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
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HPE New York 2020: The Impact of COVID-19: What’s Hot, What’s Not

In the wake of COVID-19 some health sectors have emerged as hot while others are troubled. Our panel of active investors discussed where the dollars are going and offered insights on why in relation to the events of 2020. McDermott partner Jerry Sokol moderated this dynamic panel featuring Paige Daly, partner at Harvest Partners; Chris Gordon, global head of healthcare and co-head of North America private equity at Bain Capital; Geoff Lieberthal, partner at Two Sigma Impact; and Rob Wolfson, executive managing director and head of H.I.G. Advantage Fund and U.S. Healthcare.

Below are the top takeaways for HPE New York 2020 half day session: The Impact of COVID-19: What’s Hot, What’s Not, click here to access the full webinar.

Access the PDF here.

COVID-19 has revealed weaknesses in the healthcare system and in healthcare delivery in particular. “One of the most fundamental things that we as healthcare investors all should be thinking about is investing in businesses that are making things better for the entire system—for patients, for providers and for payors,” Ms. Daly said. “That means we should be both raising quality and lowering costs.” These principles are driving some of the most exciting innovation today, particularly in payor services, physician practice management (PPM) and healthcare IT.

Healthcare IT generally and telemedicine specifically are areas of major investment. Dramatically accelerated patient and payor adoption of telehealth has created growth [...]

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DEA Proposes Regulations for Emergency Medical Services Agencies

On October 5, 2020, the US Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking establishing a registration category for emergency medical services (EMS) agencies and more generally implementing the requirements of the Protecting Patient Access to Emergency Medications Act of 2017.
The majority of the proposed regulations closely track the Act. For example, the proposed rule would:

  • Add EMS agencies as a new category of DEA registrants
  • Allow an EMS agency to obtain one DEA registration for each state where the EMS agency operates (regardless of number of locations within a state)
  • Allow hospital-based EMS agencies to operate using the hospital’s DEA registration.

The DEA also exercised its authority to implement the purposes of the Act more broadly with additional proposed regulations, including:

  • Requirements around notice to the DEA prior to delivery of controlled substances to unregistered locations of the EMS agency
  • Requirements (and options) regarding storage of controlled substances
  • Requirements associated with documentation of individual EMS professionals’ authorization to dispense controlled substances
  • Recordkeeping requirements relating to deliveries of controlled substances among all locations of the EMS agency
  • Recordkeeping requirements associated with controlled substance acquisition, administration and disposal.

Comments on the notice of proposed rulemaking are due by December 4, 2020.




After the Curve Podcast: Focus on Life Sciences

In this time of crisis, the life science industry has demonstrated remarkable speed, innovation and resilience. In this episode of the After the Curve podcast, our life sciences partners join us to discuss the most promising areas of drug discovery and device development that are emerging from the pandemic and the outlook for the industry in a post-COVID-19 world. McDermott’s Chief Marketing Officer, Leslie Tullio, is joined by Stephen Bernstein and Kristian Werling to discuss key topics impacting the life sciences industry today, including:

  • The reasons behind the immunity of life sciences to slowed investments
  • Why more investors are focusing their equity in healthcare and life sciences
  • Promising areas of drug discovery and device development emerging from the pandemic
  • Critical considerations for life science companies regarding rapid regulatory changes
  • Tactics for moving developments forward at an increased speed
  • The importance of Collaborative Transformation to the life sciences industry

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Regulating Medical Devices Post Brexit

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in England, Wales and Scotland after the BREXIT transition period (different rules will apply to Northern Ireland). This On the Subject outlines key dates for implementation of the new rules and certain practical implications of changed regime.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance (the Guidance) on new rules that will govern the regulation of medical devices after the end of the transition period. Whilst some of this guidance is similar to guidance issued as part of the “No deal BREXIT” publications in 2019, the MHRA has also set out proposals to engage and consult on a new medicines and medical devices regulatory framework for the UK.

The UK left the European Union (EU) in January 2020 but is currently in a transition period. The Guidance was released as part of a collection of updates covering various MHRA-regulated sectors (including medicines, clinical trials and licencing procedures) which will also be subject to new rules from 1 January 2021.

This update focuses on the new regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs) placed on the market in England, Wales and Scotland (Great Britain) only. Different rules will apply to Northern Ireland.

Existing law to continue
The rules that currently regulate medical [...]

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What are the Life Science Transaction Trends in the Wake of the Sanitary Crisis?

In the second installment of McDermott’s webinar series, HPE Europe 2020: What are the Life Science Transaction Trends in the Wake of the Sanitary Crisis?, moderator and McDermott partner Emmanuelle Trombe and industry experts Joseph El Khoury of Natixis, Cédric Garcia of EY’s Life Science Group, Dr. Erich Tauber of Themis Bioscience and Daniel Teper of CYTOVIA Therapeutics shared lessons learned from the first half of 2020, when COVID-19 changed the world. The panelists also discussed the outlook for life sciences transaction trends in the second half of the year and beyond.

