Tag: FDA

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Digital Health MedTech

Bigfoot Medical: Pioneering Diabetes Management Solutions & Their Future Prospects

BigFoot Unity (www.bigfootbiomedical.com)
BigFoot Unity (www.bigfootbiomedical.com)

Beginning of March 2023 Bigfoot Medical announced it has FDA clearance for the Android version of the Bigfoot Unity® Mobile App, a necessary component of the Bigfoot Unity® Diabetes Management System. Given that 41 percent of U.S. smartphone users choose Android devices, this clearance enables expanded access to a large group of people with Type 2 diabetes. Bigfoot Unity has been compatible with iOS devices since May 2021. 

The medical device landscape is continuously evolving, with companies like Bigfoot Medical revolutionizing diabetes care through cutting-edge technology and artificial intelligence. In this post, we explore the history, achievements, and future prospects of Bigfoot Medical, an industry leader in diabetes management solutions.

Early Days: Laying the Groundwork for Success

Founded in 2014 by Jeffrey Brewer and Bryan Mazlish, Bigfoot Medical was driven by a personal connection to the challenges of diabetes management. Their goal is to create an integrated system that simplifies and enhances diabetes care using advanced technology and AI.

From day one, Bigfoot Medical focused on patient-centric solutions, which has been instrumental in their success and significant progress in the diabetes care sector.

Achievements: Transforming Diabetes Care with Bigfoot Unity™

Bigfoot Medical’s flagship product, the Bigfoot Unity™ Diabetes Management System, is an innovative solution that combines a continuous glucose monitor (CGM), insulin pen caps, and a mobile app to provide a seamless, data-driven experience for those living with insulin-requiring diabetes.

Key achievements of Bigfoot Medical include:

  1. FDA Approval: In 2021, Bigfoot Medical received FDA clearance for the Bigfoot Unity™ System, a major milestone in their journey.
  2. Enhanced Patient Outcomes: The Bigfoot Unity™ System has demonstrated improved glycemic control, reduced hypoglycemic events, and enhanced quality of life for users.
  3. Strategic Partnerships: Bigfoot Medical has formed alliances with industry leaders like Abbott, ensuring technology integration and broader patient reach.
  4. Awards and Recognitions: The company has garnered numerous accolades, such as being named one of Fast Company’s Most Innovative Companies in 2021.

Competition and Market Size: Navigating a Dynamic Industry

The global diabetes care devices market is substantial, with a value of $20.0 billion in 2020, and is projected to reach $38.3 billion by 2030, growing at a CAGR of 6.6% from 2021 to 2030. This significant market size is attributed to the increasing prevalence of diabetes, the need for better management solutions, and rising awareness about diabetes care. In such a dynamic industry, Bigfoot Medical faces competition from various established and emerging players, such as Medtronic, Dexcom, Insulet, and Tandem Diabetes Care, which offer insulin pumps, CGMs, and other diabetes management solutions.

Despite the competitive landscape, Bigfoot Medical differentiates itself through its unique, integrated approach to diabetes care, focusing on providing a seamless, data-driven experience for users. Additionally, the company’s commitment to leveraging AI and machine learning for personalized treatment plans offers a competitive edge that could attract patients seeking tailored solutions for their diabetes management. By continuing to innovate and staying ahead of the curve, Bigfoot Medical aims to secure a significant share of this growing market, providing millions of diabetes patients worldwide with advanced, user-friendly, and effective diabetes care solutions.

Future Prospects: Embracing Continued Innovation

With a strong foundation and proven success, Bigfoot Medical is poised to keep transforming diabetes care. Their future prospects encompass:

  1. Diversified Product Line: Bigfoot Medical plans to expand its product offerings, addressing a broader range of patient needs.
  2. Global Market Reach: The company aims to make its groundbreaking solutions accessible to patients worldwide.
  3. Personalized Medicine: Bigfoot Medical is committed to harnessing AI and machine learning to develop tailored treatment plans for diabetes patients, further enhancing outcomes and quality of life.
  4. Research and Collaborations: The company will continue to work with research institutions, healthcare providers, and industry partners to drive innovation and uncover new ways to improve diabetes care.

Bigfoot Medical’s dedication to enhancing the lives of diabetes patients is evident in their history of innovation and promising future. As they continue to evolve and expand, Bigfoot Medical will undoubtedly remain a leader in the medical device industry, shaping the future of diabetes management for millions around the globe. With a unique approach to diabetes care and a commitment to delivering personalized solutions, Bigfoot Medical is well-positioned to make a lasting impact on patients’ lives and redefine the standards of diabetes care in the years to come.

