FDA Archives - HEALTH & LIFE SCIENCES NEWS

5 Questions with a Life Sciences Lawyer: Brian Malkin

by McDermott Will & Emery | Dec 28, 2021 | Uncategorized

Brian Malkin
Practice Focus Area: FDA (Health Industry Advisory)
Office: Washington, D.C.
Years at Firm: 1+

What is your favorite part about practicing life sciences law at McDermott?
I joined McDermott because of the depth of expertise in its life science practice, which I had been missing at other specialty or large law firms. The depth of expertise allows us to work collaboratively for clients, each with different disciplines and strengths. My favorite parts of practice at McDermott are the opportunities for us to work in cross-collaborations, because it allows us each to offer input and provide added value to our clients from these different perspectives without the need to form working groups from multiple firms.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?
My practice in FDA and IP law focuses primarily on pharmaceutical and biological product development and life cycle intellectual property protection. While the COVID pandemic has been detrimental in many aspects, in some sense it has opened an opportunity for increased contact with the agency for new product development, particularly for products to treat COVID, rare or orphan diseases and other unmet needs.

I particularly enjoy helping companies have successful meetings with FDA to obtain valuable product development input, as well as address any challenges that come up during the way. At the same time, [...]

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Regulatory Disputes With HHS: When to Negotiate and When to Litigate

by McDermott Will & Emery | Apr 9, 2021 | Hospitals & Health Systems, Life Sciences

For healthcare and life sciences companies, regulatory disputes with the US Department of Health and Human Services (HHS) and its operating divisions can present significant economic and reputational risks. Efficient resolution of such disputes is always preferable and requires a thorough grasp of both the law and the institutional relationships among the relevant HHS operating divisions, other parts of the Executive Branch, and agency personnel. When a company cannot reach an efficient resolution through negotiation and litigation is the only option, the company must vindicate its rights in a principled way that mitigates reputation risks.

In this webinar, McDermott partners Brian R. Stimson and Brian J. Malkin draw on their backgrounds with HHS and the US Food and Drug Administration, respectively, to help in-house healthcare and life sciences lawyers successfully navigate regulatory disputes with HHS and its operating divisions. Read on for select highlights from this insightful discussion.

The Administrative Procedure Act (APA) sets out the operating principles around which HHS is organized and gives litigators a lens through which they can assess agency efforts to implement policy. Among other things, the APA defines the parameters and procedures for bringing an action against the agency.
Stakeholders generally have the best chance of successfully litigating under the APA when they can challenge an agency action as contrary to the law. “Once you veer into the agency’s deference in interpreting the law, or the agency’s deference in administering a statute, it becomes very difficult under the APA to prevail, because the [...]

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Disrupting Healthcare – Constructively: Considerations for Executing Innovation

by Jennifer S. Geetter | Dec 19, 2019 | Digital Health

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 reason. Many of its laws and norms function to keep patients safe and clarify roles and responsibilities. This post explores key considerations for new entrants into the healthcare marketplace.

Know Your Audience

To help ensure that disruption is constructive, make sure you understand the needs of your customers and their obligations to their customers and internal stakeholders. Because hospitals, health plans and providers, for example, must operate within a complex regulatory environment, your product or service needs to take those constraints into account. No matter how powerful your technology is, if it shifts regulatory burden onto your customers’ shoulders, it risks being unadoptable.

Data privacy presents a [...]

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Five Questions with a Health Lawyer: Anisa Mohanty

by McDermott Will & Emery | Jul 11, 2019 | Uncategorized

Anisa Mohanty
Associate
Office: Washington, DC
Years at Firm: 3

What is your favorite part about practicing health care law at McDermott?

I started out pre-med in college, but I quickly realized what excited me was the intersection between science, medicine, policy and law. Many of our clients are at the forefront of shaping policy in the life sciences space through their innovations, and the quality of our health care practice means we have the opportunity to partner with and support them in really exciting projects. I am grateful for the breadth and depth of knowledge and experience of my colleagues—it pushes me to be a better, smarter and savvier lawyer.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?

Because our clients are addressing some of the most complex challenges in healthcare and healthcare delivery, often there aren’t straightforward regulatory paradigms for their businesses. Our clients want to do the right thing, but that can be challenging because their regulators haven’t yet articulated how they will enforce the law as it applies to their services and solutions. Digital health is a great example of this and there’s a lot of opportunity to advocate for our clients so that regulators can take industry perspectives into account when finalizing regulations.

What kind of client work [...]

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