Digital Pharma news

A digital strategy is important for pharma to remain relevant. The need to connect with both patients and providers via digital formats and mobile devices has been dictated by the successful penetration of these types of marketing, educational and engagement tools in other aspects of our daily lives. Healthcare providers expect this evolution in the workplace as well.

Pharma’s traditional collaboration with KOLs (key opinion leaders) has been successful. The quickest way to facilitate adoption of a digital pharma model of interaction with providers is to use the KOL, which is a trusted and respected leader. There is a need for physicians who champion online interactions, realize the value of social media and are familiar with best practice digital and mobile health technologies to be involved in new industry initiatives. These initiatives include furnishing needed information to both providers and patients based on evidence and experience.

The digital pharma business model has heretofore been one of a direct to patient/consumer play. It is well appreciated by industry that it is hard these days (if not impossible in many circumstances) for pharma clinical liaisons (pharma reps most trusted by physicians) or other agents to engage physicians directly due to organizational policy restrictions, lack of available time in between those 15-minute patient visits or. worse, at the scrub sink or OR lounge. I would submit that these encounters need to be redesigned to be one of a ‘pull’ by the physician and not a ‘push’ by industry.

Digital both allows for and encourages new business models. What if a provider could, by way of a digital profile, determine what individualized type of encounter was preferred (in-person, secure text message, e-mail, safety alert, published clinical study results or a combination thereof)? This would reduce marketing budgets for the industry while creating focused high-value proposition interactions based on provider preference. Digital KOLs will be used to help design, implement and lead adoption of content and presentations (both static and live). This would amount to an Amazon-type one-stop ‘shopping’ of digital pharma education for providers.

These ideas are admittedly out of the box. But physicians are thirsty for meaningful information and data provided by pharma while requiring a convenient and trusted means of obtaining it. Digital KOLs will be helpful in creating awareness and presenting the value proposition of digital to their peers at professional society meetings. 

The FDA just presented its guidance document on pharma and social media. This should only serve to enhance the industry’s digital presence, not discourage it, as some have hinted.

Digital as a DTC strategy needs to close the patient engagement loop. I submit that the only way that can happen is with involvement of clinicians. There is a historically a mistrust of the industry by the public. Healthcare providers must be involved. They are the ones who have the relationship (strained as it may be in 2015) with the patient. In addition, no digital technology is a solution. It only becomes a solution in the context of human interactions and processes built around it. Therefore, the technology necessarily involves a provider. Otherwise, these tools never become solutions.

There is presently much industry buzz about quite a few prescription drugs going over the counter (OTC). This will necessitate significant efforts devoted to patient education focused on safety and self-management. There are great opportunities in this arena for digital technologies. The delivery (‘prescribing’) of digital tools to patients can take place with results monitored by both providers and industry. KOLs in this space are needed in this critical time of creating awareness not just of products, but of ways in which digital interactions between industry and providers will take place. Scientific liaisons and sales and technical support personnel will still be critical players in the process, but the means of interactions will evolve.

Clinical trials are moving into the mobile technology arena (see Parallel 6). Physician KOLs need to help pave the way for this new model as well.

Pharma is doing progressively more marketing research and marketing via digital technology. The use ofmobile devices is catching on in the industry (see Prolifiq) . Digital health advertising is big business (seeMcCann Health and InTouch Solutions). Other targets of interest are online physician (Doximity, Medscape) and patient (Treatment Diaries, WEGO Health) communities, general social media sites (Facebook, Twitter), and even electronic records companies (Practice Fusion). 

I believe that the use of physician KOLs can markedly increase the success of these strategies. Many physicians do not encourage patients from seeking medical information online. They would if they had better tools to use. Therein lays the value proposition as a win-win for pharma. KOLs will be provider champions of prescribing digital tools (including appropriate online sites, apps and other tools). Ultimately, the primary objectives of better provider-patient, industry-provider and industry-consumer relationships and improved patient outcomes we constantly hear about can be facilitated with the use of excellent digital tools.

"To tweet or not to tweet?" is often the question for pharmaceutical and medical device companies when it comes to advertising their products in the burgeoning social media environment.

The very specific rules the U.S. Food and Drug Administration has regarding marketing for drugs and devices makes it difficult to market products on platforms like Twitter, Facebook and blogs. Counsel representing these companies should be familiar with several interpretive guidance documents the FDA released last year that help explain the agency's thinking as it grapples with emerging and future social media platforms. The issuance of guidance on social media was required by the 2012 "Food and Drug Administration Safety and Innovation Act" (FDASIA), Section 1121. This required the FDA to, by August 2014, "issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by [the FDA]." The FDA complied and issued three sets of guidance related to social media in 2014, with two more still pending. Though these guidance documents are not regulations, they represent the FDA's current thinking and best practice is to follow and comply with them.

