Author: TSA Press

It’s often noted that the Food and Drug Administration usually reaches decisions in line with recommendations from its advisory committees, though it is not required to do so. But until now, little has been done to fully quantify how frequently that happens and why it sometimes does not.

A study published Sunday in the Milbank Quarterly journal found that around 80 percent of the time, Food and Drug Administration decisions regarding drugs and devices were in accordance with the recommendations from advisory committees, also known as AdComs; about 20 percent of the time they were not. The study looked at 376 AdCom meetings regarding 298 products or product classes that took place between 2008 and 2015.

AdComs are panels of outside experts that the FDA sometimes convenes when it requires additional expertise before reaching a decision, such as whether or not to approve a drug or device or update an existing product’s label.

AdCom recommendations and FDA decisions take into account a multitude of factors related to a product’s safety and efficacy profile. Yet, the only major predictor of the FDA not following an AdCom recommendation was when the AdCom vote did not reach consensus, said lead study author Dr. Joseph Ross, a professor of medicine at Yale University, in a phone interview.

“When we looked at what predicts that discordance, that was the only variable that came up,” Ross said. More surprising, given the prior literature on the matter, was the lack of statistical significance for characteristics like media attention and conflicts of interest among committee members.

It was slightly more common for the FDA to reach decisions more cautious or restrictive than AdCom recommendations than it was for the agency to be less cautious, the study found. In 23 percent of cases when an AdCom gave a favorable recommendation, the FDA reached a decision that was more restrictive, while the agency reached decisions less restrictive than AdCom recommendations in 19 percent of cases.

A recent example of the FDA being less restrictive occurred July 3 when it granted accelerated approval to Karyopharm Therapeutics’ Xpovio (selinexor) for heavily pretreated patients with the blood cancer multiple myeloma. In that case, the Oncologic Drugs Advisory Committee, or ODAC, voted 8-5 to delay approval based on Phase IIb data and instead wait until Phase III data were out due to concerns about safety and other issues.

The FDA approved the drug anyway, based on data from the Phase IIb study as well as confidential early data from the Phase III trial provided by the study’s independent data safety monitoring board. The decision proved controversial, drawing criticism from hematologists who saw the FDA’s decision as incorrect based on what they saw as insufficient data to demonstrate Xpovio’s safety and efficacy. An ODAC member also criticized the decision, saying it should have been delayed until the Phase III data were publicly available, while also criticizing the lack of stronger warnings about Xpovio’s side-effect profile.

Ross compared the controversy surrounding Xpovio to that of Sarepta Therapeutics’ Exondys 51 (eteplirsen), which the FDA approved in September 2016 for Duchenne muscular dystrophy despite an AdCom voting against recommending its approval.

“This is a challenging gray area because what value is there in the company obtaining approval if the clinicians don’t feel like there’s sufficient evidence to support prescribing a drug?” Ross said.

Xpovio was priced at $22,000 per month, which several doctors also criticized given what they saw as insufficient evidence to support such a price.

Even if clinicians are willing to try such a drug, it may not pass the payers’ smell test. “If the evidence isn’t strong enough for the advisory committee, you have to wonder if it’s strong enough for the payers,” he said.

Photo: FDA, Flickr (free of all copyright for use and redistribution without restriction)

This presidential election cycle is unique in a lot of ways. For example, it is unusual to have an angry racist ham sprinkled with yellow Easter grass running against something like 7,000 people you’ve never heard of.

But the uniqueness spills over into more substantive areas as well, and one of those is how the candidates are building their election war chests. We have definitely seen the influence of small online donors in previous elections. But this is really the first presidential election in which they have become such a driving political force.

All the presidential candidates had to file paperwork with the Federal Election Commission detailing their second quarter fundraising totals by (literally) the end of the day on July 15. I guess anyone who didn’t meet the midnight deadline turned into a pumpkin or something. But a number of the candidates were getting their work done early, and that included Trump, whose campaign announced well in advance of the deadline that their second quarter haul would be more than $100 million. As of the reporting deadline, the Trump campaign and the Republican National Committee raised a combined $108 million during April, May, and June. That outpaced the $85 million combined fundraising total of President Obama and the Democratic National Committee during the equivalent period of 2011.

