Governor Cuomo Will Allow 6,700 Fans Watch The Buffalo Bills Playoff Game

We are entering the eleventh month of the COVID-19 pandemic. During this span, Governor Cuomo has exercised absolute authority over every aspect of life in New York. We should stop pretending he is motivated by #science. Cuomo, like every politician, acts like a politician. Racial justice marches are essential. But 11 Jews praying in synaongague that fits a 1,000 people is forbidden. Cuomo does whatever he thinks he can get away with.

Now,for the first time in a quarter century, the Buffalo Bills have made the NFL playoffs. And, Governor Cuomo will permit nearly 7,000 fans watch the game:

The plan allows for 6,772 fans, with attendees needing to register a negative COVID-19 test before being granted entrance. The team will work with the state’s Department of Health to conduct contact tracing afterward.

Fans will be socially distanced throughout the stadium, with masks required at all times. Fans who fail to comply will be ejected.

As we know all too well, tests are not always accurate. And people may contract the virus after taking the test. If the state’s goal was to keep transmission as close to zero as possible, no one would consider this feat. But that isn’t the state’s sole goal. “Essential” simply means “important” to Governor Cuomo. And Cuomo was not willing to accept the wrath of football fans in upstate New York. Orthodox Jews–who tend to vote Republican–are simply not that important.

Cuomo would be wise not to appeal the recent Agudath Israel decision to the Supreme Court. His Solicitor General will be asked about the Bills game.

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Minnesota Revenge Porn Law Upheld

From today’s Minnesota Supreme Court decision in State v. Casillas:

While “[o]ne’s naked body is a very private part of one’s person and generally known to others only by choice,” the nonconsensual dissemination of private sexual images removes this choice from a victim and exposes the victim’s most intimate moments to others against the victim’s will.

Those who are unwillingly exposed to their friends, family, bosses, co-workers, teachers, fellow students, or random strangers on the internet are often deeply and permanently scarred by the experience. Victims suffer from post-traumatic stress disorder, anxiety, depression, despair, loneliness, alcoholism, drug abuse, and significant losses in self-esteem, confidence, and trust. Survivors often require therapy and medical intervention.  The effects of revenge porn are so profound that victims have psychological profiles that match sexual assault survivors.  Tragically, not every victim survives this experience and some commit suicide as a result of their exposure online.

Those who survive this harrowing experience without significant health consequences still may have their reputations permanently tarnished. Many victims have a scarlet letter affixed to their resumes when applying for jobs or additional educational opportunities.  When a simple internet search for a victim’s name displays multiple nude images, employers frequently put the victim’s application aside.  Employers have fired employees who have been victimized by their former partners.  Losing employment is a difficult issue for any person, but is especially problematic when victims need employment-sponsored health benefits to deal with the trauma of being exposed online.

“[I]t is difficult to imagine something more private than images depicting an individual engaging in sexual conduct, or of a person’s genitals, anus, or pubic area.”  Even if a victim is fortunate enough to avoid the serious mental, emotional, economic, and physical effects, the person will still suffer from humiliation and embarrassment. The harm largely speaks for itself…. Based on this broad and direct threat to its citizens’ health and safety, we find that the State has carried its burden of showing a compelling governmental interest in criminalizing the nonconsensual dissemination of private sexual images.

Next, we analyze whether Minnesota Statutes § 617.261 is “narrowly tailored” and “the least restrictive means” to solve the underlying problem. We conclude that the State has carried this burden.

First, the Legislature explicitly defined the type of image that is criminalized. The image must be “of another person who is depicted in a sexual act or whose intimate parts are exposed.”  The terms “sexual act,” “intimate parts,” and “image” are all expressly defined.  Moreover, the person depicted in the image must be identifiable “from the image itself … or … from personal information displayed in connection with the image.”  Furthermore, the image has to be “obtained or created under circumstances in which the actor knew or reasonably should have known the person depicted had a reasonable expectation of privacy.”  Images that do not clear each of these hurdles fall outside the scope of the statute.

Second, a defendant must “intentionally” disseminate the image.  This mens rea requirement means that a defendant must knowingly and voluntarily disseminate a private sexual image; negligent, accidental, or even reckless distributions are not proscribed. This specific intent requirement further narrows the statute and keeps it from “target[ing] broad categories of speech.”

Third, the statute has seven enumerated exemptions. Some protected speech is taken outside of the scope of the statute by subdivision 5. For example, the statute exempts prosecution for image dissemination pursuant to essential law enforcement functions performed by both citizens and public safety personnel. The statute allows for private sexual images to be distributed “in the course of seeking or receiving medical or mental health treatment.” Advertisers, booksellers, and artists are protected because images “obtained in a commercial setting” for legal purposes fall outside the statute’s reach. Journalists cannot be prosecuted because there are exemptions for the dissemination of private sexual images that involve matters of public interest and “exposure[s] in public.” Educators and scientists are protected because there is an exemption for private sexual images disseminated for “legitimate scientific research or educational purposes.” Accordingly, even if protected speech falls within the ambit of subdivision one and a disseminator acted with the requisite mens rea, that person may still be exempt from prosecution under these precise exceptions.

