"Today’s most urgent challenges continue to bring us together. Some of us are collaborating on critical public safety and consumer protection initiatives. Some of us are working together to strengthen our courts and corrections systems – and to find ways to cut costs and share resources," said Attorney General Holder.

"For the Department of Justice, our commitment to preventing human trafficking, bringing traffickers to justice, and assisting victims has never been stronger – and our approach has never been more effective. Our work has sent a clear and critical message: that, in this country – and under this Administration – human trafficking crimes will not be tolerated," said Attorney General Holder.

"When it comes to violence, the challenges our children face are clear. We know that over 60 percent -- regardless of race – are exposed to some form of violence, crime, or abuse. Whether it's at home, in school, on the streets, or online, our children are witnessing and experiencing intolerable levels of violence. We also know that understanding the nature and extent of children’s exposure to violence is essential to effectively combating its effects," said Acting Associate Attorney General West.

Attorney General Eric Holder today convened the third meeting of the federal interagency Reentry Council at the Department of Justice.

"For nearly nine decades, ALI has been on the front lines of efforts to improve the strength, integrity, and effectiveness of our justice system," said Attorney General Holder.

"As our nation’s Attorney General, as a prosecutor and former judge, and as the brother of a retired New York-New Jersey Port Authority police officer, I am inspired by your service, and proud to support each of the brave men and women who make up the 'thin blue line' – a line defined by honor, heroism, and valor. Especially today, I am privileged to count the chiefs gathered here as indispensable colleagues and allies," said Attorney General Holder.

"At the Department of Justice, we are fully engaged in combating human trafficking, with many components deeply involved in this fight," said Deputy Attorney General Cole.

"This coordinated approach to finding solutions involves more than just enforcement -- we must also direct our efforts to prevent the occurrence of crime in the first place, provide support through intervention programs, and provide individuals reentering our communities from jails and prisons with the tools they need to succeed and turn away from crime," said Deputy Attorney General Cole.

Attorney General Eric Holder and Malaysian Minister for Home Affairs Datuk Seri Hishammuddin bin Tun Hussein met today, during the Attorney General’s official visit to Malaysia, to discuss transnational crime, terrorism and other areas of mutual law enforcement cooperation.

"Your role in the executive and legislative branches is unique, and you can use that position to engage with your states and encourage innovative, non-traditional partnerships across government and between local units of government and non-governmental organizations. These partnerships can create dynamic solutions to challenges we see across the country every day," said Acting Director Hanson.

"But if the arc of history bends toward justice -- and I believe it does -- then it bends not by it's own weight but by the hands of those who dare to reach," said Acting Associate Attorney General West.

"Over the last four years, we've generated tremendous momentum in our work to integrate evidence into our programs and activities. Our leadership – not only at BJS and NIJ, but across OJP – has demonstrated a strong scientific ethic," said Assistant Attorney General Leary.

"Although there’s no single solution that can bring a decisive end to this senseless violence, it’s incumbent upon each of us to try. And it’s time to consider what common-sense steps we can take – together – to save lives," said Attorney General Holder.

"In fact, this initiative constitutes a significant step forward in fostering increased levels of engagement with these partners and with Congress, in establishing a productive partnership between the Department of Justice and NIST, and in strengthening our ability to realize the goals and priorities that we all share," said Acting Assistant Attorney General Tyrangiel.

"So as we’ve seen over and over again, while we come from different parts of the country, have different backgrounds, belong to different political parties, our voices and our work are enhanced when we come together across state and federal boundaries, to combat pervasive and common threats," said Acting Associate Attorney General West.

"By helping to strengthen our state and federal criminal justice systems, fighting to expand access to legal services, and advancing critical public safety initiatives and consumer protections, you’ve addressed persistent challenges and improved countless lives," said Attorney General Holder.

The United States and the city of New Orleans announced today that public meetings would be held regarding a consent decree court monitor for the New Orleans Police Department.

U.S. Attorney General Eric Holder and European Commission Vice President Viviane Reding met today in Washington, D.C. They had cordial discussions on a wide range of fields of collaboration between the Department of Justice and the European Commission.

"Today, I am firmly committed – as I know everyone here is committed – to keep the promises we’ve made to the American people, and especially to survivors and victims’ families in communities like Newtown," said Attorney General Holder.

Attorney General Eric Holder is traveling to Auckland, New Zealand, for the Fifth Annual Meeting of the Quintet of Attorneys General of the United States, the United Kingdom, Canada, Australia and New Zealand.

This morning the Department of Justice hosted the initial meeting in the U.S.-E.U./E.U. Member State dialogue on intelligence practices.

Building on the work of the original and successful Defending Childhood Task Force and efforts across the Department of Justice in Indian country, the American Indian and Alaska Native Task Force will consist of two groups – an Advisory Committee and a Federal Working Group.

"Today, a vicious cycle of poverty, criminality, and incarceration traps too many Americans and weakens too many communities. And many aspects of our criminal justice system may actually exacerbate these problems, rather than alleviate them," said Attorney General Holder.

Attorney General Eric Holder met with Mexican Attorney General Jesús Murillo Karam today to discuss the release by the Mexican government of Rafael Caro Quintero, who was convicted of murdering Drug Enforcement Administration (DEA) Agent Enrique "Kiki" Camarena in February 1985.

Every U.S. Attorney with jurisdiction in Indian country has now appointed at least one tribal liaison, and we’ve designated a Native American Issues Coordinator to provide advice and assistance to U.S. Attorneys’ Offices on legal and policy issues.

Attorney General Eric Holder and Acting Department of Homeland Security (DHS) Secretary Rand Beers today hosted an EU/U.S. Justice and Home Affairs Ministerial with their counterparts in the European Union: Lithuanian Minister of Justice Juozas Bernatonis and Lithuanian Vice Minister of Interior Elvinas Jankevicius representing the Lithuanian Presidency of the Council of the EU; Greek Minister of Justice, Transparency and Human Rights Charalampos Athanasiou representing the incoming Greek Presidency of the EU; and European Commission Vice President Viviane Reding and Commissioner Cecilia Malmström representing the EU Commission.

Together, we can grow smarter on crime by implementing reforms and enacting legislation that ensures fairness in sentencing; by focusing scarce resources on incarcerating only those who pose the greatest threats; and by providing safe and productive paths forward for those who have paid their debts to society.

"I want to talk with you today about the crisis we have in our criminal justice system. A crisis that is fundamental and has the potential to continue to swallow important efforts in the fight against crime. This crisis is the crushing prison population."

The fact that we cannot compel other federal, state, and local laboratories and units to adopt this Commission’s guidance does underscore the need to be mindful of the diversity of practice and resources across the country. We must delicately balance the desire to develop meaningful policy with the reality of limited funding at the federal, state, and local levels. And we must do so without taking shortcuts.