Categories
MedTech Pharma Marketing

Digital marketing in MedTech and Pharma

Is digital marketing in MedTech and Pharma similar? Understanding the specifics of MedTech and Digital Health digital marketing is essential to success.

MedTech digital marketing

The four main components of digital marketing in the medical devices industry are digital strategy consulting, digital content creation and management, digital campaign execution, and analytics.

  • Digital Marketing Consulting involves helping MedTech companies assess their priorities and strengths, optimize their operations and innovation, and develop effective go-to-market strategies.
  • Digital content creation and management involves producing engaging and informative content for various channels such as email, social media, blogs, webinars, etc. that showcase medical devices’ value proposition and benefits.
  • Digital campaign execution involves designing and implementing marketing campaigns that target specific segments of healthcare professionals (HCPs) or patients using digital tools such as CRM systems, marketing automation platforms, SEO/SEM techniques, etc.
  • Digital analytics involves measuring and evaluating the performance and impact of digital marketing activities using data-driven methods such as web analytics, customer feedback surveys, ROI calculations, etc.

Digital consulting is a vital component of digital marketing for medical devices and should be a first step. It helps MedTech companies to:

  • Define their vision and goals for digital transformation
  • Assess their current capabilities and gaps
  • Develop a roadmap and action plan for implementing digital solutions
  • Align their organization and culture with digital best practices

Digital marketing of medical devices in comparison to pharmaceuticals

Digital marketing for Medical Devices in many aspects is similar to the pharmaceutical industry, however, there are significant differences.

What are the similarities between MedTech and Pharma digital marketing?

  • Both Pharma and MedTech use digital tools to inform and influence HCPs and patients about their products and services.
  • Both industries rely on data and analytics to measure and optimize their digital marketing activities.
  • Medical Devices face regulatory challenges and compliance issues when engaging with their audiences online that are similar to those in pharmaceuticals.

The key differences between Pharma and Medical Devices digital marketing are that:

  • Medtech companies tend to have more complex products that require more technical expertise and demonstration than pharma companies.
  • Medtech companies have a wider range of stakeholders to consider, such as hospital administrators, payers, distributors, etc. than pharma companies.
  • Medtech companies have more opportunities to leverage digital health and digital therapeutics (DTx), such as connected devices, apps, sensors, etc. that can enhance their value proposition and customer experience than pharma companies

Outsourcing digital marketing services in the MedTech industry

Medical device companies may look for different services or support when deciding to outsource digital marketing, depending on their needs and goals.

Some possible services or support are:

  • Quality assurance: ensuring that the digital marketing activities comply with regulatory standards and best practices.
  • Content production and management: producing digital content or products such as websites, apps, videos, etc. that showcase the features and benefits of medical devices.
  • E-commerce: setting up and managing online platforms that allow customers to order and purchase medical devices easily and securely.
  • Virtual sales channels: creating and maintaining digital tools that enable sales reps to communicate and demonstrate medical devices to HCPs remotely.
  • Data analytics: collecting and analyzing data from digital marketing activities to measure performance, optimize campaigns, and generate insights

Generally, smaller MedTech companies may need more comprehensive and flexible services and support than larger companies, as they may have less experience and capacity for digital marketing. Larger companies may need more specialized and customized support than smaller companies, as they may have more complex and diverse needs for digital marketing.

Some possible factors that influence digital marketing service requirements are:

  • The type and complexity of medical devices that the company produces or sells.
  • The level of expertise and resources that the company has internally for digital marketing.
  • The scope and scale of digital marketing activities that the company wants to undertake.
  • The budget and timeline that the company has for digital marketing outsourcing.

The skillset of MedTech digital marketer

Some of the skills of a digital marketing expert from pharma are transferrable to provide medical device digital marketing services too. For example, both sectors require:

  • Knowledge of regulatory requirements and compliance standards.
  • Ability to create engaging and informative content for different audiences and channels.
  • Proficiency in using various digital tools and platforms to design, execute, and measure campaigns.

