Daily Archives: August 20, 2021

A teacher in the Alpine School District is no longer working there after a recording of her surfaced talking about the need for people to get the COVID-19 vaccine, her disdain of former President Donald Trump and telling students they can get out if they dont believe in climate change.

The video was shared widely on social media, with many comments calling for the teachers removal.

District spokesperson David Stephenson said he couldnt comment whether the teacher had been fired or resigned, but referred to Alpines Code of Conduct, which states employees and volunteers are expected to act professionally communicating in a civil manner and not promoting personal opinions, issues or political positions as part of the instructional process.

We expect professional conduct and decorum from all of our teachers, Stephenson said in an email. Behavior otherwise that is in violation of the code of conduct will not be tolerated.

Brad Asay, president of the Utah chapter of the American Federation of Teachers, said the incident was unfortunate, but unusual in his experience.

He said teachers have always had to navigate politically-sensitive territory, but it can be especially tricky in the current climate. As the New York Times wrote, nearly all of the major issues dividing the country have dropped like an anvil on U.S. schools, from debates around mask mandates and other public health measures to conservations around race and educational equity.

That's my worry, is that folks out there, especially those that believe that students are being indoctrinated, that they have this belief that's happening all the time throughout our school system, Asay said. What we saw [in the video] was not the norm. This just does not happen often at all.

The American Civil Liberties Union of Utah notes there are many limitations to teachers First Amendment rights in the classroom as it can be considered speech on behalf of the school district. Specific policies can vary widely by district.

The issue gets blurry, however, when it comes to things like public health measures around COVID-19, which may not be political issues at their core but have become so over the last year.

We are in a lot of gray area right now of what can you discuss in a classroom, especially when it comes to COVID, Asay said. A lot of districts are saying don't even mention it.

When sensitive topics inevitably come up, he said the usual approach is that teachers try to keep the discussion open, encourage students to voice their opinions but bring the focus back to the curriculum or subject at hand.

He said he often advises teachers to assume they will be recorded and watched closely, though its less of a warning than a reminder that students are looking to them as examples.

Go here to read the rest:
Navigating Free Speech In The Classroom Is Getting Harder For Teachers When Schools Are At The Centers Of Political Debates - KUER 90.1

Federal leaders are on alert for increased threats of terrorism here at home.

This month, the Department of Homeland Security recently issued a warning about heightened threat levels leading up to the 20th anniversary of the 9/11 attacks.

Federal authorities are pointing to incidents like Thursdays bomb threat near the Library of Congress.

US Capitol Police investigators say bomb threat suspect Floyd Ray Roseberry was acting alone when he threatened to have explosives in this pickup truck.

But in a Facebook live video, Roseberry said there were others like him.

Weve seen an increasing drumbeat of conspiracy theories in the United States, some funneled by nations like Russia and China who are trying to stoke those disputes here in the United States, said Jamil N. Jaffer, who teaches classes on counterterrorism, intelligence, surveillance and cybersecurity at the Antonin Scalia Law School at George Mason University.

Jaffer is also the founder and executive director of the National Security Institute on campus. He said domestic extremists are getting bolder, often using social media to motivate others to act.

He said the real challenge is watching how people respond to those posts.

How do they act on it? How do they respond to it? If Americans reject this kind of behavior, reject this kind of stuff on social media and they hold them accountable, well see some of this stuff go away, he said.

The Department of Homeland issued this new National Terrorism Advisory System (NTAS) Bulletin aboutheightened threat environment across the United States.

DHS remains committed to sharing timely information with the public about the heightened threat environment in order to protectcommunities acrossourcountry,said Secretary of Homeland Security, Alejandro N. Mayorkas in a written statement.Todays NTAS Bulletin advisesthe public about theheightenedthreat landscape we faceand howDHSis working with our partners, at every level of government and in the community, tocombatdomestic terrorism and targeted violence in all its forms. We are committed to ensuring every initiative undertaken by DHSin response to the threatis consistent with privacy protections, civil rights and civil liberties, First Amendment-protected rights, and other applicablelaws.

Jaffer said the international terror threat changed overnight as Afghanistan fell to Taliban control.

