAL MEDIA
Usually, drug companies must submit every promotional piece — print ad, TV ad, or drug.com web page — to the FDA at the time of “initial dissemination” (e.g., when the TV ad first airs). “However,” says FDA, “for some interactive promotional media, submission ‘at the time of initial dissemination’ may pose a challenge for firms, particularly when these media communicate information that is displayed in real time.” This may sound like the much-anticipated guidance for how the FDA will regulate drug promotion on the Internet and social media sites, but it really describes when and how pharma companies should submit forms to the FDA to fulfill regulatory requirements for post marketing submissions. Nevertheless, it does give us some insight into FDA’s thinking about how it intends to regulate interactive promotions.
Posted January 13, 2014. More…
Slide 4: GLOBALLY, PHARMA’S DIGITAL SPEND IS (STILL) ONLY 6% OF TOTAL PROMOTIONAL BUDGET
According to Cegedim Strategic Data (CSD) — a provider of healthcare promotional audits — in the last 6 months of 2013, the global pharma industry spent nearly $2.5 billion on all digital channels including pharma company websites, social media, web banner advertising in professional online journals and mobile apps. That works out to be approximately 6% of the total audited marketing expenditure, which includes “traditional, personal promotional channels;” i.e., sales reps.
NOTE: I am uncertain if this CSD audit includes direct-to-consumer (DTC) promotional spending, which is only legal in the U.S. Also, keep in mind how CSD estimates these numbers; i..e., by polling thousands of physicians.
While the total expenditure remained flat, spending on some digital channels — i.e., e-detailing, e-mailing and e-meetings — was up over 14% in 2013 versus 2012. The total spend for these channels in 2013 was $1.9 billion. Posted June 4, 2014. More…
Slide 5: ANNUAL PHARMA INVESTMENT IN “ESALES,” “EDETAILING,” “VIRTUAL DETAILING” … WHATEVER!
Cutting Edge Information recently published its “Pharmaceutical Sales Management” report, which included data on “eDetailing.” Ed Silverman, a Wall Street Journal blogger, summarized the data in the report and stated “the average annual [per company] investment in electronic methods [of pharma sales interactions with physicians] is $1.96 million.” Many pharma marketing professionals were skeptical of the $1.96 million number as I mentioned in a previous post (read “Pharma Spends What on eSales?”). It turns out that the confusion has to do with the terminology used. I used the term “eSales” as Twitter shorthand for “interactions … using the Internet or mobile device to host webinars or interact with physicians by email,” which is how Silverman described what Cutting Edge Information calls “eDetailing,” which, as it turns out, may include only LIVE online activities such as virtual reps performing online informational sessions and linking field reps with doctors via webcams. That’s a much more limited definition of “eDetailing” than is typical (see this definition). A better term for what Cutting Edge measured, IMHO, is “Virtual Detailing.” The $1.6 million annual spend per company makes sense if we are talking only about virtual detailing. Posted March 21, 2014. More…
Slide 6: PHARMA DTC ADVERTISING SPEND VS. TIME CONSUMERS SPEND IN VARIOUS MEDIA
I used Nielsen data for pharma direct-to-consumer (DTC) ad spending by medium to create this version of a Meeker chart that focused on all industries. It seems that pharma marketers spend WAY too much on print advertising and TV and not enough on Internet, radio, and mobile advertising; i.e., the same as all industries but much, much more skewed. But what seems to be a misalignment of advertising budgets may actually make sense if you consider the typical target demographic of the pharma industry — older folk and mostly women. Obviously, the older you are the more likely you are to suffer from some medical condition for which pharma has a pill. And we all know that women are the caregivers and tend to visit the doctor much more often than do men. These same demographics tend to watch more TV — especially nightly news programs and daytime talk shows — and read more magazines. Hence, the focus of pharma advertising in these media. What about radio? Advertising on radio is a waste of time for the pharmaceutical industry, IMHO. Graphical imagery and video better convey the message of hope and branding that pharma marketers are aiming to get across. And mobile? I just don’t know if mobile ads — other than text messaging — is mature enough to satisfy the needs of pharma marketers. The small screen of most mobile devices is also a problem, especially when you have to include all the necessary fair balance.