However, there are also some differences between pharma and medical device digital marketing that may require additional skills or adaptation. The key differences are that:

  • Medical device customers have different expectations and needs than pharma customers. They may be more interested in product features, benefits, demonstrations, or testimonials than in disease mechanisms or outcomes.
  • Medical devices are more diverse and complex than drugs. They can range from tissue grafts to prostheses to digital devices and apps. They may also have different modes of action, indications, or usage scenarios.
  • Medical devices may have shorter product life cycles than drugs. They may face more competition or innovation from other players in the market. They may also require more frequent updates or upgrades.

Therefore, a digital marketing expert to excel in the Medical Devices industry may need to understand the nuances of device marketing and how to tailor their strategies accordingly. MedTech digital marketing specialist has to learn about the specific types of devices they are marketing and how they work, who they serve, and what value they offer. Finally, digital marketer in MedTech industry has to be flexible and agile in responding to changing market conditions and customer feedback.

Regulatory requirements for medical device digital marketing

Regulatory requirements for medical device digital marketing vary depending on the type of device, the market, and the channel. Some of the general requirements are:

  • Medical device digital marketing must be truthful, accurate, and not misleading.
  • Medical device digital marketing must comply with the relevant laws and regulations of each country or region where they operate.
  • Medical device digital marketing must respect the data privacy and security of customers and users.

Some examples of specific regulatory requirements for medical device digital marketing are:

  • The Medical Devices Regulation (MDR) applies since 26 May 2021 in the European Union. It sets out new rules for placing medical devices on the market, including requirements for clinical evidence, post-market surveillance, labeling, and advertising.
  • The In Vitro Diagnostic Devices Regulation (IVDR) applies since 26 May 2022 in the European Union. It replaces Directive 98/79/EC and introduces new classification rules, conformity assessment procedures, performance evaluation requirements, etc. for in vitro diagnostic devices.
  • The Food and Drug Administration (FDA) provides guidance documents with digital health content for medical device manufacturers in the United States. They cover topics such as software as a medical device, mobile medical applications, clinical decision support software, cybersecurity, artificial intelligence/machine learning, etc.
Categories
Digital Health

Meet Troy Tazbaz, a new director of the FDA Digital Health CoE

Troy Tazbaz Linkedin profile. Source: Linkedin

Troy Tazbaz has been appointed as a Director of the Digital Health Center of Excellence at the FDA. Mr. Tazbaz combines a long career in IT with long and personal involvement in healthcare.

Most media outlets focus on Mr. Tazbaz’s recent career as a cloud infrastructure at Oracle and earlier at social software Ning. For us, however, the most important is his voluntary and very personal engagement in patient care, especially in Hematology and Oncology.

Since 2010 Troy Tazbaz has been involved in campaigning for The Leukemia & Lymphoma Society, a Patient Advocacy Group, and the largest nonprofit dedicated to fighting blood cancer. Since 1949, the LLS has donated over $1.6 billion to support research on leukemia, lymphoma, Hodgkin’s disease, and myeloma.

Mr. Tazbaz has very personal experience in oncology treatment and care. He was supporting his wife, Brynn Fowler in her patient journey as documented on her blog, The Millenial with Cancer. Mrs. Fowler was diagnosed with Stage IV Colon Cancer at the age 37. Now, after Mrs. Fowler has passed away, the website is still maintained by Mr. Tazbaz as The Continuum Diaries.

FDA DHCoE Infographics. Source: FDA.gov

FDA Digital Health Center of Excellence is part of the Center for Devices and Radiological Health (CDRH). It is responsible for envisioning a future of safe and effective healthcare delivery with a focus on advancing public health goals with the use of technology. It performs technology evaluation, policy development, and strategic partnerships, as well as maintains a network of Digital Health experts.



Categories
Digital Health

Artificial Intelligence and Machine Learning (AI/ML) in Medical Devices

Do you know that FDA already approved 521 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices?  

PAPNET. The failure of the pioneering AI/ML-enabled test.

Five hundred apps may not surprise you in January 2023, given the noise around Open AI and its GPTChat. However, the first such device, PAPNET Testing System, was approved over 28 years ago. In 1995, the year of Johnny Mnemonic and Ghost in the Shell movies!

Fig.1 Neural net-based (PAPNET, Neuromedical Systems, Suffern, NY) display of squamous cells (Papanicolaou stain) from a balloon smear showing effects of radiotherapy. Marked cell enlargement and vacuolization of cytoplasm are easily recognized.
Source: Koss, Leopold & Morgenstern, Nora & Tahir-Kheli, Naveed & Suhrland, Mark & Schreiber, Katie & Greenebaum, Ellen. (1998). Evaluation of Esophageal Cytology Using a Neural Net–Based Interactive Scanning System (the PAPNET System): Its Possible Role in Screening for Esophageal and Gastric Carcinoma. American journal of clinical pathology. 109. 549-57. 10.1093/ajcp/109.5.549.

