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What We’re Reading - July 23, 2021

July 23, 2021 | Blog | By Cynthia Larose

There is a glut of information out there regarding privacy and cybersecurity these days.  Our new feature “What We’re Reading” provides a curated list of articles, blogs, newsletters, and books that you may find interesting and helpful.
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Meet Scott Thompson: Battling for the Wireless Infrastructure Industry in Cities and in Courts

Mintz Member and Chair of the firm’s Communications Infrastructure Litigation Practice, Scott Thompson, was profiled as an industry leader by the Wireless Infrastructure Association. In the blog post, Mr. Thompson reflected on making a major career move by joining Mintz in the middle of a global pandemic, his 20+ year career path and high profile cases, and the most significant issues facing the wireless infrastructure industry today and in the near future.

Source

Wireless Infrastructure Association

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In this episode of the EXCLUSIVE RIGHTS: Intellectual Property podcast, Mintz IP attorneys Drew DeVoogd and Daniel Weinger welcome guest David Duski for the first of a two-part series covering patent trial damages.
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Four Mintz Members Recognized by Benchmark Litigation’s 40 & Under Hot List 2021

Mintz is pleased to announce that four Litigation Members have been named to Benchmark Litigation’s 40 & Under Hot List 2021. The annual ranking recognizes the best and brightest law firm partners under 40 in the United States and Canada who stand out due to their high-stakes wins, precedent-setting matters and positioning for future success. 

The following Mintz attorneys were selected for inclusion in their respective practice areas: 

Mr. Frey is a skilled litigator that advises clients on a broad range of disputes involving commercial real estate and government regulation. He has extensive experience litigating complex lease disputes, commercial evictions, permits/zoning appeals, tax abatements, property valuations, government investigations, and administrative proceedings before state and federal agencies.

Mr. Hupart’s practice encompasses complex commercial litigation, including cases involving securities, employment, and environmental claims, as well as class action litigation, white collar criminal defense, and regulatory investigations. Mr. Hupart has extensive experience representing clients in a variety of industries, including financial services, energy, education, and the media.

Ms. Musgrave is Co-Chair of the firm’s Appellate Practice Group. She leads clients through the appellate process, designing a successful appellate strategy, drafting briefs, and preparing for oral argument. She also assists clients with amicus curiae submissions, including to the U.S. Supreme Court. Working as a litigator both at the trial and appellate phases, her practice focuses on complex commercial litigation across a variety of areas, including contract disputes, securities litigation and government investigations.

Alec has significant experience advising directors, officers, members, managers, and shareholders of closely-held businesses regarding their fiduciary duties, corporate governance, and indemnification rights and responsibilities. He also litigates and advises insurers concerning complex coverage issues. Alec is well-known for his pro bono work in Massachusetts, which focuses primarily on representing survivors of sex trafficking and domestic violence and raising awareness of legal issues impacting survivors of human trafficking.

Benchmark Litigation is the definitive guide to the world’s leading litigation firms and lawyers. The law firm and lawyer rankings are based on extensive interviews with litigators, dispute resolution specialists and their clients as well as analysis of the market’s most important cases and firm developments.

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On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance, which describes the agency’s current thinking on activities that meet the definition of remanufacturing and a process for determining whether an act done to an original equipment manufacturer’s (OEM’s) legally marketed finished device is considered remanufacturing (the “Draft Remanufacturing Guidance”).
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Trio of Firm Attorneys Receive 2021 Richard Mintz Pro Bono Award for Partnership with Lawyers Clearinghouse to Establish Criminal Record Sealing Clinic

Mintz is pleased to announce that firm attorneys Nicholas Armington, Nadia Do Canto, and Rithika Kulathila have received the 2021 Richard Mintz Pro Bono Award, which is presented annually on behalf of the firm by Mintz’s Pro Bono Committee to attorneys who demonstrate exemplary commitment to pro bono work. The trio of honorees was recognized for their efforts with legal services nonprofit and the firm’s longstanding pro bono partner Lawyers Clearinghouse to establish a Massachusetts Criminal Offender Record Information (CORI) sealing clinic. The attorneys were celebrated virtually during the firm’s 30th annual Pro Bono Award reception held on July 12.