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What Impact has Coronavirus had on Doing Healthcare Deals?

In the fifth and final installment of McDermott’s HPE Europe 2020 Summer Webinar Series, McDermott partner Tom Whelan hosted a discussion with Marc Benatar of Apax Partners, Markus Peterseim of Alvarez & Marsal, and fellow McDermott partner Dr. Nikolaus von Jacobs to examine how the Coronavirus (COVID-19) pandemic is affecting deal making in the healthcare industry.

Whelan led the group through a wide-ranging conversation centered on five key pandemic deal impact areas: pricing, process, timing, regulation and future prospects. Read on for discussion highlights, and click here to access the full webinar.

Pricing

“You’ve clearly seen a polarization,” Benatar said. “Nonessential businesses were hit hard by the lockdown effect and remain impacted, while those that were related to essential elements of healthcare were hit but started to experience a catch-up at the beginning of May and are already getting close to the normal run rate volume. I think that businesses that demonstrated that they are related to an essential part of the healthcare offering and that they can survive this type of crisis have almost strengthened their value. Those businesses that we know have experience with this first wave and those that are getting even more prepared for the next one will probably attract the highest valuations.”

COVID-19 has had a significant impact on the due diligence process, Peterseim noted. “When you’re advising investors on commercial or operations due diligence, there are always questions such as, ‘What will be the new normal of profitability? Will it be a swift [...]

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What is the Impact of Recent Regulation and Government Measures on Investments in Healthcare and Life Sciences in Europe?

In the fourth installment of McDermott’s HPE Europe Summer Webinar Series 2020: What’s the Impact of Recent Regulation and Government Measures on Investments in Healthcare and Life Sciences in Europe? moderator and McDermott partner Dr. Stephan Rau and industry experts Karthic Jayaraman of TPG Capital, Max Müller of Bayer, Ben Faircloth of L.E.K. Consulting and Dr. Ulrich Wandschneider, former CEO of Asklepios AG, currently at Trilantic Capital Partners and Supervisory Board member of BioNTech SE, the Nasdaq-listed developer of COVID vaccine, headquartered in Germany, discussed the impact that COVID-19 and the government measures to address it have had on investments in healthcare and life sciences in Europe.

“I think it’s about as interesting a time as any in my last 20 years investing,” said Jayaraman. “People are beginning to focus a lot more on innovation, the speed of innovation and how innovation is brought to market. I think the question is, “How can we continue to reward innovation, both by simplifying the process by which it’s made possible and how we value it?”

“New developments in digital health have become more and more attractive as people have had faster access to care and governments have understood that some of their regulations needed to be adjusted,” added Müller.

Jayaraman agreed. “There has been an acceleration of the provision of care through telehealth services and any kind of remote administration of care. It’s probably been an acceleration of two-plus years collapsed into months. I also think we’re going to see some vigorous [...]

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Top Takeaways: Critical Business Considerations for Life Sciences and Medical Device Companies During COVID-19

Life sciences and medical device companies are dealing with an unprecedented crisis. The industry is not only managing the impact of Coronavirus (COVID-19), they are also a solution provider. Companies are rapidly adapting products, services, facilities and distribution channels to aid in the pandemic response. Simultaneously, they must maintain shareholder value, navigate highly complex regulatory hurdles and compliance obligations while rethinking strategies for growth in a post-COVID-19 world. McDermott Will & Emery and EY co-hosted a webinar to discuss critical COVID-19-related operational, regulatory and legal developments. Below are top takeaways from the program. For a deeper dive into these issues, listen to our webinar recording. 

  1. FDA enforcement discretion is a flexible, risk-based approach, not a free pass. Companies operating under FDA’s enforcement policies to provide COVID-19 countermeasures should have a strategy to ensure that products comply with the standard applicable requirements if the products will still be in distribution after the public health emergency ends. FDA will prioritize areas for follow-up and review after this crisis; clear documentation and protocols describing deviations from standard FDA procedures or requirements will be important in a post-COVID-19 environment.
  2. Clinical trials remain an important FDA priority, and COVID-19 presents an opportunity to transform the clinical development model. The agency has been very flexible in terms of the approaches it is taking to allow trials to continue, including through the use of technology, such as remote patient monitoring, video consent and telemedicine, as well as the use of home health. [...]

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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 many serious conditions that often lack alternative treatment options. Although Congress enacted an abbreviated FDA-approval process for biosimilars nearly a decade ago, adoption of biosimilars has been relatively slow. The FTC and the FDA will focus on competition for biologics in hopes of improving patient access to important treatment options and curbing costs. The joint guidance highlights the agencies’ efforts to transfer recent investigatory and enforcement efforts to biologics markets.

The joint guidance sets forth goals for which the FTC and the FDA will agree to collaborate in their efforts to support adoption of biosimilars and enhance competition in biologics markets. These goals build on [...]

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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 report. 




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