PAPNET was using a neural network to analyze and interpret cytology from Pap smears. While this early system generated a lot of interest and Google Scholar lists 217 peer-reviewed articles on PAPNET results, the business side of it was not that great. The cost-effectiveness of the system in comparison to manual screening by cytotechnician was not there. Neuromedical Systems Inc, the company behind PAPNET went bust in 1999, and now its intellectual property is a part of Becton, Dickinson and Company portfolio.

List of FDA-approved Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices

If you look at the list of approved AI/ML-enabled medical devices, you will notice that the vast majority (392 medical devices, 75% of the whole) are for Radiology. Cardiovascular (57,11%), Hematology (15, 3%), and Neurology (14, 3%) are the remaining three significant categories.

Fig. 2: Split of approved AI/ML-enabled medical devices by Specialty Panel.
Source: FDA.gov, graphics by disrupting.healthcare

There are only 15 companies that have more than five AI/ML-enabled medical devices approved. Five of those companies are actually subsidiaries of GE, which in total owns 42 AI/ML-enabled medical devices. Then there is Siemens with 27 devices, Canon with 15, Aidoc Medical with 13, and Zebra Medical Vision with 9 devices. Philips, which also submitted its devices via different subsidiaries has in total 10 approved AI-enabled devices

Table 1. Companies with over 5 approved AI/ML-enabled medical devices
CompanyAI/ML-enabled medical devices
GE Medical Systems42
Siemens Healthineers27
Canon17
Aidoc Medical13
Philips Healthcare10
Zebra Medical Vision9
Quantib BV6
Arterys Inc.5
Clarius Mobile Health Corp.5
HeartFlow, Inc.5
RaySearch Laboratories AB5
Viz.ai, Inc.5
Source: FDA.gov, disrupting.healthcare

The future of AI-enabled and data-driven MedTech

The market for Artificial Intelligence / Machine Learning – enabled Medical Devices seems to be poised for growth. At a recent HLTH 2022 conference in Las Vegas, Michelle Wu, CEO of NyquistData, a company offering an AI-supported intelligence platform dedicated to MedTech companies discusses the advantages of using AI to unlock the potential of unstructured data from medical devices.

Leveraging Artificial Intelligence, Data to Improve Medical Devices
Source: Xtelligent Healthcare Media

Cleerly. An example of an AI-enabled medical device for a heart-attack-free future.

A good example of upcoming Artificial Intelligence / Machine Learning – enabled Medical Device may be Cleerly. The startup has raised $279 million from investors including Fidelity, T. Rowe Price, Novartis and Peter Thiel.

Founded by cardiologist James Min, former professor at Weill Cornell Medical College and director of the Dalio Institute of Cardiovascular Imaging at New York-Presbyterian, Cleerly uses AI to improve diagnostics cutting down on the time it takes to flag patients at risk.

Its proprietary AI algorithms analyze CCTA images to generate a 3D model of patients’ coronary arteries, identify their lumen (the cavity or channel within a tube or tubular organ such as a blood vessel) and vessel walls, locate and quantify stenoses, as well as identify, quantify and categorize plaque.

Source: Cleerly
Categories
Pharma Marketing

Is Twitter for Pharma Banned by the FDA?

The recent FDA’s Office of Prescription Drug Promotion (OPDP) draft guidance on Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices effectively bans Twitter for pharma advertising. It does the same with Google Sitelink ads.
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K-messsage’s take on the FDA’s social media guidance from June 17th:
[checklist]
1. DO NOT use Twitter for promotional messaging about prescription drugs and medical devices
2. DO NOT use Google Sitelinks for promotional messaging about prescription drugs and medical devices
3. DO PERFORM social media monitoring to identify and engage in conversation about your prescription drugs and medical devices with misleading information on prescription drugs or medical devices
4. KEEP your Twitter presence for corporate and employer branding and for correcting misinformation
[/checklist]
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K-message believes that this is not what the Agency wanted to achieve, but we strongly suggest to all risk-averse pharmaceutical companies to cease any promotional activities for prescribed drugs in both space limited channels.
While the guidance includes imaginary examples of legally approved tweets and ads, in the real world it will not be possible to recreate such compliance for any of the existing products. Or at least it would cause a serious “Headhurtz” for the pharma marketing teams.