Fourth, to be prosecuted under the statute, a disseminator must act without consent. This provision provides additional protection for commercial advertisements, certain adult films, artistic works, and other creative expression outside the statute’s scope.

Finally, this statute only encompasses private speech. “[R]estricting speech on purely private matters does not implicate the same constitutional concerns as limiting speech on matters of public interest.” Snyder v. Phelps (2011). “Speech on matters of purely private concern is of less First Amendment concern” than speech on public matters that go to the heart of our democratic system. Dun & Bradstreet, Inc. v. Greenmoss Builders, Inc. (1985). Unlike the overly broad statutes at issue in our recent decisions in In re Welfare of A.J.B. and Jorgenson, this statute covers only private sexual images and does not prohibit speech that is “at the core of protected First Amendment speech.”

I think that narrowly crafted bans on revenge porn (or, to be precise, nonconsensual porn) are indeed constitutional, but I think that the key here is that the speech really can be defined—at a categorical level—as both harmful and essentially lacking in First Amendment value.

The harm alone, I think, can’t be enough: For instance, accurate revelations of people’s past misconduct (or public condemnation of someone as a supposed racist or sexist or homophobe or lion-killer) may lead to “employers frequently put[ing] the [subject’s] application aside,” and could lead to severe emotional distress or even suicide. Nor do I trust courts to decide on a case-by-case basis whether certain facts or opinions about people can be criminalized on the theory that they relate to matters of “private concern” (see pp. 783-88 of this article).

But (whether under the rubric of strict scrutiny or some other formulation), it does make sense that such speech could be restrictable when it reveals nothing other than how the person looks naked or when having sex. That is a rare category of speech that one can generally say lacks any real value to public discussion (or even to people’s decisions about whom to trust in their daily lives), except in highly unusual cases. And, again, it does cause privacy harm that is both severe and (as unlike with the revelation of past misconduct) unjustifiable.

In any case, that’s my tentative sense of the matter, and one that fits the results we’ve been getting so far from the state high court cases that have considered such statutes.

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Governor Cuomo Will Allow 6,700 Fans Watch The Buffalo Bills Playoff Game

We are entering the eleventh month of the COVID-19 pandemic. During this span, Governor Cuomo has exercised absolute authority over every aspect of life in New York. We should stop pretending he is motivated by #science. Cuomo, like every politician, acts like a politician. Racial justice marches are essential. But 11 Jews praying in synaongague that fits a 1,000 people is forbidden. Cuomo does whatever he thinks he can get away with.

Now,for the first time in a quarter century, the Buffalo Bills have made the NFL playoffs. And, Governor Cuomo will permit nearly 7,000 fans watch the game:

The plan allows for 6,772 fans, with attendees needing to register a negative COVID-19 test before being granted entrance. The team will work with the state’s Department of Health to conduct contact tracing afterward.

Fans will be socially distanced throughout the stadium, with masks required at all times. Fans who fail to comply will be ejected.

As we know all too well, tests are not always accurate. And people may contract the virus after taking the test. If the state’s goal was to keep transmission as close to zero as possible, no one would consider this feat. But that isn’t the state’s sole goal. “Essential” simply means “important” to Governor Cuomo. And Cuomo was not willing to accept the wrath of football fans in upstate New York. Orthodox Jews–who tend to vote Republican–are simply not that important.

Cuomo would be wise not to appeal the recent Agudath Israel decision to the Supreme Court. His Solicitor General will be asked about the Bills game.

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Biden Administration Seeks to Avoid Obama Administration Missteps on Judicial Nominations

The Obama Administration was notoriously slow to make judicial nominations. Even where there was no need to consult with home-state Senators (as with D.C. vacancies), the White House put forward nominees at a tepid pace, resulting in fewer and slower confirmations than one might have expected. The nomination pipeline was rarely full, so it was easier for Senate Republicans to slow things down, particularly once Mitch McConnell became Senate Majority Leader.

It is unclear whether President Biden’s nominees will face a democratic or a Republican Senate, but there are early signs the Biden Administration wants to hit the ground running when it comes to judicial nominations, so as to begin to undo the Trump Administration imprint on the federal judiciary.

The Huffington Post reports that incoming White House counsel Dana Remus has sent a letter to Democratic Senators requesting that they submit names of potential nominees for existing district court vacancies “as soon as possible” and no later than January 19. In other words, the Biden Administration wants to be able to start reviewing potential nominees on day one.

As of today (12/30) there are a total of 49 current judicial vacancies and five announced future vacancies. In all likelihood, these numbers will increase in January as additional judges announce plans to retire or take senior status. It is also likely that some judges will announce retirements upon the confirmation of their successors, so as to prevent extended vacancies on their courts. It is also possible there may be additional judgeships, particularly if Democrats manage to take control of the Senate. The Judicial Conference has requested additional seats on some courts.

