In scenic Puerto Varas, APEC delegates engaged in constructive dialogue about how to adopt to a changing world.

Policies impacting women’s economic advancement have improved in some areas, but more reforms are needed to enable women to fully thrive, reports the newly updated APEC Women and the Economy Dashboard 2019.

Media Registration is Open for the APEC Informal Senior Officials’ Meeting

Chinese Taipei has voluntarily contributed USD 550,000 in funding to support APEC initiatives that advance regional economic integration and inclusive sustainable growth across the Asia-Pacific.

Stronger cooperation is essential for APEC as economies address inequality, environmental health, and the digital economy – the region’s critical challenges – said the APEC Secretariat’s Executive Director Dr Rebecca Sta Maria.

An APEC Business Travel Card mobile application will make travel easier and more secure

Medical supplies and personal protective products are facing barriers worldwide

Trade Ministers agree to work together towards a healthy, resilient and inclusive Asia-Pacific community.

From : Communities>>Regulatory Open Forum
Yes, I think there were some previous posts where people uploaded Word versions you can get; just need to look around a little. ------------------------------ Richard Vincins RAC Vice President Global Regulatory Affairs ------------------------------

From : Communities>>Regulatory Open Forum
Thank you Dinar! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

From : Communities>>Regulatory Open Forum
Thank you Richard! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Why not use Adobe to fill out the form?  You will need it to compile the submission anyway.

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous When this was first issued we printed it out, filled in the answers with careful handwriting and then scanned it back in - which seemed to be perfectly acceptable. Since then we've converted their form to a fillable PDF.​

Latest innovation in quadrivalent meningococcal vaccination designed for use in persons 2 years of age and older in the U.S.

• Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced “critical” group with Kevzara higher-dose versus placebo and discontinuing less advanced “severe” group

- Libtayo decreased the risk of death by 32.4% compared to chemotherapy

Objective responses seen in 29% of patients with locally advanced basal cell carcinoma (BCC)

Celltrion has submitted an application to the European Medicines Agency (EMA) for its adalimumab biosimilar, currently known as CT-P17.

US-based drugmaker Mylan and partner, India-based biologicals specialist Biocon, announced on 28 April 2020 the launch of their pegfilgrastim biosimilar, Fulphila, in Canada. This is the second biosimilar from the pair to be launched in the country.

Top-line: The Congressional schedule and work practices are uncertain over the next few months, leaving many questions about whether and how appropriations bills will move forward. There is a possibility that increased funding at public health agencies, including FDA, may be exempt from FY 21 budget caps. The Alliance’s meeting with Dr. Boon, FDA Associate Commissioner […]

Top-Line: There is no new information about the appropriations schedule for Congress. The House will require a rules change for appropriators to work remotely. The death of former FDA Commissioner Donald Kennedy is noted. More on FDA’s extraordinary efforts to address food safety and supply issues. Eventually, Congress will need to address FY 21 funding and […]

Top-Line: This week we look at House and Senate schedules for returning to DC and starting on the FY 21 appropriations process. This week’s Analysis and Commentary explores the reasons why advances in science and technology foretell that FDA will need significant additional funding in FY 21. This column focuses on vaccine development. Senate Returns […]

Top-line: Congress is inching forward on the FY 21 appropriations process. However, neither the House nor the Senate has adopted rules permitting virtual committee mark-ups. Also hanging over the process is the tight budget ceiling for non-defense discretionary (NDD) programs. Various ways it might be solved and implications for FDA are discussed in this week’s Analysis […]

WASHINGTON, D.C. – Co-Chairs of the Childhood Cancer Caucus, Reps. Michael McCaul (R-TX), Jackie Speier (D-CA), Mike Kelly (R-PA), and G. K. Butterfield (D-NC), applaud the passage of the Senate companion to their bill – S. 292, the Childhood Cancer STAR Act.

The STAR Act passed the House today by a unanimous vote.  It addresses the four major concerns facing the pediatric cancer community: Survivorship, Treatment, Access, and Research, and will elevate and prioritize the fight against childhood cancer at the National Institute of Health (NIH).

The members released the following joint statement:

"Today was a long anticipated day for the pediatric cancer community, and one to be celebrated.  This bill is the most comprehensive childhood cancer bill to ever pass Congress and will finally head to the president’s desk to be signed into law. Childhood cancer remains one of the deadliest killers of our kids and we as a Congress, and a nation, must say, ‘Enough is enough.’  As co-chairs of the Childhood Cancer Caucus, we would like to thank all those who made this possible, including the Alliance for Childhood Cancer and the entire childhood cancer advocacy community.”