Headhurtz example Draft Guidance for Industry- Internet-Social Media Platforms with Character Space Limitations
Headhurtz example Draft Guidance for Industry- Internet-Social Media Platforms with Character Space Limitations

 
FDA requires to include in the tweet both benefit and risk information, and to link from the tweet to full page with Important Safety Information, preferably using word “risk” in an URL. As tweet has only 140 characters, it would be almost impossible to crunch in risks related to the product, even if you decide to skip benefit part.
 
Nofocus tweet example Draft Guidance for Industry- Internet-Social Media Platforms with Character Space Limitations
Nofocus tweet example Draft Guidance for Industry- Internet-Social Media Platforms with Character Space Limitations

 
The same happens with FDA’s proposal on how to use Google Sitelink ad format. The Agency may not know that, but what is displayed in the ad depends on the Google’s own algorithm, that tries to increase CTR. The chance of having very similar, risk focused links displayed under the ad, even if we manage to be always on the top of SERP, is limited. From our perspective the risk of not being able to follow the guidance is too high. Our recommendation is to use other Search Engine Marketing tactics instead.
 
Above does not mean, that pharma marketing on twitter is no longer possible. From the global perspective, the new regulation (if adopted without changes), affects only the United States market. Globally, there is no promotional activity directed to consumers, so there is no need to send promotional tweets. Instead, pharmaceutical firms focus on their corporate brands and disease awareness education – without promoting or even mentioning prescription drugs in the communication. So, yes, advertising prescription drugs  and medical devices on twitter seems to be forbidden. But you should keep your presence there for
 
On the brighter side of the regulatory proposals, another draft guidance has been published. The Internet/Social Media Platforms: Correcting Independent Third-party Misinformation About Prescription Drugs and Medical Devices document paves the way to correct misleading or false information on pharmaceutical products and medical devices that is spreading over the web.
It will hopefully encourage pharma marketing departments worldwide to take a closer look into the social media and web monitoring in a search for online conversations around pharmaceutical brands and products. As the recent Accenture’s study shows, patients are expecting more of such engagement from the industry.
 

Categories
Pharma Marketing

FDA Guidance on Social Media in Pharma: We need more of this

Federal Drug Administration (FDA) has announced its draft guidance on Social Media in Pharma. What question does it answer and what remains still unregulated? What are the consequences of this guidance and expected next steps? 

English: Logo of the .
English: Logo of the FDA. (Photo credit: Wikipedia)

When finalized this guidance will regulate all Internet activities of pharmaceutical companies operating in the United States. The guidance was long expected by the pharma industry. According to earlier announcements from FDA more comprehensive guidance shall be released by July 2014.

Main proposals of the new FDA guidance for Social Media in Pharma

Pharma companies responsibility for the content published in social media:

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  1. A firm is responsible for product promotional communications on sites that are owned, controlled,  created, influenced, or operated by, or on behalf of, the firm.

  2. Under certain circumstances, a firm is responsible for promotion on third-party sites.

  3. A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product.

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Pharma companies obligation to submit interactive promotional materials to FDA:

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  1. At the time of initial display, a firm should submit in its entirety all sites for which it is responsible on Form FDA 2253 or Form FDA 2301. For example, the firm should submit the comprehensive static product website with the addition of the interactive or real-time components.

  1. For third-party sites on which a firm’s participation is limited to interactive or real-time communications, a firm should submit the home page of the third-party site, along with the interactive page within the third-party site and the firm’s first communication, on Form FDA 2253 or Form FDA 2301 at the time of initial display.

  1. Once every month, a firm should submit an updated listing of all non-restricted sites for which it is responsible or in which it remains an active participant and that include interactive or real-time communications. Firms need not submit screenshots or other visual representations of the actual interactive or real-time communications with the monthly updates.

  1. However, if a site has restricted access and, as such, FDA may not have access to the site, a firm  should submit all content related to the discussion (e.g., all UGC about the topic), which may or may not include independent UGC, to adequately provide context to facilitate the review. Screenshots or other visual representations of the actual site, including the interactive or real-time communications, should be submitted monthly on Form FDA 2253 or Form FDA 2301.

  2. When submitting the site, FDA recommends that a firm take formatting factors (e.g., appearance, layout, visual impression) into consideration to enable the Agency to view the communications as a whole.