The Remus letter makes clear this is not simply about current vacancies. It further asks Democratic Senators to quickly identify additional nominees “within 45 days of any new vacancy being announced, so that we can expeditiously consider your recommendations.” This is an aggressive time-table, particularly for Senators from states where it is common to rely upon advisory commissions to identify and vet potential nominees. Having served on Ohio’s commission, I can attest it would be quite difficult to meet such a deadline while performing the traditional degree of vetting and review.

In addition to seeking early input from Democratic Senators, the letter indicates that the Biden Administration would like to draw nominees from a broader pool of potential jurists. According to the letter, the Biden team is “particularly focused on nominating individuals whose legal experiences have been historically underrepresented on the federal bench, including those who are public defenders, civil rights and legal aid attorneys, and those who represent Americans in every walk of life.” Progressive activist groups have been urging such a broader focus. The lack of federal judges with meaningful criminal defense experience, in particular, is a widely recognized problem. As this Cato study noted, there are lots of former prosecutors on the federal bench, but relatively few former public defenders.

Without question, control of the Senate will make or break the Biden Administration’s ability to make an early mark on the federal judiciary. A Democratic Senate will begin considering and confirming Biden nominees much more quickly than a Republican one. That said, it still makes sense for the Biden White House to begin moving now.

The more nominees there are in the pipeline, the more pressure there is to let some of them through. For this reason, the Biden White House will want to put forward names as quickly as it feels comfortable doing so. It will also want to put forward names that have local GOP support, where possible.

Beginning the identification and vetting of potential nominees early will also put the Biden White House in a stronger position to negotiate over packages of nominees. Though rarely reported, the Trump White House was quite effective at putting together bipartisan packages of nominees in states with Democratic Senators who were willing to negotiate. This is how some key vacancies in states like Illinois and Hawaii were filled without Democratic opposition. While the political dynamic will be somewhat different, a Biden White House would be well advised to make such deals where possible.

A few other tidbits worth noting. First, the letter focuses on district court nominees, suggesting the Biden Administration intends to take the lead on appellate nominees. This is what the Trump Administration did, and (in my view) it makes sense. Local interests are much stronger when it comes to district court nominations.

Second, even before this letter was sent, progressive activist groups had begun working to help fill the roster of potential nominees. The American Constitution Society, for one, has sent out a fund-raising appeal noting that it is “uniquely positioned to build the bench of the next generation of progressive leaders in the law” and boasting that it had “developed a highly qualified pool of legal professionals and delivered the names to President-elect Biden’s transition team just hours after he became the President-elect.” Other groups have reportedly made similar efforts, though these lists of potential nominees have not been made public.

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Minnesota Revenge Porn Law Upheld

From today’s Minnesota Supreme Court decision in State v. Casillas:

While “[o]ne’s naked body is a very private part of one’s person and generally known to others only by choice,” the nonconsensual dissemination of private sexual images removes this choice from a victim and exposes the victim’s most intimate moments to others against the victim’s will.

Those who are unwillingly exposed to their friends, family, bosses, co-workers, teachers, fellow students, or random strangers on the internet are often deeply and permanently scarred by the experience. Victims suffer from post-traumatic stress disorder, anxiety, depression, despair, loneliness, alcoholism, drug abuse, and significant losses in self-esteem, confidence, and trust. Survivors often require therapy and medical intervention.  The effects of revenge porn are so profound that victims have psychological profiles that match sexual assault survivors.  Tragically, not every victim survives this experience and some commit suicide as a result of their exposure online.

Those who survive this harrowing experience without significant health consequences still may have their reputations permanently tarnished. Many victims have a scarlet letter affixed to their resumes when applying for jobs or additional educational opportunities.  When a simple internet search for a victim’s name displays multiple nude images, employers frequently put the victim’s application aside.  Employers have fired employees who have been victimized by their former partners.  Losing employment is a difficult issue for any person, but is especially problematic when victims need employment-sponsored health benefits to deal with the trauma of being exposed online.

“[I]t is difficult to imagine something more private than images depicting an individual engaging in sexual conduct, or of a person’s genitals, anus, or pubic area.”  Even if a victim is fortunate enough to avoid the serious mental, emotional, economic, and physical effects, the person will still suffer from humiliation and embarrassment. The harm largely speaks for itself…. Based on this broad and direct threat to its citizens’ health and safety, we find that the State has carried its burden of showing a compelling governmental interest in criminalizing the nonconsensual dissemination of private sexual images.

Next, we analyze whether Minnesota Statutes § 617.261 is “narrowly tailored” and “the least restrictive means” to solve the underlying problem. We conclude that the State has carried this burden.

First, the Legislature explicitly defined the type of image that is criminalized. The image must be “of another person who is depicted in a sexual act or whose intimate parts are exposed.”  The terms “sexual act,” “intimate parts,” and “image” are all expressly defined.  Moreover, the person depicted in the image must be identifiable “from the image itself … or … from personal information displayed in connection with the image.”  Furthermore, the image has to be “obtained or created under circumstances in which the actor knew or reasonably should have known the person depicted had a reasonable expectation of privacy.”  Images that do not clear each of these hurdles fall outside the scope of the statute.