The heads of the antitrust agencies of the United States, Canada and Mexico – Assistant Attorney General Bill Baer of the Department of Justice’s Antitrust Division, Chairwoman Edith Ramirez of the Federal Trade Commission, Canadian Commissioner of Competition John Pecman and President Alejandra Palacios Prieto of the Mexican Federal Competition Commission – met today in Washington, D.C., to discuss their mutual efforts to ensure continued effective antitrust enforcement cooperation in our increasingly interconnected markets.

There can be no doubt that we share a common goal to hold accountable those whose actions contributed to the last financial crisis, which was felt not just at the national or global level, but in the countless communities you represent, as well.

It is a pleasure to be with you today. And it’s an honor to join so many distinguished jurists, dedicated public servants, devoted members of the private bar, hardworking students, and good friends in discussing the challenges we face – and the opportunities now before us – to expand access to justice; to strengthen the rule of law; and to improve America’s legal system across the board – so we can move our nation closer to its founding ideals of equality, opportunity, and justice for all.

Assistant Attorney General Bill Baer in charge of the Department of Justice’s Antitrust Division today met with 35 international antitrust enforcement agencies and dozens of private antitrust practitioners in Washington, D.C.

Today, Attorney General Eric Holder met with campus leadership from eight Washington, D.C.-area colleges and universities: American University; Catholic University of America; Gallaudet University; Georgetown University; George Washington University; Howard University; Trinity University; and University of the District of Columbia, to discuss how administrations are addressing sexual assault on campus.

"This morning, as I look around this crowd of passionate professionals and dedicated public servants, I cannot help but feel confident in our ability to do just that; to develop smart solutions to the toughest problems we face; to protect the rights of everyone in this country, no matter their salary or their skin color; and to further enshrine the ideals of American justice into the annals of American law."

Earlier today, Associate Attorney General Tony West, Assistant Attorney General Stuart Delery for the Civil Division and members of the Department’s Elder Justice Initiative met with stakeholders in the field of elder abuse and financial exploitation to launch the Elder Justice website.

The following statement is attributable to Justice Department spokesman Brian Fallon regarding Attorney General Eric Holder’s visit to Mexico City today to meet with his fellow attorneys general from across Central America to discuss the situation involving migrant children.

By Alice Li, MD, MSc, RAC(CAN), Regulatory Scientist, Cato Research Special Interest Guidances/Information Date Posted Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics – Final Guidance 30 Dec 2019 Submission of Plans for Cigarette Packages …

Continue reading »

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS Special Interest Guidances/Information Date Posted Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry: Draft Guidance for Industry – Draft Guidance 30 Jan 2020 Arthroscopy Pump Tubing Sets …

Continue reading »

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS    Special Interest Guidances/Information Date Posted Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories and Food and …

Continue reading »

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS FDA guidances from March 2020 as well as upcoming advisory committee meeting announcements are below.  We note that approximately one-third of FDA’s guidances this past month are related to COVID-19.    Special Interest Guidances/Information Date Posted Enforcement Policy for Gowns, Other Apparel, and …

Continue reading »

By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 30 April 2020 FDA Deems Certain Tobacco Products Subject to FDA Authority, …

Continue reading »

Today's Daily Dose brings you news about FDA approval of Immunomedics' breast cancer drug; promising results from Kiniksa Pharma's prurigo nodularis trial; Mallinckrodt's regulatory catalyst; Myovant Sciences' phase III SPIRIT 2 study results and another disappointment in Parkinson's disease drug development space.

Malaysia, the host of APEC 2020, has announced the postponement of the upcoming Second Senior Officials’ Meeting, the 2020 APEC Tourism Ministerial Meeting, and the 2020 APEC Ministers Responsible of Trade Meeting, which were scheduled for April this year.

Developing safe and effective drugs requires a coordinated effort across a diverse set of disciplines. This is easier to observe at some points in the process than at others. Once a product is well into human trials, it can be easy to forget that developments on the manufacturing side of the house can affect the clinicians who are conducting the studies.




Trialed Drug vs Marketed Drug


Once researchers are satisfied that animal studies show that an Active Pharmaceutical Ingredient (API) is effective and nontoxic at initial doses, there’s an urgency to get it into the clinic and begin human studies as soon as possible. Though the ultimate product may be marketed in one form, a different form may take less time to manufacture, and so would be the form given to human volunteers in earlier clinical trials.

A tablet, for example, is much harder to manufacture than a 2-piece hard shell capsule because determining the appropriate compression for a tablet takes time. (Tablets that aren’t sufficiently compressed will break apart in the bottle; tablets compressed too tightly may not dissolve as they should, earning themselves the entertainingly accurate moniker “bedpan bullets.”) Rather than wait until a tablet form of the drug can be fully developed, to save time, sponsors would likely begin human studies using a hard shell capsule version.*

To ensure that clinical trial data for the Investigational Product (IP) are applicable to the ultimately marketed product, clinicians run bioequivalence for dosage form studies. These small pharmacokinetics studies may result in changes, such as dosage amount or frequency, if people do not metabolize the studied formulation and the final formulation the same way.


Stability Test Failures

When we hear of a pharmaceutical company having to “pull its product,” we typically think of a recall scenario that involves consumers, distributers, and retailers.  Recall procedures fall under the GMP umbrella, and are spelled out in great detail in 21 CFR Part 211. However, similar procedures may very well be required of clinical site staff, long before the product ever sees its first drugstore.


Before any clinical trials begin on a drug, manufacturers would have been conducting stability tests for months. But stability testing may continue for years after the start of human trials, and analysts could detect a variety of troubling conditions in the course of their work. Product can change color or break apart. Capsules can crack and leak. Microbes could begin to grow, especially in moister product. The container closure system itself could be problematic; it could leech contaminating material into the product, introducing impurities, or it could extract material from the product, diminishing its potency. Any of these finding could mean that study drug would need to be pulled from clinical sites.

No one expects site staff to have detailed quarantining and recall procedures; the Sponsor will tell site staff exactly what they need to do. But what would this look like?

(1) Adulterated product that cannot be dispensed will need to be moved to a separate, secure area so it won’t be confused with good product. It might need to be stored there for a period of time or shipped back to the Sponsor.

(2) For certain, a site’s drug accountability procedures will be center stage. The only way a site can successfully recall bad product is if it has -- all along -- closely tracked the amount of IP it has received, dispensed, and still has on hand.

(3) Study participants who have any quantity of the bad product will need to be contacted, told not to use it, and told how to return it. (Note that this pertains to participants on the placebo arm as well, otherwise the blind will be broken.) Phone calls may not be sufficient; sites may need to invoke lost-to-follow-up procedures, such as sending registered letters. Remote, virtual trials, which often ship IP to participants, need to be designed to allow for the tracking and retrieval of bad product.