Mr. Armington, Mrs. Do Canto, and Ms. Kulathila initiated a successful partnership with Lawyers Clearinghouse and the City of Boston to establish a virtual clinic that helps low-income residents seal or expunge criminal records. This groundbreaking program is especially important in addressing the disproportionate impact the criminal justice system has had on Black men and other communities of color in Boston. By collaborating with Mintz’s partners on this clinic, Mr. Armington, Mrs. Do Canto, Ms. Kulathila, and other firm attorneys have helped individuals throughout Greater Boston remove significant barriers that would have made it difficult for them to pursue future employment, housing, and educational opportunities.

The virtual Pro Bono Award reception was punctuated by congratulatory remarks from firm leaders including Member and Chairman of the firm Robert Popeo, Managing Member Bob Bodian, and Member and Chair of the Pro Bono Committee Susan Finegan. In addition, Susan Gedrick, Executive Director of Lawyers Clearinghouse, and Crispin Birnbaum, a Lawyers Clearinghouse Access to Justice Fellow, joined to reflect on Mintz’s pro bono partnership over the past 27+ years and the impact of this latest collaboration to serve individuals in need through the CORI sealing clinic.

“This has been a challenging year for many, and in particular for our pro bono clients in vulnerable and low-income communities,” said Ms. Finegan. “The Pro Bono Committee has been greatly impressed by the enthusiasm and commitment of this group – Nick, Nadia, and Rithika – to tackle systemic racism through the CORI sealing clinic. Due to their leadership, the project has been a huge success at Mintz, with 32 attorneys and professional staff helping over 30 individuals to seal their criminal records throughout the last year.”

During the event, all three Richard Mintz Pro Bono Award honorees shared their experience and impressions of the CORI sealing clinic and encouraged their colleagues to volunteer a relatively small amount of their time to make a lasting difference in someone’s life.

The Richard Mintz Pro Bono Award is named in honor of Richard Mintz, the son of one of the firm’s founders, who in many ways embodied the generous spirit of Mintz and was a strong supporter of the firm’s pro bono contributions.

Pro bono service is at the heart of Mintz’s culture and identity. The firm partners with nonprofits, legal services organizations, in-house legal departments, and other law firms to provide life-changing assistance for individuals in need. Significantly, in the past year, more than 400 Mintz attorneys contributed to over 300 unique pro bono matters. To learn more about the firm’s pro bono work, please click here.

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To note the one year anniversary of the California Consumer Privacy Act (CCPA) enforcement date, California Attorney General Rob Banta held a press conference on July 19, 2021 to share key information about enforcement efforts and announce a new consumer privacy tool. He also praised businesses for their prompt compliance efforts and urged consumers to be proactive about their privacy rights.
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Mintz Continues Washington, D.C. Growth, Relocates to and Expands Office Space at the Thurman Arnold Building

Mintz announced today the relocation of its office in Washington, D.C. to accommodate the firm’s continued strategic expansion. The firm has moved into the Thurman Arnold Building, occupying 57,000 square feet of office space at 555 12th St., NW, a nearly 782,000-square-foot building by F and 12th Streets NW.

“As we continue to expand the firm’s capabilities to better serve the needs of our clients, a new office in D.C. became a priority. Just in the last year D.C. has added 13 lawyers,” said Susan Berson, Managing Member of Mintz’s Washington, D.C. Office and Chair of the firm’s Health Law, Communications, Antitrust & ML Strategies Division. “The state-of-the-art Thurman Arnold Building provides us with a modern, technologically advanced workplace designed to facilitate collaboration with each other and with our clients, and offers a host of additional amenities. While the new space meets the firm’s needs today, it is also flexible to adapt to its future needs.”

Mintz opened an office in Washington, D.C. in 1979, headed by Charles D. Ferris, former Chairman of the Federal Communications Commission (FCC). Since then it has grown to more than 70 attorneys and ML Strategies government consultants, focused primarily on federal regulation, legislation, and litigation, with an emphasis on communications, the environment, health care, and antitrust. 

Spanning one city block, 555 12th St. NW, known as the Thurman Arnold Building, is located in Washington, D.C.'s historic downtown. With an exceptional location between Capitol Hill and the White House, the building boasts immediate access to seats of power and those advising policy makers and true agents of change. In addition to being named a “showcase project” by the Better Buildings Initiative of the U.S. Department of Energy (DOE) for its technology upgrades, 555 12th Street is also certified LEED Gold.