Click here to watch McCaul’s floor remarks ahead of the House passage of the STAR Act.

J&J agrees a manufacturing partnership with Emergent, as it looks to hit its target of one billion doses.

The company receives approval for MenQuadfi to prevent meningococcal disease.

The WHO and world leaders commit to a fund to accelerate development of vaccines, tests and treatments for COVID-19.

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading →

Posted by Reed Beall and Amir Attaran (respectively Phd Candidate and Professor, University of Ottawa) In 2005, the FDA launched an investigation into pharmaceuticals bought from “Canadian” internet pharmacies online and shipped to US consumers. Of 1700 packages these pharmacies supplied, fully 85 percent of those actually came from somewhere else, but 15 percent really came from Canada.  Worse, 32 of the drugs were found to be counterfeit.  All of these pacakges were ente [...]

Posted by Reed Beall and Amir Attaran (respectively Phd Candidate and Professor, University of Ottawa) On September 8, we posted a blogspot about our recent article published in Health Law in Canada, in which we write that Canada is providing haven for internet pharmacies located on Canadian soil that advertise and sell unapproved medicines illegally.  We called this a transnational transnational organized crime, which Canadian officials are knowingly facilitating.  We offered example [...]

Posted by Roger Bate A Star Newspaper investigation of drug quality in Canada (see here) demonstrates the risks patients in rich nations like Canada run from receiving poor quality medicines, especially imported from India. What is most worrying is the lack of transparency at some western health agencies. What the investigation shows is that Health Canada has hidden information about problems with medications. While it is true that educated people occasionally make bad medicine choices (think [...]

by Alice Wilder, WNYC

Presidential lawyer and former New York City Mayor Rudy Giuliani has largely fallen out of the public eye since his starring role in President Donald Trump’s impeachment. But Giuliani hasn’t gone silent.

Instead, he’s in his home, doing a call-in radio show and a podcast — “Common Sense” — during which he has repeatedly gone on bigoted rants about China and its government.

“They have no morals,” he said on his April 28 radio show. “They’re amoral in the sense that human life means something in Western civilization, it means a lot. Human life doesn’t mean the same thing to them.”

Giuliani has also speculated that the spread of the coronavirus may be a plot by the Chinese government.

For example, Giuliani has raised the possibility that China purposely released the virus from a biological lab in Wuhan. “We have to say accidentally,” Giuliani said in a recent radio broadcast. “But I don’t think as responsible investigators we can rule out that it wasn’t done deliberately.”

Experts say there’s no public evidence the virus came from the lab. Amid a reported White House push, U.S. intelligence agencies have said they are investigating the origins of the virus.

Giuliani is also fixated on the idea that the Chinese government sent sick people overseas. In an April 27 episode of his podcast, he said that China allowed “over a million people from Wuhan travel to us, to the United States, to England to France to Italy to Germany.” He added, “I hope the people there have the same reaction we have to the value of human life and the loss of human life.”

“When they found out about this terrible virus that escaped, assuming they didn’t do it on purpose,” Giuliani said a day later on his radio show, “they were going to make sure the West suffered as much if not more than they did and jumped on top of an opportunity, it’s not a big assumption to make. And there isn’t a contrary explanation.”

The New York Times found that thousands, not millions, of people flew internationally out of Wuhan.

Asked about his comments, Giuliani did not respond.

The comments by Giuliani have come as discrimination against Asian Americans has spiked. And they reinforce the White House’s emerging push to blame China for the pandemic.

Giuliani has said he’s spoken to the president a number of times about the coronavirus. Two days after Giuliani said he was sure the virus came from the Wuhan lab, Trump said he has evidence of the same. (The president declined to give the evidence, saying it’s secret.)

Giuliani appears to have found a receptive wider audience too. An advertising executive at 77 WABC, which airs Giuliani’s radio show, said “feedback has been amazing” and online listening has “skyrocketed.”

The station’s parent company, Red Apple Media, did not respond to a request for comment.

In an April 23 radio show, Giuliani interviewed Gordon Chang, a conservative pundit who frequently predicts the collapse of the Chinese government. Chang said if China released the virus accidentally — for which, again, there’s no evidence — it then decided to create a global pandemic. “I think what Xi Jinping did was he decided he was going to spread the virus so that he would level the playing field so that China would not be in such a hole,” Chang said, referring to China’s president.

“Wow,” Giuliani responded. “So he saw an opportunity, if that theory is correct, and it wasn’t a bioweapon to start with, he saw an opportunity that was sort of accidentally presented to him, and then he took advantage of it. It was opportunistic.”

