Sheppard's Nota Bene

The core responsibilities of the Food and Drug Administration (FDA) are to promote public health by reviewing and assuring the safety, effectiveness, quality, and security of drugs, vaccines, medical devices, and several other products.

In this episode, we're exploring how the FDA operates in the U.S., the types of products it regulates, and how multinational companies can better understand the regulations that relate to their products. Joining me for this conversation is Allison Fulton. Allison is a partner in the Life Sciences and FDA team and is based in Sheppard Mullin's Washington, D.C. office. Allison advises life sciences companies, including pharmaceutical, medical device, dietary supplement, food and cosmetic companies, in matters relating to the development, manufacture, and marketing of products regulated by the U.S. FDA.

What We Discussed in this Episode:

• What is the FDA and how does it function?
• What types of products the FDA regulates
• What is digital health and what types of products incorporate this new trend in the health space?
• How the FDA regulates medical devices that are software-based and includes artificial intelligence
• Is there any merit to the belief that the U.S. FDA process is more restrictive than similar agencies in foreign countries?
• How do other countries and their agencies regulate products and how can multinationals analyze the classification of their products in those countries?
• What's the difference between clearance and approval by the FDA?
• What are some recent developments at the agency, especially with a new Commissioner coming in?
• How does the FDA handle products, food, and supplements with cannabis-derived ingredients in them?

Contact Information:

Allison's Sheppard Mullin attorney profile

[email protected]

Thank you for listening!

Don't forget to SUBSCRIBE to the show to receive every new episode delivered straight to your podcast player every Wednesday.

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This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.

What does the U.S. Food and Drug Administration (FDA) do and how can you tell if your product is regulated by the agency?

It can often be difficult to understand all of the ramifications of the current administration's political actions and the effect on U.S. companies doing business across borders. We're taking a closer look at several trending events including the potential Mexican border closure, another government shutdown, Obamacare, the Mueller report, and current Congressional oversight.

Joining me today is repeat guest, Jonathan Meyer. Jonathan is a partner at Sheppard Mullin and counsels clients on their interactions with federal and state government, as well as cybersecurity, homeland security, Congressional oversight and immigration, among other challenges.

What We Discuss in this Episode:

• What does closing the border with Mexico really mean?
• How would a border closure affect the U.S. economy?
• Is it normal behavior to threaten border closure in the absence of a national security threat?
• Does a border closure fly in the face of other treaties, like NAFTA, and commitments that the U.S. is committed to?
• Can a President unilaterally cancel a treaty?
• What does the Federal Reserve Board do and why is Steve Moore's nomination to the Board controversial?
• How has the President managed to be so successful at influencing bureaucracies that should otherwise be immune from influence?
• Will there be another government shutdown?
• What three things could converge in 2019 and contribute to another government shutdown?
• What will happen with Obamacare given changes to the tax code and a new Court decision?
• Will the American public ever know the contents of the Mueller report?
• Where does Congressional oversight sit right now?

Contact Information:

Jonathan's Sheppard Mullin attorney profile

[email protected]

Thank you for listening!

Don't forget to SUBSCRIBE to the show to receive every new episode delivered straight to your podcast player every Wednesday.

If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show in Apple Podcasts, Stitcher Radio, or Google Play. It helps other listeners find this show.

Be sure to connect with us and reach out with any questions/concerns:

LinkedIn

Facebook

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Sheppard Mullin website

This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.

We’re exploring the ramifications of the current administration’s actions with regards to the Mexican border closure, the debt ceiling, Obamacare, Mueller’s report, and Congressional oversight.

In this recap episode, I'm extracting the valuable lessons shared by our guests in the prior 5 episodes. I offer my two cents about the practical advice shared by our guests to help the C-Suite understand the legal, political, and economic underpinnings impacting the 21st Century intercontinental business landscape in which they operate.

In Episode 25, we were brought up to speed on privacy laws by Liisa Thomas. Liisa discussed the importance of identifying how data collected can best be used (and not simply kept safe). Liisa covered the newly minted CCPA in California and GDPR in the European Union and explained the uptick in enforcement by administrations in various states across the country. We explored the prohibitive nature of the density of emerging privacy laws.

In Episode 26, I spoke with Oliver Heinisch, and we discussed the latest updates on the state of Brexit and addressed the question of whether or not there will be a deal. Since the airing of this episode, matters have not improved in the United Kingdom as there is still no deal regarding Brexit.

In Episode 27, we were joined by Luca Salvi who shared his insight on the gangbuster state of merger and acquisitions and private equity markets. Luca explained the current attractive state of affairs for investors who are looking to place their money somewhere - something to note if you're looking to invest.

In Episode 28, we explored the California cannabis industry with Christopher Sabec. Christopher, along with building quite the career in entertainment as the manager for The Dave Matthews Band as well as Hanson, established his expertise in cannabis law. Chris shared his insight on the new California cannabis regulations taking effect this year and explained what companies should know regarding licensing in this space.

