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

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

The critical elements of effective academic-practice partnerships: a framework derived from the Department of Veterans Affairs Nursing Academy.

BackgroundThe nursing profession is exploring how academic-practice partnerships should be structured to maximize the potential benefits for each partner. As part of an evaluation of the U.S. Department of Veterans Affairs Nursing Academy (VANA) program, we sought to identify indicators of successful partnerships during the crucial first year.MethodsWe conducted a qualitative analysis of 142 individual interviews and 23 focus groups with stakeholders from 15 partnerships across the nation. Interview respondents typically included the nursing school Dean, the VA chief nurse, both VANA Program Directors (VA-based and nursing school-based), and select VANA faculty members. The focus groups included a total of 222 VANA students and the nursing unit managers and staff from units where VANA students were placed. An ethnographic approach was utilized to identify emergent themes from these data that underscored indicators of and influences on Launch Year achievement.ResultsWe emphasize five key themes: the criticality of inter-organizational collaboration; challenges arising from blending different cultures; challenges associated with recruiting nurses to take on faculty roles; the importance of structuring the partnership to promote evidence-based practice and simulation-based learning in the clinical setting; and recognizing that stable relationships must be based on long-term commitments rather than short-term changes in the demand for nursing care.ConclusionsDeveloping an academic-clinical partnership requires identifying how organizations with different leadership and management structures, different responsibilities, goals and priorities, different cultures, and different financial models and accountability systems can bridge these differences to develop joint programs integrating activities across the organizations. The experience of the VANA sites in implementing academic-clinical partnerships provides a broad set of experiences from which to learn about how such partnerships can be effectively implemented, the barriers and challenges that will be encountered, and strategies and factors to overcome challenges and build an effective, sustainable partnership. This framework provides actionable guidelines for structuring and implementing effective academic-practice partnerships that support undergraduate nursing education

Newly Insured Californians Would Fall by More than 1 Million Under the Affordable Care Act Without the Requirement to Purchase Insurance

Compares the estimated number and percentage of currently uninsured Californians who will be insured by 2019 under the Affordable Care Act with the individual mandate and without. Highlights the need for the mandate to ensure affordable coverage

Achieving Equity by Building a Bridge From Eligible to Enrolled

Calls for multilingual outreach and enrollment efforts to enable Californians of color and those with limited English proficiency to benefit from the Health Benefit Exchange. Recommends targeting high-need groups and strengthening data collection

A Comparison of rpoB and 16S rRNA as Markers in Pyrosequencing Studies of Bacterial Diversity

Background: The 16S rRNA gene is the gold standard in molecular surveys of bacterial and archaeal diversity, but it has the disadvantages that it is often multiple-copy, has little resolution below the species level and cannot be readily interpreted in an evolutionary framework. We compared the 16S rRNA marker with the single-copy, protein-coding rpoB marker by amplifying and sequencing both from a single soil sample. Because the higher genetic resolution of the rpoB gene prohibits its use as a universal marker, we employed consensus-degenerate primers targeting the Proteobacteria. <p/>Methodology/Principal Findings: Pyrosequencing can be problematic because of the poor resolution of homopolymer runs. As these erroneous runs disrupt the reading frame of protein-coding sequences, removal of sequences containing nonsense mutations was found to be a valuable filter in addition to flowgram-based denoising. Although both markers gave similar estimates of total diversity, the rpoB marker revealed more species, requiring an order of magnitude fewer reads to obtain 90% of the true diversity. The application of population genetic methods was demonstrated on a particularly abundant sequence cluster. <p/>Conclusions/Significance: The rpoB marker can be a complement to the 16S rRNA marker for high throughput microbial diversity studies focusing on specific taxonomic groups. Additional error filtering is possible and tests for recombination or selection can be employed