Of course, it’s not all that surprising that the party of big money, well, brought in a lot of big money. The Republican donor class, many of whom turned up their noses at Trump the last time around, are now flocking to him in droves. For example, one percent of the combined Trump and RNC second quarter haul came from just three people:

• Stephen Rosenberg, founder and CEO of real estate company Greystone, contributed $360,600 to the Trump Victory Committee, a joint Trump and RNC fundraising apparatus.
• Billionaire Isaac Perlmutter, chairman of Marvel Entertainment, also gave $360,600 to the Trump Victory Committee.
• Perlmutter’s wife, Laura Perlmutter, offered her own matching $360,600 contribution. Isn’t it cute when couples share a pastime together, like handing out more money than most working people make in a decade to fund a xenophobic presidential campaign?

Even though the Trump campaign fundraising efforts are supported by a solid bulwark of the one percent, his appeal among the unwashed masses is nothing to scoff at either. According to Trump campaign officials (who probably didn’t totally make up their stats, but maybe take the exact numbers with a grain of salt), individual online donations to reelect Trump averaged $48 apiece during the second quarter, and a total of 725,000 small donors contributed. That is only two-tenths of one percent of the U.S. population. Still, nearly a whole Seattle-worth of online donors at this stage in the election cycle is a pretty solid base of donor support.

The Democrats were all over the map, which is not at all unexpected given that Americans, except maybe those with that tree-man disease, have fewer digits than Democratic presidential candidates at the moment. But the top tier candidates all did quite well. The top five, by second quarter fundraising total, were:

• Mayor Pete, with $24.8 million (for your reference, if this is the first time you’re hearing about him, his last name is pronounced “boot-edge-edge”);
• Former VP Joe Biden, despite a few notable gaffes, at $21.5 million;
• Senator Elizabeth Warren policy-hounded her way to $19.1 million (she has a plan for that);
• Senator Bernie Sanders came in with $18 million, not bad but no political revolution either; and, finally,
• Senator Kamala Harris leveraged her strong debate performance at the end of the quarter to pull in just shy of $12 million.

Out of those, the most impressive total to me is actually Elizabeth Warren’s, because out of the top three Democratic fundraisers, she is the only one who has largely eschewed big-donor events and PAC or lobbyist money.

I’m not going to go into the rest of the Democratic candidates individually, because I only have a limited number of words to hold your attention in these articles and who cares about the rest of the candidates anyway, but suffice it to say that the next 15 Democratic candidates combined raised about $33.6 million. That puts the total for all of the Democratic candidates at $129 million, and that does not even include however much the DNC raised in Q2 (which will be less than the RNC raised, but will still be several million dollars).

Trump’s second quarter campaign fundraising total is impressive, no doubt. But when you add up what all the Democratic candidates are generating, they are outraising him, and by quite a lot. The likelihood of an ultimate Democratic fundraising victory, of course, depends on the willingness of Democratic donors to coalesce around a smaller and smaller group of candidates as the field is slowly winnowed down. Only time will tell if “anyone but Trump” will be a strong enough rallying cry to again entice veteran Democratic donors after their candidates of choice drop out.

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Jonathan Wolf is a litigation associate at a midsize, full-service Minnesota firm. He also teaches as an adjunct writing professor at Mitchell Hamline School of Law, has written for a wide variety of publications, and makes it both his business and his pleasure to be financially and scientifically literate. Any views he expresses are probably pure gold, but are nonetheless solely his own and should not be attributed to any organization with which he is affiliated. He wouldn’t want to share the credit anyway. He can be reached at jon_wolf@hotmail.com.

The IRS is now beginning its crackdown on people holding Bitcoin and other cryptocurrencies. There have been reports that some taxpayers have received a letter from the Service specifically addressing their cryptocurrency holdings. The letter is known as Letter 6174.

The letter begins by stating that the IRS has information that the recipient has or had one or more accounts containing virtual currencies. It is unclear what exactly the IRS knows. But in 2016, the agency issued a summons to popular crypto exchange Coinbase seeking the identities of their account holders. Other exchanges may have disclosed information to the IRS.