Its critical for the Presidents national security team to really keep up that fight against the terrorists and if they need to go back into Afghanistan or anywhere else, they need to do that if it keeps Americans safe, said Jaffer.

DHS is also on alert for people who are inspired by foreign terrorists.

2021 Cox Media Group

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Heightened threat alert for domestic terrorism ahead of 9/11 anniversary - ActionNewsJax.com

The state of Iowa has agreed to pay $70,000 and improve First Amendment training for state troopers in order to settle a lawsuit filed last year by five protesters who were banned from the Iowa Capitol Complex.

Jalesha Johnson, Louise Bequeaith, Brad Penna, Brandi Ramus, and Haley Jo Dikkers were among seventeen people whom state troopers had banned from the capitol grounds following a July 1, 2020 Black Lives Matter protest that led to numerous arrests. They filed suit last October against Iowa Department of Public Safety Commissioner Stephen Bayens and several Iowa State Patrol officials, saying the bans violated their rights under the First, Fifth, Ninth, and Fourteenth Amendments.

Under a settlement U.S. District Court Judge Rebecca Goodgame Ebinger approved on August 17, the Iowa Department of Public Safety and Iowa State Patrol agreed to withdraw all verbal and written bans, sometimes called trespass warnings, issued to each plaintiff and other persons receiving such notices on and after July 1, 2020. The state will inform affected individuals in writing that the bans were rescinded and that they may continue to enter and use the Iowa Capitol Complex on the same basis and under the same terms as any other law abiding member of the public.

The state will pay each plaintiff $5,000 and $45,000 to Des Moines attorney Nate Mundy, who along with the ACLU of Iowa represented the protesters. The Iowa State Patrol also agreed to continue First Amendment training for officers assigned to the capitol complex.

Attorneys for the state and ACLU agreed in June on terms to settle the lawsuit. The three-member State Appeal Board unanimously approved the settlement agreement earlier this month, and the federal courts action finalized the resolution.

Judge Goodgame Ebinger had ruled last December that the bans likely burden more speech than is necessary to achieve the significant state interests of preventing violence and ensuring public safety, since there was no way for protesters to petition to exercise their First Amendment rights at the Capitol or on the Capitol Complex grounds.

The ACLU of Iowas legal director Rita Bettis Austen said in a written statement on August 17,

The Capitol Complex is approximately 24 city blocks and includes many traditional public forumsplaces where Iowans often go to express their rights of free speech like the West Capitol Terrace, outdoor green spaces, sidewalks, streets, paths, and areas around public monuments. There is perhaps no more important traditional public forum in Iowa than the State Capitol.

The area is intentionally designed for Iowans to gather and speak to an audience of leaders from all three branches of state government. Before we obtained a preliminary injunction in this case, the ban meant that the protestors were unable to participate in demonstrations organized by BLM or other groups on the grounds. The ban also would have prevented the banned protesters from communicating directly with legislators and the Governors office during the upcoming 2021 legislative session. This outcome was important to protect the First Amendment rights of our clients and all other Iowans to speak, assemble, and petition their government for redress of grievances.

Appendix: Full text of August 17 news release from the ACLU of Iowa:

Des Moines, Iowa Today the federal District Court for the Southern District of Iowaapproved and adopted a settlement in which the Iowa Department of Public Safety and Iowa State Patrol (ISP) agreed to withdraw bans that the ISP issued to 17 BLM protesters last summer, including five ACLU clients. The bans forbade the protesters from going to the Iowa Capitol Complex grounds for six months or a year.

Earlier this month, the Iowa State Appeals board voted to approve a recommendation by state lawyers to settle the lawsuit out of court. The settlement included the law enforcement agencies agreeing to not issue similar bans in the future, to continue to provide training on First Amendment rights to the Iowa State Patrol Post 16 (which is responsible for law enforcement on the Iowa Capitol Complex grounds), to pay a financial settlement to the ACLUs five clients, and attorney fees.

Rita Bettis Austen, ACLU of Iowa Legal Director, said, We are very pleased with this outcome. We are grateful to our clients for challenging the constitutionality of these bans. They are protecting their fellow protesters and everyone else who wasnt a plaintiff in this case by getting the bans of all protesters withdrawn. Thestate also agreed to not to issue the same type of ban in the future.