Second, a defendant must “intentionally” disseminate the image.  This mens rea requirement means that a defendant must knowingly and voluntarily disseminate a private sexual image; negligent, accidental, or even reckless distributions are not proscribed. This specific intent requirement further narrows the statute and keeps it from “target[ing] broad categories of speech.”

Third, the statute has seven enumerated exemptions. Some protected speech is taken outside of the scope of the statute by subdivision 5. For example, the statute exempts prosecution for image dissemination pursuant to essential law enforcement functions performed by both citizens and public safety personnel. The statute allows for private sexual images to be distributed “in the course of seeking or receiving medical or mental health treatment.” Advertisers, booksellers, and artists are protected because images “obtained in a commercial setting” for legal purposes fall outside the statute’s reach. Journalists cannot be prosecuted because there are exemptions for the dissemination of private sexual images that involve matters of public interest and “exposure[s] in public.” Educators and scientists are protected because there is an exemption for private sexual images disseminated for “legitimate scientific research or educational purposes.” Accordingly, even if protected speech falls within the ambit of subdivision one and a disseminator acted with the requisite mens rea, that person may still be exempt from prosecution under these precise exceptions.

Fourth, to be prosecuted under the statute, a disseminator must act without consent. This provision provides additional protection for commercial advertisements, certain adult films, artistic works, and other creative expression outside the statute’s scope.

Finally, this statute only encompasses private speech. “[R]estricting speech on purely private matters does not implicate the same constitutional concerns as limiting speech on matters of public interest.” Snyder v. Phelps (2011). “Speech on matters of purely private concern is of less First Amendment concern” than speech on public matters that go to the heart of our democratic system. Dun & Bradstreet, Inc. v. Greenmoss Builders, Inc. (1985). Unlike the overly broad statutes at issue in our recent decisions in In re Welfare of A.J.B. and Jorgenson, this statute covers only private sexual images and does not prohibit speech that is “at the core of protected First Amendment speech.”

I think that narrowly crafted bans on revenge porn (or, to be precise, nonconsensual porn) are indeed constitutional, but I think that the key here is that the speech really can be defined—at a categorical level—as both harmful and essentially lacking in First Amendment value.

The harm alone, I think, can’t be enough: For instance, accurate revelations of people’s past misconduct (or public condemnation of someone as a supposed racist or sexist or homophobe or lion-killer) may lead to “employers frequently put[ing] the [subject’s] application aside,” and could lead to severe emotional distress or even suicide. Nor do I trust courts to decide on a case-by-case basis whether certain facts or opinions about people can be criminalized on the theory that they relate to matters of “private concern” (see pp. 783-88 of this article).

But (whether under the rubric of strict scrutiny or some other formulation), it does make sense that such speech could be restrictable when it reveals nothing other than how the person looks naked or when having sex. That is a rare category of speech that one can generally say lacks any real value to public discussion (or even to people’s decisions about whom to trust in their daily lives), except in highly unusual cases. And, again, it does cause privacy harm that is both severe and (as unlike with the revelation of past misconduct) unjustifiable.

In any case, that’s my tentative sense of the matter, and one that fits the results we’ve been getting so far from the state high court cases that have considered such statutes.

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Biden Administration Seeks to Avoid Obama Administration Missteps on Judicial Nominations

The Obama Administration was notoriously slow to make judicial nominations. Even where there was no need to consult with home-state Senators (as with D.C. vacancies), the White House put forward nominees at a tepid pace, resulting in fewer and slower confirmations than one might have expected. The nomination pipeline was rarely full, so it was easier for Senate Republicans to slow things down, particularly once Mitch McConnell became Senate Majority Leader.

It is unclear whether President Biden’s nominees will face a democratic or a Republican Senate, but there are early signs the Biden Administration wants to hit the ground running when it comes to judicial nominations, so as to begin to undo the Trump Administration imprint on the federal judiciary.

The Huffington Post reports that incoming White House counsel Dana Remus has sent a letter to Democratic Senators requesting that they submit names of potential nominees for existing district court vacancies “as soon as possible” and no later than January 19. In other words, the Biden Administration wants to be able to start reviewing potential nominees on day one.

As of today (12/30) there are a total of 49 current judicial vacancies and five announced future vacancies. In all likelihood, these numbers will increase in January as additional judges announce plans to retire or take senior status. It is also likely that some judges will announce retirements upon the confirmation of their successors, so as to prevent extended vacancies on their courts. It is also possible there may be additional judgeships, particularly if Democrats manage to take control of the Senate. The Judicial Conference has requested additional seats on some courts.

The Remus letter makes clear this is not simply about current vacancies. It further asks Democratic Senators to quickly identify additional nominees “within 45 days of any new vacancy being announced, so that we can expeditiously consider your recommendations.” This is an aggressive time-table, particularly for Senators from states where it is common to rely upon advisory commissions to identify and vet potential nominees. Having served on Ohio’s commission, I can attest it would be quite difficult to meet such a deadline while performing the traditional degree of vetting and review.