[/box]

What the industry expected to be addressed? Is it addressed with the new FDA draft guidance?

In general FDA has addressed two of five main points raised by pharmaceutical companies. Those are responsibility for the content published in the Internet and in Social Media, and 2253 Submissions requirements.

Internet control and 3rd party controlled social media responsibility

FDA has defined scope of responsibility for pharma companies. In general pharmaceutical companies are responsible for any content that they have control or influence on. Let us repeat the phrasing of the document:

[box type=”info” align=”aligncenter” ]
Pharma companies responsibility for the content published in social media:
1. A firm is responsible for product promotional communications on sites that are owned, controlled,  created, influenced, or operated by, or on behalf of, the firm.

2. Under certain circumstances, a firm is responsible for promotion on third-party sites.

3. A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product.

[/box]

2253 Submissions

FDA requires all prescription drug labeling and advertising to be submitted at the time of initial dissemination through an FDA Form 2253. [21 C.F.R. § 314.81 (b)(3)(i)].

Until this draft guidance however, it was not clear what are companies obligations for submitting social media content. For the sake of security social media activities were limited to the safe topics and avoided mentions of any product. It may change now, as the guidance states clearly what and when should be submitted to the Agency. While industry may not be happy with the request to feed FDA with all User Generated Content that may be considered promotional, at least now everyone knows what to report.

What is left unanswered by the new FDA Guidance on Social Media in Pharma?

Space limitations and one click statement rule

FDA requires that every promotional material includes comprehensive information about the product, including safety information. Due to space limitation and “hypertexted” nature of the digital media, pharmaceutical industry developed theory of  so called “one-click rule”. The assumption was that to meet FDA’s expectation it is enough to provide on the interactive promotional material a link to the website that would include required information.

This has been questioned by the Agency which issued enforcement letters to 14 companies who used Google display advertisement where risk information was available under “one-click”. In the following statements FDA declined existence of any one-click rule, but did not offer any alternative. New guidance does not refer to this aspect of the regulation. Therefore any promotional activities mentioning pharmaceutical products on platforms with limited message space ie. on Twitter are still not possible.

Off-label discussions

Another issue that is not addressed by the guidance is off-label use discussion. Promotional messages may not recommend or suggest the drug for off-label uses. Technically it means that anyone in relation to the company is not allowed to even mention any use of the drug that is not approved by FDA. Any response to such mention in social media by pharmaceutical company may be considered as suggesting and therefore promoting off-label use. As we are discussing here open communication channels available to general public, even scientifically valid and supported by pending trials question about any product use that is not approved has to remain unanswered. This limitation remains in force with the new draft guidelines.

Drug Safety and Adverse Events Reporting

Drug Safety or Pharmacovigilance is probably the most important reason why embracing social media in pharma marketing is so slow. It is extremely important (human life is at stake), and there are too many questions unanswered around it.

The first obligation is to provide possibility to report any adverse event to the public. For websites addressed to US-based audience it is usually solved by adding MedWatch icon/link, or easily available report form. In social media this is much more difficult, as there is no way to include such link in every message.

If the company engages in social media, should not it also proactively monitor this space for any possible adverse events? Companies are obliged to report any AE found within limited timeframe, but there is possibility that report is discovered long after it was posted online. It may be written in exotic language and not recognized immediately.

Another question is if the company is obliged to actively pursue any post that may be adverse event but does not include all necessary information for AER. If that would be the case the workload could be overwhelming. Another complication is when the post mentions generic name of the drug manufactured and distributed by many companies. Shall all of them contact the original poster to find out missing information?

Those questions remain unanswered with the draft guidelines.

What will happen next?

All interested parties can submit their comments to FDA within 90 days from the date of publication in the Federal Register (01/14/2014) to www.regulations.gov electronically or in written form to the addresses provided in the document. We also expect more comprehensive guidance as mandated in FDA Safety and Innovation Act (FDASIA) of 2012. Section 1121 of FDASIA orders FDA to, “issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by the FDA.”.