Posted May 29, 2014. More…
Slide 7: PROMOTIONAL SPENDING IN 2013 OF THE TOP 20 BIG PHARMA SPENDERS
Obviously, some companies spend a great deal on DTC (e.g. Pfizer), whereas others spend $0 or close to $0 on DTC. I’m sure that varies year to year and depends a lot upon the type of products being promoted and the life cycle stage they are in. This pie chart shows the overall allocation of the promotional spend of the 20 (by sales) pharma companies. According to CSD, the top 20 pharma companies spent a total of $14,784 Bn on traditional professional detailing, eDetailing, Direct-to-Consumer (DTC) advertising, professional meetings, and journal advertising. This does NOT include the cost of supplying drug samples. Obviously, some companies spend a great deal on DTC (e.g. Pfizer), whereas others spend $0 or close to $0 on DTC. I’m sure that varies year to year and depends a lot upon the type of products being promoted and the life cycle stage they are in. How representative is this of the entire industry? I’m not sure, but I estimate these numbers represent about 80% of the total spend of ALL pharma companies. So, I’d say that the pie chart above reasonably accurately reflects the industry as a whole. What’s immediately evident from the pie chart — aside from the practically 0% spent on journals ads — is the minuscule fraction spent on “eDetailing.” 2% of the total is $217 million, which is only “minuscule” comparatively speaking. More important, however, is the fact that this percentage has not changed since I’ve been keeping track of eDetailing despite the 20 to 30% decrease in the number of live sales reps.
Posted May 16, 2014. More…
Slide 8: TOP DTC AD SPENDERS VIRTUALLY IGNORED DIGITAL
These top 18 brands spent $2.1 billion on DTC advertising in 2013, which is about 55% of the total DTC spend for the year. Most of these brands, however, devoted less than 5% of their DTC ad budget on digital. According to Larry Dobrow writing in MM&M, “the top overall brand, Cialis, devoted just $6 million of its marketing spend to digital, a meager 2.7% of its budget. The third highest-spending brand, Celebrex, similarly gave only passing consideration to digital: $5.4 million, which represented 3.5% of its ad expenditures. Humira (for arthritis), ranked fourth in brand spend, devoted less than $1 million to the digital space, and it wasn’t alone: of the top 20 brands, 16 didn’t clear that $1 million mark. “With companies,” said Dobrow, “it was the same story. Pfizer, the biggest overall and digital spender, alloted $21.5 million of its $872.2 ad budget to digital, amounting to a measly 2.5% of its outlays. Percentage-wise, other top spenders devoted even less: Lilly ($9.9 million, 2.2%), AbbVie ($1.2 million, 0.3%), AstraZeneca (around $100,000, 0.03%) and Merck ($5.1 million, 1.8%). Towards the bottom of the top 20 companies, only Sumitomo showed any kind of real commitment to digital—and that was just $3.8 million of its $29.7 million in spending, or 12.8%. The Nielsen digital data doesn’t include spending on Yahoo! sites, Realtor.com, MySpace or YouTube, but however you measure it: companies and brands aren’t walking the walk when it comes to digital.” Posted April 11, 2014. More…
Slide 9: DO TV DTC ADS OVERSTATE RX DRUG RISKS? FDA MAY MAKE CHANGES THAT PUT PATIENTS AT RISK
Balancing drug benefits (efficacy) against risks in direct-to-consumer (DTC) advertising has always been a contentious issue between pharma marketers and the FDA. 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.” When space or time is limited — as in TV DTC ads — the drug industry is concerned that the major statement of risks — as currently implemented in DTC ads — is often too long and “may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic noncompliance due to fear of side effects.” When the industry is concerned, the FDA acts. However, before the FDA issues guidelines that may alter how it views risk information in TV ads, the agency will do a study. In the Federal Register announcement of the proposed study, FDA reveals some ways that it may allow drug companies to substantially shorten the litany of risks in TV drug ads. Would these changes be in the best interest of patients or of drug marketers?