In addition to seeking early input from Democratic Senators, the letter indicates that the Biden Administration would like to draw nominees from a broader pool of potential jurists. According to the letter, the Biden team is “particularly focused on nominating individuals whose legal experiences have been historically underrepresented on the federal bench, including those who are public defenders, civil rights and legal aid attorneys, and those who represent Americans in every walk of life.” Progressive activist groups have been urging such a broader focus. The lack of federal judges with meaningful criminal defense experience, in particular, is a widely recognized problem. As this Cato study noted, there are lots of former prosecutors on the federal bench, but relatively few former public defenders.

Without question, control of the Senate will make or break the Biden Administration’s ability to make an early mark on the federal judiciary. A Democratic Senate will begin considering and confirming Biden nominees much more quickly than a Republican one. That said, it still makes sense for the Biden White House to begin moving now.

The more nominees there are in the pipeline, the more pressure there is to let some of them through. For this reason, the Biden White House will want to put forward names as quickly as it feels comfortable doing so. It will also want to put forward names that have local GOP support, where possible.

Beginning the identification and vetting of potential nominees early will also put the Biden White House in a stronger position to negotiate over packages of nominees. Though rarely reported, the Trump White House was quite effective at putting together bipartisan packages of nominees in states with Democratic Senators who were willing to negotiate. This is how some key vacancies in states like Illinois and Hawaii were filled without Democratic opposition. While the political dynamic will be somewhat different, a Biden White House would be well advised to make such deals where possible.

A few other tidbits worth noting. First, the letter focuses on district court nominees, suggesting the Biden Administration intends to take the lead on appellate nominees. This is what the Trump Administration did, and (in my view) it makes sense. Local interests are much stronger when it comes to district court nominations.

Second, even before this letter was sent, progressive activist groups had begun working to help fill the roster of potential nominees. The American Constitution Society, for one, has sent out a fund-raising appeal noting that it is “uniquely positioned to build the bench of the next generation of progressive leaders in the law” and boasting that it had “developed a highly qualified pool of legal professionals and delivered the names to President-elect Biden’s transition team just hours after he became the President-elect.” Other groups have reportedly made similar efforts, though these lists of potential nominees have not been made public.

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When There Wasn’t Enough Hand Sanitizer, Distilleries Stepped Up. Now They’re Facing $14,060 FDA Fees.

DistillerHandSan

For many American craft distillers, 2020 was already one of their worst years ever. The COVID-19-related closure of tasting rooms and cocktail bars, loss of tourism, and inability to offer in-store sampling slashed their sales revenue and cut them off from their customers. Then this week, just as it seemed they’d made it through the worst of a terrible year, the Food and Drug Administration (FDA) had one more surprise in store: The agency delivered notice to distilleries that had produced hand sanitizer in the early days of the pandemic that they now owe an unexpected fee to the government of more than $14,000.

“I was in literal disbelief when I read it yesterday,” says Aaron Bergh, president and distiller at Calwise Spirits in Paso Robles, California. “I had to confirm with my attorney this morning that it’s true.” The surprise fee caught distillers completely off guard, throwing the already suffering industry into confusion.

When the onset of the pandemic led to a massive increase in demand for hand sanitizer this spring, many distilleries stepped up to alleviate the sudden shortage. The main ingredient in sanitizer is ethanol, which they are in the business of making, albeit typically in more fun and tasty formats. More than 800 distilleries pivoted from spirits to sanitizer, offering it for sale or in many cases donating it to their communities free of charge. Their prompt action helped ensure supplies of sanitizer when it was otherwise unobtainable.

(Even then, the FDA needlessly complicated things, imposing additional requirements on top of guidelines published by the World Health Organization for emergency production. The FDA’s mandate that all alcohol used in sanitizer first be denatured—rendering it undrinkable—created a bottleneck that raised costs for distillers and slowed production.)

Producing sanitizer is viewed as a point of pride in the distilling business, a way that they were able to help their communities in a fearful time of crisis. 

Now, however, that good deed is being punished with unanticipated fees by the FDA. “I compare it to surprise medical billing,” says Becky Harris, president of the American Craft Spirits Association (ACSA) and of Catoctin Creek Distilling in Purcellville, Virginia.

At issue is a provision of the CARES Act that reformed regulation of non-prescription drugs. Under the revised law, distilleries that produced sanitizer have been classified as “over-the-counter drug monograph facilities.” The CARES Act also enacted user fees on these facilities to fund the FDA’s regulatory activities. For small distillers, that means ending the year with a surprise bill for $14,060 due on February 11.

“People are incredibly anxious,” Harris says. “We have been dealing with tons of phone calls talking to individual members and state guilds to tell them what we know and what we don’t know.”

Harris and the ACSA have spent the day trying to learn more details about the law and the FDA’s intentions, but the combination of the holidays and the pandemic makes this a difficult time to reach anyone. “We recognize that this bill [the CARES ACT] was not written specifically for the issue of sanitizer,” Harris says. “The problem that we have right now is that [the fee assessment] is going out to a whole lot of small businesses who are struggling in the pandemic.”