Although in his e-mail conversation with Regulatory Focus Stephen King, FDA’s spokesman maintains that the guidance released on 13 January 2014 actually meets the statutory requirements of FDASIA, FDA “plans to issue additional guidance for drug and device manufacturers related to the Internet and social media,”  Those documents, according to the same spokesman: “Issues with character space limitations, links (the appropriate use of links), and sponsor correction of misinformation about their products disseminated by third parties.” We may then wait longer than expected for full set of regulations, but at least some steps have been done and we know that there is no need to submit every tweet to FDA before publication.
Full text of the FDA guidance: Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics
Federal Register link

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Categories
Pharma Marketing

Top 5 most expensive pharma marketing failures since 2010

Pharma marketing costs the most when it is not compliant to the regulations. Any unlawful or improper marketing campaigns in pharmaceutical can result in fines counted in billions of dollars. A report “Pharmaceutical Industry Criminal and Civil Penalties: An Update” by Public Citizen ranks the largest settlements by drugmakers, and shows these companies paid out 74 settlements to the tune of $10.2 billion from Nov. 2010 to July 2012. Public Citizen’s report does not include recent Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals settlement regarding Risperdal, Wellbutrin and Avandia misleading promotion.
Basing on the report of Public Citizen and U.S. Department of Justice data, K-message.com has compiled a list of top 5 most expensive failures of pharma marketing that resulted in heavy fines.
1. $3 000 000 000 – on 2nd of July 2012, GlaxoSmithKline LLC (GSK) has agreed to pay total 3 billion dollars to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices. There were three brands that GSK promoted against the law.

fix_me
Paxil (Photo credit: ~!)

  • The first, Paxil was unlawfully promoted for treating depression in patients under age 18, even though the FDA has never approved it for pediatric use. NB. Paxil, as other antidepressants, included on its label a “black box warning” stating that antidepressants may increase the risk of suicidal thinking and behavior in short-term studies in patients under age 18.
  • The second brand included in the settlement was Wellbutrin. From January 1999 to December 2003, GSK promoted Wellbutrin, approved at that time only for Major Depressive Disorder, for weight loss, the treatment of sexual dysfunction, substance addictions and Attention Deficit Hyperactivity Disorder, among other off-label uses. 
  • The last brand involved was Avandia. In this case GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA.  Since 2007, the FDA has added two black box warnings to the Avandia label to alert physicians about the potential increased risk of congestive heart failure, and myocardial infarction (heart attack). [Source]

2. $ 2 200 000 000 – on 30th of August 2013, Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals settled for 2.2 billion dollars in total multiple civil and criminal cases arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the U.S. largest long-term care pharmacy provider.

English: Risperdal (United Kingdom packaging)
English: Risperdal (United Kingdom packaging) (Photo credit: Wikipedia)

  • Janssen Pharmaceuticals Inc., a J&J subsidiary, promoted the antipsychotic drug Risperdal to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion. The medicine was approved at the time only to treat schizophrenia. Risperdal was also promoted for use for elderly, children and individuals with mental disabilities, against repeated FDA warnings (Until 2006 Risperdal was not approved for use in children for any purpose). For all this groups drug posed certain health risks that J&J was aware.
  • Similar allegations were made regarding to the newer J&J antipsychotic drug, Invega.  Although Invega was approved only for the treatment of schizophrenia and schizoaffective disorder, the government alleges that, from 2006 through 2009, J&J and Janssen marketed the drug for off-label indications and made false and misleading statements about its safety and efficacy.
  • J&J and another of its subsidiaries, Scios Inc., caused false and fraudulent claims to be submitted to federal health care programs for the heart failure drug Natrecor.  In August 2001, the FDA approved Natrecor to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity.  Government alleged that, shortly after Natrecor was approved, Scios launched an aggressive campaign to market the drug for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in the FDA-approved label and not covered by federal health care programs. Scios had no sustainable evidence to support medical necessity of these outpatient infusions. [Source]

3. $1 500 000 000 – on 7th of May 2012,  Abbott Laboratories Inc. has agreed to pay $1.5 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration.

depakote
depakote (Photo credit: JTony)

  • Abbott admits that from 1998 through 2006, the company maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use.   In addition, from 2001 through 2006, the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use.  The FDA approved Depakote for only three uses: epileptic seizures, bipolar mania and the prevention of migraines. [Source]

4. $1 200 000 000 – on 11th of July 2012 a judge in Arkansas ordered Johnson & Johnson and its subsidiary Janssen to pay more than $1.2 billion in fines on Wednesday, a day after a jury found that the companies had minimized or concealed the dangers associated with an antipsychotic drug Risperdal. For details of the allegations see number 2 of this list. Risperdal case generated also other, smaller fines in Texas ($158 million), South Carolina ($327 million) and Louisiana ($258 million). [Source]

5. $950 000 – on 22nd of November 2011, an american pharmaceutical company Merck, Sharp & Dohme has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx® (rofecoxib).