Posted February 18, 2014. More…
Slide 10: PUBLIC CITIZEN PETITIONS FDA TO ADD A BLACK BOX WARNING TO LOW-T DRUG LABELING
Public Citizen called on the U.S. Food and Drug Administration 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. FDA stated on Jan. 31 that it “has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death.” “In the face of … accumulating evidence [see, for example, “Testosterone Therapy Tied to Heart Risks”], this statement is reckless and is a betrayal of the FDA’s role as an agency in the U.S. Public Health Service,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group. “It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks.”
Posted January 25 February 2014. More…
Slide 11: ARE FDA’S EFFORTS TO IMPROVE ADVERSE EVENT REPORTING BEING HOBBLED BY PHARMA?
Between 2003 and 2012, FDA received 588,000 death notices via Adverse Event Reports (AERs). DEATHS reported to the FDA via its adverse event reporting system have increased dramatically in the last few years for which data is available. FDA scrubbed a project that would have developed “predictions for safety signals that have not yet been recognized for drug candidates that have come to the FDA as New Drug Applications (NDAs),” which is a pretty radical idea. Did the pharma industry put the kibosh on the study? Posted April 7, 2014. More…
Slide 12: FDA WAKES UP TO SOCIAL MEDIA’S ABILITY TO MONITOR DRUG ADVERSE EVENTS
A recent FDA Notice of Solicitation calls for a “contractor capable of providing it with social media monitoring services capable of analyzing consumer sentiment and social media ‘buzz.’” Specifically, one objective is to provide FDA with “surveillance through social media listening for early detection of adverse events.” Instead of passive listening and creating interesting but useless “dashboards” and reports, why doesn’t the FDA and/or the American pharmaceutical industry follow the lead of the Association of the British Pharmaceutical Industry (ABPI) and advocate a more proactive approach to using technology to help consumers report adverse events? The ABPI issued guidance that addressed three different ways that pharmaceutical companies may learn of adverse events (AEs) through social media: “Listening in” — Monitoring social media sites allows a company to “listen to” or “see” what the public are discussing, saying or sharing about the company itself, diseases, conditions, and treatment options. “Giving out” — Many social media sites allow companies to initiate one-way communications to share important messages with the public, where interactive dialogue is not permitted or practical. “Engaging with” — Engaging, exchanging and participating in interactive communication with the public. This type of activity is performed in both company and non-company sponsored sites. I’m not sure if any pharma company has acted upon ABPI’a recommendation, however. It’s all self-regulated. That’s why there should be a law requiring drug companies to implement better adverse event reporting features on their web sites and FDA should follow ABPI’s lead and provide guidance on how companies can monitor social media.
Posted February 27, 2014. More…
Slide 13: TAKEDA MAY PAY $6 BILLION PENALTY FOR HIDING ACTOS CANCER LINK
According to an article in the Financial Times, “Takeda has been ordered to pay $6bn in punitive damages for hiding a possible link between a best-selling diabetes drug and bladder cancer in one of the biggest corporate fines by a US jury. Eli Lilly, which marketed the drug in the US until 2006, was ordered to pay $3bn.” Although Takeda has vowed to appeal the decision, I have updated my “Pharma Criminal & Civil Settlement Planetary System” diagram to put this decision in context of other fines and jury awards against the drug industry made in the past couple of years. Posted April 8, 2014. More…
Slide 14: WHEN BIG PHARMA SELLS OLDER DRUGS, IS “PUTTING THE PATIENT FIRST” DEVALUED?