The letter also states that virtual currencies mean cryptocurrencies and non-crypto virtual currencies. I am not sure why they needed to distinguish these two. It might be because some might be confused and think both are the same. Non-crypto virtual currencies are usually in-game currencies in online role-playing games where there is a two-way conversion mechanism between real money and the game’s own currency. Two popular examples of non-crypto virtual currencies are the Second Life Linden and the Entropia Universe PED. Over a decade ago, there were reports of a few people who supposedly made a fortune selling items in-game and then cashing out their earnings into real money. The most well known example was Anshe Chung.

The letter then states that the IRS treats virtual currencies similar to non-cash property. In other words, anything other than money. This means that trading a virtual currency for anything else is a taxable event, even trading one virtual currency for another. More details can be found in IRS Notice 2014-21.

So purchasing 1 Bitcoin at $100 is not a taxable event. But if you later trade it for $1,000 worth of Ripple, you will realize a gain of $900 and will have to pay income tax on that gain. But since the IRS only accepts U.S. dollars for payment, you will have to cash out the Ripple to pay it. Suppose you cash out your entire Ripple holding for $900 to pay the tax. That is also a taxable event and you will realize a $100 loss since you obtained the Ripple when it was worth $1,000.

The above is a simple example, but it can get very confusing if you have done multiple trades on different exchanges and have multiple crypto accounts or “wallets.” While there are apps that track your trades for tax purposes they are not foolproof.

Also, Notice 2014-21 does not address what happens when the cryptocurrency splits or “forks.” Some have suggested that they be treated similar to nontaxable stock splits when one stock splits into two.

The letter advises the recipient to file amended or delinquent tax returns reporting all virtual currency transactions. But unlike regular returns, they advise the recipient to write “Letter 6174” on top of the returns and mail them to a special address. The letter also warns that not filing accurate returns can subject them to future civil and criminal enforcement activity.

So what does this mean? Given the special treatment of these tax returns, it is likely that they will be given special scrutiny. It is also likely that those with large transactions have a higher chance of being audited.

The IRS may use the returns and subsequent audits to investigate and study crypto transactions. This can lead to finding others who are willfully noncompliant. The IRS’s criminal investigation division has set up a special division for crypto transactions.

But all might not be as dire as it seems. In May, IRS Commissioner Charles Rettig sent a letter to members of Congress telling them additional guidance on cryptocurrencies will be forthcoming. The guidance will address determining cost basis and the tax consequences of forks. Unfortunately, there is no word on when these new guidelines will be released.

Also, there are some in the tax professional community who question whether the rules in Notice 2014-21 should be challenged in light of the crypto boom in the last few years. For example, there are over 1,000 cryptocurrencies and most of them are worth less than used toilet paper. Should trading Scamcoin for Fakecoin be taxable events if both are worth nothing? The possibility of litigation might incentivize the IRS to provide additional guidance as soon as possible.

For those holding cryptocurrencies, you may one day receive a Letter 6174 from the IRS. If you receive one, contact a tax professional for guidance and submit amended or delinquent returns as soon as possible. Even if you don’t get this letter, you should still file correct tax returns the old-fashioned way. The IRS’s criminal division and the Department of Justice will eventually make an example out of someone who does not comply.

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Steven Chung is a tax attorney in Los Angeles, California. He helps people with basic tax planning and resolve tax disputes. He is also sympathetic to people with large student loans. He can be reached via email at sachimalbe@excite.com. Or you can connect with him on Twitter (@stevenchung) and connect with him on LinkedIn.

Lawyers are integral to almost every large-scale event, including the Democratic primary. And it makes sense, since all those candidates need attorneys to advise them on all manner of election issues — they wouldn’t want to inadvertently collude with a foreign nation or anything. Thanks to campaign finance disclosure, we are getting a sense of which firms are doing the most business with Democratic candidates for president.

As reported by Law.com, the Biglaw firm of Perkins Coie is really raking in the fees. Elizabeth Warren has paid the firm $320,000 dollars. And she isn’t the only candidate turning to Perkins Coie. Kamala Harris also paid the firm this season — to the tune of $90,000 — and the head of Perkins Coie’s political law practice, Marc Elias, is the campaign’s general counsel. Jay Inslee spent approximately $110,000 with Perkins Coie. Kirsten Gillibrand and Amy Klobuchar spent more than $85,000 at the firm according to financial disclosure documents. Plus Julian Castro spent $23,000 with Perkins Coie and John Hickenlooper racked up a $4,000 legal bill with the firm.

