Enforcement Discretion Research Articles

Medicated feeds and the Veterinary Feed Directive (VFD) in small ruminants

The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) amended the Food Drug & Cosmetic Act to permit extralabel use of animal drugs under certain conditions. However, AMDUCA does not permit the extralabel use of medicated feed articles. Minor species such as sheep and goats (small ruminants) have very few animal drugs approved for their use and practitioners may determine that extralabel use is justified to prevent suffering and death. Compliance Policy Guide Sec. 615.115 Extralabel Use of Medicated Feeds for Minor Species (CPG 615.115) provides guidance on the current thinking of the Food and Drug Administration related to exercising enforcement discretion with regard to the extralabel use of medicated feeds in minor species. This presentation will walk through the CPG 615.115 from a practitioner’s perspective with goal of addressing common questions and situations where extralabel use of medicated feeds in sheep and goats may be indicated.

HHS Adjusts Penalties for HIPAA Violations

Back to table of contents Previous article Next article ProfessionalFull AccessHHS Adjusts Penalties for HIPAA ViolationsTerri D’ArrigoTerri D’ArrigoSearch for more papers by this authorPublished Online:2 Jul 2019https://doi.org/10.1176/appi.pn.2019.6b11AbstractNew annual limits reflect the level of culpability when violations occur and whether corrective action was taken.The Department of Health and Human Services (HHS) has changed the annual maximum penalties for violating the Health Insurance Portability and Accountability Act (HIPAA). The annual maximum penalties were previously capped at $1.5 million for every tier of violation. Now the annual limit is different for each tier, with only violators who demonstrate willful neglect and failure to correct violations facing a potential $1.5 million annual penalty (see table). The new penalties went into effect in April.In a notice published in the April 30 Federal Register, HHS cited “inconsistent language” in the Health Information Technology for Economic and Clinical Health (HITECH) Act, which established the tiers in 2009, as the impetus for the changes.“Upon further review of the statute by the HHS Office of the General Counsel, HHS has determined that the better reading of the HITECH Act is to apply [the new] annual limits,” Roger Severino, director of the HHS Office for Civil Rights, wrote. “HHS expects to engage in future rulemaking to revise the penalty tiers in the current regulation to better reflect the text of the HITECH Act.”The tiers are defined as follows:Tier 1: The person did not know and, by exercising reasonable diligence, would not have known that the person violated the provision.Tier 2: The violation was due to reasonable cause and not willful neglect.Tier 3: The violation was due to willful neglect that was corrected in a timely manner.Tier 4: The violation was due to willful neglect that was not corrected in a timely manner.APA offers HIPAA guides for members, including “APA’s HIPAA Privacy Rule Manual: A Guide for Your Psychiatric Practice” and “APA HIPAA Security Rule Manual.” They are posted here. ■“Notification of Enforcement Discretion Regarding HIPAA Civil Money Penalties” is posted here. ISSUES NewArchived

The Impact of Regulatory Policies on the Future of Fecal Microbiota Transplantation.

In this article, the authors explore the impact of a potential future regulatory decision by FDA whether or not to continue its enforcement discretion policy allowing physicians to perform, and stool banks to sell, stool product for fecal microbiota transplantation as a treatment for recurrent Clostridium Difficile infection without an Investigative New Drug (IND) application. The paper looks at the Agency's regulatory options in light of the current gut microbiota based products that are in the FDA pipeline for drug approval and the potential impact and repercussions of their approval on FDA action. In laying out FDA's options we consider the implications of market exclusivity and off-label use of newly approved drugs. Ultimately, we explore the potential impact of FDA's decision on patients, research, and innovation.

Criminological Dimension of Environmental Crime

Despite the increased public danger and the prevalence of criminal attacks on the environment, statistics show that since 2010 the officially registered environmental crime has a negative trend. The reasons for this are many, and they are, as shown by the study, to a greater extent subjective. The fact that the legislator classifies the majority of criminal violations of the environment (60%) as minor, difficulties in investigating the facts of criminal pollution of the environment, the minimum Statute of limitations of criminal liability lead to the fact that combating environmental crimes is not a priority in the activities of law enforcement agencies. As a result, the reduction in the number of registered environmental crimes occurs against the background of the growth of administrative offenses. This is facilitated by the lack of clear, regulatory features that allow to distinguish between these types of responsibility, which often leads to an excessively broad law enforcement discretion. According to the results of the study, the level of latency of criminal attacks on the environment is 30-60% on the facts of illegal extraction of biological resources and 70-90% on the facts of environmental pollution. Increased latency of crimes related to the negative impact on natural objects, contributes to the poor design of their compositions as material.