According to a Reuters article, “Leading global pharmaceutical companies have started to view their vast portfolios of older, established prescription drugs as vehicles for raising large sums of cash to fuel development of new medicines with far higher profit margins.” I can’t help but interpret this trend as another example of how big pharmaceutical companies put profit before patients despite all the hype about being more patient centric. I can’t help but interpret this trend as another example of how big pharmaceutical companies put profit before patients despite all the hype about being more patient centric. True, higher profits may bring new drugs to market, but new drugs are likely to serve a much more narrow base of patients; e.g., targeted biologics and extremely expensive drugs like Sovaldi, which only wealthy patients can afford (see “Sovaldi – A Cure for the One to Ten Percenters”). But the many more millions of patients who take “older” drugs are left without the kind of “beyond-the-pill” support big pharma has been hyping up recently. Instead, they will have to depend on branded generics whose formulations may differ from the original forms and may be dangerous — an argument big pharma often makes against generic medications. And generic manufacturers are even less likely than brand companies to offer patient support and services. Posted May 5, 2014. More…
Slide 15: TOTAL CME REVENUE IS UP, BUT PHARMA SUPPORT IS DOWN (AGAIN) IN 2013
The Accreditation Council for Continuing Medical Education (ACCME) 2013 Annual Report is out. Here’s the data regarding total CME income and breakdown according to source of income. The pharmaceutical industry supports CME through grants to accredited providers such as medical societies, medical schools and for-profit Medical Education Communications Companies (MECC’s). It also helps finance CME through advertising and exhibiting at CME events. I include the latter in my analysis of total pharma support, which decreased slightly (0.6%) in 2013 compared to 2012 (dropping from $1,006,327,936 in 2012 to $999,791,328 in 2013). Advertising and exhibit income increased from #331.6 million in 2012 to $339.8 million in 2013. Pharma continues to provide more funding to for-profit MECCs than to non-profit physician societies and medical schools as shown in the following chart. This may be due to the fact that some schools and societies implemented policies whereby CME funding is grouped into on big fund and pharma companies have less say in which programs will receive the money donated. Posted July 15, 2014. More…
Slide 16: FDA’S TEN COMMANDMENTS?
Remember FDA’s Social Media Webinar? Listeners were surprised that the FDA presenters were simply reading the guidance documents verbatim. This reminded me of Moses reading the ten commandments to the Israelites, who afterward agreed to obey those laws. Whether or not the pharma industry will obey the current drafts of FDA’s “ten commandments” remains to be seen. Personally, I think the industry wants to send Moses, er, Abrams, back up the mountain. Posted July 21, 2014. Find FDA’s 10 commandments here…
Slide 17: HOMER SIMPSON TRIES TO UNDERSTAND FDA’S SOCIAL MEDIA GUIDELINES
FDA Launches Social Media Educational Initiative for Pharma Posted April 1, 2014. More… How I Learned to Stop Worrying and Love Social Media Posted April 7, 2014. More…
Slide 18: WILL TWITTER’S CARD TECHNOLOGY ALLOW PHARMA BRANDS TO POST FDA-COMPLIANT PROMOTIONAL TWEETS?
I reviewed three “workarounds” that might allow pharma marketers to post promotional tweets that satisfy FDA’s recently published guidelines: 1. Chain of Tweets 2. Tweets with Images 3. Twitter Cards. A little Twitter bird told me that Twitter Cards, which allow your tweets to go beyond basic text, are the best way for pharma marketers to work around FDA’s new guidelines. Brands can create a media-rich experience through images, product info, videos, etc. There are several types of Twitter cards. One type — Summary Cards — gives you 200 extra characters besides the tweet itself. For most drugs, this is probably enough room to include all the desired benefit information, plus the FDA-required important safety information (ISI) and link to full ISI. There’s only ONE problem with Twitter Cards and it’s a BIG one as far as promotional Rx drug tweets are concerned. That problem can be summed up in ONE word: Mobile
Posted June 10, 2014. More…
Slide 19: CORRECTING MISINFORMATION: ELIMINATE THE “INFLUENCE PRONG,” SAYS PHARMA
In comments to the FDA, PhRMA wrote: “PhRMA recommends that FDA will provide an adequate safe harbor for companies to correct misinformation about medicines online by expanding the scope of the Draft Guidance through elimination of the ‘influenced’ prong of FDA‘s definition of applicable communication.” PhRMA also said: “PhRMA member companies have the most complete and timely information about the medicines they research, develop and manufacture. Given the extraordinary growth of the Internet as a source of health information—and the enormous amount of inaccurate and non-regulated information about medical products online—FDA should avoid chilling manufacturers‘ responsible communication of medical information about their products and the correction of third-party misinformation concerning these products… FDA‘s draft guidance, perversely, is likely to result in more inaccurate information about medicines online that will go uncorrected.”