That’s nearly $750,000 in billables for advising Dems this season. Not bad at all.

While Perkins Coie had an eye-catching haul, they aren’t the only firm out there advising Democrats. Pete Buttigieg paid more than $320,000 to Jenner & Block, and he has a Harvard classmate and partner at the firm, Previn Warren, as the campaign’s general counsel. Bernie Sanders spent $260,000 on legal services, the majority of it going to Garvey Schubert Barer.

Utrecht, Kleinfeld, Fiori, Partners also got in the game, receiving $15,000 from Michael Bennet as well as $40,000 from Inslee and $45,000 from Castro. Covington & Burling got almost $68,000 from Joe Biden’s campaign. John Delaney split his $30,000 legal spend between Arent Fox, Ballard Spahr, and Cozen O’Connor.

And, for the sake of completeness, we’ll go through they rest of the candidates’ legal spend. Sandler Reiff Lamb Rosenstein & Birkenstock got $64,114 from Beto O’Rourke. Andrew Yang spent $10,000 with Dentons. Tim Ryan spent $8,500 with Venable. Tulsi Gabbard’s $7,500 in legal spending was divided between Bergeson and Blank Rome. Trister, Ross, Schadler & Gold got ~$3,500 from Bill de Blasio.

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Kathryn Rubino is a Senior Editor at Above the Law, and host of The Jabot podcast. AtL tipsters are the best, so please connect with her. Feel free to email her with any tips, questions, or comments and follow her on Twitter (@Kathryn1).

Mayer Brown is helping a bunch of landlords challenge New York’s rent control laws, which is already an act of cartoonish super-villainy, but they’ve decided to solidify their mustache-twirling by bolstering their filing by pointing out that rent control goes against the very bedrock value of this nation — specifically, that black people are 3/5ths of a human being.

The new rent stabilization and control laws in New York add a bit more heft to a system that’s been in place since just after World War I. If the courts respected precedent as much as Susan Collins pretends they do, this wouldn’t be much of a case. But a group of landlords have decided to take the occasion of tighter regulation to argue that the whole legal regime should be junked as an unconstitutional taking of property.

Mayer Brown is representing the landlords and in a massive, 386-paragraph complaint that would make John Galt blush, leveling all sorts of libertarian nonsense about the tyrannical government stepping on the poor, downtrodden Manhattan landlords. There are definitely abuses of the system — tenants who have no business enjoying the fruits of a system designed to help the poor and elderly amount to infamous anecdotes. But we don’t make sweeping policies based on a handful of anecdotes for a reason and even if there’s a better way to implement it (bring me your “give tenants vouchers” claptrap and I’ll at least listen), the policy has mostly been a success for almost a century.

But then Mayer Brown decided to throw this into its already bloated, self-indulgent pleading:

This protection of property rights is deeply rooted in American history and traditions, and is a fundamental right on which America was founded. See, e.g., Federalist No. 10, at 78 (Madison) (C. Rossiter ed. 1961) (describing protection of property rights, especially in land, as “the first object of government”); Federalist No. 54, supra, at 339 (Madison) (government is “instituted no less for protection of the property than of the persons of individuals”).

Oh, it sure was a foundational right! That’s why Federalist No. 54 was written — to explain to worried anti-federalists that the Constitution was a fair compromise because it appropriately recognized slaves as less than human. Just take a gander at some of the paragraph that immediately precedes Mayer Brown’s quote:

Let the case of the slaves be considered, as it is in truth, a peculiar one. Let the compromising expedient of the Constitution be mutually adopted, which regards them as inhabitants, but as debased by servitude below the equal level of free inhabitants, which regards the slave as divested of two fifths of the man.

Now, there are some who might say that of all the flowery but ultimately empty platitudes to property rights that it amounts to a spectacular research fail to include a damning tribute to America’s slaving past in a filing. On the other hand, for a lawsuit based upon kicking, by and large, poor and minority tenants out of their homes — and to do so in many cases so the landlord can gut the building and gentrify the neighborhood, pushing working people further and further from their jobs and historic communities — perhaps this was the most unintentionally appropriate citation of all.