Justice Department Independence and White House Control

Problematic relations between the White House and the U.S. Department of Justice stand out amidst the broader tumult of President Donald Trump’s first year in office. With respect to written policy restricting contacts between the White House staff and the Department, the Trump White House has followed the general contours of predecessor administrations. Those policies recognize that White House contacts restrictions vary with the Department’s complex functions, restrict channels of contact, and restrict personnel authorized to make contacts. They also grant limited exceptions where White House-Department contact is required to assist the President in the performance of a constitutional duty and contact would be appropriate from a law enforcement perspective. A number of episodes, however, suggest that the President and senior administration officials have not honored the spirit, and in some cases the letter, of that contacts policy. One of the frequent criticisms leveled against President Trump is that he disregards many norms and traditions that have been observed by presidential administrations of both parties for decades. Restrictions on White House interference in criminal investigations do not merely protect norms. Rather, those policies also seek to prevent unconstitutional conduct by the President and his political appointees. This Article demonstrates that political interference by the President undertaken in bad faith could violate the Take Care Clause even in the absence of a criminal statute. Obstructive behavior is even worse. Whether or not the President is indictable for the commission of a statutory criminal offense of obstruction of justice during his tenure in office, this Article explains why the President may violate the Take Care Clause independently of criminal offenses. A principle of political noninterference by the White House in the federal prosecution function in particular matters is consistent with Article II. Neither the Vesting Clause, the President’s position atop the Executive Branch, nor the President’s broader enforcement discretion defeat the anti-interference principles commanded by the Presidential Oath and the Take Care Clause. It is a question that goes to the very concept of Rule of Law itself. However, political processes, rather than justiciable legal proceedings, serve as the presumptive source of Take Care Clause enforcement as to White House-Department relations.

P168 WHERE WILL FECAL MICROBIOTA TRANSPLANTATION FIT IN THE TREATMENT ALGORITHMS FOR CROHN’S DISEASE AND ULCERATIVE COLITIS: A SYNTHESIS OF COMPLETED, ONGOING AND FUTURE TRIALS

The United States Food and Drug Administration (FDA) exercises enforcement discretion for fecal microbiota transplantation (FMT) for Clostridium difficile infection not responsive to standard therapies. An investigational new drug (IND) is required for all other uses. Since enforcement discretion took effect in 2013, patients with Crohn’s disease (CD) and ulcerative colitis (UC) have enrolled in multiple trials as they are at an increased risk of Clostridium difficile infection. Trials of FMT to treat the inflammatory bowel disease (IBD) directly, independent of the impact on Clostridium difficile infection, are of particular interest to patients. We aimed to summarize the completed, ongoing and future FMT trials to explore where evidence is being generated for CD and UC treatment algorithms. We searched PubMed for randomized trials related to FMT resulting in 930 citations. ClinicalTrials.gov and the WHO Trial Registry yielded an additional 257 and 262 studies. Trial registrations, published randomized trials and systematic reviews were reviewed to identify randomized trials of FMT with an IBD indication. Four randomized trials were identified in the published literature (277 UC participants). An additional 33 randomized trials were identified from the trial registries. Most trials were for UC (70%), followed by 18% for CD and 12% allowing both conditions. The majority of studies were for induction of remission (97%) with the Mayo score and HBI as the most common inclusion criteria. There are 21 ongoing trials (5 CD, 14 UC, 2 both) scheduled to end between 2017 and 2023, and 5 trials that have not yet started to recruit participants (0 CD, 4 UC, 1 for both). As more evidence is published in peer reviewed journals, the IBD community will be able to make an evidence-based decision on the role of FMT to induce remission in UC. Evidence is lacking on UC maintenance of remission and the role of FMT for CD.

Luminal Clinical

<b>Luminal Clinical</b>

Theranos Experience Exposes Weaknesses in FDA Regulatory Discretion.

Theranos Experience Exposes Weaknesses in FDA Regulatory Discretion.