(4) What should be done if it turns out some participants have already used the bad product? Unfortunately, that’s one SOP you can’t write in advance; it would completely depend on the nature of the IP and the problem it has, the vulnerability of the patient population, the protocol, the participant’s proximity to the site, etc. Perhaps a careful case review to look for AEs associated with affected participants would suffice. More critical situations may require participants to undergo physical examinations or special testing. In many cases, study data associated with the use of the tainted IP would need to be identified and removed from the efficacy analysis.

(5) These quarantining and recall activities must be carefully recorded. IRBs and regulators will want written proof that all suspect IP has been accounted for. Sponsors might consider sending a CRA to ensure adequate documentation.


Re-labeling

Stability tests don’t have to fail to trigger action for clinical staff. Should a chemist discover a condition that requires a labeling modification -- a new expiry date**, for example – all the labels on existing product held at clinical study sites would need to be replaced. In these situations, the Sponsor may dispatch CRAs to replace the labels themselves, or negotiate with individual site staffs to do it instead. 


No GxP is an Island…

GMP professionals manufacture, package, and label biopharmaceutical products. GCP professionals conduct clinical trials on those same products. These roles are very different from each other, yet they don’t work in isolation. Formulation changes, stability testing, and re-labeling requirements represent three examples in which activities performed by GMP folks impact their GCP counterparts. Have you experienced any additional examples? Feel free to share them in the Comments section.

In case you missed it, our last post was about how attributes of the Study Drug influence the Site Selection and Feasibility process.

___________________________________________________________

* “By the time clinical trials start, they know what ingredients go in the cookie, they just don’t know how the cookie is going to turn out yet.”
       - Rosanne Sylvia-Heeter, Polaris Director of GMP Compliance and phenomenal cook

** Expiry dates are not required but are sometimes included on IP labels.

Q: Do study site personnel need to be able to answer questions about sponsor-provided computer systems during an inspection?

A: Yes, and there’s a simple thing that sponsors and CROs can do to prepare their sites.

This excerpt was lifted from an online, interactive course entitled “Developing a Part 11 Compliance Plan in Clinical Research.” While the course mainly targeted sponsors and CROs, who have the heaviest regulatory burden in this area, sites also have Part 11 and validation concerns, as demonstrated by this question.

Presenter Lisa Olson, a CSV/Part 11 expert with Polaris Compliance Consultants, briefly described her recommendation, which is both simple and effective. (And since that is total catnip to a compliance blogger, I interviewed her after her presentation to develop the following piece.)

So here it is. Here’s what she said...

Clinical research sites rely heavily on technology to store and manage study data, so regulators are focusing on computer systems and electronic data more than ever before. Many of the systems – such as Electronic Data Collection (EDCs), Interactive Response Technology (IRTs), and e-diaries – are selected and largely controlled by sponsors, CROs, and/or third-party vendors. That doesn’t mean, however, that site staff won’t be expected to answer questions about these systems during a regulatory inspection. Quite the contrary: site personnel are responsible for the integrity of the data these systems house. They need to be able to demonstrate the knowledge required to meet their regulatory obligations.

No one is expecting site staff to be computer specialists; the expertise on these systems resides within the sponsor/CRO/vendor organizations. But the better a site can satisfy a basic, frontline inquiry into the systems it uses, the less likely it is that an inspector will pursue additional lines of questions.

So how can sponsors and CROs help?

They can provide a set of short summaries (one page per system) that answer the questions regulators are likely to ask site staff members. Filed in the Investigator Site File (ISF), ready for use, these summaries will be valuable resources.


The Basics

First, sponsors/CROs should supply identifying information: the name of the system, the vendor, the version of the system currently being used, and a few sentences that describe what the system does.
User Access and Control

To ensure both data integrity and compliance with Part 11 e-record/e-signature regulation, it’s essential that access to a system be controlled and data entry/updates be traceable to a specific person. To that end, the one-pager should describe how unique logins are assigned and how users are restricted to activities appropriate to their roles in the study. A monitor requires read-only access to an EDC system. A study coordinator needs to be able to enter and change EDC data. A Principal Investigator must be able to sign electronic Case Report Forms (CRFs). The role determines the access. Staff should also be able to briefly describe how an audit trail captures metadata that show what data were entered/altered, by whom, and when. (And someone, though not everyone, needs to be able to demonstrate how the audit trail can be used to piece together the “story of the data.” That, however, is too much to ask from our one-pager.)

Validation 101

It would be unusual for site personnel to have detailed knowledge of Computer System Validation (CSV) activities. Nevertheless, the one-pager could include a single line that confirms that the system was validated and by whom. A contact number could be included in case a regulator asks for more information or wants to see validation documents.

Where’s The Data?

Regulators will often ask where system data are stored. The answer to that question can be a simple sentence: The data are hosted by the EDC vendor at such-and-such location, or stored at the CRO, or sit on a local server within the site’s IT department.

Finally, the last line of our one-pager could be a simple statement prepared by the sponsor, CRO, or vendor, confirming that the data are protected wherever they are being stored. The data center is secure and environmentally controlled; the data are backed up to protect against loss; the system is accessed via the web through an encrypted channel -- whatever protections apply.

Conclusion

Regulators are increasingly focused on the integrity of study-related data, and that means added scrutiny of electronic systems and records. More inspections are being conducted mid-study so regulators can evaluate and ask about live systems in current operation. It’s very difficult for sites to field these questions without help from the organizations who make the decisions and have the expertise.

It’s okay to tell an inspector, “I don’t know.” (And it’s always preferable to admit that than to improvise an answer.) But say it too many times, and it casts doubt on a site’s ability to produce and maintain reliable study data. That’s in no one’s interest.

It shouldn’t be overly burdensome to develop a one-page summary sheet for each system so site personnel can address an inspector’s questions on the spot. The Investigator Meetings or Site Initiation Visits would be a good opportunity for sites to raise this point with their sponsors/CROs.

Lisa Olson will be giving an encore presentation of “Developing a Part 11 Compliance Plan in Clinical Research,” on March 24th. She describes all the elements that regulators and clients will be expecting, and since sponsors and CROs can’t implement everything all at once, Lisa prioritizes the activities necessary for developing your plan. You can register for the online course, sponsored by the Life Science Training Institute, here. Use the promotion code olson to receive a 10% discount.