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On Friday, July 9th, President Biden released an Executive Order “to promote competition in the American economy” and to “to reduce the trend of corporate consolidation” (the “Order”). As part of this Order, the Biden Administration specifically targets competition in the pharmaceutical industry and sets forth policies to combat the high cost of prescription drugs. As the Administration’s first major policy initiative on drug pricing, this Order may serve as a preview of the Administration’s drug pricing reform agenda. For additional information about the Executive Order, please see our Antitrust colleagues' alert on the Order's initiatives specifically earmarked for the Federal Trade Commission and the Department of Justice’s Antitrust Division.
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How Western States Help The Wealthy Avoid Taxes, Creditors

Daniel Pascucci, Managing Member of Mintz’s San Diego office and Co-Chair of the firm’s Cross-Border Asset Recovery Practice, authored a Law360 expert analysis article spotlighting the growing allure of Western states as asset havens, highlighting the need for creditors and claimants to consider robust U.S. enforcement strategies in asset-recovery efforts.

Source

Law360

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FDA Places Two Food Orders on Restaurants’ Tables

April 8, 2020 | Blog | By Daniel Herling, Nicole Ozeran

The food industry has been upended by the recent COVID-19 pandemic – restaurants and bars are scrambling to adjust to a new way of life after governors across America issued statewide “stay at home” orders in response to the coronavirus pandemic. Restaurants are now only permitted to serve take-out or drive-thru orders, and some restaurants have transformed themselves into neighborhood markets, or bodegas, selling food items not labeled for retail.
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On April 2, 2020, the Food and Drug Administration (FDA) issued a revised temporary enforcement policy regarding the manufacture and distribution of face masks and filtering facepiece respirators during the COVID-19 public health emergency. The revisions address two key omissions from the initial policy, which was released on March 25, 2020 and which we summarized in a prior blog post. Specifically, the agency has now provided guidance on: (1) the importation of respirators not approved by the National Institute for Occupational Safety and Health (NIOSH) and (2) the manufacture and distribution of face shields. FDA also added a question and answer about respirators manufactured in China to the KN95 air filtering standard (the Chinese equivalent of the U.S. government’s N95 standard) to its FAQ page on the personal protective equipment shortage and issued an emergency use authorization for non-NIOSH-approved respirators made in China.
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We’ve been blogging periodically on the various actions taken and enforcement policies being developed by the Food and Drug Administration (FDA) to support and expand the national response to the declared COVID-19 public health emergency. At the same time, however, the agency has also been taking various steps to help medical product sponsors and consumer product manufacturers and distributors prioritize their ongoing regulatory compliance activities during this challenging period for business-as-usual.

As we’ve already covered in depth (see prior post here), on March 18, 2020 the agency issued guidance for clinical trial sponsors regarding how to ensure the continued safety and informed consent of human subjects. That critical guidance document was updated on March 30 to add a new appendix with common sponsor questions, and FDA has stated that it plans to further update the appendix as new questions arise. Over the past several weeks, the agency has issued the following important policies on other issues that also seek to provide some much-needed regulatory relief to FDA-regulated manufacturers and distributors.
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As a follow up to our recent blog post, FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round, President Trump signed the bipartisan over-the-counter (OTC) monograph teform bill into law on March 27, 2020.  The passage of the OTC monograph reform bill is a surprise addition into the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the third COVID-19 stimulus bill enacted since the pandemic began. The reform legislation represents the first significant update to federal oversight of OTC drug products since 1972. It enables the Food and Drug Administration (FDA) to quickly respond to safety concerns and keep pace with innovation in hopes of protecting consumers from unsafe drugs and permitting manufacturers to market new products more expeditiously. 
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On March 25, 2020, the Food and Drug Administration (FDA) issued a temporary policy relating to enforcement of regulatory requirements for face masks and respirators during the COVID-19 crisis. Since the public health emergency began, the United States has experienced a shortage of masks, respirators, and other personal protective equipment (PPE) which are critically needed for health care workers caring for COVID-19 patients in all states. FDA previously created emergency use authorizations (EUAs) for NIOSH-approved disposable respirators for use in health care settings and imported non-NIOSH-approved disposable respirators, but the temporary enforcement policy represents an attempt to open the manufacturing, importation, and distribution flood gates to make more masks and respirators available as quickly as possible.
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FDA Issues Guidance Addressing COVID-19 Interference with Clinical Trials