We also appreciate the state for working to come to an agreement with us in this case, both to resolve this dispute and to protect the First Amendment rights of Iowans at the Capitol moving forward. Thats the optimal outcome, Bettis Austen said.

The bans were issued to protesters who were arrested while protesting in July 2020, even though most of the charges against the ACLUs clients were dropped.

In October 2020, the ACLU filed the lawsuit on behalf of five of the 17 Des Moines BLM protesters who the ISP banned verbally and in writing from the State Capitol. The ISP informed the protestors that if they entered the Capitol Complex grounds in the next six months or a year (depending on the protester), they would be arrested.

However, the law that the ISP cited to issue those bans (Iowa Code section 716.8(1)) does not actually authorize any such bans.

In December 2020, a federal court issued a preliminary injunction, saying the ban indeed was likely violating the protestors First Amendment rights. In June 2021, the parties reached an agreement that required approval by the State Appeal Board and the district court to take effect. On August 2, the Appeal Board approved the settlement. Today, the court dismissed the case and approval of the settlement, making the agreement becomes fully effective, resolving the dispute, and ending the case.

Bettis Austen said the activists were banned from a key area for public free speech. The Capitol Complex is approximately 24 city blocks and includes many traditional public forumsplaces where Iowans often go to express their rights of free speech like the West Capitol Terrace, outdoor green spaces, sidewalks, streets, paths, and areas around public monuments. There is perhaps no more important traditional public forum in Iowa than the State Capitol.

The area is intentionally designed for Iowans to gather and speak to an audience of leaders from all three branches of state government. Before we obtained a preliminary injunction in this case, the ban meant that the protestors were unable to participate in demonstrations organized by BLM or other groups on the grounds. The ban also would have prevented the banned protesters from communicating directly with legislators and the Governors office during the upcoming 2021 legislative session. This outcome was important to protect the First Amendment rights of our clients and all other Iowans to speak, assemble, and petition their government for redress of grievances, Bettis Austen said.

Jalesha Johnson, an employee of a Des Moines Public Schools creative arts program, said the win was important not just for her, but for the larger community of protestors.

The most important work we did happened on the Capitol grounds. I feel hopeful and inspired that well be able to frequent the Capitol again. When the ban was in place, it meant I was at risk of arrest by police for nothing more than protesting lawfully at the Capitol. I am relieved that I dont have to feel that way anymore, Johnson said.

Louise Bequeaith, a college student and Des Moines native, said the win was bittersweet. Its hard because this shouldnt have happened in the first place. The Capitol and government are meant to be there for us and to listen. People being punished for protecting our communities and wanting our voices to be heard felt ridiculous. But this is the result that feels like the most justice in this moment.

Haley Jo Dikkers, an educational assistant to elementary school children, said, I think protesting is still an important and vital way to interact with our government, especially if they dont give us other outlets to do so. Im excited to get back to the streets. When youre up against the police that have all this qualified immunity and societal power, I feel like they can get away with pretty much anything. So its really great that now they wont be able to ban people from the Capitol, and I hope they wont try to ban people from protesting in public spaces in the future.

Brad Penna, who owns a coffee shop in Des Moines, said the win is a huge step towards making the most political space in the city and even the whole state accessible to people. They cant ban people following protests now and they know its part of a larger movement.

Before the temporary injunction allowed us back into the area, as a business owner, I would have liked to go to the Capitol when policies about COVID-19 were being discussed. I felt like I didnt have a voice during that time. Now I feel encouraged to once again advocate for our community, Penna said.

Brandi Ramus, who owns a Des Moines vegan bakery, said, I feel like that was a really unreasonable thing that happened to me and the rest of us. Im glad that theyre saying that they were wrong, even though it just seemed like common sense to me. People should be able to protest in public spaces.

I think theres still a lot of work to do here in Iowa as far as protestors and how our state continues to treat us. This is making an example, showing that overreach of law enforcement to silence protestors is wrong. Thats not their place. The police claim they protect and serve the community, but what they are actually doing is battling against it, Ramus said.

