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Dr. Kulkarni is the Principal Attorney at the Kulkarni Law Firm.

He focuses on strategic compliance and their regulatory and counseling needs. His extensive experiences managing the needs of global life sciences companies and their service providers including Contract Manufacturing Organizations, Contract Research Organizations and advertising and training companies. Dr. Kulkarni has assisted his clients in meeting a variety of legal and regulatory needs including crafting responses to FDA 483s, FDA recalls, promotional and compliance review and clinical trial negotiations. Besides his experience as an attorney, Dr. Kulkarni is a pharmacist, Associate Professor, and author. Follow him on Twitter @FDALawyers.

Darshan Kulkarni
statements on pages that were under their control. NOTE: This information does not constitute legal advice. To have the Kulkarni Law Firm (Firm) determine if the advice is appropriate for you, you must talk to a lawyer at the Firm and create an attorney-client relationship. A recent case in Australia (Australian Competition and Consumer Commission v Allergy Pathway Pty Ltd) shed some light on how the court there views responsibility and control of health and medical content online. Any insights for companies in the US? Despite the fact that Australian Competition and Consumer Commission v Allergy Pathway Pty Ltd is a non-US case, it provides an example of a reasonable court trying to apply decades old principles of food/drug/medical device law to an ever-changing world of Internet technology. The Court drew a good balance and based its opinion on the simple principles of whether Allergy Pathway Pty Ltd. knew or should have known of inaccurate or misleading statements and whether they took appropriate steps to fix these inaccurate and/or misleading Informal discussions and non-binding discussions with US stakeholders including life sciences companies, providers, and the government seem to result in similar views. The FDA has, multiple times, indicated that they consider the Internet to be just another channel of communication subject to the same rules as other channels. Resultantly, while there are no definitive views on the issue, the duty to control inaccurate and/or misleading statements likely exists, and companies would likely be expected to control pages. Any concerns about this case? Is the premise or interpretation flawed in your opinion? As applied to US law: There are a few separate concerns that can give a life sciences company pause. Specifically, the court held that a life sciences company is responsible for the actions of consumers and patients and effectively acts in their place if it fails to remove potentially misleading content. This opens up a range of issues including how (1) How often must a company review the variety of websites to be able to demonstrate that it does not wish to act as one of its consumers (2) Is there a duty to

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correct misinformation? Or is merely removing the content inadequately and effectively constitutes subscribing to such opinions? As global multi-national companies seek to participate in an increasingly global and connected digital world, how can companies think about geographic boundaries (in a legal sense) when the Internet tends to view content from the perspective of language today? It is increasingly difficult to control what patients see on the Internet. Think about your audience, think about what you can say, and consider the fact that patients from across the globe will likely be able to access the work that your company is putting out irrespective of where in the world they are. Each country has different laws and it is hence important if possible to limit access to viewers from the specific country in question. Alternatively a company, if necessary, must appropriately define the country being targeted (even if other countries may potentially access the site.) Thus, it is often advantageous to consider having a web-use policy and making it accessible. Decide which sites you will adopt and monitor, the extent to which you will monitor these sites, and then have appropriate processes to review. There are a few cases working through the US legal system, which will have significant implications for off label and the ability of companies to communicate with patients,

professionals, and the public at large. How would you characterize the possible impact of these cases to the future of digital pharmaceutical marketing? The forthcoming debate on off-label discussions is likely to have a significant and permanent impact on pharmaceutical marketing in general, and digital and in-person marketing in particular. Companies have been hesitant to get on social media because the potential for off-label discussions was significantly placated by the guidance that the FDA recently put out on unsolicited off-label discussions. Nevertheless, the pending decisions may add further certainty to an individual companys decision-making process and potentially provide marketing and medical education departments with the ability to communicate better with patients and providers. If you had three lines to sum up the definition of control and responsibility of health and medical content online from the manufacturer perspective how would you do it? If you wish to adopt a site, you must control the content. If you control the content, you must ensure its accuracy. You must use appropriate measures to educate and empower the correct individuals to confirm that they can properly monitor and control the site for you.

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Any advice to a general counsel trying to get their head around the future of digital health? 1. Talk to your stakeholders and decide your level of risk-taking ability. 2. Dont try to be your companys compliance officer. Your role is to appropriately represent your companys interests (including its marketing interests). Conversely, the role of a compliance officer is not to look at the best interests of the company from a marketing perspective but from a compliance perspective. There is a potential conflict of interest, and the DOJ would likely not look kindly on you overruling the compliance officer. 3. Technology is changing; let marketing guide you on the direction of technology, but use your own gut instinct on the appropriateness of its use and the suitability of the message for your patients. What are your favorite health and medical sites today? Medscape.com and Drugs.com. What technology companies do you most admire? Apple for its ability to brand and Google for its desire to innovate. Google has a program that encourages innovation and allows it employees to spend up to 20% of their resources on personal projects, which eventually may develop into hits like Gmail.

What technology device do you most admire? The Google eyeglasses What technology advancement do you most admire? An oldie but a goodie: Cell phones. I can be anywhere in the world, and I am always reachable. What technology advancement do you most despise? Text messaging. Please talk to me when you want to have a conversation. When is the last time you went off the grid for at least 24 hours? I often find myself going off the grid on my frequent trips to India. It is unsettling to start with, but you begin enjoying people again after you get used to the idea that your emails arent coming through immediately.

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