Bergh’s CalWise Spirits is a typical example. He says that his distillery produced 5,000 gallons of hand sanitizer, with distribution prioritized to medical workers and others on the frontlines of the pandemic response. “Some of my hand sanitizer was donated,” he said in a statement today. “The rest was sold at a fraction of the market price. My goal was to get as much out as I could, at as low of a price as I could, while being able to bring my furloughed employees back to work. The hand sanitizer business saved me from bankruptcy – but I didn’t make an enormous profit.”

Potentially compounding the impact of the fee is that it is determined by registration as an OTC (over-the-counter) monograph drug production facility in the previous calendar year. That means that distilleries not only have to contend with this year’s fee; if they fail to update their status with the FDA by tomorrow, they may be liable for an additional fee in 2022 as well.

For now, Harris is advising members not to pay the fee right away. “We want to push back on this,” she says. She’s hopeful that if the FDA has some discretion as to the applicability of the fee, that they will exercise it to exclude distilleries, most of which no longer produce sanitizer and have no intention of continuing to do so now that the emergency shortage has passed. Currently, however, the FDA’s website explicitly notes that facilities that produced sanitizer under the agency’s temporary COVID-19 policy are not exempt. Reason‘s inquiry with the FDA has yet to receive a detailed response, but we will update if we receive one.

Paying a surprise $14,000 bill would be a challenge for small businesses in any year, but it’s a particular challenge for craft distilleries in 2020. An industry survey conducted earlier this year by the Distilled Spirits Council of the United States and the American Distilling Institute projected that sales revenue at craft distilleries would decline by more than $700 million this year, amounting to approximately 40 percent of their sales.

For many distillers, the unexpected fee assessment from the FDA thus arrives as one more substantial blow in an already devastating year. “If you were making sanitizer for your community at a limited capacity, this should not be something you have to deal with,” says Harris. “It will be a slap in the face to make it through all of this and then get hit with this bill.” 

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Increases in Opioid-Related Deaths Show That Drug Warriors (Including Biden) Have No Idea What They’re Doing

Joe-Biden-12-30-20-Newscom

Last year President Donald Trump bragged that “we are making progress” in reducing opioid-related deaths, noting that they fell in 2018 “for the first time since 1990.” That 1.7 percent drop was thin evidence of success at the time, and it looks even less impressive in light of the the 6.5 percent increase recorded by the Centers for Disease Control and Prevention (CDC) in 2019. When you add preliminary CDC data indicating that opioid-related deaths rose dramatically this year, you have even more reason to wonder whether the government is actually winning the war on drugs.

The 49,860 deaths involving opioids that the CDC counted in 2019 set a new record that is likely to be broken when the data for 2020 are finalized. “Synthetic opioids other than methadone,” the category that includes fentanyl and its analogs, were involved in 73 percent of opioid-related deaths last year. According to the CDC’s preliminary data, “the 12-month count of synthetic opioid deaths increased 38.4% from the 12 months ending in June 2019 compared with the 12 months ending in May 2020.”

During the same period, total drug-related deaths rose by 18 percent. Although that includes increases in deaths involving cocaine and methamphetamine, the CDC says, “synthetic opioids are the primary driver,” and “the increases in drug overdose deaths appear to have accelerated during the COVID-19 pandemic.” As Zachary Siegel notes in a New York magazine piece, the pandemic and the lockdowns it inspired probably have driven drug-related deaths in two main ways: by contributing to the economic woes and social isolation that make drug use more appealing and by increasing the likelihood that people will use drugs without anyone else around, which magnifies the risk of fatal outcomes.

Although the pandemic and the restrictions associated with it have made matters worse, opioid-related deaths were already on the rise, which suggests once again that reducing access to prescription pain pills, the main thrust of the Trump administration’s strategy, has not had the intended effect. To the contrary, it has driven nonmedical users toward black-market substitutes that are more dangerous because their potency is inconsistent and unpredictable, while depriving bona fide patients of the medication they need to make their lives bearable.

Although the government has succeeded in driving down opioid prescriptions, the upward trend in opioid-related deaths has not just continued but accelerated. In 2019, “natural and semisynthetic opioids,” the category that includes commonly prescribed pain relievers such as hydrocodone and oxycodone, were involved in 24 percent of opioid-related deaths (many of which also involved fentanyl and/or heroin). That’s down from 52 percent in 2010. Meanwhile, opioid-related deaths rose by 136 percent, while the fraction involving synthetic opioids increased from one-seventh to nearly three-quarters. That does not seem like a good tradeoff.

President-elect Joe Biden’s “Plan to End the Opioid Crisis” promises more of the same. Biden emphasizes access to “substance use disorder treatment and mental health services”—a big Trump talking point. Biden wants to “hold accountable big pharmaceutical companies, executives, and others responsible for their role in triggering the opioid crisis,” which the current administration also has tried. Such lawsuits and prosecutions might make drug warriors feel good, but they do absolutely nothing to reduce opioid-related deaths.