The ACLU of Iowa legal team was joined by cooperating Des Moines civil rights attorneys Nathan A. Mundy of Mundy Law Office, P.C., and Glen Downey of The Law Offices of Glen S. Downey, LLC, who also worked tirelessly to represent the five clients in successfully defending against separate criminal charges brought against them after they were arrested while protesting.

Top photos all obtained from the ACLU of Iowa. Top row, from left: Jalesha Johnson, Louise Bequeaith. Bottom row, from left: Brad Penna, Brandi Ramus, and Haley Jo Dikkers.

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Bleeding Heartland - bleedingheartland.com

Legal battles over masks in schools are being fought across the country, including in Arkansas, California, Florida, Kentucky, Michigan, Oklahoma, Nevada and Texas.

Rather than clarifying policy, these legal challenges have led to more confusion.

As a new school year begins and COVID-19 hospitalizations rise across the country, the Centers for Disease Control and Prevention and the American Academy of Pediatrics recommend that students wear masks in school to help slow the spread of the coronavirus.

This guidance, and schools responses to it, has resulted in an intense debate. Some parents argue that they should be able to decide when and where their children wear masks, whereas others argue collective health and safety concerns take priority over individual choices. These arguments fall sharply along partisan lines, with 88% of Democrats supporting mask mandates and 69% of Republicans against the requirements.

State rules reflect this division. In eight states, as of Aug. 16, 2021, laws were enacted or governors issued orders banning public schools from requiring students to wear masks. On the opposite side of the debate, 12 states and the District of Columbia are requiring students to wear masks indoors.

Further complicating matters, some school districts have acted in outright defiance of their states regulations. These conflicts pose one key question: Who has the power to control the health and safety measures schools take state leaders or local officials?

Texas provides a good example of this conflict. Even after Texas Gov. Greg Abbott issued an executive order banning school mask mandates, local officials in several school districts adopted policies that required students to wear masks.

Simultaneous legal battles across multiple state court districts ensued and resulted in inconsistent rulings on whether banning masks in schools is constitutional.

On Aug. 15, the Texas Supreme Court weighed in, siding with the governor and saying that schools cannot require masks. Yet some schools still do, defying both the governor and the states highest court.

With all of the partisan rhetoric, lawsuits and conflict, many parents are left bewildered about how to proceed with the school year.

This is not the first time legal battles have erupted in the wake of a public health emergency. During the influenza pandemic of 1918, state and local governments enacted a variety of restrictions to combat the spread of the virus. As they must now, officials had to make hard decisions about whether to close schools or prevent public gatherings. Mask mandates even existed in some areas. State and local judges routinely upheld these measures.

Many of the same constitutional questions debated over 100 years ago arise today about mask mandates and other pandemic-related regulations.

Long-standing U.S. Supreme Court precedent recognizes that states have broad powers to regulate the health and safety of their citizens during a public health crisis.

But no right is absolute. When evaluating a states actions in a pandemic, courts weigh the governments interest in protecting the health and safety of its citizens against an individuals civil liberties.

Common challenges against COVID-19-related regulations argue that some requirements violate the First Amendment or an individuals right to liberty, including the right to make choices about ones own health.

Over the past year, the challenges that have been most successful in the courts argued that certain COVID-19 rules violated the First Amendment right to freely exercise ones religion.

For example, the U.S. Supreme Court recently blocked the state of California from enforcing COVID-19 restrictions on an at-home Bible study group and prevented New York state from enforcing occupancy limits on religious services.

But with respect to mask mandates, legal precedent supporting similar challenges is not as strong.

For example, in Maryland, a federal district court recently suggested in a decision that litigants were unlikely to succeed with claims that challenged mask mandates as unconstitutional violations of the First Amendment.

Arguments that mask mandates violate an individuals constitutional right to liberty defined by a leading legal resource as freedom from arbitrary and unreasonable restraint upon an individual face an even greater uphill battle. Courts have interpreted the Constitution as giving elected officials leeway when it comes to social policy, particularly in areas fraught with medical and scientific uncertainties.

This does not bode well for challenges like one recently filed in Nevada, which claims mask mandates infringe upon the fundamental right of parents to make child-rearing decisions.

On the other side of the debate, in some states litigants have gone to court to advocate for more stringent COVID-19 regulations.