March 21, 2020 | Blog | By Dianne Bourque, Benjamin Zegarelli

In recognition of the widespread disruptions the COVID-19 crisis is posing to planned and ongoing clinical trials at sites throughout the United States (and global clinical sites), the Food and Drug Administration (FDA) issued on Wednesday, March 18 a guidance describing potential considerations for adjusting trial processes and, potentially, protocols and statistical analysis plans to mitigate any difficulties meeting trial objectives due to interference from the virus and related social and governmental restrictions. The document, titled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, describes various potential complications, such as subjects being unable to travel to the trial site, loss of access to investigational product, or the need to screen subjects for COVID-19, as well as general recommendations for addressing them.
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FDA’s Ongoing Response to the COVID-19 (Coronavirus) Outbreak

March 18, 2020 | Blog | By Joanne Hawana, Benjamin Zegarelli

As we write this update on the actions of the Food and Drug Administration (FDA), more state and local governments (along with private businesses and employers) are taking sweeping actions to protect the public from the continued spread of COVID-19. The federal response to what is now a pandemic of COVID-19 started off slowly, but we are now seeing frequent and promising announcements from FDA and other agencies within the Department of Health and Human Services.

We published our first installment highlighting FDA’s role in this public health emergency on March 4, 2020 (see our prior post here). In the two weeks that have elapsed since then, FDA has taken several actions related to COVID-19 testing and other important public health protections which are explained below. One of the most striking things about the list of actions included in this post may be how diverse and broad FDA’s authorities are and what a substantial role the agency plays in protecting Americans from a variety of different types of harm.
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Following years of discussion, on March 5, 2020, U.S. Representatives Larry Buchson (R-IN) and Diana DeGette (D-CO) and U.S. Senators Richard Burr (R-NC) and Michael Bennet (D-CO) introduced identical versions of the Verifying Accurate and Leading-edge IVCT Development (VALID) Act in both chambers of Congress. The bipartisan legislation closely tracks existing medical device laws, with some notable exceptions, discussed below and in a prior post. If enacted, many regulatory elements familiar to in vitro diagnostic (IVD) and other medical device manufacturers would be applied to clinical laboratories that develop their own tests, commonly known as laboratory developed tests (LDTs). The bill also includes elements that are priorities for the Food and Drug Administration (FDA), including a program conceptually similar to pre-certification, third-party review, and Collaborative Communities. Unlike previously-circulated discussion drafts, the introduced bills include specific language designed to address public health emergencies, including COVID-19.
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We have previously blogged about the regulation of cannabidiol (CBD) products by the Food and Drug Administration (FDA) and the government’s actions to create a comprehensive regulatory framework for CBD, which includes introducing the Cannabidiol and Marijuana Research Expansion Act and hosting an FDA Public Hearing in May 2019 to obtain scientific data and safety information regarding cannabis-derived compounds. Most recently, on March 5, 2020, Commissioner Stephen Hahn provided an update to FDA’s efforts to increase education, research, and enforcement in this area. While the update alerted consumers, health professionals, and industry of FDA’s ongoing efforts to regulate CBD products, the efforts themselves are not dramatically new.
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Some clinical trial sponsors and principal investigators will be digging through their archives soon as a result of a recent ruling in the case of Seife v. U.S. Department of Health and Human Services, case number 1:18-cv-11462 (S.D.N.Y. 2018). In Seife, the plaintiffs – an investigative journalist and a former Associate Commissioner at the Food and Drug Administration (FDA) – challenged a Department of Health and Human Services (HHS) final rule that implemented clinical trial reporting requirements mandated by the Food and Drug Administration Amendments Act (FDAAA).
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Within the U.S. Department of Health and Human Services (HHS), many agencies have responsibility for responding to public health emergencies. The Centers for Disease Control and Prevention (CDC), as its name implies, is at the forefront of the COVID-19 (coronavirus) outbreak as the government seeks to control and prevent the spread of the virus in the United States. The National Institutes of Health (NIH), particularly the National Institute of Allergy and Infectious Diseases, are also involved, primarily conducting research into the sources, cause, and means of transmission of the new virus and coordinating vaccine development efforts. The Food and Drug Administration (FDA) is responsible for assuring the safety and effectiveness of medical products and therefore has oversight over any clinical trials for promising coronavirus treatments (drugs, vaccines, devices), as well as authority to authorize the marketing of any such product. The agency oversees the drug supply chain and monitors drug and device shortages. This blog post covers steps that FDA has taken to mitigate potential drug and device shortages related to coronavirus and to otherwise respond to the coronavirus situation.
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Collaborative Communities