Chang acknowledged, “We can’t know what was in Xi Jinping’s mind for sure.” But then he went on, “It looks more like they were deliberate and malicious and that means Mr. Mayor ... this is a crime against all of humanity.”

Giuliani ended the interview by inviting Chang to be a guest on his other show, the podcast.

Giuliani has also said he’d use his access to help guests on his show move ahead with exploratory treatments. Talking with one pharmaceutical executive on his show in late March, Giuliani told his guest, “I’ll use whatever my yelling and screaming can do to do it faster, to help you.”

As the Times reported, the executive’s company received initial trial approval from the Food and Drug Administration soon after. (The FDA has said the application was subject to “internal scientific review.” And Giuliani has said he has no business connection to the company.)

“I don’t lobby the government,” Giuliani emailed in response to a request for comment. “I do hope, however, that they and others are successful.”

Giuliani appears to have strong feelings about the government’s process for approving drugs.

In an April 23 broadcast, Mark, a pharmacist from New Jersey, called in to report on his “informal study” of the patients who have used a drug cocktail that includes hydroxychloroquine — the anti-malaria drug that Trump long has touted.

Giuliani was excited when Mark reported that none of his patients had been hospitalized: “Why doesn’t this count with all these geniuses in Washington? The double blind study and the triple blind study and this study and that study, we don’t have time for that, we’ve got to go to people like Mark in New Jersey!”

In fact, the FDA has warned against widespread use of the drug, noting that it can cause heart problems.

The discussions with his listeners, though, often come back to China.

One caller to Giuliani’s radio show, identifying himself as “George from Bay Ridge,” went on a rant against Chinese people, likening them to serial killers with “no conscience” who are attempting to take over businesses all over the world.

Giuliani responded, “George, I’ve been getting complaints about this for a long time.” He added: “It almost reminds me of the Mafia. You know, they say, if you do business with America it’s one thing. If you do business with China you don’t realize, all of a sudden you start owing them too much and they believe they own you.”

by Annie Waldman

Last September, over pancakes at a diner in central Massachusetts, Molly Baldwin told her husband, Jonathan, they were going to have a baby. He cried into his coffee mug, elated and a little surprised. They had only been trying for about a week, and they had yearned for a summer baby, ideally in June, which would enable their parents to spend more time with their first grandchild.

“We thought we had the best timing,” she said.

But as the novel coronavirus began to spread through the country this year, Baldwin realized in early March that it was only a matter of time before the virus hit her town, Fitchburg, and the nursing home where she’s a social worker. Her patients would be among the most vulnerable: Some had battled addiction, many had experienced homelessness and most were elderly. Flu seasons were always hard on her patients, and she dreaded the havoc a more lethal disease would wreak.

Baldwin also worried about her baby. She spent hours looking up the prenatal effects of COVID-19, and the lack of evidence-based research concerned her. She called her obstetrician, who cautioned that because of the unknowns, she should consider working from home to limit her exposure to the virus.

So Baldwin made a plan for when COVID-19 arrived at her nursing home: She would swap shifts with a colleague to work fewer hours and request to work from home, as many of her duties are paperwork or computer-based.

She would work from the comfort of her kitchen table. She would avoid catching the virus. She would keep visiting her doctor until it was time to deliver, her belly swelling with a baby girl she knew was healthy and safe.

None of it, not a single thing, would go according to plan.

Baldwin said her supervisor and the human resources representative from the facility verbally agreed in mid-March to let her work from home. (Baldwin spoke with ProPublica on the condition that her workplace not be named; ProPublica contacted her employers with questions for this story.)

Then, on April 16, one of the residents at her facility tested positive for the virus. Baldwin sought testing at a walk-in clinic, and the results came back negative. But when she called her obstetrician’s office, she got a warning: If she continued to work at the facility, potentially exposing herself to the virus, they would not allow her to enter their office for prenatal appointments unless she could prove with a test, before each visit, that she was negative for COVID-19.

She understood their caution; her job was beginning to feel at odds with her pregnancy. It was time for her work-from-home plan to go into action.

She called her employer and asked to start the accommodations she had requested the month before. But they told her that now the plan would not be feasible, she said. Other pregnant employees were continuing to work at the facilities, and she would have to as well, she said she was told.

“The services provided at a nursing home do not typically allow for remote working,” a company spokesperson told ProPublica. “However, we have made changes to accommodate our staff whenever possible, provided there is no impact on patient care.”

After finding out her request to work from home would not be granted, Baldwin panicked. “I’m not even a mom yet,” she said. “This is my first baby, and I already feel like I’m doing everything wrong.”

