HEALTH & LIFE SCIENCES NEWS
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries

Anticompetitive Conduct in Biologics – An Enforcement Priority with FTC and FDA

This blog was originally published on McDermott’s Antitrust Alert Blog. On February 4, 2020, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) released joint guidance concerning competition for biologics, including biosimilars. The joint guidance seeks to enhance competition for biologics and reduce manufacturers’ use of false or misleading statements or promotional communications concerning the efficacy or safety of biosimilars and other biologics. This guidance appears to be part of the Trump administration’s effort to reduce the cost of medications for consumers, as it is aimed at increasing the level of competition biosimilars can offer and raising awareness of the safety and efficacy of biosimilars. The fast-growing biologics market has become an important sector of the healthcare and pharmaceutical industry. According to the joint guidance, private insurers spent over $125 billion on biologics in 2018 alone. Biologics treat...

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Five Questions with a Health Lawyer: Joe Parise

Joe Parise Partner Office: Boston Years at Firm: 6 What is your favorite part about practicing healthcare law at McDermott?  In short: the people. I have always had a cross-office practice, and as a result have been lucky enough to work with many different attorneys within the Health practice group. I am constantly impressed by the depth and breadth of experience that the group offers, as well as the creativity and thoughtful approach that our attorneys bring to tricky client issues. Being surrounded by talented attorneys (from the senior partner to the junior associate ranks) makes me want to “raise my game” and, I think, brings out the best in each of us. In addition to the professional qualities, I am grateful for the fact that our attorneys bring a positive attitude each and every day, and create an enjoyable working environment. I have made some great personal connections over the years, and consider many of my colleagues to be good friends. What is the...

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Five Questions with a Health Lawyer: Larry Guess

Larry Guess Partner Office: Chicago Years at the Firm: 6 years What is your favorite part about practicing healthcare law at McDermott?  My favorite part of practicing healthcare law at McDermott is the complexity of our client matters and working with my colleagues to get great results for our clients. The healthcare industry is constantly changing and innovating, and our clients engage us to help them adapt to these changes and maximize innovation in the space. What is the biggest opportunity and greatest challenge facing clients in your area of focus today?  The biggest opportunity facing our clients is the bullish investment perspective in the healthcare industry. Currently, there are buyers with a tremendous amount of capital to deploy and sellers looking to maximize current market conditions. The healthcare transactional climate is very dynamic and certain clients are willing to invest in more risky assets. While the payoff can be substantial, the speed...

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FDA 2019 Year in Review

2019 was a robust year for the US Food and Drug Administration’s (FDA’s) regulatory agenda. The agency continued to implement initiatives and mandates required by the 21st Century Cures Act (Cures Act), and navigated leadership and staffing changes at many levels. Most notably, Commissioner Scott Gottlieb resigned on April 5. Norman Sharpless and Brett Giroir served as acting interim commissioners following Commissioner Gottlieb’s resignation. On December 17, Congress swore in Commissioner Stephen Hahn, a radiation oncologist and former chief executive of MD Anderson Cancer Center. This Special Report reviews notable actions that shaped FDA-regulated industries and products last year, and offers insight into the agency’s 2020 priorities and expected actions in a number of areas, including: Digital health; Streamlined product approvals; Evolving evidentiary thresholds for product approvals; Strategic enforcement; And much more. Click here to read the full...

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Disrupting Healthcare – Constructively: Considerations for Executing Innovation

The healthcare industry is facing significant disruption from new market entrants and technology innovations that have the potential to improve how care is delivered, to lower healthcare costs, and to improve healthcare outcomes. But not all disruption is built to have a sustained and positive impact—how do you tell which innovative technologies and ventures will change healthcare for the better, and which are just noise? We all hear about disruptive innovation – the power of innovative thinking that sees beyond traditional ways of doing things in favor of new, better methods. When innovators enter the health arena and consider its problems creatively, they seek to break down inefficient aspects that don’t work well for stakeholders and patients. Problems can arise, however, if these innovators simultaneously disrupt processes or protective expectations that serve important functions. Healthcare is a heavily regulated and normative environment—for good...