After all, what better summary of this case could there be than to say that government should serve the interests of higher profits for mostly white, wealthy landholders at the expense of their sub-human minority tenants?

(Full filing on the next page.)

Landlords Strike Back, Suing to Dismantle Rent Regulation System [New York Times]

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Joe Patrice is a senior editor at Above the Law and co-host of Thinking Like A Lawyer. Feel free to email any tips, questions, or comments. Follow him on Twitter if you’re interested in law, politics, and a healthy dose of college sports news. Joe also serves as a Managing Director at RPN Executive Search.

A lot of digital ink will (rightfully) be spilled today memorializing the late Justice John Paul Stevens. The man had a long career on the Supreme Court — 34 years — and penned some landmark decisions. Plenty of commentators will attempt to put Justice Stevens, and his jurisprudence, into properly historical context over the next few days, but this post will do something a little different.

Above the Law has a wide audience of lawyers and law students, and so we want to know what you think was the late justice’s most memorable decision.

Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984)
Stevens wrote the incredibly influential Chevron decision which gave administrative agencies deference over their interpretation of ambiguous statutes. The case became an insta-classic that’s been cited a shit-ton by lower courts and is a cornerstone of the modern regulatory regime.

Crawford v. Marion County Election Board, 553 U.S. 181 (2008)
Not every opinion he wrote became a backbone of liberal thought. In this case, he sided with the Republicans and held states can require people to provide photographic identification in order to vote.

Federal Communications Commission v. Pacifica Foundation, 438 U.S. 726 (1978)
Another case where Justice Stevens sided with the conservatives. In this case, he held the FCC can regulate indecent content — in this case, a George Carlin comedy routine — without violating the First Amendment.

Clinton v. Jones, 520 U.S. 681 (1997)
In a case that’s still relevant today, ahem, Steven wrote for the majority that a sitting president is not immune from civil lawsuits for actions taken before they became president or unrelated to the office.

Citizens United v. Federal Election Commission, 558 U.S. 310 (2010)
Stevens also knew how to launch a blistering dissent, and he did so in this case when the majority opened the floodgates to corporate influence over elections.

District of Columbia v. Heller, 554 U.S. 570 (2008)
Another time that Stevens unleashed on the majority decision in a fantastic dissent, this time when they struck down the Firearms Control Regulations Act of 1975.

Bush v. Gore, 531 U.S. 98 (2000)
A final dissent to consider as the most memorable of Stevens’s opinions. This case decided the fate of the 2000 election, and Stevens was none too happy about the way it all went down.

So what do you think was Justice Stevens’s most memorable opinion?

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Kathryn Rubino is a Senior Editor at Above the Law, and host of The Jabot podcast. AtL tipsters are the best, so please connect with her. Feel free to email her with any tips, questions, or comments and follow her on Twitter (@Kathryn1).

There has been much discussion about student loan bailouts recently.  Indeed, some politicians have proposed paying off a certain amount of student debt for every borrower, and other politicians have even proposed completely paying off everyone’s student debt.  Of course, it is unlikely if any of these proposals will ever get passed, since there is not much political will these days to do much of anything.  In addition, many people have already argued that such proposals would be unfair, since many people take scholarships at lower ranked schools or make other sacrifices to reduce their student debt, and this effort would be undermined by a student loan bailout.  Others have also opined about how such proposals would disproportionately affect the wealthy, since individuals with degrees and a higher income potential might realize the most benefits from a bailout.

Along with these points, it is also important to consider the effect that any student loan bailout would have on the legal pubic sector.  As many people know, individuals who work for the government and nonprofits can typically have their student loans forgiven after 10 years.  Many people pursue public sector jobs for the express purpose of obtaining debt forgiveness, and most lawyers know individuals in this situation.  However, if people had their student debt forgiven by the government, they might not have much incentive to work in public interest fields.

For instance, before I started my own law firm, I worked on a case with the most amazing attorney for a municipality that was also being sued in the matter.  Even though my colleague had double the caseload that I had, he brought his “A game” to every brief, argument, deposition, and other activity related to this case.  I remember one time, we were trying to view surveillance files that had been corrupted and were unable to be opened.  In a last-ditch effort, this attorney told me he tried putting the CD of the surveillance files into his Xbox to see if it would somehow work.  As I am sure everyone would agree, this attorney was dedicated!