Spatially Challenged

One of the guidance documents addresses social media platforms with limited character spacing. The most common example of such a platform is Twitter, which is limited to 140 characters for a single tweet. The FDA guidance says that if an "accurate and balanced" presentation of both risks and benefits is not possible within the constraints of the specific platform, the company should reconsider using that platform. In other words, if a company cannot present both the benefits and the warnings and risks about a product in the space provided, it should not advertise it there.

The FDA rules on labeling govern how a company is allowed to market its product. The agency requires company advertising to meet several requirements: be truthful and non-misleading (FD&C Act 502(a), 201(n)); include certain information, such as the indicated use and risks (21 CFR 201.100(d), 201.105(d), 801.109(d)); be prominently placed on the label; and any advertisement that makes representations about drugs must include certain risk information (502(n), 21 CFR 202.1). Advertising on social media must be presented in a fair and balanced way.

Handling Misinformation

Most of us are familiar with Internet "trolls," those sometimes angry and often misinformed commenters to online articles or blog posts. What happens, however, when someone posts something online about your client's medical device or drug that is false? What if, say, this person posts that the drug is dangerous and caused Side Effect X and killed his elderly mother who had diabetes? What if the company knows the drug does not cause Side Effect X, or the drug was specifically labeled warning people with diabetes to not take it? It is these types of situations where a company may feel the need to say something—so others do not take the drug incorrectly and to protect its brand.

The FDA has issued guidance on this type of situation. The agency understands a company cannot be the sheriff of the Internet and correct, much less know about, each instance of someone saying something wrong about a company's product. Its guidance states a company is not responsible for user-generated content on social media platforms it does not operate or control. This means that if misinformation is generated in a tweet or Facebook post, the company has the option, but not the obligation, to post something and correct the misinformed poster. However, if the post is on the company's page, or in a forum the company hosts, then it is responsible for setting the record straight.

Whether the company is obligated to respond to misinformation or voluntarily chooses to respond, the FDA guidance sets forth the following specific things the company must do when responding.

1. Be relevant and responsive to the misinformation

2. Tailor the message to the misinformation

3. Be non-promotional in nature, tone and presentation

4. Be accurate

5. Be consistent with the FDA-required labeling

6. Be supported by sufficient evidence

7. Post in conjunction with the misinformation in the same area or forum

8. Disclose the person providing corrective information affiliated with the company that makes the product

Legal Implications of Social Media Rules

The FDA guidance leaves open the issue of liability faced by drug and device companies, even if complying with the rules. Specifically, "failure to warn" claims are possible for a company advertising on social media. Even if it complies with the FDA guidance, a company can still face liability over its labeling. If, for example, a company decides to tweet and tries to highlight the use of the drug with its risk, what if it only includes the most significant risk and not others? Will that expose the company to a failure to warn claim?

In addition to product liability, social media advertising raises the issue of competitors having the ability to bring suit under the Lanham Act (15 U.S.C. §1525). This law allows a private right of action so a party may sue a competitor for any false or misleading description or representation of fact which

" … in commercial advertising or promotion, misrepresents the nature, characteristics, qualities, or geographic origin of his or her or another person's goods, services or commercial activities." Pharmaceutical companies can face Lanham Act liability for many types of claims, including minimizing risks, broadening indications, overstating efficacy and making comparative claims in the absence of supporting head-to-head clinical data.

Read more: http://www.therecorder.com/id=1202721749266/Following-the-Social-Media-Rules-for-Pharma-and-Medical-Device-Companies#ixzz3VZElZUQy

Les impacts de la transformation numérique sur les laboratoires pharmaceutiques ont été discutés lors des sixièmes Assises des technologies numériques de santé, organisées le 10 mars à Neuilly-sur-Seine (Hauts-de-Seine) par l'agence Aromates.

Dive Brief:

RAPS' Alec Gaffney notes that the FDA has issued six warning letters to six different companies for posting unapproved claims on their Facebook pages in the last six months.The unapproved claims occurred not only as part of posting, but also in the "About" section.February 2015 was the highest level of Facebook regulatory oversight (in the form of warning letters) ever. 

Dive Insight:

Last summer, the FDA released draft guidance on social media policy, opening the door for pharma companies to use social media channels more effectively, while also signaling that greater regulatory oversight would be forthcoming. Not only has the FDA been policing Facebook, but also looking at tweets from pharma companies as well. As Thomas Abrams, director of the FDA Office of Prescription Drug Promotion, has noted, the FDA's social media policy is evolving. 