Posted September 29, 2014. More…
Slide 20: “WIKIPEDIA IS AN INSANE PLACE” – PHARMA SHOULD BE WARY ABOUT CORRECTING “MISINFORMATION”
“Wikipedia is an insane place, and it cannot be handled or used as if sane people administer it,” said Eric Barbour, a moderator of Wikipediocracy (wikipediocracy.com), a website dedicated to criticizing Wikipedia, in a comment submitted to the docket regarding FDA’s recent draft guidelines for correcting third-party “misinformation” on Internet/social media platforms such as Wikipedia. As evidence of that, I offer this image of Wikipedian Kevin Gorman, formerly known as “Wiki-Gnome.” Aside from belittling the sanity of Wikipedians, Barbour had this piece of advice for the pharmaceutical industry: “Any drug or medical company that openly follows the proposed FDA guideline will quickly find their accounts banned and their changes reverted. And the FDA will ultimately look foolish.” That’s because of Wikipedia’s “Bright Line” rule, which is taken as “gospel” by many Wikipedians. What is the “Bright Line” rule? This rule, invented by Wikipedia co-founder Jimmy Wales, “absolutely forbids ‘paid advocacy editing’,” says Barbour. “Despite its questionable provenance, certain Jimmy Wales fans take it as ‘gospel’, and act on it as if it were ‘official’.” By early 2012, the Bright Line Rule was fully formed and stated as such: “No editing of Wikipedia article space by paid advocates. There is absolutely no reason to ever do this – the talk pages, notice boards, wikiprojects, and OTRS provide ample opportunity for ethical engagement of Wikipedia. This is easy. The most common opposition to this comes from corrupt interests.” Not only does the pharma industry have to contend with FDA regulations when attempting to edit articles on Wikipedia, it must also contend with “insane” Wikipedians who, says Barbour, “will then go to the news media. And tell them the Federal government is advising what they call ‘COI abuse’ on Wikipedia. And the news media will probably listen to them. (Journalists love Wikipedia, because most of them are lazy and they can use it to “check facts” quickly, despite the known issues with its accuracy.)”
Posted September 28, 2014. More…
Slide 21: DIE-HARD PHARMA RX BRAND MARKETERS SHOULD GET OUT OF THE SOCIAL MEDIA GAME
The FDA has been the butt of jokes on pundit blogs and also behind “closed doors” at industry conferences. In particular, the agency was criticized for not being technically savvy enough to understand the nuances of social media and search engine advertising. Two savvy social media marketing consultants to the pharma industry contend that “die-hard” Rx brand pharma marketers need to forget about hawking brand name drugs via social media and focus on using social media to provide real benefits to patients. Posted October 2, 2014. More…
Slide 22: PATIENT ENGAGEMENT: WHO’S THE ENGAGER & WHO’S THE ENGAGEE?
“There is a subtle form of power-politics implied in just about every deployment of ‘patient engagement’ you’re likely to encounter that can serve to deprive the patient of authority rather than promote the autonomy of the patient,” said Andrew Spong. “More often than not, pharmaceutical companies’ ‘patient engagement’ is still done to, not done with patients. It’s small wonder that they fail so often as a consequence.” Andrew often takes an anti-pharma marketing stance, which is different than taking an anti-pharma stance. He also uses very big words that might cause most patients and pharma marketers who opt to read his posts to tune out and stop reading before they get to the meat of the matter. Basically, Andrew is saying that pharma must be the “engagee,” not the “engager.” If you are going to compare “patient engagement” to a proposal of marriage between a man and a woman — Andrew uses an engagement ring image within his post to suggest this — then I would think that the “engager” (the man in most cases) is subordinate to the “enagee” (the woman in most cases). That is, the engager is NOT “dominate,” but is asking “permission” to be engaged to the engagee with the aim of one day getting married. What pharma marketers want from patient engagement is permission from patients to “woo” them with a delightful period of sharing experiences, information, etc. and ultimately “marrying” them – i.e., getting the patient to take their product as directed by the physician (another stakeholder pharma marketers woo). Hopefully, after the “marriage,” the pharma company will continue to support the patient and not participate in extramarital affairs with others — although we all know that won’t happen!