Duty vs. Discretion: What Youngstown Can Teach Us About Inherent Executive Enforcement Discretion

This Article takes United States v. Texas, a case about the legality of President Obama’s “Deferred Action for Parents of Americans” (DAPA) immigration initiative, as an entry point for analyzing a significant and publically-salient, yet undertheorized, problem in constitutional law: executive discretion in enforcing the law. Although Republican and Democratic administration alike have long asserted a constitutionally-inherent power to decline to enforce civil and criminal laws, former-President Obama’s recent high profile exercises of this authority, including his enforcement policy on federal marijuana law and immigration law, have led to increased attention to enforcement discretion among popular and scholarly commentators. Surprisingly, however, academic commentators have almost completely ignored the relevance of a canonical separation of powers precedent to the constitutional debate surrounding executive nonenforcement: Youngstown Sheet & Tube Co. v. Sawyer. This Article is the first to systematically apply Justice Jackson’s famous Youngstown concurrence to the puzzle of the executive’s constitutional discretion in law enforcement. By doing so, the Essay provides a common lexicon within which commentators can debate the constitutionality of presidential nonenforcement in particular contexts, including DAPA. The Article's second contribution is to offer a positive theory of constitutionally-inherent enforcement discretion, including the power to supervise and prioritize law enforcement activities. I derive this theory from constitutional text, including the Executive Power Clause, the Take Care Clause, and the Due Process Clause. This inherent power, however, is malleable and defeasible rather than fixed and absolute. Congress can either explicitly or implicitly confer executive enforcement discretion to the constitutional maximum (Youngstown Category 1). Likewise, Congress can explicitly or implicitly cabin executive enforcement discretion, reducing it to the constitutional minimum (Youngstown Category 3). When the Executive is faced with Congressional silence, he acts in Youngstown Category 2. In the second category’s “zone of twilight,” however, executive enforcement discretion is limited to the President’s inherent constitutional powers. Based on my positive theory of constitutionally-sanctioned enforcement discretion, I argue that, in Category 2, the Take Care Clause does not preclude the Executive from exercising enforcement discretion, including the power to coordinate categorical enforcement priorities. Finally, I argue that, even in Category 3, the President’s inherent power of enforcement discretion ensures that he always retains at least some discretion to decline enforcement in individual cases, especially in the criminal context. Furthermore, in light of the powers concomitant to his constitutional duty to supervise, including the power to coordinate and prioritize enforcement, I argue offer a novel argument that the President’s inherent enforcement discretion power may extend beyond individualized discretion to countenance the creation of categorical civil enforcement priorities, even in Category 3. The Article concludes by applying the Youngstown framework and my positive theory of executive enforcement discretion to the question whether DAPA violates the Constitution. I conclude that DAPA most comfortably falls in Category 2, and that its provisions do not exceed the Executive’s inherent enforcement discretion under the Constitution.

Payer Perspectives on Coverage of Biomarker Testing in Cardiovascular Disease.

Cardiovascular (CV)2 disease is a leading cause of morbidity and mortality, currently attributing to 1 of every 4 deaths in the US (1). Conventional risk prediction algorithms are based on major CV risk factors identified in the diseased population. Better tools for early identification and treatment of risk factors are needed (2). To this end, research on CV biomarkers has burgeoned; a PubMed search on “cardiovascular biomarkers” reveals more than a fivefold increase in publications on this topic between 1995 and 2015. These efforts have led to the discovery of a range of emerging biomarkers that may better identify at-risk patients earlier and more effectively for disease prevention and morbidity improvement (3). Yet to date, major national health plans only cover biomarkers conventionally used to diagnose and risk stratify CV disease. Here, we review payer perspectives on coverage for biomarkers tests and suggest resources for gaining greater clarity and transparency in payer evidence expectations for diagnostic and prognostic testing in CV disease. Generally speaking, coverage is provided for medical products and services when there is strong scientific evidence that patients derive meaningful clinical benefits from use of those services. The regulatory frameworks for drugs, biologics, and devices generally provide some basis for payers to make an assessment of benefit in the populations they cover, although there may still be evidence deficits to address. In the context of in vitro diagnostics (IVD) and laboratory-developed tests, however, the regulatory requirements are in flux. Previously, the Food and Drug Administration (FDA) exercised “enforcement discretion” for these products. Then, in 2014, noting that IVD have grown increasingly complex, the FDA proposed a draft framework for oversight of testing (4). Accordingly, payers are less able to rely on regulatory assessment of IVD and apply their own standards for coverage. As a result, for example, …

Test anxiety

Test anxiety

The Third Bound

This paper was prepared for a conference about constraints on executive discretion. In addition to law and politics (to whatever extent they do or do not constrain the executive), there is also a distinct third bound on executive discretion: conventions, roughly understood as unwritten but obligatory rules of the political game. Debates over executive discretion should take account of distinctions between contingent politics and conventions; between intragovernmental conventions and extragovernmental conventions; and between conventions against doing things and conventions against saying things. The last distinction, in particular, illuminates the strong resistance, in contexts such as immigration, to executive policy statements that make explicit a pattern of enforcement discretion, one that would otherwise remain only implicit. Even holding legal authority constant, making that authority explicit through general policy statements may trigger the normatively-inflected political sanctions that are characteristic of conventions.

