Evaluation of Suspected Counterfeit Pharmaceutical Tablets Declared to Contain Controlled Substances Using Handheld Raman Spectrometers

This study describes the performance of handheld Raman devices for determining whether suspect pharmaceutical tablets declared to contain controlled substances were consistent with authentic (CWA) or not consistent with authentic (NCWA) tablets using a simple, rapid, field-friendly method capable of being used by nonexperts. Twenty-five authentic products and 84 known NCWA tablets were examined using three “parent” devices for a total of 327 analyses. On average, the parent devices yielded a true pass rate of 100%, a true fail rate of 98.4%, a false pass rate of 1.6%, and a false fail rate of 0%. The methods/libraries were then transferred to 13 identical “daughter” devices, which were used to examine 10 suspect finished dosage forms in duplicate (six known NCWA tablets and four authentic tablets) for a total of 260 measurements. On average, the daughter devices had a true pass rate of 100%, a true fail rate of 95.5%, a false pass rate of 4.5%, and a false fail rate of 0.0%. These data demonstrate that the parent–daughter electronic transfer method was successful, which permits the ability to develop methods in the laboratory that can be seamlessly pushed out to field devices. The methods can then be used to (i) prioritize samples for additional testing using other more time-consuming laboratory-based techniques needed to detect and quantify active ingredients and (ii) help support the interdiction of dangerous tablets at ports of entry, thereby preventing them from reaching the supply chain.     

Toxicology and Circumstances of Completed Suicide by Means Other than Overdose*

Abstract: To determine the prevalence and circumstances of psychoactive substances amongst nonoverdose completed suicide, 1436 consecutive cases autopsied at the NSW Department of Forensic Medicine over the period 1/1/1997–12/31/2006 were analyzed. Substances were detected in 67.2% of cases, and illicit drugs in 20.1%. Alcohol was present in 40.6% of cases. Males were more likely to be positive for alcohol, cannabis, and psychostimulants, and females for pharmaceuticals. Illicits were associated with younger age. Alcohol was most prominent amongst toxicity cases, as were opioids, psychostimulants amongst gunshot cases, and pharmaceuticals amongst drownings. Cases in which drug and alcohol histories were noted were more likely to have a substance detected. Alcohol was more common where a suicide note was left and where relationship problems were involved. Pharmaceuticals were more common where a previous attempt was noted. Licit and illicit substances are strongly associated with suicide, even when the method does not involve drug overdose.     

Three statutory regimes at impasse： ＂Reverse payments＂ in ＂pay-for-delay＂ settlement agreements between brand-name and generic drug companies

Antitrust authorities in both the United States and Europe have expressed deep concern over settlements of antitrust cases in the pharmaceutical sector, settlements involving ＂reverse payments＂ from plaintiffs to defendants, large sums paid by branded pharmaceutical companies to generic competitors in exchange for promises to stay offthe market. Such ＂pay-for-delay＂ settlements have proliferated in the United States since Federal Circuit Courts of Appeals have found them unproblematic despite the Federal Trade Commission＇s persistently strong position that they violate the antitrust laws. These cases arise at the intersection of three statutory regimes seeking to promote innovation, three clusters of doctrine and policy that have interacted only to reach impasse： the Patent Act, the 1984 amendment to the Food, Drug, and Cosmetic Act, and finally the Sherman Anti-Trust Act. Antitrust is a late comer to the fierce competition over patented drugs, competition that permeates the approval process in the Food ＆ Drug Administration [FDA], competition that is restrained by these pay-for-delay settlement agreements. To set the stage, we begin with the Patent Act and its relationship to the FDA approval process. The story of pay-for-delay settlements then proceeds to the settlement agreements and their antitrust implications. We conclude that the best solution in these antitrust cases would be adoption of the FTC＇s approach of presumptive illegality. Together with an amendment proposed to fix the food and drug act, the presumptive illegality of pay-for-delay settlements under the antitrust laws would make the market for pharmaceuticals more price competitive, open weak patents to serious challenge, and as a result save consumers billions of dollars annually without taking from branded drug companies legitimately earned incentives to engage in research and development.     