Years later, I saw this lawyer on a train, and I told him that the firm I was currently working at was looking to hire new associates.  I told my colleague how impressed I was with his work, and I thought my new firm would pay him much more money than he earned as a government lawyer.  This lawyer appreciated my consideration, but he told me that he needed to work in the public sector for at least 10 years to receive debt repayment.  The amount of debt repayment my colleague would receive exceeded the difference in compensation between his current role and the job at my firm.  In addition, my colleague was already well into his 10 years, and he didn’t want to quit working toward debt repayment after all of the effort he had already put into this program.

Without Public Service Loan Forgiveness, my friend would have had few incentives to stay in the public sector.  Some might argue that public sector jobs often afford greater lifestyle benefits and the opportunity to work on matters in ways not possible in private practice.  However, these incentives are not available in a number of public sector roles.  Indeed, my colleague who was employed for a municipality was overworked and underpaid in the public sector, and he could work on the same types of matters at a firm or by starting his own shop.  Of course, some people like to work in the public sector, since they are doing good and serving others.  However, when it comes down to it, there is currently no better incentive to work in public sector roles than the debt forgiveness that is available through Public Service Loan Forgiveness.

Of course, one could argue that it is not fair for lawyers to be shackled to a career simply because they need to pay off student loans.  It could easily be argued that a student loan bailout would empower attorneys to find jobs that bring them fulfillment separate from the need to pay off their student loans.  In fact, it could be argued that a student loan bailout would empower individuals to enter the public sector, since the need to pay student loans might be keeping attorneys from lower-paid jobs in public interest roles.  Ultimately, one positive aspect about a student loan bailout would be that it would allow attorneys and other individuals to pursue passions rather than stay shackled in certain roles.

In any case, I have already seen a number of articles about how a student loan bailout could affect people’s decisions to enter the military, live in certain parts of the country, and make a number of life decisions. However, it is also worth noting that a student loan bailout would have massive implications on the legal public sector.  Since many dedicated attorneys stay in the public sector to receive debt forgiveness, a student loan bailout could impact the legal services provided to governments and nonprofits.

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Jordan Rothman is the Managing Attorney of The Rothman Law Firm, a New Jersey and New York litigation boutique. He is also the founder of Student Debt Diaries, a website discussing how he paid off his student loans. You can reach Jordan through email at jrothman@rothmanlawyer.com.

* A divided House of Representatives voted to “strongly condemn[] President Donald Trump’s racist comments” that were recently lodged against four Democratic congresswomen of color “that have legitimized and increased fear and hatred of new Americans and people of color.” [NBC News]

* Plaintiffs in the census citizenship case are seeking sanctions against the Department of Justice for committing “fraud on the court” after allegedly hiding the truth about the case’s origins during trial. This should be interesting, considering the Supreme Court seemed to agree… [Reuters]

* Which Biglaw firms are playing host to 2020 Democratic presidential candidates? Quite a few, actually! From Milbank to Kirkland to Paul Weiss, these politicians are getting cozy with their future lawyers. [American Lawyer]

* Philadelphia District Attorney Larry Krasner has Pennsylvania Supreme Court to declare the death penalty unconstitutional because he claims it’s arbitrary and racially biased. [Philadelphia Inquirer]

* Salary news you can use: If you’ve got a law degree and you work in a compliance role, you can expect to make more money than your colleagues without JDs at each and every stage of your career. [Corporate Counsel]

* Retired Justice John Paul Stevens, the former leader of the liberal wing of the Supreme Court, RIP. [New York Times]

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Staci Zaretsky is a senior editor at Above the Law, where she’s worked since 2011. She’d love to hear from you, so please feel free to email her with any tips, questions, comments, or critiques. You can follow her on Twitter or connect with her on LinkedIn.

Despite the large number of large-scale projects being announced or tendered over the past years and the recent introduction of a net metering scheme for rooftop solar, Zimbabwe had only 11 MW of installed solar capacity at the end of December 2018, according to the latest statistics released by the International Renewable Energy Agency (IRENA).