  • Rofecoxib
    Rofecoxib (Photo credit: Wikipedia)

    Merck’s criminal plea relates to misbranding of Vioxx® by promoting the drug for treating rheumatoid arthritis, before that use was approved by the Food and Drug Administration. The FDA approved Vioxx® for three indications in May 1999, but did not approve its use against rheumatoid arthritis until April 2002.   In the interim, for nearly three years, Merck promoted Vioxx® for rheumatoid arthritis, conduct for which it was admonished in an FDA warning letter issued in September 2001.  Additionally Merck representatives  made inaccurate, unsupported, or misleading statements about Vioxx’s cardiovascular safety in order to increase sales of the drug. [Source]

 

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Pharma Marketing

FDA asks 23andme to stop marketing of unapproved test and device

After months of negotiations, FDA finally lost patience and sends a warning letter to Google-backed 23andme, a genome testing company. 23andme was marketing its saliva based genetic test device and the test (Personal Genome Service) itself without an obligatory marketing clearance.

23andMe
23andMe (Photo credit: brendanlim)

 

What FDA’s letter means

The letter is very direct and harsh and its tone, reminding Mrs. Anne Wojcicki, the founder of 23andme, that FDA really tried to help:

More than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies

The letter is the final warning. If 23andme fails to cease its marketing activities and provide a plan to align itself to the regulatory demands, FDA will start a regulatory action without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties – FDA warns.
At K-Message, we usually praise innovation, courage and development of new ways of dealing with complicated problems. 23andme could be a hero of our story. But Mrs Anne Wojcicki‘s approach is hard to support.

FDA’s concerns

FDA’s main concern is, as specified in the letter, a potential risk of negative impact of the often alarming test results coming from PGS. False positive or false negative from the PGS may affect actions of the people. Someone who was falsely informed that has high risk of breast cancer (BRCA mutation), can undergo prophylactic surgery, chemoprevention, invasive screenings and last, but not least will suffer tremendous psychological stress.
On the other hand, false negative may lead people from the risk groups to ignore prevention at all. Another dangerous part of 23andme service is informing about personal reaction to the drug. It produces a risk of “self-managing” therapy and lowering adherence to the therapy prescribed by real HCP. Such non-compliance may lead to serious risk of illness, injury and even death, as in the FDAs example of wayfarin, popular anticoagulant or “blood thinner“, which may cause internal bleeding if overdosed.

Problems with 23andme technology

23andme technology is far from being bulletproof. The assumptions it bases on, the links between particular genes and diseases are not really mapped and confirmed in regular clinical trials on big samples. Even Mrs. Wojcicki admits, that her goal is to gather a test sample big enough to  falsify the assumptions on which results are presented to the patients.
But it is not only about state-of-knowledge about human genome as today. Even the software that generates PGS results can mislead patients, as described in this personal story “My deadly disease was just a bug”. It also happened, that 23andme simply mixed the samples and 96 of its users recveived data od someone else, who just had a bad luck to have his/hers saliva on the same testing  plate.
It does not make Mrs. Wojcicki any more apologetic though.

Linda Avey and Anne Wojcicki of 23 and Me
Linda Avey and Anne Wojcicki of 23 and Me (Photo credit: dfarber)

Right to know, but what?

The problem is, Mrs. Wojcicki often diminishes such concerns. She said once, that the main concern of doctors is that her service generates “non-billable, educated questions“. When the Agency first warned 23andme together with other gene testing companies in 2010, Mrs. Wojcicki’s line of defense was freedom to know information about your own body.
FDA has nothing against testing itself and having this knowledge available. The problem is that the knowledge has to be true and not misleading. As Mrs. Elizabeth A. Mansfield, director of personalized medicine in the F.D.A.’s medical device division, said to NYT, the agency agreed that people had a right to their genetic information.
The concern, she said, was that 23andMe was also providing interpretations of what that data meant medically. Some commentators, that come more from a tech than pharma tend to see the conflict between 23andme and FDA as “new vs old” clash.
We believe it is not the case this time. It is rather good ol’ regulatory action against dangerous false claim in healthcare, or even quackery. 23andme does not offer substantial evidence to support the reports provided to their clients. Their often misleading information can lead to health risk, and therefore FDA has to intervene. It has nothing to do with freedom of the information, as the information is too often false and affects really important matter.
 

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