According to a blog post from Abrams last summer, "FDA sees social media as an important resource for industry and is committed to developing additional guidance for drug and device manufacturers that outline the agency’s current thinking," he wrote. "We do all of this work with the best interest of patients in mind."

What we understand today as “social media” has been with us for about a decade now. And the use of Facebook, Twitter, YouTube, and LinkedIn, to name but a few, has been embraced by enterprises for various business purposes from the very beginning. Besides research and development, human resources, and sales, one of its major areas of application is marketing. Big companies from many sectors benefit from building strong customer relations and, thus, brand recognition by means of social media.

Present Use of Social Media and its Risks

While many industries like consumer goods or banking have been making extensive use of social media for some years now, the pharmaceuticals sector lags behind for the most part. Thus, forgoing a powerful tool to boost their businesses. With the rapid spread of mobile internet devices such as smartphones and tablet computers the importance of social media applications as a major source of information for consumers is bound to grow.

By now, hundreds of millions of people and businesses around the world have connected via social media applications and built huge networks at low cost. They generate, share, and consume content that is spread in the twinkling of an eye. Such social dynamics can gain huge momentum and are hard to control. Once a piece of content goes viral, one better hopes it rebounds to one’s advantage. Particularly, since the internet doesn’t forget.

This inherent reputational risk is not the only risk in social media engagement enterprises need to take into account when developing a successful social media strategy. Those risks are manifold and can be divided into risks of a corporate social media presence itself and risks induced by the use of social media by employees.

Among the former, there is the risk of data leakage and identity theft by means of viruses and malware introduced into the corporate network. Likewise, customers or the enterprise can get publicly exposed through a hijacked or fraudulent organizational presence. This may result in adverse legal actions, customer backlashes, phishing attacks on the concerned parties and reputational damage. Poorly defined content rights to posted information pose the risks of the company’s loss of control and legal rights of the posted information. Moreover, a move to a digital business model can increase customer service expectations possibly leading to customer dissatisfaction with the responsiveness in the introduced social media channels. Fines and regulatory sanctions as well as adverse legal actions are risks posed by mismanagement of digital communications, which can be effected by retention regulations or electronic discovery.

In addition to those risks of a corporate social media presence, there are a number of risks posed by the use of social media by employees, which need to be taken into account when building up an integrated social media risk management. Among those are the risks of privacy violations, damage to corporate reputation, and the loss of competitive advantage, in case personal accounts are used to post work-related information. Employees who publish content, which relates them to the company, can pose one more potential source of damage to the brand or corporate reputation. Likewise, the risks of network utilization issues, productivity losses and increased exposure to viruses and malware can arise through the excessive use of social media applications in the workplace. And furthermore, the access of employees to social media with company-supplied mobile devices can pose the risk of infections, data theft and leakage, and the circumvention of company controls.

Those are a lot of risks, one may argue. But there is one more significant risk that every enterprise faces, which tinkers with the idea of missing out on taking advantage of this powerful instrument, and that is the risk of opportunity costs. The question is not whether or not to engage in social media. The question is which tools from this versatile set of social media applications best support the business purposes, and how it can be managed in a manner that guarantees that potential risks are being outweighed by material benefits.

Social Media in the Pharmaceutical Industry

For several years enterprises from various sectors have gained experience in this area. In collaboration with research institutions, associations, and consulting agencies, they have developed specific safeguards. Such measures include corporate strategies, frameworks, policies, as well as awareness trainings communications for employees, vendors, and customers, which address and mitigate potential risks. And, thus, empower enterprises to profit from engaging in social media.

The relative reluctance of the pharmaceuticals industry may have prevented it from some teething troubles or other in the past. But it definitely prevents enterprises in the sector from taking huge opportunities.

Of course, the pharmaceuticals industry is different from other sectors. Safety and quality management, risk management, marketing, and other areas of operations play a more crucial role than in other sectors. And the enterprises are object to strict laws and regulations and close monitoring. Some of this relative reluctance in the application of social media is certainly due to the legal and regulatory environment. In this field of regulatory compliance in the US, for instance, further clarification on the use of social media in the sector may facilitate a catching up. The US Food and Drug Administration (FDA) made a move in addressing this by its January 2014 publication of a Draft “Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” (for comment purposes only).

This draft FDA guidance is “intended to describe FDA’s current thinking about how manufacturers, packers, and distributors (firms), that may either be the applicant or acting on behalf of the applicant, of prescription human and animal drug and biological products (drugs) can fulfill regulatory requirements for postmarketing submissions of interactive promotional media for their FDA-approved products.”