Biden promises to “stem the flow of illicit drugs, like fentanyl and heroin, into the United States.” Why didn’t anyone think of that before? To the extent that such supply control efforts succeed, they drive traffickers toward more potent and concealable products. That helps explain why heroin has been displaced by fentanyl, which is far more potent, and fentanyl analogs, some of which are more potent still. The proliferation of such drugs increases the variability that makes black-market opioids more lethal than legally produced narcotics.

Worst of all, Biden says he will “stop overprescribing while improving access to effective and needed pain management.” We know from years of experience how the government is apt to strike that balance, and it is bad news for patients and nonmedical users alike.

Biden’s plan says nothing about harm reduction measures such as fentanyl test kits, supervised consumption facilities, or expanding “medication-assisted treatment” beyond methadone and buprenorphine (although it does recommend looser restrictions on buprenorphine). The plan mentions “harm reduction” just once, and the phrase is immediately followed by a list of law enforcement initiatives. It looks like Biden, despite all his compassionate talk, will replicate the strategy that is helping to sustain the “opioid crisis” he says he wants to end.

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When There Wasn’t Enough Hand Sanitizer, Distilleries Stepped Up. Now They’re Facing $14,060 FDA Fees.

DistillerHandSan

For many American craft distillers, 2020 was already one of their worst years ever. The COVID-19-related closure of tasting rooms and cocktail bars, loss of tourism, and inability to offer in-store sampling slashed their sales revenue and cut them off from their customers. Then this week, just as it seemed they’d made it through the worst of a terrible year, the Food and Drug Administration (FDA) had one more surprise in store: The agency delivered notice to distilleries that had produced hand sanitizer in the early days of the pandemic that they now owe an unexpected fee to the government of more than $14,000.

“I was in literal disbelief when I read it yesterday,” says Aaron Bergh, president and distiller at Calwise Spirits in Paso Robles, California. “I had to confirm with my attorney this morning that it’s true.” The surprise fee caught distillers completely off guard, throwing the already suffering industry into confusion.

When the onset of the pandemic led to a massive increase in demand for hand sanitizer this spring, many distilleries stepped up to alleviate the sudden shortage. The main ingredient in sanitizer is ethanol, which they are in the business of making, albeit typically in more fun and tasty formats. More than 800 distilleries pivoted from spirits to sanitizer, offering it for sale or in many cases donating it to their communities free of charge. Their prompt action helped ensure supplies of sanitizer when it was otherwise unobtainable.

(Even then, the FDA needlessly complicated things, imposing additional requirements on top of guidelines published by the World Health Organization for emergency production. The FDA’s mandate that all alcohol used in sanitizer first be denatured—rendering it undrinkable—created a bottleneck that raised costs for distillers and slowed production.)

Producing sanitizer is viewed as a point of pride in the distilling business, a way that they were able to help their communities in a fearful time of crisis. 

Now, however, that good deed is being punished with unanticipated fees by the FDA. “I compare it to surprise medical billing,” says Becky Harris, president of the American Craft Spirits Association (ACSA) and of Catoctin Creek Distilling in Purcellville, Virginia.

At issue is a provision of the CARES Act that reformed regulation of non-prescription drugs. Under the revised law, distilleries that produced sanitizer have been classified as “over-the-counter drug monograph facilities.” The CARES Act also enacted user fees on these facilities to fund the FDA’s regulatory activities. For small distillers, that means ending the year with a surprise bill for $14,060 due on February 11.

“People are incredibly anxious,” Harris says. “We have been dealing with tons of phone calls talking to individual members and state guilds to tell them what we know and what we don’t know.”

Harris and the ACSA have spent the day trying to learn more details about the law and the FDA’s intentions, but the combination of the holidays and the pandemic makes this a difficult time to reach anyone. “We recognize that this bill [the CARES ACT] was not written specifically for the issue of sanitizer,” Harris says. “The problem that we have right now is that [the fee assessment] is going out to a whole lot of small businesses who are struggling in the pandemic.”

Bergh’s CalWise Spirits is a typical example. He says that his distillery produced 5,000 gallons of hand sanitizer, with distribution prioritized to medical workers and others on the frontlines of the pandemic response. “Some of my hand sanitizer was donated,” he said in a statement today. “The rest was sold at a fraction of the market price. My goal was to get as much out as I could, at as low of a price as I could, while being able to bring my furloughed employees back to work. The hand sanitizer business saved me from bankruptcy – but I didn’t make an enormous profit.”

Potentially compounding the impact of the fee is that it is determined by registration as an OTC (over-the-counter) monograph drug production facility in the previous calendar year. That means that distilleries not only have to contend with this year’s fee; if they fail to update their status with the FDA by tomorrow, they may be liable for an additional fee in 2022 as well.