Virtually everyone is going virtual. Even in February, which seems like a very long time ago, many organizers began either postponing or canceling major conferences and meetings. This has included major medical meetings and given that large gatherings will be … Continue reading →

by Peter Elkind, ProPublica, and Meg Cramer, WNYC, with Doris Burke, ProPublica

On May 12, after a six-week delay caused by the pandemic, the U.S. Supreme Court will hear arguments in the epic battle by congressional committees and New York prosecutors to pry loose eight years of President Donald Trump’s tax returns.

Much about the case is without precedent. Oral arguments will be publicly broadcast on live audio. The nine justices and opposing lawyers will debate the issues remotely, from their offices and homes. And the central question is extraordinary: Is the president of the United States immune from congressional — and even criminal — investigation?

Next week’s arguments concern whether Trump’s accounting firm, Mazars USA, must hand over his tax returns and other records to a House committee and the Manhattan district attorney, which have separately subpoenaed them. (There will also be arguments on congressional subpoenas to two of Trump’s banks.) Trump, who promised while running for president to make his tax returns public, has sued to block the documents’ release. The questions apply beyond this case. Trump has repeatedly resisted congressional scrutiny, most recently by vowing to ignore oversight requirements included in the trillion-dollar pandemic-bailout legislation. “I’ll be the oversight,” he declared.

The president’s accounting firm has found itself at the center of this high-stakes fight. The American arm of a global firm, Mazars has portrayed itself as an innocent bystander in the war between Trump and his pursuers, dragged into the conflict merely for possessing the trove of subpoenaed records. It’s the firm’s first burst into the media glare apart from an unfortunate moment of tabloid coverage in 2016 after one of its New York partners stabbed his wife to death in the shower of their suburban home. (He pleaded guilty to manslaughter.) Mazars has said it will abide by whatever decision the court makes in the Trump matter.

But Trump’s accountants are far from bystanders in the matters under scrutiny — or in the rise of Trump. Over a span of decades, they have played two critical, but discordant, roles for Trump. One is common for an accounting firm: to help him pay the smallest amount of taxes possible. The second is not common at all: to help him appear to the world to be rich beyond imagining. That sometimes requires creating precisely the opposite impression of what’s in his tax filings.

Time and again, from press interviews in the 1980s to the launch of his 2016 campaign, Trump has trotted out evermore outsized claims of his wealth, frequently brandishing papers prepared by members of his accounting team, who have sometimes been called on to appear in person when they were presented, offering a sort of mute testimony in support of the findings. The accountants’ written disclaimers — that the calculations rely on Trump’s own numbers, rendering them essentially meaningless — are rarely mentioned.

Trump’s accountants have been crucial enablers in his remarkable rise. And like their marquee client, they have a surprisingly colorful and tangled story of their own. It’s dramatically at odds with the image Trump has presented of his accountants as “one of the most highly respected” big firms, solemnly confirming his numbers after months of careful scrutiny. For starters, it’s only technically true to say Trump’s accounting work is handled by a large firm.

In fact, Trump entrusts his taxes and planning to a tiny, secretive team of CPAs who have operated at various times from humble quarters in Queens and two Long Island office parks. That team, which has had two leaders with back-to-back multidecade terms, has been working for the Trumps since Fred Trump began using the firm back in the 1950s. It was eventually subsumed into Mazars USA, the American arm of a large international firm, through a series of mergers over decades.

Listen to the Episode

One theme has been consistent: partners and sometimes the firm itself have faced accusations of fraud, misconduct and malpractice on multiple occasions, an investigation by ProPublica and WNYC has found.

That pattern dates to the 30 years during which the Trump accounting team was led by Jack Mitnick, whose pugnaciousness was exceeded only by his aversion to his clients paying the IRS. He was the architect of the notorious schemes, revealed by The New York Times, to dodge more than $500 million in gift and inheritance taxes and funnel hundreds of millions from Fred Trump to his children, helping keep Donald Trump afloat through four of his business bankruptcies. Mitnick was known as an accounting star — at least until 1996, when his partners threw him out of the firm amid accusations of fraud and malpractice.

Years of turmoil followed. The firm operated without malpractice insurance for a period and was dogged by feuds — with current and former partners suing each other — and financial problems.

And it ran afoul of regulators. In January of 2004 — one week after “The Apprentice” premiered on NBC — the Securities and Exchange Commission formally censured the firm for willfully aiding and abetting misconduct. The SEC suspended one partner from practicing before it for four years for what the agency called “highly unreasonable” and “improper professional conduct.”

Since Trump’s accountants merged their practice into Mazars in 2010, they have been present for Trump’s scandals, too. Mazars accountants prepared the tax returns for the Donald J. Trump Foundation, forced to shut down and ordered to pay more than $2 million in damages after a New York attorney general’s investigation exposed a history of illegal self-dealing. And the Manhattan DA’s office, which is investigating whether the Trump Organization falsified its business records to cover up hush-money payments to adult film actress Stormy Daniels, subpoenaed not only Trump’s tax returns but also various internal records and assessments prepared by Mazars.

Today, the CEO of Mazars USA is the same partner who was suspended by the SEC for four years for improper conduct. (Mazars defends its CEO, saying he meets all ethical and professional standards, and asserts that the firm has encountered no more sanctions or litigation than other comparable firms.)

The choice of a formerly suspended accountant as CEO surprised former SEC Chief Accountant Lynn Turner, now a senior adviser at the Hemming Morse financial consulting firm. “In my opinion,” said Turner, “that speaks loudly with the respect to the confidence one would have in that firm — better yet, the total lack of confidence one would have in that firm. And it would certainly make me wonder about the culture of that firm and whether or not that firm acts with integrity.”

---

Whether by design, or perhaps just coincidence, Trump’s accountants have occasionally displayed the sort of audacity often associated with their client. Consider this example involving New York City taxes back in the 1980s. Mitnick claimed that Trump was exempt from paying tax on profit he made by flipping a Trump Tower condo. He had acquired the unit at cost, $634,648, ostensibly for providing “consulting services” to his development partnership, then sold it 19 days later for $3 million.

At an administrative court hearing, Mitnick defended deductions that he’d claimed offset any profits from Trump’s consulting business, even as he failed to provide any documentation or explanation for those expenses, according to the 15-page court opinion in the case. He went so far as to deny that he’d prepared the federal tax return for Trump that also claimed the deductions, even though his signature was on the document.

The accountant evidently protested vociferously in the New York case, leading the administrative law judge to scoff, “The problem at issue is not one of double taxation, but of no taxation.” The total amount at stake was relatively modest — $87,693.57, including penalties and interest — but Mitnick, on Trump’s behalf, contested it for more than a decade before a city appeals panel finally put an end to the case, ordering Trump to pay up.

