Sonali Gunawardhana
Q&A on Regulatory Developments, Cybersecurity Issues and Her Decade at FDA

A former U.S. Food and Drug Administration (FDA) attorney, Sonali Gunawardhana joined Shook in early 2018 to counsel drug and device, food and beverage, and dietary supplement companies on regulatory and compliance matters from Shook’s office in Washington, D.C. The following is a conversation about trends she has seen in life sciences and her take on the FDA climate in 2018.

What are the top trends you’re seeing in life sciences that health and science companies should be watching?

It’s an interesting time for industry right now. From an FDA perspective, regulators are watching digital health and cybersecurity issues, which should be front and center for everybody. I’m also monitoring how FDA plans to navigate the regulatory framework for Real World Evidence. I’ve heard a lot of discussion about the 21st Century Cures Act in terms of requirements and best practices that will be developed through new regulations and guidance documents. Lastly, FDA will be examining medical devices as part of the Case for Quality initiative and realigning the Office of Regulatory Affairs to organize around subject matters rather than geographic locations.

Broadly, pricing and market access are top issues, in addition to the 340B Drug Pricing Program. On an ongoing basis, discussion in the industry focuses on research and development, expanded access programs and health care economic information.

Why are digital health and cybersecurity issues important for everyone to watch?

Medical device manufacturers create new products to help patients, never imagining they might be used to do harm. But a rise in malicious hacking of devices in the home and in health care facilities has introduced new risks to both patients and health care providers.

Medical device manufacturers understand that cybersecurity vulnerabilities pose a threat, but I’ve found that they’re not sure where to begin. FDA has issued guidance to help them address and respond to threats and attacks, but given the potential pitfalls of a medical device cybersecurity breach, attorneys need to ensure their clients are prepared for a security-related product recall in the event a breach does occur. Attorneys should also take the lead in counseling clients through the concrete but often overlooked steps that may prevent hacking.

You co-authored a Law360 article about medical device cybersecurity, specifically mentioning “recall fatigue.” Can you explain?

Product recalls occur with such exhaustive regularity across all industries that they are becoming lost on many consumers, creating safety and brand damage risks for medical device manufacturers. Think about the current stream of direct mail, emails and news stories about recalls and it’s no wonder consumers are experiencing recall fatigue. Medical device and other product recalls have reached an all-time high, with more than 3,400 in 2017. It can be challenging to connect with and encourage action from consumers when they’ve muted their antennae.

Manufacturers must work to ensure recall fatigue is minimized, especially when potentially life-threatening products such as medical devices are in the mix. By refining communications approaches to reach consumers where they like to consume information—such as on mobile devices—manufacturers have a better chance of compliance.

You bring to Shook nearly ten years of regulatory experience in-house with FDA. How do you see the FDA climate in 2018?

The agency is working diligently to address the mandates of the new administration. FDA is taking a collaborative and educational approach to streamlining its regulatory approach in order to be more effective. It appears that policy changes and new guidance documents are being issued quickly and that transparency is a top priority as the agency tackles many legislative enhancements such as 21st Century Cures Act.

What is your client philosophy?

I try to understand both the regulatory and business challenges that my clients’ businesses face on a daily basis. I feel that truly understanding these challenges allows me to provide assistance that will benefit my client both from a short-term and long-term perspective. I also try to provide options on how to best move forward with any regulatory issues; many people are unaware that FDA is generally willing to work with its regulated industries to come to a mutually acceptable plan of action. ●

Sonali P. Gunawardhana
Sonali draws on nearly ten years of experience as an attorney at the U.S. Food and Drug Administration (FDA) to offer clients detailed and practical guidance on how to avoid and resolve FDA regulatory challenges. She gives her clients the benefit of her deep knowledge of the law and a keen, forward-looking sense of how FDA may view a particular matter, giving the client the ability to develop the most effective and persuasive approach to any situation.
2019-02-05T21:50:11+00:00June 1st, 2017|