For now, Harris is advising members not to pay the fee right away. “We want to push back on this,” she says. She’s hopeful that if the FDA has some discretion as to the applicability of the fee, that they will exercise it to exclude distilleries, most of which no longer produce sanitizer and have no intention of continuing to do so now that the emergency shortage has passed. Currently, however, the FDA’s website explicitly notes that facilities that produced sanitizer under the agency’s temporary COVID-19 policy are not exempt. Reason‘s inquiry with the FDA has yet to receive a detailed response, but we will update if we receive one.

Paying a surprise $14,000 bill would be a challenge for small businesses in any year, but it’s a particular challenge for craft distilleries in 2020. An industry survey conducted earlier this year by the Distilled Spirits Council of the United States and the American Distilling Institute projected that sales revenue at craft distilleries would decline by more than $700 million this year, amounting to approximately 40 percent of their sales.

For many distillers, the unexpected fee assessment from the FDA thus arrives as one more substantial blow in an already devastating year. “If you were making sanitizer for your community at a limited capacity, this should not be something you have to deal with,” says Harris. “It will be a slap in the face to make it through all of this and then get hit with this bill.” 

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Increases in Opioid-Related Deaths Show That Drug Warriors (Including Biden) Have No Idea What They’re Doing

Joe-Biden-12-30-20-Newscom

Last year President Donald Trump bragged that “we are making progress” in reducing opioid-related deaths, noting that they fell in 2018 “for the first time since 1990.” That 1.7 percent drop was thin evidence of success at the time, and it looks even less impressive in light of the the 6.5 percent increase recorded by the Centers for Disease Control and Prevention (CDC) in 2019. When you add preliminary CDC data indicating that opioid-related deaths rose dramatically this year, you have even more reason to wonder whether the government is actually winning the war on drugs.

The 49,860 deaths involving opioids that the CDC counted in 2019 set a new record that is likely to be broken when the data for 2020 are finalized. “Synthetic opioids other than methadone,” the category that includes fentanyl and its analogs, were involved in 73 percent of opioid-related deaths last year. According to the CDC’s preliminary data, “the 12-month count of synthetic opioid deaths increased 38.4% from the 12 months ending in June 2019 compared with the 12 months ending in May 2020.”

During the same period, total drug-related deaths rose by 18 percent. Although that includes increases in deaths involving cocaine and methamphetamine, the CDC says, “synthetic opioids are the primary driver,” and “the increases in drug overdose deaths appear to have accelerated during the COVID-19 pandemic.” As Zachary Siegel notes in a New York magazine piece, the pandemic and the lockdowns it inspired probably have driven drug-related deaths in two main ways: by contributing to the economic woes and social isolation that make drug use more appealing and by increasing the likelihood that people will use drugs without anyone else around, which magnifies the risk of fatal outcomes.

Although the pandemic and the restrictions associated with it have made matters worse, opioid-related deaths were already on the rise, which suggests once again that reducing access to prescription pain pills, the main thrust of the Trump administration’s strategy, has not had the intended effect. To the contrary, it has driven nonmedical users toward black-market substitutes that are more dangerous because their potency is inconsistent and unpredictable, while depriving bona fide patients of the medication they need to make their lives bearable.

Although the government has succeeded in driving down opioid prescriptions, the upward trend in opioid-related deaths has not just continued but accelerated. In 2019, “natural and semisynthetic opioids,” the category that includes commonly prescribed pain relievers such as hydrocodone and oxycodone, were involved in 24 percent of opioid-related deaths (many of which also involved fentanyl and/or heroin). That’s down from 52 percent in 2010. Meanwhile, opioid-related deaths rose by 136 percent, while the fraction involving synthetic opioids increased from one-seventh to nearly three-quarters. That does not seem like a good tradeoff.

President-elect Joe Biden’s “Plan to End the Opioid Crisis” promises more of the same. Biden emphasizes access to “substance use disorder treatment and mental health services”—a big Trump talking point. Biden wants to “hold accountable big pharmaceutical companies, executives, and others responsible for their role in triggering the opioid crisis,” which the current administration also has tried. Such lawsuits and prosecutions might make drug warriors feel good, but they do absolutely nothing to reduce opioid-related deaths.

Biden promises to “stem the flow of illicit drugs, like fentanyl and heroin, into the United States.” Why didn’t anyone think of that before? To the extent that such supply control efforts succeed, they drive traffickers toward more potent and concealable products. That helps explain why heroin has been displaced by fentanyl, which is far more potent, and fentanyl analogs, some of which are more potent still. The proliferation of such drugs increases the variability that makes black-market opioids more lethal than legally produced narcotics.

Worst of all, Biden says he will “stop overprescribing while improving access to effective and needed pain management.” We know from years of experience how the government is apt to strike that balance, and it is bad news for patients and nonmedical users alike.

Biden’s plan says nothing about harm reduction measures such as fentanyl test kits, supervised consumption facilities, or expanding “medication-assisted treatment” beyond methadone and buprenorphine (although it does recommend looser restrictions on buprenorphine). The plan mentions “harm reduction” just once, and the phrase is immediately followed by a list of law enforcement initiatives. It looks like Biden, despite all his compassionate talk, will replicate the strategy that is helping to sustain the “opioid crisis” he says he wants to end.

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