Decades after he left the Trump account, Mitnick briefly surfaced in the press in 2016, after the Times reported that Trump’s 1995 tax return reported a $916 million loss. Mitnick, then 80, dismissed Trump’s boast that he was a tax genius for using the loss to avoid paying taxes for as much as a decade. “I did all the tax preparation,” the dour accountant told TV interviewers. “He never saw the product until it was presented to him for signature.” Mitnick added, with apparent pride: “Those returns were entirely created by us.”

When ProPublica first sought to speak with Mitnick late last year, he asked, “What’s in it for me?” and said he’d discuss Trump only if he were paid for his time. (In a longer second call, where he also asked to be paid, he eventually offered brief responses to some questions.)

An accountant and attorney, Mitnick first arrived at Spahr Lacher & Berk, the tiny firm later merged into Mazars, in 1963, at age 27. Mitnick soon took charge of the Trumps’ accounts. He would oversee them for the next 30 years.

In its early years, Spahr was located in Jamaica, Queens, and employed just a handful of CPAs. The firm had been working with the Trump family, whose five-bedroom Tudor home was in tonier Jamaica Estates, at least since 1951, when Fred Trump cemented the relationship by hiring a Spahr partner as controller for his growing real estate business.

Fred Trump was far and away Spahr’s biggest client. His cash-spewing rental apartment empire in Brooklyn and Queens required lots of accounting work, and Fred paid his bills in full and on time. By 1979, Spahr Lacher had moved into a nondescript suburban office park in Lake Success, Long Island, just beyond the Queens border and the reach of New York City taxes.

By then Donald Trump had begun pursuing his big, risky and expensive ambitions: glitzy towers and hotels in Manhattan; three over-the-top Atlantic City casinos; his own airline; a massive yacht and a professional football team. In 1987, as his father had done, Donald hired his company’s controller from the ranks of his accounting firm.

Trump’s accountants played a critical role in Donald’s survival through the 1980s and early ʼ90s, a period when many of his projects crashed and burned, requiring massive infusions of cash from his father. With Mitnick in charge, Spahr hatched the strategies that minimized both gift and estate taxes on the transfer of Fred’s wealth to Donald and his siblings.

A 2018 Times investigation found that Fred Trump had funneled at least $413 million in current dollars to his son and that the Trumps’ tax-avoidance tactics, all told, had slashed their tax bill by about $500 million. The article described some of the tax moves as “outright fraud.” (Trump’s lawyer called that conclusion “100% false” and said the relevant authorities “fully approved all of the tax filings.”)

A lynchpin of the strategy was the 1992 creation of a corporation, All County Building Supply & Maintenance, through which Fred Trump’s children charged their father’s business grossly inflated prices, then split the markup, allowing them to avoid gift taxes even as they reeled in millions from their father.

The strategy was viewed as a major success inside the accounting firm. “I wish I could take credit for it,” Mitchell Zachary, a former Spahr partner who worked on the Trumps’ accounts for more than a decade, told ProPublica and WNYC. “It was brilliant, but it wasn’t mine,” Zachary said. “It was a team of accountants, partners at Spahr.” Zachary defended the firm’s practices for the Trumps as “aggressive” but “within the letter of the law.”

Mitnick was viewed as “a tax god” inside the firm, said Zachary, who worked at Spahr Lacher from 1986 to 2002 and teamed with Mitnick on the Trumps’ accounts. The family “wouldn’t make a move” without checking with Mitnick, he said. Mitnick even made a cameo appearance (albeit with his name misspelled) in the first chapter of Trump’s 1987 book, “The Art of the Deal.”

Mitnick pressed for every advantage on Trump’s behalf, ever urging Zachary to be bolder. A fundamental Mitnick principle: “If you can’t find me where the law says you can’t do it, you can do it.” Said Zachary: “He always took these very aggressive positions and would never back down. Never. He always felt, ‘I’ll just keep appealing.’”

Mitnick’s team developed virtually all the Trumps’ tax-avoidance maneuvers, Zachary said. “I mean, it was all for their benefit in so many ways,” he said. “It’s not like they were going to question it.”

Donald Trump’s accounting work was much more complex than that of his father. His business operated scores of separate entities, each requiring its own tax filings. Just preparing his annual personal return took three to four months.

Diving into Trump’s personal finances, as Zachary did in the late 1980s, proved bewildering. Warned that his work for Trump was sure to face an audit, Zachary said he took special care to trace every asset, expense and receipt. When he finally finished, he was mystified. Zachary couldn’t find evidence that Trump, in fact, possessed any cash beyond a recent payment in a casino deal.

“I went to Jack Mitnick, and I said, ‘Look, I must be missing something: There’s nothing here!’… I thought for sure I screwed up. I thought for sure I missed something big.”

Zachary recalled Mitnick’s reply. “He just laughed and went: ‘Well, you just figured it out!’”

---

Spahr took unusual steps to safeguard the confidentiality of Donald Trump’s returns. No work papers or documents could be left on a CPA’s desk overnight; everything had to be carefully locked up.

The secrecy was imposed to hide the chasm between Trump’s public claims and reality, according to Zachary: “He bragged a lot. … More than any other individual that I’ve ever seen, he was very big at promoting that he’s this super-rich billionaire.”

Trump was a difficult client. He demanded discounts on fees and took forever to pay his bills. “Collecting from Trump was awful,” Zachary said. Eventually Spahr agreed to give Trump a 50% discount and allow him 12 months to pay. Zachary said: “Donald always made it clear: ‘You get the privilege of saying you’re Donald Trump’s accountants, so you have to pay the price.’”

Trump’s nearly $1 billion write-off for 1995 represented an aggregation of the enormous losses his business blunders had run up — and Spahr skillfully exploited them on Trump’s behalf. Trump paid no federal income tax in nine of the 11 years from 1984 through 1994, according to tax materials obtained by the Times and publicly released documents.

It is true that the Trumps’ aggressive tactics drew virtually nonstop scrutiny from tax authorities. Indeed, they spent so much time examining the Trumps’ books, Zachary said, that Spahr Lacher had a special room permanently set aside for the IRS’s Trump auditors. (Zachary also cites this scrutiny, and the relatively modest resulting adjustments, as evidence that Spahr’s tactics didn’t cross the line.)

Spahr’s focus on wealth-transfer strategies intensified in the early 1990s, after Fred Trump, a detail-minded workaholic, began suffering from poor health and dementia. One tactic was to divide legal ownership of Fred’s properties into separate family partnerships, so Fred lacked complete control. That helped justify lowball appraisals for tax purposes. “There was an appraiser out there that the IRS hated … because he was so aggressive. And that’s the guy we used,” Zachary said. That appraiser, he said, reduced the claimed values of Fred Trump’s properties by 35% to 40% — and occasionally dramatically more.

