The Newest \u27War on Drugs:\u27 Regulating Pharmaceuticals through State Litigation

State-driven litigation has had increasing influence in the development of national policy in recent years, including in national health policy. One prominent recent example includes the efforts of several state governments to bring coordinated constitutional challenges against one of the Obama Administration’s key first term achievements, the Patient Protection and Affordable Care Act. This paper examines how states have influenced health care policy influence in a more subtle but no less important litigation campaign. Over the past decade, state prosecutors have reached numerous multi-million dollar settlements with the nation’s largest pharmaceutical companies imposing a variety of restrictions on prescription drug pricing and advertising. Though often relying upon state law claims, these settlements have created new de facto national standards covering the drug industry – frequently going beyond and even against express congressional action. Relying upon an analysis of numerous legal cases, investigations, and settlements, this paper traces the development of this persistent litigation campaign and discusses the wide policy implications state litigation has had in this area. In doing so, the paper raises important broader questions about the operation of modern American public policy

Custom Made Versus Ready to Wear Treatments; Behavioral Propensities in Physician's Choices

To customize treatments to individual patients entails costs of coordination and cognition. Thus, providers sometimes choose treatments based on norms for broad classes of patients. We develop behavioral hypotheses explaining when and why doctors customize to the particular patient, and when instead they employ "ready-to-wear" treatments. Our empirical studies examining length of office visits and physician prescribing behavior find evidence of norm-following behavior. Some such behavior, from our studies and from the literature, proves sensible; but other behavior seems far from optimal.

Role of contrast-enhanced ultrasound (CEUS) in paediatric practice: an EFSUMB position statement

The use of contrast-enhanced ultrasound (CEUS) in adults is well established in many different areas, with a number of current applications deemed off-label, but the use supported by clinical experience and evidence. Paediatric CEUS is also an off-label application until recently with approval specifically for assessment of focal liver lesions. Nevertheless there is mounting evidence of the usefulness of CEUS in children in many areas, primarily as an imaging technique that reduces exposure to radiation, iodinated contrast medium and the patient-friendly circumstances of ultrasonography. This position statement of the European Federation of Societies in Ultrasound and Medicine (EFSUMB) assesses the current status of CEUS applications in children and makes suggestions for further development of this technique

Designing theoretically-informed implementation interventions.

Canadian Institutes of Health Research; Ontario Ministry of Healt

The Major Role of Clinicians in the Discovery of Off-Label Drug Therapies

Objective: To determine, through a review of the medical literature and author contact, the role of clinicians in the discovery of off label use of Food and Drug Administration approved prescription drugs. Data Sources: The literature was accessed through MEDLINE (1999-December 2003). Additional sources accessed included the U.S. Patent Office and Micromedex, Thompson Scientific and Healthcare, Inc. Data Synthesis: A survey of new therapeutic uses for New Molecular Entity drugs approved in 1998 was conducted for the subsequent 5 years of commercial availability. During that time period, a total of 144 new applications were identified in a computerized search of the literature for the 29 new drugs approved in 1998. Literature and patent searches were conducted to identify the first report of each new application. Authors of the seminal articles were contacted via survey and telephone interview to determine whether they were in fact the originators of the new applications. If they were, examinations of article contents and author surveys were used to explore whether each new application was discovered via clinical practice that was independent of pharmaceutical company or university research (field discovery) or whether the discovery was made by or with the involvement of pharmaceutical firm or university researchers (central discovery). Conclusions: Post-NDA discoveries of new, off-label uses for new drugs were present in 22 of the 29 drugs in our sample. We found that 59% (85/144) of the drug therapy innovations in our sample were discovered by practicing clinicians via field discovery. The major role of clinicians in the discovery of new, off-label drug therapies has not been previously documented or explored. We propose that this finding has important regulatory and health policy implications

Designing theoretically-informed implementation interventions

Clinical and health services research is continually producing new findings that may contribute to effective and efficient patient care. However, the transfer of research findings into practice is unpredictable and can be a slow and haphazard process. Ideally, the choice of implementation strategies would be based upon evidence from randomised controlled trials or systematic reviews of a given implementation strategy. Unfortunately, reviews of implementation strategies consistently report effectiveness some, but not all of the time; possible causes of this variation are seldom reported or measured by the investigators in the original studies. Thus, any attempts to extrapolate from study settings to the real world are hampered by a lack of understanding of the effects of key elements of individuals, interventions, and the settings in which they were trialled. The explicit use of theory offers a way of addressing these issues and has a number of advantages, such as providing: a generalisable framework within which to represent the dimensions that implementation studies address, a process by which to inform the development and delivery of interventions, a guide when evaluating, and a way to allow for an exploration of potential causal mechanisms. However, the use of theory in designing implementation interventions is methodologically challenging for a number of reasons, including choosing between theories and faithfully translating theoretical constructs into interventions. The explicit use of theory offers potential advantages in terms of facilitating a better understanding of the generalisability and replicability of implementation interventions. However, this is a relatively unexplored methodological area

The Indirect Consequences of Expanded Off-Label Promotion

The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as suggested in the dissenting opinion in United States v. Caronia, a high-profile 2012 case regarding off-label promotion—protections for off-label promotion might affect the FDA’s decision-making in areas other than drug promotion, and analyzes precisely what those effects could be in light of the FDA’s current statutory authority

The Law, Economics, and Medicine of Off-Label Prescribing

There is a major dissonance in the current structure of regulating new drugs that have more than one medical indication. Physicians are authorized to prescribe these drugs for all indications including those beyond their approved purposes. However, product manufacturers are expressly prohibited from marketing or promoting their drugs for any purpose other than those which have been specifically indicated. While prescribing physicians are encouraged to gain medical information on any additional indications, they cannot obtain it from one of its most likely sources: the drug’s supplier. The Second Circuit Court of Appeals’ recent opinion in United States v. Caronia has challenged this regulatory structure. For the three states in the Second Circuit, although not the rest of the country, the FDA’s regulations prohibiting promotion of non-approved indications have been restricted. In this Article, we review the legal, economic, and medical aspects of the FDA’s current regulatory approach, and explore the likely consequences of a widespread adoption of the Caronia rule