In Florida, two different lawsuits seek to overturn the governors ban on school mask requirements. They claim that the Florida Constitution guarantees a safe school environment and grants local governments the authority to govern schools.

Some of the more successful lawsuits have focused on the fact that, by law, most states can regulate mask wearing in only public schools. This means that state laws and orders that ban mask requirements do not extend to private schools. In Arizona, Arkansas and Oklahoma, lawsuits claim that this creates unconstitutional distinctions between public and private students rights to a safe educational environment and therefore, they say, the state cannot ban mask mandates in schools at all.

All of this fighting within and among the states led the Biden administration to step into the fray. While the federal government cannot constitutionally command the states to do something, it can create incentives for them with money.

In response to the governors orders in Florida and Texas that prohibit mask mandates in schools, U.S. Secretary of Education Miguel Cardona reminded both states governors that federal CDC guidance recommends students wear masks. Cardona also suggested that the Biden administration would closely monitor whether the states were meeting requirements for federal relief funding under the American Rescue Plan Act of 2021. That law requires states to adhere to CDC guidance, including implementing mitigation strategies such as contact tracing or mask requirements, in order to receive the federal money the act provides.

President Joe Biden followed up Cardonas letters to the governors with a phone call of support to one of the superintendents who adopted mask mandates in violation of his governors executive order.

If it all sounds confusing and as if the law is all over the place regarding school mask mandates, thats because it is. The nations schools are subject to a complex web of local, state and federal laws that make it difficult to impose uniform standards.

Add in an intense political battle over the appropriate policies to adopt in the wake of the delta variant and you have precisely the kind of situation that may well end up at the U.S. Supreme Court.

Read more:
Who has the power to say kids do or don't have to wear masks in school the governor or the school district? It's not clear - The Conversation US

On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128,1 marking the end of an effort FDA began in 2015.2 While the agencys 6-year rulemaking process took many turns along the way and stakeholders tried repeatedly to limit the broad scope of the intended use regulations in the end, FDA wound up right back where [it] started from,3 confirming that a manufacturers mere knowledge of an unapproved use cannot, standing alone, constitute evidence of a new intended use, but FDA may consider such knowledge along with a host of other factors as evidence of intended use.

While the final rule provides greater insight into FDAs evaluation of intended use than did some of the interim iterations (most notably the 2017 Proposed Rule, which included a vague totality of the evidence standard), questions remain about how the agency will address various manufacturer activities that extend beyond mere knowledge but may be entitled to protection under the First Amendment. Ultimately, FDA continues to construe intended use broadly, and pharmaceutical companies and medical device manufacturers should continue to tread carefully when making any statements or claims that stray beyond FDA-approved labeling, even when those claims are truthful and non-misleading.

FDAs proposed changes to the intended use regulations merit attention because intended use shapes enforcement actions, criminal prosecutions, and False Claims Act (FCA) cases. FDAs labeling regulations define intended use as the objective intent of the persons legally responsible for the labeling of the drug or device a definition that covers a broad array of activities and speech, which can then be used as evidence that a manufacturer is promoting its product beyond the indicated use.

Under this historical approach, FDA and the Department of Justice (DOJ) have cited a variety of relevant sources of evidence to establish intended use, including labels, labeling, advertisements, press releases, training documents, speeches and verbal statements offered in a variety of contexts to support enforcement actions based on the alleged sale of misbranded medical products. Industry has long argued that this approach overreaches and fails, among other things, to draw principled legal distinctions between promotional and non-promotional speech, a distinction FDA has rejected in the 2021 Final Rule.

In 2015, FDA proposed eliminating a provision in the intended use regulations that required a manufacturer to provide adequate labeling if the manufacturer knew that its approved product was being promoted or used for an unapproved use.4 This proposed revision eliminated the risk that the agency would bring an enforcement action based on a manufacturers mere knowledge that its product was being used off-label. Drug and device makers received the 2015 proposed rule with hope that the proposal signaled an understanding by FDA of the challenges inherent in the existing intended use definition and that FDA would take the opportunity to amend the intended use rule to align more closely with various judicial defeats it had sustained under the First Amendment.