By the time Fred Trump died in 1999, Mitnick was gone from the firm. His departure followed a series of troubling lawsuits and other setbacks relating to work for non-Trump clients. In one case brought over Mitnick’s administration of a tax-shelter investment involving coal mine leases, a federal appeals court wrote in 1985: “The record amply demonstrates that he committed fraud.”

In a second case, longtime Spahr clients charged Mitnick and the firm with “a long-term coverup of Mitnick’s malpractice” on their family’s estate and audit work, accusing them of missing filing deadlines and making false statements to the IRS, which they claimed cost the family millions in taxes and penalties. They asserted that Mitnick and his team neglected them and “devoted most of their professional time to other clients, including Donald Trump and his enterprises.” After the trial judge found that Mitnick was “the primary wrongdoer,” the matter was eventually settled for about $500,000, according to Mitnick’s deposition testimony in yet another malpractice suit against both him and the firm.

Mitnick, meanwhile, had his own problems with the IRS. He had filed three federal tax court cases between 1987 and 1990 challenging IRS levies against him and his wife on their personal taxes.

He became an enigma to his Spahr partners. Mitnick often seemed oblivious to important deadlines. One partner recalls finding Mitnick, just hours before a critical tax filing was due, in the firm’s staff room with a hammer and screwdriver, fixing a broken chair.

By the mid-1990s, the litigation had left Spahr Lacher unable to obtain insurance, threatening the firm’s continued existence. Partners, including Zachary, shifted their assets into their spouses’ names. Records show the Mitnicks’ home, located 2 miles from the firm’s office, was held in his wife’s name.

In September 1996, the partners expelled Mitnick. They told clients that Mitnick, then 60, was retiring. Less than a year later, he became a tax counsel with a Long Island law firm, where he remained until 2014.

Asked about these events, Mitnick, now 84, repeatedly declined to comment, saying he couldn’t discuss “confidential communications between myself and the client.” He added, “You’re going back to the dark ages.”

Mitnick eventually fell on hard times. In 2007, after Citibank filed a foreclosure action on an unpaid $500,000 mortgage loan, Mitnick and his wife sold their $1.4 million Long Island home. Three years later the IRS slapped him with a lien for more than $155,000 in unpaid federal tax debts dating back to 2003. Mitnick and his wife relocated to a modest house in Palm Beach County, Florida.

In May 2017 Mitnick and his wife were evicted after failing to pay $11,331 in assessments and penalties to their homeowners association. Their possessions were placed out on the street. Less than two years later, in March 2019, they were ejected again, this time evicted from an apartment for unpaid rent and, according to a court filing, “physically removed from the premises.”

---

At the time Mitnick left the firm, partners feared his departure might cost them the Trump business, which Zachary estimates represented about a third of the firm’s total billings. But Trump agreed to stick with Spahr.

Still, the firm’s existence was precarious. Unable to obtain malpractice coverage, Spahr’s eight partners, after being hit by another lawsuit settlement, learned they would have to dig into their own pockets to pay it.

So they happily welcomed an acquirer: M.R. Weiser & Co., a midsize Manhattan accounting firm eager to establish a big presence on Long Island. Spahr’s leaders signed off on the deal only after again seeking Trump’s personal blessing. He gave it, Zachary said, after being assured his fees wouldn’t increase.

As it turned out, Weiser had problems of its own. The firm had engaged in a disastrous buying binge aimed at transforming the firm into a regional powerhouse. The deals instead triggered what partners later described as a “crisis of finances and morale.” Just a year after swallowing Spahr, Weiser’s partners ousted the firm’s chairman, Stanley Nasberg, who then sued, demanding $5 million in damages and sending the dispute to an arbitration panel. (In an interview, Nasberg maintained he was “instrumental” in the rapid growth of the firm and recruitment of major clients. He blamed his ouster on the “greed” of his then-partners.)

The 24-page report from the arbitration panel detailed a litany of “recriminations and factual and legal disputes.” The firm had suffered such “acute cash shortages” that some senior partners had delayed depositing their year-end paychecks in 1999; partner draws had been withheld altogether in early 2000.

For years Weiser was roiled by factional conflicts, cash-flow problems and bitter litigation. “It became just a disjointed mess,” said Jeff Coopersmith, a partner who arrived in 1999 as the result of one merger and was frog-marched out six years later after the firm discovered his plans to start his own firm with two other partners (and take clients with him).

Amid all this turmoil, the Trump group remained a constant. With Mitnick’s departure, the firm handed its leadership to a CPA who seemed even more single-mindedly dedicated to the mogul: Donald Bender.

Bespectacled, bald and bookish, Bender had arrived at Spahr in 1981, shortly after earning his accounting degree at Queens College. He’s been there ever since. (Through a firm spokesman, Bender declined requests for an interview.)

Bender had a monkish devotion to his work, and to Trump, who became his sole client. Bender remained single well into middle age, when he married a woman who’d worked at Weiser. Now 62, he still runs the Trump account and lives with his family in a drab townhouse, six minutes’ drive from his office.

Bender’s dedication won Trump’s respect, said Zachary, who worked closely with Bender until leaving the firm in 2002. “He really devoted his life to Donald Trump,” Zachary said, enough to earn him an invitation to Trump’s wedding to Melania Knauss at Mar-a-Lago in 2005.

Operating from offices at one end of the accounting firm’s floor, Bender and his small Trump team kept to themselves. It had long been standard practice to maintain extraordinary security provisions for all of Trump’s electronic files, including barring anyone from viewing them without a special password.

Bender’s group had a mystique within the firm. In a 2017 essay published on a literary website, a former junior accountant at Weiser, Henry Kogan, recounted meeting Bender — whom he referred to as “the other Donald” — in the firm’s cafeteria. “After I introduced myself and the small talk subsided he said, ‘Everything you say will be repeated.’… In my two years at Weiser LLP, I learned the other Donald didn’t talk much but when he did it was worth listening to.”

Kogan described the knowledge of Trump’s financial world as “passed down from one generation to the next through a single, chosen accountant, orally.” As he put it, “You could sense the weight of this knowledge in the way [Bender] walked, the way he carried himself, carefully and with precision. Sometimes it seemed as if he were moving across a tightrope, invisible across the thickly carpeted office floor.” Bender’s “entire professional existence,” he wrote, “revolved around one client, that client’s organization, and the hundreds of entities represented inside an IRS form.”

---

As Trump banked evermore on his image for breathtaking wealth, he enlisted his accountants to back his dubious claims. For example, struggling to avoid personal bankruptcy in 1994, Trump cooperated with a cover story in Vanity Fair promoting his “comeback.”