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Five Questions with a Health Lawyer: Jeremy Earl

Jeremy Earl Partner Office: Washington, DC Years at the Firm: 10 What is your favorite part about practicing healthcare law at McDermott? My favorite part about practicing at McDermott is the challenging and constantly evolving nature of the work. Our clients put trust in us to advise them on their toughest legal questions and business challenges. I don’t take that trust lightly and it is exciting to come to work every day to meet and exceed the high expectations clients rightly have for us. What is the biggest opportunity and greatest challenge facing clients in your area of focus today? I represent managed care companies, which has traditionally meant health insurers and health maintenance organizations (HMOs). Due to legislative and competitive factors, healthcare financing and delivery is rapidly evolving and new models are being introduced to compete with traditional health insurers and HMOs. In 2012, Ezekiel Emanuel and Jeffrey Liebman boldly predicted...

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How to Engage in Constructive Disruption

The healthcare industry is facing significant disruption from new market entrants and technology innovations that have the potential to improve how healthcare is delivered. But how do you tell which innovative technologies and ventures will have a sustained and positive impact, and which are just noise? In this episode of the Collaborative Transformation podcast series, Lucia Savage, chief privacy and regulatory officer at Omada Health, joins McDermott partner Jennifer S. Geetter to discuss: What it takes for disruption to be truly constructive in today’s dynamic market The rise of mobile healthcare delivery and patient engagement, driven by technological advances and consumer expectations The limits of the HIPAA regulatory framework and current reimbursement rules as they relate to digital health technologies Tips for tapping into the growing digital health innovation community through strategic investment Click here to listen to the episode....

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Five Questions with a Health Lawyer: Marshall E. Jackson, Jr.

Marshall E. Jackson, Jr. Associate Office: Washington, DC Year at Firm: 4 What is your favorite part about practicing healthcare law at McDermott?  My favorite part of practicing healthcare law at McDermott is working with clients that are out in front tackling very interesting and unique issues. The healthcare industry continues to evolve, and our clients are at the forefront. The changes in the industry have required clients to navigate areas of uncertainty, and our clients look to us to help them navigate that uncertainty. I have been blessed to sit shoulder to shoulder with a dynamic McDermott team helping our clients tackle new and unprecedented issues. No day is a dull day. What is the biggest opportunity and greatest challenge facing clients in your area of focus today?  Many of our clients face the challenge of balancing the need to deliver affordable, quality healthcare to people when and where they need it, while maximizing return on investment for...

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Podcast: Collaboration Through Innovation Centers

Healthcare is facing a time of transformation as regulators, providers and other stakeholders take action to improve care coordination and increase the use of technology to deliver care. Hospital and health system innovation centers are increasingly acting as the catalyst to fuel growth and expansion through technology and data. In this episode of the Collaborative Transformation podcast series, McDermott partners Kerrin Slattery and Krist Werling discuss: Opportunities for innovation centers and other collaborative arrangements in healthcare Top regulatory and compliance challenges innovators face and ways to navigate them Organizational and cultural issues for healthcare leaders to consider when making innovation a strategic priority Investment structures and unique due diligence concerns to address when designing or investing in innovative deals Key considerations when executing cross-border transactions in healthcare and life sciences Click here to listen...

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Five Questions with a Health Lawyer: James A. Cannatti III

Name: James A. Cannatti III Practice Focus Area: Healthcare Fraud & Abuse Office: Washington, DC Years at Firm: 1 What is your favorite part about practicing healthcare law at McDermott? My favorite part of working in the McDermott Health practice, and at the Firm generally, is the team approach to advising clients. Each of us has unique subject matter knowledge and experience in different areas of law. Very often, our clients require advice that cuts across multiple areas and issues. By working together across different disciplines within the Firm and within the Health practice we can provide comprehensive advice and counsel to our clients – not just advice on one discrete issue – and approach things from a broader, strategic perspective to help meet their needs. What is the biggest opportunity and greatest challenge facing clients in your area of focus today? I work in the healthcare regulatory space, focusing on federal and state fraud and abuse...

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