Free‐range apps

Free‐range apps

DAPA, 'Lawful Presence,' and the Illusion of a Problem

When the Supreme Court adjudicates United States v. Texas, the lawsuit challenging the Obama administration's executive actions on immigration, one focal point may be the question of whether those initiatives — Deferred Action for Parents of Americans and Lawful Permanent Residents and its predecessor, Deferred Action for Childhood Arrivals — impermissibly confer upon their recipients. In both of his opinions for the U.S. Court of Appeals for the Fifth Circuit, Judge Jerry E. Smith went out of his way to characterize DAPA and DACA as affirmatively conferring their recipients with presence. In their briefing to the Supreme Court the plaintiffs have now followed his lead, arguing that DAPA and DACA impermissibly transform presence deemed by Congress into lawful presence.In this essay, I explain why these claims about are incorrect and ultimately a red herring. Describing DAPA and DACA as entailing a grant of mischaracterizes those initiatives, relying upon a misunderstanding of both the structure and content of immigration law and the manner in which undocumented immigrants are recognized and constructed as legal subjects. Moreover, as a legal matter, “lawful presence” does not even exist as a thing in the sense that Judge Smith and the plaintiffs describe it. In order to characterize DAPA and DACA as something other than guidance structuring the exercise of enforcement discretion, as permitted by existing law, both Judge Smith and the plaintiffs fashion a conception of as constituting an aggregated, intertwined package of benefits, in a manner that approximates conventional understandings of lawful immigration status. That conception, however, has no actual legal basis. Ultimately, since unlawful does not carry the meaning that Judge Smith and the plaintiffs ascribe to it, there is only the illusion of a substantive problem here.

FDA's draft guidance on laboratory-developed tests increases clinical and economic risk to adoption of pharmacogenetic testing.

The US Food and Drug Administration (FDA) notified Congress July 31, 2014,1 of its intent to regulate laboratory developed tests. These encompass thousands of clinical assays currently used in medical practice including most pharmacogenetic tests. This guidance has the potential to impact the innovation and sustainability of pharmacogenetic research and its clinical implementation.

Deferred Action, Supervised Enforcement Discretion, and the Litigation Over Administrative Action on Immigration

In November 2014, the Obama administration announced the Deferred Action for Parents of Americans and Lawful Permanent Residents (DAPA) initiative, which built upon a program instituted two years earlier, the Deferred Action for Childhood Arrivals (DACA) initiative. As mechanisms to channel the government’s scarce resources toward its enforcement priorities more efficiently and effectively, both DACA and DAPA permit certain individuals falling outside those priorities to seek “deferred action,” which provides its recipients with time-limited, nonbinding, and revocable notification that officials have exercised prosecutorial discretion to deprioritize their removal. While deferred action thereby facilitates a highly tenuous form of quasi-legal recognition for its recipients, it does not provide legal immigration status. Accordingly, the two initiatives are not an equivalent substitute for legislative reform proposals that would create a pathway to durable legal status for a much larger number of individuals. Nevertheless, critics have accused the Obama administration of imposing by decree precisely that which Congress has declined to authorize by statute: namely, legalization of noncitizens who lack lawful immigration status. In this Article, I critically examine those assertions and develop a rationale for the deferred action initiatives, anchored in rule of law values, that has received no meaningful attention in recent debates about DACA and DAPA. As the decision by U.S. District Judge Andrew S. Hanen enjoining those initiatives illustrates, legal discourse has mirrored and reinforced the same incorrect claims about deferred action that circulate in anti-immigration political discourse. Like the Obama administration’s political critics, Judge Hanen repeatedly mischaracterizes the initiatives as providing “legal status” and, on that basis, flays the Obama administration for “total[ly] abdicat[ing]” immigration enforcement. These conclusions ultimately amount to what I describe elsewhere as “judicial truthiness,” highlighting an erosion of the conventional lines between litigation, adjudication, and public discourse in politically salient cases more generally.The flawed discourse surrounding DACA and DAPA underscores the need for a more careful assessment of the complex relationships between enforcement priorities, prosecutorial discretion, and the rule of law in an era of mass deportation. The blunt and distorted nature of that discourse, however, in turn has distorted the substantive analysis of those relationships. As the scale of the expansive and fragmented immigration enforcement regime has grown to such enormous levels — making the interrelated challenges of ensuring consistent execution of the law and fidelity to enforcement priorities more formidable — the need for effective mechanisms to supervise the discretion exercised by rank-and-file officials has only grown more important. But even as it purports to respect the government’s enforcement priorities, the logic of Judge Hanen’s ruling would largely disable policymaking officials from implementing such mechanisms, requiring them instead to let the vagaries of the bureaucracy reign supreme. The decision therefore not only inhibits the agency’s ability to establish enforcement priorities and manage its scarce resources, but also fails to acknowledge the importance of rule of law values such as consistency, transparency, accountability, and nonarbitrariness in the execution of the immigration laws.