Posted October 24, 2014. More…
Slide 23: MAD MEN VS. MED MEN: BRAND VS. PATIENT
In the September 2014 issue of MM&M, I came across what these days is referred to as “content marketing,” but what MM&M calls “ViewPoint.” I’m referring to the piece titled “Medical marketing needs mainstream Mad Men.” The premise of the piece is the pharmaceutical industry should hire agencies that “don’t know the difference between the FDA and FDR. But [who] know branding.” Patient activists (i.e., “ePatients”) might take exception to being referred to as a “target audience.” Empowered patients — aided and abetted by ACA — are not sitting around in a passive audience waiting to be targeted like some ISIS tank! They are using all the new information technologies — especially social media & mobile — to seek out and collect the information they need from TRUSTED sources. If pharma wants to be one of those sources, it needs to engage patients through these channels in an authentic manner. Agencies that know how to create brand awareness may get this, but if they (1) are ignorant about FDA regulations, and (2) don’t know dick about ePatients, they should not be hired by pharma, IMHO. Posted September 18, 2014. More…
Slide 24: BRAND VS CORPORATE: A DISTINCTION WITHOUT A DIFFERENCE IN SOCIAL MEDIA
“Do you want someone from corporate communications talking to your audience or should it be someone from the brand team who understands your audience and can converse with them in a meaningful way that adds value to your brand?” Meyer argues that “only someone from the brand team, who understands the who, what and why of the product, should be responsible for implementing social media not a mouth piece from corporate communications who every once in awhile Tweets a link.” It’s natural that Meyer, who has a brand marketing interest and background, would favor one of his own for the job of communicating with consumers about brands. But I’ve come to realize that the distinction between pharma brand managers and corporate communications is a distinction without much of a difference these days, especially with regard to social media. Many of the pharma people to whom I have given kudos for their social media acumen are employed in the corporate communications department.
Posted May 6, 2014. More…
Slide 25: “LEAKY” PHARMA MOBILE APPS AND THE BRAVE NEW WORLD OF BIG DATA
“A secret 2012 British intelligence document says that spies can scrub smartphone apps that contain details like a user’s ‘political alignment’ and sexual orientation.” Which leads me to wonder: What kinds of data can “leak” from Pharma mobile apps and who besides spies are likely to “scrub” pharma apps for these data? If spies can scrub smartphone apps, so can agents of the pharmaceutical industry who are actively “listening” in on social media and collecting reams of “big data.” That is, the technology is available to anyone with the budget and the will to “mine” smartphone data. It is a fact that pharma companies are creating apps that only are available to users with a prescription. Users must enter a code that proves they have a prescription (e.g., scan a bar code on the Rx package). Thus, pharma is NOT just collecting “de-identified” data — or, at least — they have the ability to collect a great deal of personal identifiable data and mash it with the data “leaking” from your smartphone or iPad. We are definitely entering the Brave New World of Pharma Big Data.
Posted January 28, 2014. More…
Slide 26: A CALL FOR PHARMA TO DEVELOP MOBILE HEALTH “GUIDING PRINCIPLES”
Shouldn’t the pharmaceutical industry (e.g., via PhRMA) differentiate itself from “wild west” developers by being pro- active in issuing mHealth Guiding Principles for Mobile Health Apps Developed by the Pharmaceutical Industry in much the same manner as it developed other self- regulatory guidelines such as the DTC Guiding Principles and the Code on Interactions With Healthcare Professionals? IMHO, the answer is YES! Based on my reviews of pharma mobile apps to date and my experience developing the eHealth Code of Ethics back in 2000, here are a few “Guiding Principles” that I think PhRMA members should follow:
Full Disclosure: Pharma mobile apps must include full disclosure regarding the company that has created the app or the sponsoring pharma company. This includes contact information. The app should also include appropriate disclaimers and Terms of Use that the user MUST agree to before the app will run.
Assure Accuracy: If a pharma mobile app relies on algorithms or formulas, it must be validated through rigorous testing and documentation to ensure it works properly (i.e,. calculations are correct). At least one pharma app for physicians — Pfizer’s Rheumatology Calculator — had to be recalled because of “a bug in the app … gives wrong results.”