In Episode 29, we discussed establishing effective corporate compliance programs with Jim McGinnis. Jim expressed the importance of compliance since compliance regulations appear in every industry and reach every dimension of doing business. Jim emphasized the need for businesses to pay attention to assembling strong corporate compliance programs and actively complying with them.

Thank you for listening! Don't forget to SUBSCRIBE to the show to receive every new episode delivered straight to your podcast player every Wednesday.

If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show in Apple Podcasts, Stitcher Radio, or Google Play. It helps other listeners find this show.

Be sure to connect with us and reach out with any questions/concerns:

LinkedIn

Facebook

Twitter

Sheppard Mullin website

This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.

We’re reflecting on the last 5 episodes and extracting the salient lessons about current privacy laws and how collecting information can be used, the latest on Brexit negotiations, the current state of the merger and acquisitions and private equity markets, California’s emerging cannabis industry, and establishing an effective corporate compliance program.

Corporate compliance is increasingly becoming an important part of corporate culture and existence. However, there is a great deal of mystery around what compliance truly means, why it's important, and what needs to be done to meet legal guidelines.

I'm joined by Jim McGinnis, a member of the Antitrust and Competition Practice Group in Sheppard Mullin's San Francisco office. Jim was formerly an Assistant United States Attorney for the Eastern and Central Districts of California, serving in the Criminal Division from 1984-1988. He specializes in complex litigation and white collar criminal matters with a focus on antitrust issues, often in the international arena.

What We Discuss in this Episode:

• What does compliance mean in the corporate setting?
• What areas of corporate existence does compliance touch upon?
• Why is it important for corporations to have compliance plans?
• The Yates Memo and what it aimed to achieve
• How can a compliance program help protect against exposure to liability?
• Is there greater compliance when the consequences of noncompliance are criminal penalties as opposed to civil ones?
• What is the biggest challenge facing multinationals when it comes to compliance programs?
• Are companies expected to understand the laws and regulations of every country they're doing business in?
• How clear is the framework and guidelines for setting up a compliance program?
• What are certain actions an organization must establish in order to meet the compliance requirements?
• What is "tone at the top" and how does it affect corporate compliance?
• Some mistakes Jim has seen throughout his years working in this space

Resources Mentioned:

The Yates Memo

Department of Justice – US Sentencing Guidelines

Section 8B2.1 – Effective Compliance and Ethics Program

Contact Information:

Jim's Sheppard Mullin attorney profile

[email protected]

Thank you for listening! Don't forget to SUBSCRIBE to the show to receive every new episode delivered straight to your podcast player every Wednesday.

If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show in Apple Podcasts, Stitcher Radio, or Google Play. It helps other listeners find this show.

Be sure to connect with us and reach out with any questions/concerns:

LinkedIn

Facebook

Twitter

Sheppard Mullin website

This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.

As corporate compliance grows in importance within an organization, we’re exploring what compliance looks like and what C-Suite members must do to establish effective compliance programs.

With cannabis quickly becoming big business for new and established companies alike, we're turning out attention to one of the largest cannabis markets in the world - California. From trademark and cultivation licensing to banking, the laws and regulations of the state of California are ever-evolving in order to keep up with this growing field.

Joining me to discuss the evolution of the cannabis industry and related laws and regulations is Christopher Sabec, a Cannabis and Entertainment Law attorney with Fox Rothschild with decades' worth of successful business management and executive leadership.

What We Discuss in This Episode:

• Christopher's interesting background working and representing the Dave Matthews Band and Hanson
• How the cannabis industry has evolved over the years
• What three agencies are in charge of regulating the California cannabis market?
• What is the process for putting forth regulations in this industry?
• Why the California cannabis market required emergency regulations?
• Were there major changes between the initial emergency regulations and the permanent regulations?
• What types of brand licensing agreements exist in this space?
• How does the Bureau of Cannabis Control (BCC) define "ownership" for trademark and licensing purposes?
• The current bill being considered by the California Senate regarding license applications
• What are the types of licenses a business can apply for and which agencies issue them?
• Can cannabis be cultivated without a license in California? What are the limitations there?
• Given Federal law limitations on this industry, how do cannabis companies handle their banking?
• How can attorneys better deal with the state regulatory agencies in this space?

Resources Mentioned:

Bureau of Cannabis Control (BCC)

California Department of Food and Agriculture (CDFA)

Contact Information:

[email protected]

Fox Rothschild attorney profile

Thank you for listening! Don't forget to SUBSCRIBE to the show to receive every new episode delivered straight to your podcast player every Wednesday.

If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show in Apple Podcasts, Stitcher Radio, or Google Play. It helps other listeners find this show.

Be sure to connect with us and reach out with any questions/concerns:

LinkedIn

Facebook

Twitter

Sheppard Mullin website

This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.

California’s emerging cannabis industry was projected to reach $6 Billion in its first years. It fell just short, in the $5B range. The industry is poised to explode with regulatory support. How will the State adapt and evolve regulations that promote growth and opportunity for the sector, and what businesses are poised to benefit from California Cannabis regulations 2.0?