The Politics of Agency Enforcement Discretion

Accusations of presidential attempts to subvert an agency’s fulfillment of its statutory duties have become a staple of contemporary political discourse. Although White House influence over the most salient form of agency decisionmaking – rulemaking – remains subject to considerable oversight by other institutional actors, administrative agencies possess a variety of policymaking tools beyond rulemaking, including the issuance of policy guidance documents and the strategic exercise of enforcement discretion. The relative weakness of legal and political checks on these alternative tools would appear to create powerful incentives for agencies to channel policies – particularly contested or controversial ones – through particular tools to minimize constraints on executive power. This article evaluates the extent to which this account reflects contemporary agency practice through a case study of the Department of Education’s Office for Civil Rights (OCR). It finds that OCR has employed rulemaking to implement presidential policy preferences only once in the past quarter century, and the rare instances of OCR rulemaking show a judiciary and public eager and able to challenge resultant policies. The agency has been far more reliant on guidance documents to adopt presidential priorities, and these policies have proven immune from judicial attack, although they have been exposed to some public criticism. Most interestingly, OCR appears to effectuate significant policy shifts through the strategic exercise of enforcement discretion and has succeeded in evading any legal or political oversight in doing so, raising significant normative concerns regarding the accountability and legitimacy of such policies. While the importance of OCR’s mission renders this agency worthy of study in its own right, these findings carry broader implications regarding checks to presidential control across the administration state. The article closes by exploring the potential for institutional design reforms to strengthen existing checks on presidential control, focusing in particular on structural reforms to temper politically-motivated enforcement decisions.

Fecal microbiota transplant protocol for clostridium difficile infection.

Fecal microbiota transplant has become more acceptable as a therapeutic for recurrent Clostridium difficile infection. The FDA has an enforcement discretion policy for practitioner's performing this therapy, which includes informed consent for this experimental treatment. This manuscript describes a typical procedure that can be followed that includes the important aspects of this preparation and treatment.

Ensuring quality in genomic medicine: amid the rise in complex laboratory-developed tests, regulatory officials are seeking the right balance on quality assurance.

Ensuring quality in genomic medicine: amid the rise in complex laboratory-developed tests, regulatory officials are seeking the right balance on quality assurance.

Clemency and the Unitary Executive

President Obama’s use of enforcement discretion to achieve important domestic policy initiatives – including in the field of criminal law – have sparked a vigorous debate about where the President’s duty under the Take Care Clause ends and legitimate enforcement discretion begins. But even with broad power to set enforcement charging policies, the President controls only the discretion of his or her agents at the front-end to achieve policy goals. What about enforcement decisions already made, either by his or her own agents or actors in previous administrations, with which the President disagrees? The Framers anticipated this issue in the context of criminal law and vested the President with broad and explicit back-end control through the constitutional pardon power. But while centralized authority over enforcement discretion at the front-end has grown, the clemency power finds itself falling into desuetude.This Article explores the fall of the clemency power and argues for its resurrection as a critical mechanism for the President to assert control over the executive branch in criminal cases. While clemency has typically been referred to as an exercise of mercy and even analogized to religious forgiveness, it also serves a more structurally important role in the American constitutional order that has been all but overlooked. It is a critical mechanism for the President to control the executive department. Those in favor of a unitary executive should encourage its more robust employment. But even critics of unitary executive theory should embrace clemency as a mechanism of control because, whatever the merits of other unitary executive claims involving military power or oversight over administrative agencies, clemency stands on different footing. It is explicitly and unambiguously grounded in the Constitution’s text, and it comes with an established historical pedigree. It is also a crucial checking mechanism given the landscape of criminal justice today. The current environment of overbroad federal criminal laws and excessive charging by federal prosecutors has produced a criminal justice system of unprecedented size and scope with overcrowded and expensive federal prisons and hundreds of thousands of individuals hindered from reentering society because of a federal record. Clemency is a key tool for addressing poor enforcement decisions and injustices in this system, as well as checking disparities in how different United States Attorneys enforce the law.