“Piece by piece, deal by deal, a beautiful story is starting to emerge about me,” Trump declared, after picking up writer Edward Klein in his stretch limo. As they were driven to a black-tie dinner at the Waldorf-Astoria hotel honoring Trump as “Humanitarian of the Year,” Klein wrote, “he handed me a folder containing his personal financial statement, which had been prepared by the accounting firm of Spahr, Lacher & Sperber.” It showed $139,326,000 in cash and equivalents.” That figure seemed unlikely given that four of Trump’s companies had gone bankrupt during the early 1990s.

Similar documents surfaced in 2006, after Trump was stung by a book written by Tim O’Brien that ridiculed his boasts of being worth as much as $6 billion. The book, “TrumpNation: The Art of Being the Donald,” cited three confidential sources “with direct knowledge of Donald’s finances” who said the number was actually between $150 million and $250 million.

Looking to rehabilitate the image of his net worth — on Forbes’ annual list of billionaires — Trump enlisted his accountants. He summoned two Forbes reporters, according to one of them, Stephane Fitch. They arrived at his Trump Tower conference room to find a table piled with leather-bound volumes and stacks of manila folders, supposedly documenting how much Trump was worth. Also present, to help make the case: Bender and his Weiser partner Gerald Rosenblum. The two accountants sat silently as Trump and his deputies touted his wealth. Forbes ultimately pegged it at $2.9 billion — about half of what Trump claimed — but far higher than O’Brien’s assessment.

Trump sued O’Brien for defamation, and in the litigation, too, the accountants and their work played a supporting role. A 25-page document, on Weiser letterhead, titled “Accountants Compilation Report” was produced during discovery. (“I do keep one actually on my desk, hidden,” Trump testified during the case.) A two-page disclaimer explained that the report (which claimed a net worth of $3.5 billion) was based entirely on “the representation of the individual whose financial statements are presented.” In other words, all the numbers came from Trump.

Trump made clear just how unreliable that was, at one point testifying during his deposition: “My net worth fluctuates, and it goes up and down with markets and with attitudes and with feelings, even my own feelings.” Asked if he’d ever exaggerated in statements about his properties, Trump replied: “I think everyone does.”

The disclaimer on the “compilation” noted that Weiser had done nothing to confirm the unaudited numbers, which included wholesale departures from generally accepted accounting principles (GAAP). In particular, the statement acknowledged counting future income streams that were in doubt; excluding much of Trump’s debt; failing to reflect whether Trump actually owned only a portion of the assets he listed; and ignoring both repayment obligations and whatever taxes he owed.

Weiser did sometimes prepare GAAP-compliant audited financial statements for Trump, when required by some lenders and regulators. These statements revealed a lower net worth. So Trump shared the “compilation” documents with reporters instead.

O’Brien’s lawyers deposed the two Weiser partners who worked on the Trump document. Asked to explain a memo he’d written calling Trump’s valuations on properties “subjective,” Bender demurred: “I don’t have the professional expertise to discuss valuations.” Rosenblum, who said he had been preparing such statements for Trump since the early 1980s, was more direct. “In the compilation process, it is not the role of the accountant to assess the values,” he testified. “The role is to accept those values and move them forward.” He acknowledged he made no attempt to corroborate any of the figures. (A judge granted O’Brien a summary judgment, later upheld by an appeals court, in Trump’s libel suit.)

Trump continued to offer selective financial statements. If anything, the list of recipients seemed to grow, to include banks and insurance companies, according to congressional testimony last year by former Trump lawyer Michael Cohen, shortly before he went to prison. Cohen released copies of Trump’s financial statements for 2011, 2012 and 2013 and testified: “It was my experience that Mr. Trump inflated his total assets when it served his purposes, such as trying to be listed among the wealthiest people in Forbes, and deflated his assets to reduce his real estate taxes.”

By this point, Mazars had become his accountants of record (the Weiser merger occurred in 2010) and the disclaimers in the financial statements had grown to exclude anything involving the finances of Trump’s large hotels in Las Vegas and Chicago. The 2011 and 2012 statements placed Trump’s net worth at $4,261,590,000 and $4,558,680,000, respectively.

They included multiple false claims. As The Washington Post reported last year, the 2011 statement claimed Trump Tower was 68 stories tall (it’s 58); exaggerated the size of Trump’s Virginia vineyard (it’s 1,200 acres, not 2,000); inflated the number of lots approved for sale at his golf course in southern California (it was 31, not 55); and claimed a 212-acre Westchester County estate he’d bought in 1996 for $7.5 million was already “zoned for 9 luxurious homes” and thus worth $291 million. Local officials said the property was really worth about $20 million, and the project, which faced years of opposition from area residents, was never built. Trump took a tax write-off on the property instead. These false statements alone appear to have inflated Trump’s claimed wealth by hundreds of millions.

Once again, when Trump announced his campaign for the presidency in gala fashion in 2015, he waved a financial statement that he said his accountants had prepared. This time the tally was $8,737,540,000.

“To pay an auditor to say ‘we have not checked the numbers, and the numbers don’t follow any rules’ — you just don’t see that,” said George Washington University assistant accountancy professor Kyle Welch. “This is not a real financial statement. This is a promotional document.” Welch said the sweeping disclaimer protects the accountants from legal liability or industry sanctions.

He doubts a larger firm would have been willing to affix its name to such statements. “I don’t think any of the Big Four would put their name on those financial statements,” Welch said. “I don’t think they could have been paid enough to get it done.”

---

Not long after it acquired Trump’s accounting firm, Weiser came under investigation by the SEC. The matter was resolved in 2004, with an agreed settlement order: Two Weiser CPAs were suspended from practicing before the commission for “highly unreasonable” and “improper professional conduct.” The SEC also censured Weiser, ordering it to disgorge $39,679 and hire an outside consultant to review its policies and compliance procedures.

According to the SEC, Weiser had failed to properly monitor its client, a financial advisory firm called Sagam Capital Management, that was already operating under a cease-and-desist order for securities fraud and thus, as Weiser knew, warranted “heightened scrutiny.” These failures, the SEC found, had “willfully aided and abetted” more misconduct. (Sagam’s CEO later went to prison for stealing millions from his customers.)

Victor Wahba, the Weiser partner in charge of the assignment, was barred from SEC practice for a minimum of four years. (He didn’t admit or deny wrongdoing.) But Wahba remained at the firm, and was promoted, just one year later, to run its New York office. In 2012, 15 months after being reinstated by the SEC, Wahba was named co-CEO of Mazars. He became chairman and CEO of Mazars USA in 2015.

Wahba declined requests for an interview, but Mazars provided a statement that read, in part: “Under Victor Wahba’s leadership, Mazars USA has become a national leader in tax, accounting and consulting. He is well recognized as a thoughtful and charitable CEO.” It noted that Wahba now “remains in good standing” with various industry and government regulators, including the SEC.