In 2017, however, FDA withdrew its proposed revision and proposed new language indicating that although the agency was eliminating knowledge evidence as the sole source of intended use, FDA would still look to the totality of evidence to determine intended use. FDA stated that both the 2015 proposed rule and the new proposal were intended to clarify FDAs existing position on intended use, not to change it. Nevertheless, the totality of evidence standard sparked opposition from stakeholders who viewed it as introducing even more uncertainty to an already complex landscape and urged the agency to narrow or eliminate certain categories of intended use evidence.5

In September 2020, FDA withdrew the totality of evidence standard but declined to otherwise limit or exclude any of the types of intended use evidence on which the agency had traditionally relied. The agency clarified how it would treat a firms knowledge of off-label uses by stating that a firm would not be regarded as intending an unapproved new use solely on that firms knowledge that such [drug or device] was being prescribed or used by health care providers for such use.6 However, tracking language that had long been in the relevant regulations, FDA reiterated that intended use may be established by circumstances in which the product is, with the firms knowledge, offered or used for a purpose for which it is neither labeled nor advertised.7

The 2021 Final Rule remains largely unchanged from the 2020 Proposed Rule. The only change in the codified language clarifies the regulations applicability to devices that are exempt from premarket notification.8 Nevertheless, a careful read of the 66-page preamble to the 2021 Final Rule reveals more of FDAs perspective. In the preamble, FDA has attempted to reconcile years of legislative history, decades of case law and numerous excerpts from agency briefs that underlie FDAs approach to intended use.

Although the long rulemaking odyssey may not have produced significant changes to the scope of intended use evidence, the 2021 Final Rule gives stakeholders a comprehensive repository of FDAs views on the issue. Whether the agencys approach will survive First Amendment scrutiny remains a pressing question, and the evolving jurisprudence seems certain to impact what enforcement actions FDA and DOJ will bring, even armed with such a permissive regulation.

So what evidence does FDA consider relevant to determining a medical products intended use?

A number of comments to the 2020 Proposed Rule encouraged FDA to focus primarily or exclusively on promotional claims. Others challenged FDAs authority to look to any relevant source9 of evidence to determine intended use. Rejecting stakeholders arguments that looking beyond promotional claims to consider a variety of other manufacturer activities and knowledge creates significant uncertainty and potential First Amendment issues the agency declined to take an exclusively claims-based approach. Instead, the agency referred to decades of case law and legislative history to assert its authority to rely on a broad scope of intended use evidence, stating that intended use of a product may be determined from its label, accompanying labeling, promotional material, advertising, and any other relevant source.10

Most importantly, FDA continues to assert that it is not limited to statements made by the manufacturer in determining intended use. Rather, the agency can establish intended use based on knowledge of actual use by customers, consumer conduct, the environment in which the product is sold, the absence of labeling, witness testimony, training programs, internal documents and financial arrangements, to name a few evidentiary sources. The FDAs confirmation that it may rely on a broad scope of evidence in evaluating intended use means that manufacturers will continue to face challenges in navigating the intended use regulations.

The codified language of the 2021 Final Rule defines intended use to include a medical products design or composition.11 FDA states that the addition of design or composition to the meaning of intended use reflects long-standing and current policy that a products characteristics may be indicative of intended use. For example, in FDAs view, a stent sized for a use different from the approved use is relevant to intended use, as is a spacer made to extract one liquid but designed with holes to extract a more viscous substance different from the approved use.12 Unlike the broad scope of considerations otherwise identified as potentially relevant to intended use, this criteria appears to be more objective and, because it does not involve speech, not as susceptible to First Amendment complications.

In the 2021 Final Rule, FDA asserts that the intended use regulation does not implicate the First Amendment because intended use is only one element of a violation under the Federal Food, Drug, and Cosmetic Act (FDCA), and FDA is not seeking to regulate the speech itself. FDA notes that during premarket review and postmarket surveillance, the agency has always been required to review a firms speech in the form of appropriate labeling and states that [t]he categorical exclusion of all truthful speech from regulatory review would undermine FDAs ability to promote and protect the public health.13 To support this position, FDA looks to case law involving other industries whose operations involve communications with the public and takes the view that [i]t has never been deemed an abridgment of freedom of speech to make a course of conduct illegal merely because the conduct was in part initiated, evidenced, or carried out by means of language, either spoken, written, or printed.14