While such initiatives towards further clarification in the area of regulatory compliance are welcome and may be helpful, not all enterprises have waited to engage social media applications for their business purposes. A couple of enterprises are pioneering. Among them is big fish – realizing the huge potential of this dynamic set of tools.

Conclusion

To allow for such engagement to fully and sustainably strengthen the company’s competitive position and satisfy stakeholder interests it is crucial to adequately address and prioritize inherent risks, develop an integrated social media strategy, and implement effective and efficient safeguards.

Social media plays an increasingly important role in the marketing and communications plans for pharmaceutical firms.

Trends point to patients and healthcare professionals using social media to research, communicate and influence buying decisions. There are already examples of pharmaceutical firms who are already successfully using social media.

However, many firms have been waiting on the sidelines waiting for guidance from the regulator, the Food and Drug Administration (FDA).

In response to the industry’s request for guidance, the FDA has been busy coming up with some. Over the last 6 months, it has released 3 draft guidance documents for social media.

This is a fast-changing situation with the FDA widely expected to release final guidance on social media very soon.

Acknowledging the keen interest in this area, on July 10th the FDA delivered “The Social Media Draft Guidance Webinar”. The slides for the webinar are available on the FDA’s website.

There are a few recurring points running through all the pieces of FDA guidance, namely:

Communications must be balanced, accurate and non-misleadingThe closer to the creation or adoption of the content, the more likely a firm is responsible for that content.There is no “one-click rule”.  Risk information should be given equal prominence to benefit information, regardless of space constraints.Direct hyperlinks to risk information and/or FDA approved labeling may to be provided from the message, update, ad or tweet as a means to learn more about the product.Organizations must capture and preserve full and proper recordsSocial media communications need to be properly retained, preferably in context, in a format that preserves interactive linksFull metadata such as author, date, etc., also needs to be archived

What is clear is that the FDA means business when it comes to the conduct of pharmaceutical firms on social media.  Firms can expect to be held accountable if these standards are not met. Even before the draft guidelines were released, the FDA already demonstrated that it is closely monitoring pharmaceutical firm’s use of social media.  This is illustrated by the warning letters issued to firms it believed had used social media inappropriately, for example:

Failure to reference risk about a drug on a Facebook pageWarned for “Liking” a consumer’s comment on its Facebook drug pageFirm warned that its Facebook Share widget does not provide adequate risk information

With the key guidance on the use of social media from the FDA widely expected to be finalized in soon, there is a real likelihood that the FDA will increasingly step up its monitoring program and impose sanctions on non-compliant firms.

However, in response to this recent guidance, we may begin to see more firms explore how they can use social media to build brand awareness, facilitate communities, even drive revenues. These firms need to take thoughtful steps in order to deploy social media compliantly, including, making sure communications are balanced, accurate and non-misleading as well as taking steps to monitor and preserve real-time communications.

Check out these compliant social media guidelines from the FDA:

Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (December 2011)Fulfilling Regulatory Requirements for Postmarking Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (Draft Jan 2014, Final expected July 2014)FDA Draft Guidance for Industry Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (June 2014)FDA Draft Guidance for Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (June 2014)

Hackathon e-santé
48h pour innover au service des patients


Porteurs d'idée, développeurs, designers, makers, entrepreneurs : vous êtes conviés au hackathon e-santé, organisé pour Novartis, qui se déroulera les 27-28-29 mars à l'école d'ingénieur Polytech Paris-UPMC (dans l'Université Pierre et Marie Curie).
L'objectif est de mettre en place des prototypes digitaux pour le patient diabétique de type II avec ou sans complications oculaires. 
 
Pendant le hackathon, de nombreux experts seront présents pour vous conseiller et vous accompagner dans la concrétisation de vos idées. Au programme également, des mini-conférences sur le sommeil, la nutrition et la santé connectée.
Pour vous préparer au hackathon, une soirée idéation est prévue le
vendredi 20 mars
à La Cartonnerie 
12 rue Deguerry Paris 11
Ce sera l'occasion d'échanger avec des médecins, des représentants d'associations de patients et de confronter vos idées à leur réalité.

About 25% of patients do not feel connected to the companies that make the medications they depend on for one key reason: They do not see themselves in the marketing with which brands expect to reach them

Hack Epilepsy will bring together developers, designers and digital experts, along with healthcare providers and patients to imagine new ways of applying digital technologies that can make a real difference for the epilepsy community.

An IMS Institute for Healthcare Informatics report last year asked the provocative question, ‘Is healthcare ready for empowered and digitally demanding patients?’

Within 24 hours of Apple launching its platform for health research this month, tens of thousands of iPhone users had signed up to take part in five inaugural studies involving some of the US’s most respected medical institutions. A Harvard-affiliate