Baldwin is one of dozens of pregnant workers who ProPublica has heard from who are navigating the risks of COVID-19 while in the field of health care.

“There are plenty of pregnant women across the country who are trying to figure out what to do to protect themselves, given the uncertainty,” said Emily Martin, vice president for education and workplace justice at the National Women’s Law Center. “If you feel like you can’t do your job because there aren’t certain accommodations and you feel like you’re at risk, it’s difficult to see where to go next.”

About half of the states have laws that allow pregnant women to request reasonable accommodations, including Massachusetts, Martin said.

According to the Massachusetts Pregnant Workers Fairness Act, signed into state law in July 2017, employers must grant reasonable accommodations to their pregnant employees that allow them to continue to do their job, “unless doing so would impose an ’undue hardship’ on the employer.” An employer also “cannot make an employee accept a particular accommodation if another reasonable accommodation would allow the employee to perform the essential functions of the job.”

Both the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists have stated that based on the data available, pregnant women do not face a higher risk of infection or severe morbidity related to COVID-19. That said, both the CDC and ACOG have suggested that health care facilities may want to consider reducing the exposure of pregnant health care workers to patients with confirmed or suspected COVID-19, if staffing permits.

“In the overwhelming majority of pregnancies, the person who is pregnant recovered well with mild illness,” said Dr. Neel Shah, an obstetrician and assistant professor at Harvard Medical School, echoing the current guidance. But, he cautioned, there is a lot we still don’t know about how the virus impacts bodies, let alone those that are pregnant. “We can’t say that it’s completely safe — we don’t know.”

Baldwin and her husband went through their options.

She couldn’t quit because they needed her paycheck. They had a mortgage, student loans and a new baby on the way. She also loved her job and cared deeply for her patients, whom she wanted to continue to serve. Her employer, trying to manage understaffing, had discouraged employees from taking time off, she said. She didn’t want to take any additional sick days, because she needed to save them for her maternity leave.

They decided that she would have to return to work.

Her employer told her to wear a mask and gloves, use hand sanitizer and remain in her small, boxy office, which has three desks for four people. Though she didn’t have contact with the residents, her office mates still did.

Even though she was scared, she tried to stay optimistic. “I was grateful for what I had because I have friends that are out of work right now,” she said. But she remained perplexed about why her requests had been denied. “I was sitting in my office doing work that would have easily been done from a laptop on my kitchen table.”

The company spokesperson did not respond to a question about whether it had originally given Baldwin verbal approval to work from home. When asked why she couldn’t have done the same work remotely, he said, “Based on your questions, our HR and Risk Management are anticipating action and would prefer to not comment at all.”

The next day, the Massachusetts National Guard delivered testing kits to the nursing home, and every resident was checked for the virus. When the results came back, at least 22 residents and 20 other staff members tested positive.

“We are conducting cleanings and infection control measures multiple times per day, with extra focus on high touch areas,” the company spokesperson said. “We screen and take the temperature of anyone entering our building, and we have increased monitoring of our residents.”

Public data shows the facility has more than 30 cases among residents and staff, the maximum number that the state reports publicly.

“I thought if I just keep working, stay in my office, use hand sanitizer, wear my mask, go home and shower right away, disinfect my clothes, then I will be fine, and I can keep my baby safe, and I can shed all this guilt,” she said.

Then on April 24, two of her office mates texted to tell her they had the virus.

And that morning, she’d felt a tickle in her throat.

“I know I’m positive,” she thought to herself, as she left work midday and drove to a CVS drugstore testing site an hour away that was offering free rapid tests for front-line and health care workers. Hundreds of cars were already lined up.

She waited alone in her Jeep Wrangler for three hours, wearing her mask as required, which muffled her nagging cough. She shifted around constantly, to keep blood from pooling in her swelling feet. At the front of the line, she received a 6-inch cotton swab, wedged it deep in her nasal cavity, and returned it to the technicians. They directed her into a side parking lot, and 30 minutes later, she got a phone call with her results.

“We’re sorry to tell you that you’re positive,” the voice on the line told her. Baldwin’s mind stalled, engulfed in a wave of anxiety, which gave way to seething frustration.

“This was so preventable,” she said. “Now here I am, 33 weeks pregnant and positive. My most important job is to keep the baby safe, and my actual job wasn’t making that happen.”