February 27, 2020 | Video

ML Strategies’ Aaron Josephson explains why FDA is looking to Collaborative Communities to help solve challenges in 2020 and the potential benefit to companies who participate in the development of public policy.
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Closing the Orphan Drug Act Loophole

February 18, 2020 | Blog

On Tuesday, February 11, 2020, Senators Bill Cassidy (R-LA), Jeanne Shaheen (D-NH), and Tammy Baldwin (D-WI) introduced legislation to eliminate the “orphan drug loophole.” Current law allows the Food and Drug Administration (FDA) to grant seven years of market exclusivity to a drug manufacturer if the drug is intended to treat a disease or condition affecting fewer than 200,000 patients in the U.S., or less commonly, if the manufacturer cannot expect to recover the costs of developing and marketing a drug. In some cases, even if the drug developer meets the orphan drug criterion of having no hope of recovering the costs, the drug does actually become profitable—some significantly so—but competitors are still barred from entering the market with a lower-cost alternative during the 7-year exclusivity period that exists by operation of law. To combat this issue, the recently introduced Senate bill (as well as a nearly-identical House bill introduced in October 2019) targets a loophole that allows market exclusivity under the Orphan Drug Act to be extended for future versions of the same drug without the drug's manufacturer having to show that the drug remains unprofitable.
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FDA User Fee Agreements

February 14, 2020 | Video

In this video, Aaron Josephson discusses FDA user fee agreements, the timeline for the reauthorization process, and why it is important for companies with FDA-regulated products to be paying attention now.
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FDA Regulatory Due Diligence

February 7, 2020 | Video | By Joanne Hawana

Joanne Hawana explains how FDA regulatory due diligence fits into the broader diligence that is done when a transaction involves an FDA-regulated entity as well as what the team is looking for when conducting an FDA regulatory diligence project.
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FDA’s Approach to Direct-to-Consumer Genetic Testing

February 7, 2020 | Video | By Joanne Hawana

Joanne Hawana talks about the rise in direct-to-consumer genetic testing and how FDA has adapted its regulatory approach to such tests over the past few years as it has become more comfortable with genetic testing and sequencing technologies.
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Continuing progress on the initiatives announced in its Biosimilars Action Plan in July 2018 (see our prior post here), the Food and Drug Administration (FDA) released information about several important biosimilar-related actions on February 3, 2020. These recent moves make clear that FDA Commissioner Stephen Hahn, who was confirmed and sworn in to his new role at the tail end of 2019, is continuing to focus agency resources on the Biosimilars and Drug Competition Action Plans developed under the leadership of his predecessor, Dr. Scott Gottlieb.
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As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA) for another 5-year period is getting started this year. Below we highlight some changes made to the programs when they were last reauthorized through the 2017 Food and Drug Administration Reauthorization Act (FDARA) (P.L. 115-52) and consider what could be included in the upcoming user fee reauthorization package.
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FDA User Fees: How Do They Work?

January 28, 2020 | Blog

A history of FDA human medical product user fee programs, including those for prescription drugs (PDUFA), generic drugs (GDUFA), biosimilars (BsUFA), and medical devices (MDUFA), their negotiation and reauthorization, and how manufacturers and patients can participate and get involved in the negotiations.
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In a coordinated effort, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9, 2020. The website serves to streamline information regarding agriculture biotechnology products, which are regulated by FDA, USDA, and EPA. The implementation of the website is in response to the June 2019 Executive Order issued by President Donald Trump on Modernizing the Regulatory Framework for Agricultural Biotechnology Products. The Unified Website for Biotechnology Regulation complements prior joint actions such as the Coordinated Framework for the Regulation of Biotechnology, an Obama administration effort to reform the biotechnology regulatory process by enhancing transparency, predictability, and efficacy.
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