Informed Consent/Good Privacy Practices: Personal health data is very sensitive, and the consequences of inappropriate disclosure can be grave. To protect users, if a pharma mobile app collects personal information, it should include a privacy policy that explains how such data is protected (Security), who owns the data, how users can access the data, where data is stored (on device or on remote web site) and instructions for opting out of data collection.
Regulatory Compliance: BRANDED Rx Drug apps MUST comply with applicable FDA regulations such as including ISI (important safety information). Such information should be presented in an easily accessible manner (e.g., on start-up screen). In addition, such apps must be available ONLY from the appropriate U.S. app site (e.g., Apple App Store).
HIPAA Compliance: Pharma apps intended to be used by healthcare professionals in the U.S. that collect patient health data must be HIPAA compliant. Apps for use by non-U.S. physicians must obey similar local laws relating to patient data.
Posted August 11, 2014. More…
Slide 27: IS IMS HEALTH’S MOBILE HEALTH APP “CERTIFICATION” PROGRAM DOOMED TO #FAIL?
“Welcome to the wild, wild, west of mobile health apps,” says the voice over of an IMS Health animated Youtube video that promotes a new mobile health app ranking service. IMS mentions “certifications” as part of its ranking process. This is a red flag for me because mobile health app certification programs are tricky and prone to failure. I agree with Satish Misra, MD, who wrote in January, 2014 (here): “[The certification] process is very resource intense. Happtique took a year and a half to certify 16 apps from 10 developers. Similarly, the NHS Health Apps Library, which evaluates apps to ensure they are clinically safe, launched in March 2013 with about 70 apps; nearly a year later, its at about 100 apps. But these certified apps are a drop in the bucket compared to the nearly 50,000 apps in the iOS App Store Health/Fitness and Medical sections alone. These kinds of intensive programs are simply not scalable. And in a pay-for-certification model, it’s not necessarily the best that become certified but rather those with sufficiently deep pockets.”
Posted December 12, 2014. More…
Slide 28: COST TO BRING A NEW DRUG TO MARKET IS $2.6 BILLION – 3X MORE THAN IN 2003!
According to a new study by the Tufts Center for the Study of Drug Development (CSDD), which receives funding from the pharmaceutical industry, the estimated cost to develop a new Rx drug for marketing in the U.S. is $2,558 million or $2.6 billion (see press release). That’s 3.25 times the $800 previously estimated and frequently cited by the pharmaceutical industry, pharma trade publications, and the general media. No doubt the new Tufts estimate will reign supreme in coming PR campaigns launched by the pharmaceutical industry and repeated ad naseum in the press. You’ll never guess who said the oft-cited 2003 Tufts estimate was “one of the great myths of the industry”. As reported by Pharmalot back in 2011, “Speaking at a healthcare conference in London … Andrew Witty explained that the $1 billion cost to develop a drug, which is often cited as the reason why some medicines have high price tags, is actually ‘one of the great myths of the industry.’” I doubt Witty would do a repeat of his opinion today regarding the new Tufts estimate.
Posted November 19, 2014. More…
Slide 29: ET TU, AMGEN? BLINCYTO’S BLING! BLING! PRICE TAG!
FDA approved Amgen’s Blincyto (blinatumomab) on December 3, 2014, as a second-line treatment for Philadelphia chromosome- negative precursor B-cell acute lymphoblastic leukemia, which affects around 6,000 patients in the US. The price tag of $178,000 per two- cycle course makes it one of the most costly drugs on the market. Despite the extraordinarily high price of Blincyto, payers are not likely to complain about the price as much as they complained about the price of Sovaldi. Read on to learn why I believe that is true. It’s simple. Whereas if all the 3.2 million patients in the U.S. were treated with Sovaldi to cure their Hep C infection, it would cost payers (insurance companies and Medicare/Medicaid) $378 billion at $84,000 per treatment. That, of course, is the wholesale price, not the discounted price. In comparison, to treat all the 6,000 leukemia patients with Blincyto at the wholesale price of $178,000 per patient, payers would have to shell out only $1.07 Billion, which is a mere pittance compared with the cost of Sovaldi treatment, wholesale or discounted.
Posted December 18, 2014. More…
WISHING YOU A HAPPY NEW YEAR!