“Embedded regulation:” The migration of objects,scripts, and governance

This paper asks why an officially unregulated market in pharmaceuticals in a least developed country, Djibouti, behaves as if it were strictly regulated, with limited access to a small number of high‐cost drugs. We use Actor‐Network Theory (ANT) to show that the explanation is more complex than critics of the international pharmaceutical industry have supposed. Regulation and property rights generated in developed countries have become embedded in the drugs and “black boxed” to the point of invisibility. This has allowed them to travel to Djibouti with the drugs, while maintaining their effects in action. This case study develops our understanding of the way in which materials that are not designated as regulatory agents may still have regulatory impacts through their ability to enrol complex networks of actors, rules, values, and practices. Finally, it argues against the notion of law as a fixed and distinctive space for action, as opposed to the ANT vision of a fluid and contingent order, where law is part of a socio‐technico‐legal alliance that happens to achieve certain effects.     

TRIPS agreement and public health crisis in developing countries： Problems and solutions

While the health crisis in developing world has caused innumerable deaths, the balance between patent protection and public health attracts lots of debates globally. This paper examines the legal background for the access problems of essential drugs in developing countries, evaluates TRIPS agreement and the WTO decisions in theory, argues both patent protection for pharmaceuticals and TRIPS agreement are the genuine causes for the access problem, then attempts to provide some suggestions and evaluations for the possible solutions. Though the development of national pharmaceutical industries, adoption of early working exemptions, compulsory license, parallel import, acquirements of generic drugs and discount drugs, amendments of TRIPS agreement are all beneficial measures, the access problem may only be solved at an international level.     

Public Perceptions of Benefits from and Worries over Plant‐Made Industrial Products and Plant‐Made Pharmaceuticals: The Influence of Institutional Trust

Although agricultural biotechnology has been a seminal reference point in risk perception studies, public awareness of their exposure to risk deriving from this new technology has been minimal at best. However, recent events indicate there may be growing public concern as new variations of this technology appear. Understanding what drives perceptions of benefits from the third generation of the agricultural biotechnology and what determines public worries are keys for the future of this technology. To this end, this study analyzes survey data from the midsouth region of the United States to construct four separate regression models of perceived benefits from and worries over plant‐made industrial products and plant‐made pharmaceuticals. Findings suggest that while prior experience with and knowledge about agricultural biotechnology has an impact on perceptions of benefits and worries, trust in farmers plays a highly important role in determining perceptions.     

论医药购销领域商业贿赂的现状与对策

医药购销领域存在的商业贿赂行为,不但败坏了医生的职业道德,还是造成当前药价虚高的一个重要原因,已被列为商业贿赂重灾区之首,打击医药购销领域的商业贿赂犯罪形势比较严峻。本文将在对当前医药购销领域的商业贿赂犯罪的现状、特征的分析基础上,对医药购销领域的商业贿赂成因、查处困难进行剖析,并由此进一步提出防范和打击医药购销领域商业贿赂的对策。     

Institutional Collective Action on Drugs: Functional and Vertical Dilemmas of Unused Pharmaceuticals

The authors use the Institutional Collective Action Framework to analyze the barriers, opposition, and opportunities for residential pharmaceutical disposal programs in the United States via a case study on a series of take‐back programs pioneered in the state of Washington by local and state governments, as well as the corresponding backlash from federal agencies. While successful in some ways, these innovative solutions directly challenged the competing federal policy regimes controlled by the Drug Enforcement Agency (DEA), and, to a lesser extent, the Environmental Protection Agency (EPA). Findings from case studies suggest that functional dilemmas created by existing institutions with entrenched regulatory regimes are a key challenge to finding efficient solutions to vertical ICA dilemmas. Conclusions, then, connect to the broader ICA research agenda, and implications for multi‐level governance issues.     

EU Regulation of Medical Devices and Pharmaceuticals in Comparative Perspective

This paper provides a comparison of European Union regulatory policy for pharmaceuticals and medical devices. The discussion highlights key similarities and differences in regulatory approach for the two sectors. More importantly, it explores the balance that has been struck between public health, health care, and industrial policy as “competing” objectives within the respective regulatory regimes. It is argued that, despite both sectors being affected by the same institutional rules and constraints at the EU level, and both being central to the delivery of high-quality health care in Europe, there are a surprising number of differences between the regulatory frameworks. That this stems in part from their different “launch” times, hence different institutional conditions of regulation, and commensurate political climates, as well as reflecting different aims and goals among member-state and EU-level policy makers, are among the paper's main conclusions.     

British Pharmaceuticals: a cautionary tale

British pharmaccuticals is generally represented as a successful sector which illustrates the potential of knowledge-intensive, high-valve-added activities. This article presents a revisionist account based on evidence and argument. Pharmaceuticals is a small sector which combines high-value-added and average wages to benefit capital not labour. The knowledge base in the laboratory creates imitative product with marketing then applied to capture social expenditure. When product-market growth slows, the sector restructures defensively without solving its problems.