When she called her co-workers and supervisor to tell them she tested positive, she said they were “all very caring and compassionate.” They told her to stay home for at least a week, or until her symptoms subsided. The Families First Coronavirus Response Act requires most employers to provide their workers with two weeks of paid leave if the employee is quarantined or experiencing COVID-19 symptoms. Baldwin said she would have to exhaust her sick days first; she’d been saving them for her maternity leave. Her husband, who works as a correctional officer at a county jail, was allowed to take 14 days of paid leave to tend to his wife, without using his own sick days.

She could no longer go to her normal obstetrician for in-person appointments, and instead, she would have to rely on telemedicine. Her doctor connected her with an obstetrician specializing in COVID-19 cases, with whom she planned to meet this week.

Last Saturday, Baldwin’s mother had planned to throw her daughter a baby shower. She had invited 50 of their closest friends to celebrate at a new restaurant and had ordered dozens of pink favors from Etsy.

Because of the stay-at-home order, her shower morphed into a drive-by celebration, where her friends and family passed by her house, honking their horns and holding celebratory signs, balloons and streamers. They dropped gifts in front of her house, including first aid kits and a handsewn pink mask for an infant.

Her symptoms have, so far, been relatively mild, similar to a normal flu: headaches, a stuffy nose, a sore throat and muscle pains. She’s spent most of the past week resting in bed and taking baths to soothe her body aches. While taking care of Baldwin, her husband has also contracted the virus and is experiencing severe body aches as well.

In addition to her disappointment that the hypnobirthing and breastfeeding classes she had signed up for are canceled, her time in quarantine is now filled with anxious questions about how the disease may impact her baby.

Will the stress of this experience damage her baby neurologically? Will her baby be born early? Will she have to deliver by cesarean section to relieve pressure on her body and lungs, like so many stories she had read? Will she have to be secluded from her baby for days or weeks after birth? And what if her own symptoms worsen?

“This is our first baby, and it was so planned and wanted,” she said. “But had we known this awful thing would happen, would we have tried when we did?”

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.

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.

It was just confirmed that I'll be teaching in Temple University's RA/QA MS program this spring. Specifically, I'll be teaching the ad-promo course.

If you or anyone you know is interested, please reach out to me for information. The course will be taught out of the Fort Washington campus, but online enrollment is permitted.

Here's the complete schedule of classes for the spring.

The COVID-19 pandemic has brought to the fore some issues of ad-promo for FDA-regulated products. I'm posting here to highlight some developments and correct some of the discussion.

Snake Oil & Enforcement

Off-Label Promotion & Outbreaks

Supplies of the selective serotonin reuptake inhibitor, sertraline, are returning to stock after manufacturers reported “industry-wide” supply challenges, exacerbated by export bans and border closures implemented as a result of COVID-19. 

To read the whole article click on the headline

Community pharmacies need millions of pounds extra “to keep their heads above water” during the COVID-19 pandemic, pharmacy bodies have warned.

To read the whole article click on the headline

Wholesalers have “almost completely run out” of the personal protective equipment supplied by Public Health England for distribution to community pharmacies during the COVID-19 pandemic, the wholesaler trade body has warned.

To read the whole article click on the headline

NHS England has advised pharmacies to risk assess staff who may be particularly vulnerable to COVID-19, including those from a black, Asian or minority ethnic background.

To read the whole article click on the headline

March 12, 2020 —[Note: Due to the coronavirus epidemic, the Conference has been rescheduled from May.] Healthcare was already the top issue for voters—and the coronavirus pandemic only intensifies the focus heading into a hotly-contested election. Both parties want to “do something” about the cost of healthcare and especially drug prices, and what happens when […]

April 6, 2020 – The Coalition for Healthcare Communication last week endorsed an urgent request to Maryland Governor Larry Hogan (R) to veto HB 732, which would put in place the nation’s first tax on digital advertising. The request, sent March 31 by national media and advertising trade associations and members of The Advertising Coalition, […]

April 13, 2020 – The Food and Drug Administration (FDA) is responding to the challenges of COVID-19 in new ways that streamline product review and policy approaches, while also ensuring that entities promoting unapproved products that claim to be effective against the virus do not go unchecked. Last week, the FDA and the Federal Trade […]

The European Medicines Agency has begun a rolling review of data on Gilead’s remdesivir, positioning it to cut the time it takes to decide whether to approve the drug in COVID-19 patients.

After penning a deal with Eli Lilly last month with the aim to have an antibody in the clinic within four months, Canadian-based AbCellera has been given a financial boost by its government.

PTC Therapeutics is adding to its rare disease pipeline with a midstage biotech buyout with a low upfront payment tied in with stock and biobucks.

Johnson & Johnson taps Khan for chief data role; Icon poaches AstraZeneca vet Buck as CMO; Intellia signs on Lebwohl as CMO.