Trump’s accounting firm faced other issues. In 2009, a partner received a three-year SEC suspension for secretly negotiating for a high-level job with a client he was then auditing. The SEC called the partner’s conduct “at a minimum, reckless.” He eventually left the firm.

In separate, more recent cases, the U.S. attorney’s office in Manhattan prosecuted two other CPAs who worked at the firm for their involvement in illegal tax shelters.

Ronald Katz, a partner at Weiser for five years starting in 2004, received a nine-month prison sentence in 2017 after pleading guilty to conspiring with a New York tax attorney in what federal prosecutors described as a “corrupt multi-year tax evasion scheme.” Katz had been indicted, among other offenses, on charges of failing to pay taxes on $1.2 million in fee income while at the firm. Internal firm financial documents show that for 2004, Katz billed $6.6 million in fees, far more than any other partner in the firm. Katz declined to comment.

In August 2019, New York federal prosecutors settled a civil complaint against former Mazars senior manager Michael Schwartz. In legal filings, prosecutors said he had arranged for more than 100 taxpayers to claim “large phony tax losses,” cheating the government out of hundreds of millions of dollars in taxes. (The shelters dated back to 2002, but were already under court challenge by the government when Mazars hired Schwartz in 2008.) In 2010, a federal appeals court found that one of Schwartz’s transactions, which allowed a tech executive to shelter $60 million in stock gains with an investment of less than $1 million, was “specifically designed to create a massive tax loss devoid of economic reality.”

Despite this, Schwartz remained at the accounting firm until 2015, just weeks before the IRS assessed him for $35.4 million for promoting unregistered fraudulent tax shelters. After filing for bankruptcy, Schwartz settled the IRS claim by agreeing to pay $650,000. (“This had nothing to do with WeiserMazar,” Schwartz said. “This was all activities done way before I joined the firm. They knew about it. But they hired me for my international tax expertise.”)

In its statement, Mazars dismissed the notion that it had a troubling record. “Any suggestion that Mazars USA is an industry outlier with regard to its business practices or litigation history is false and misleading. Even a cursory review of the history of any large accounting firm or business will reveal the inevitability of litigation. Our history is no different than any other similarly situated firm.”

Mazars declined to respond to a long list of questions regarding its work for the Trumps, citing the need to protect client confidentiality. Its statement noted, “Mazars USA prides itself on providing professional accounting, audit and consulting services in accordance with all professional and ethical standards, rules, and regulations.”

---

Because it handles virtually all the tax and accounting needs for Donald Trump, Mazars has inevitably found itself immersed in more recent controversies surrounding its famous client.

This extends to the Donald J. Trump Foundation, whose annual tax returns Bender has regularly prepared and signed. For 2016 and 2017, before the foundation’s dissolution, Mazars also audited its financial statements, filed with the New York attorney general’s office. Among these documents, there is no indication the firm did anything to spotlight or curtail the financial abuses that eventually forced the charity’s shutdown.

The Mazars accountants were complicit in the foundation’s illegal practices, according to Marcus Owens, an attorney and expert in nonprofit law who ran the IRS’ exempt-organizations division for a decade. “I cannot fathom how they would not know,” he said. Owens called the firm’s role in the foundation’s misconduct “extraordinary. ... I’ve been practicing charity law for 45 years, including 25 at the IRS, and I’ve never seen anything like it.” Added Owens: “This is aiding and abetting someone doing something that is in clear violation of federal tax law. It really calls into question what’s going on with every other tax return that firm prepared.”

Mazars’ role, if any, in the Stormy Daniels hush money scandal remains unclear. As ProPublica has reported, the Manhattan DA’s office is investigating whether the Trump Organization’s payments, falsely reimbursed to Michael Cohen as a “legal retainer,” represented an illegal falsification of the company’s books and records. It is not evident what Mazars, in preparing its tax filings and auditing its books, knew — or should have known — about this.

But it is clear that the investigation by Manhattan DA Cyrus Vance extends far beyond the scope of that 2016 episode. Vance’s grand jury subpoena seeks tax returns, work papers, financial statements and communications dating back to 2011. If the Supreme Court affirms two federal lower court rulings that he should get them, Vance’s investigators will be free to look for evidence of other potential crimes.

For all the anticipation about the documents being sought by both the criminal prosecutors and Congress, it is possible that the public may never see them even if the Supreme Court orders Mazars to turn over the records.

In Vance’s investigation, requirements for grand jury secrecy will prevail unless the documents lead to criminal prosecutions. It’s also not clear whether the congressional committees would make public any Trump records.

The greatest revelations also may not be contained in the tax returns themselves, which will lack detail about Trump and his businesses, but in the thousands of pages of other materials that Congress and the DA have also subpoenaed. These include the hundreds of corporate returns, also prepared by Mazars, detailing Trump’s investments, his debts, his sources of income and his partners. Equally important, the accountants’ work papers and communications with the Trump Organization could reveal unguarded internal assessments and exchanges about his finances.

The Supreme Court fight may end with a whimper. On April 27, the court hinted that it may be looking for a way to punt at least part of the three cases involving Trump’s tax records: It asked the parties to submit supplemental briefs to answer effectively whether the court should even be trying to resolve the two cases in which Congress has subpoenaed the records. (This would not affect the third case, involving the Manhattan DA). The question, as Scotusblog characterized it, is “whether courts should stay out of the fight over the subpoenas because it is fundamentally a political dispute between the branches of government. If the justices were to conclude that the doctrine applies, they could dismiss the cases without ruling on the merits of the dispute — which might be a particularly appealing outcome for some justices in the lead-up to the presidential election.”

Such a decision would clear the way for Mazars and Trump’s banks to comply with the congressional subpoenas if they chose to do so — but would provide no judicial means of enforcement, according to University of Texas law professor Stephen Vladeck, a Supreme Court expert. (Asked about such a Supreme Court outcome, a Mazars spokesman said the firm stands by its previous statement that it will “respect the legal process and fully comply with its legal obligations.”) That would provide for a much less stirring conclusion than, say, a unanimous high-court opinion declaring that the president is not above the law.

But the court could still affirm the third case, in which federal courts ordered Mazars to turn over the returns to the Manhattan DA. If Mazars then complies with that subpoena, that will leave the firm in good graces with the court — but likely facing the wrath of its client of many decades, the president of the United States.

On Friday 3 April 2020 it finally happened: the Commission proposal for amendment of the MDR to defer the date of application with a year that everyone was waiting for and was in the works for some time was finally published. As I have heard from many directions immediately after the announcement of the proposal being […]

Film critic Justin Chang hosted a live discussion of 'The Avengers,' the first film Times readers chose in the Ultimate Summer Movie Showdown series.