While FDA has acknowledged stakeholders concerns regarding the First Amendment implications of the 2021 Final Rule, including the interest of health care professionals and patients in information about off-label uses, the agency ultimately dismisses those concerns. FDA confirms that nothing in the 2021 Final Rule changes the agencys policies and practices as set forth in guidance documents relating to circumstances in which FDA does not intend to object to a firms product communications or to view such communications as evidence of a new intended use. In doing so, it rejects the argument that recent First Amendment case law prohibits the 2021 Final Rule as a content-based restriction on free speech.15 And FDA asserts that it can consistent with the First Amendment prove misbranding by using promotional speech as evidence that a medical product is intended for a use that falls outside its FDA-approved label.

While FDA acknowledged stakeholders First Amendment concerns, it is not clear that FDA appreciates the complexity created by the intended use regulations. Under the Supreme Courts ruling in Central Hudson Gas & Elec. Corp. v. Pub. Serv. Commn of New York, commercial speech cannot be restricted unless: (i) the restriction is justified by a substantial government interest, and (ii) the means used to directly advance the government interest is not more extensive than necessary to serve the interest.16 The Supreme Court has recognized that the First Amendment is particularly important in the fields of medicine and public health, where information can save lives.17 FDA views its public health mandate as justifying restrictions on speech inherent in the intended use regulations.

Given the breadth of factors involving speech that FDA addresses in the preamble to the 2021 Final Rule such as training programs and internal documents, for example, whether FDAs approach is not more extensive than necessary to serve its public health goals is unclear. Coupled with the agencys insistence that it can pursue civil and criminal misbranding cases based, at least in part, on such activities, the application of the intended use regulation will likely continue to engender First Amendment challenges.

The preamble to the 2021 Final Rule similarly dismisses criticisms that the intended use regulations are unconstitutionally vague, with FDA relying on a litany of cases holding that use of an intent standard does not render a statute unconstitutionally vague, even in a statute regulating speech.18 FDA points out that courts have routinely rejected due process challenges to FDAs authority under the FDCA as unconstitutionally vague or ambiguous, and asserts that [o]ver nearly seven decades, medical product manufacturers have shown little difficulty in understanding how the [intended use] regulations are applied.19 FDAs view that the intended use regulations are clear may not relieve the concerns of manufacturers who continue to question how the agency will perceive various key product support activities, such as providing safety information regarding off-label uses.

In its preamble to the new rule, the agency reiterated that the 2021 Final Rule does not reflect a change in FDAs policies and practices regarding the types of firm communications that ordinarily would not, on their own, establish a new intended use.20 FDA noted that this includes policies and practices articulated in various guidance documents, including FDAs June 2018 Guidance for Industry, Medical Product Communications That Are Consistent With the FDA-Required Labeling Questions and Answers.

However, FDA did not expressly exclude safe harbor communications, such as scientific exchange and communications with health care providers about unapproved uses, as evidence of intended use. Instead, the agency expressed interest in continuing discussion around formalizing safe harbor communications, but stated that codifying such safe harbors was beyond the scope of this rulemaking. While such certainty would be reassuring, given FDAs statement that its policies and practices have not changed, its unwillingness to codify the safe harbors at this point should not create additional uncertainty as to their application.

Perhaps of most value in the record of the new intended use rule are the examples provided to illustrate facts that, standing alone, the agency would not consider as evidence of a new intended use. Although FDA notes that every situation will be evaluated on its own unique facts, the illustrations offer stakeholders insight in assessing the level of risk in their own conduct and operations.

A. A firm will not be regarded as intending an unapproved use of an approved product based solely on that firms knowledge of such use.

A pharmaceutical firm tracks sales and distribution metrics. The firm notes that one of its products, approved for use only in adults, is being ordered by and distributed to many medical practices that treat exclusively pediatric populations. The firm does not give any direction to its sales or marketing staff to disseminate samples or information about this product to these pediatric practices. 21

B. Knowledge combined with conduct that falls within an acknowledged safe harbor would not be determinative of intended use.

A pharmaceutical firm tracks sales and distribution metrics. The firm notes that one of its products, approved for the treatment of adult patients with acute lymphoblastic leukemia (ALL), is being ordered by and distributed to many medical practices that treat exclusively pediatric oncology populations. The firm also notes that the National Comprehensive Cancer Network clinical practice guidelines (CPG) for the treatment of ALL in pediatric patients recommends the firms drug product as a treatment option. The pharmaceutical firm distributes copies of the CPG at medical conferences, following all recommendations made in the revised draft guidance, Distributing Scientific and Medical Publications on Unapproved New Uses Recommended Practices. The firm does not give any direction to its sales or marketing staff to disseminate samples or information about this product to practices that treat pediatric cancer patients exclusively. 22

C. In certain circumstances, a firms dissemination of safety information about an unapproved use to health care providers to minimize risk to patients would not be dispositive of a new intended use.

The unapproved use of a firms approved drug is broadly accepted by the medical community and the firm has submitted an efficacy supplement to add the unapproved use to the labeling. The boxed warning and risk evaluation and mitigation strategy (REMS) materials for the drug warn of potential risks related to the unapproved use in general terms, but the firm disseminates additional specific safety and warning information to health care providers to minimize the risk to patients receiving the drug for the unapproved use. The safety and warning information does not expressly or implicitly promote the efficacy of the unapproved use.23

FDA also provided the following examples of fact patterns that firms may routinely encounter in the normal course of their business that would not trigger regulatory action.

Over the course of FDAs 6-year rulemaking process, the agency has made clear that knowledge of off-label use, standing alone, will not be sufficient evidence of intended use, absent circumstances showing objective intent by the firm to otherwise promote the unapproved use. FDAs effort to provide specific examples of how it intends to treat certain commonly occurring scenarios is helpful, both because statements in preambles to rulemakings are legally binding and because the examples seem to point to a larger message: Where the facts do not suggest affirmative conduct by a company to cause an off-label use unsupported by scientific consensus, FDA will be less likely to consider the conduct as evidence of intended use requiring adequate labeling.

Those hoping the 2021 Final Rule would dramatically limit FDAs legal options regarding intended use may be disappointed, but they should not be surprised. FDA continues to assert the obligation and need to look broadly to any relevant source of evidence to establish intended use. The agency believes it can do so without differentiating between promotional and non-promotional speech and without implicating the First Amendment.

In the final analysis, the 2021 Final Rule essentially repurposes FDAs old playbook. The critical question now is what will FDA do under the breadth of this rule: What types of misbranding cases will it initiate and which will it avoid as First Amendment cases against the agency continue to raise enduring questions about the governments regulatory relationship to truthful, non-misleading speech?

Associate Amanda Chan contributed to this article.

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1 See 86 Fed. Reg. 41,383 (Aug. 2, 2021) (2021 Final Rule).

2 See 80 Fed. Reg. 57,756 (Sept. 25, 2015) (2015 Proposed Rule).

3 Maxine Nightingale, Right Back Where We Started From (United Artists, 1976).

4 Id.

5 82 Fed. Reg. 2,194 (Jan. 9, 2017).

6 85 Fed. Reg. 59,718, 59,720 (Sept. 23, 2020) (2020 Proposed Rule).

7 Id. at 59,729.

8 2021 Final Rule at 41,384.

9 Id. at 41,386.

10 Id. (citing United States v. Article of 216 Cartoned Bottles, Sudden Change, 409 F.2d 734,739 (2d Cir. 1969)).

11 Id. at 41,401.

12 Id. at 41,390.

13 Id. at 41,391.

14 Id. at 41,392, referencing Rumsfeld v. Forum for Academic and Institutional Rights, Inc., 547 U.S. 47, 62 (2006).

15 Id. at 41,394-395.

16 447 U.S. 557, 566 (1979).

17 See Sorrell v. IMS Health, 564 U.S. 552, 566 (2011).

18 Id.

19 Id.

20 Id. at 41,396.

21 2020 Proposed Rule at 59,725, incorporated by reference into the 2021 Final Rule.

22 Id.

23 Id. at 59,725-726.

24 Id. at 59,726.

25 Id.

26 Id.

27 Id.

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FDAs Final Rule on Intended Use: Getting Right Back to Where We Started From - JD Supra