An Ex‐Regulator's View of the Microbiology QA/QC Functions in the US Pharmaceutical Industries

2019 ◽  
pp. 489-503
Author(s):  
David Hussong
Keyword(s):  
The Us ◽  
Pharmaceutical Industries

scholarly journals 2019: A year of expansion in psychedelic research, industry, and deregulation

2020 ◽  
Vol 6 ◽  
pp. 205032452097448
Author(s):  
Jacob S Aday ◽  
Emily K Bloesch ◽  
Christopher C Davoli
Keyword(s):  
International Expansion ◽  
Regulatory Changes ◽  
Research Themes ◽  
The Us ◽  
Psychedelic Drugs ◽  
History Of ◽  
Pharmaceutical Industries ◽  
Novel Applications ◽  
First Time ◽  
Psychedelic Research

Public and scientific interest into psychedelic drugs has grown steadily over much of the last two decades, before an exponential increase in recent years. We contend that 2019, in particular, involved myriad notable changes in the science, industry, and deregulation of psychedelic drugs. However, it is becoming increasingly difficult for professionals to keep up-to-date on these advancements given the rapid growth of the field. Further, broad contemporary synopses are critical in maintaining records in the history of science. To address these concerns, this article synthesizes the significant number of scientific, business, and regulatory changes related to psychedelic drugs which occurred in 2019. Establishment of psychedelic research centers, novel applications of the drugs, and international expansion of the field in 2019 seemed to solidify psychedelic research’s place in science. Additionally, many in the business and pharmaceutical industries stimulated considerable investment and innovation in psychedelics for the first time. In the US, successful decriminalization efforts and endorsements by eminent political figures, such as Alexandria Ocasio-Cortez, Andrew Yang, and the heads of the NIH and FDA, in 2019 were representative of unprecedented regulatory changes. Collectively, this article serves as a succinct summary of the changes psychedelic drugs made across various levels of society in 2019—by coalescing emerging research themes, industrial innovations, and attitude shifts.

scholarly journals Mining Open Payments Data: Analysis of Industry Payments to Thoracic Surgeons From 2014-2016 (Preprint)

2018 ◽  
Author(s):  
Xu Na ◽  
Haihong Guo ◽  
Yu Zhang ◽  
Liu Shen ◽  
Sizhu Wu ◽  
...  
Keyword(s):  
Noncommunicable Disease ◽  
World Health ◽  
Chord Diagram ◽  
Strong Concentration ◽  
The Us ◽  
Food And Beverage ◽  
Pharmaceutical Industries ◽  
Health Organization ◽  
Financial Relationship ◽  
Open Payments

BACKGROUND The financial relationship between physicians and industries has become a hotly debated issue globally. The Physician Payments Sunshine Act of the US Affordable Care Act (2010) promoted transparency of the transactions between industries and physicians by making remuneration data publicly accessible in the Open Payments Program database. Meanwhile, according to the World Health Organization, the majority of all noncommunicable disease deaths were caused by cardiovascular disease. OBJECTIVE This study aimed to investigate the distribution of non-research and non-ownership payments made to thoracic surgeons, to explore the regularity of financial relationships between industries and thoracic surgeons. METHODS Annual statistical data were obtained from the Open Payments Program general payment dataset from 2014-2016. We characterized the distribution of annual payments with single payment transactions greater than US $10,000, quantified the major expense categories (eg, Compensation, Consulting Fees, Travel and Lodging), and identified the 30 highest-paying industries. Moreover, we drew out the financial relations between industries to thoracic surgeons using chord diagram visualization. RESULTS The three highest categories with single payments greater than US $10,000 were Royalty or License, Compensation, and Consulting Fees. Payments related to Royalty or License transferred from only 5.38% of industries to 0.75% of surgeons with the highest median (US $13,753, $11,992, and $10,614 respectively) in 3-year period. In contrast, payments related to Food and Beverage transferred from 93.50% of industries to 98.48% of surgeons with the lowest median (US $28, $27, and $27). The top 30 highest-paying industries made up approximately 90% of the total payments (US $21,036,972, $23,304,996, and $28,116,336). Furthermore, just under 9% of surgeons received approximately 80% of the total payments in each of the 3 years. Specifically, the 100 highest cumulative payments, accounting for 52.69% of the total, transferred from 27 (6.05%) pharmaceutical industries to 86 (1.89%) thoracic surgeons from 2014-2016; 7 surgeons received payments greater than US $1,000,000; 12 surgeons received payments greater than US $400,000. The majority (90%) of these surgeons received tremendous value from only one industry. CONCLUSIONS There exists a great discrepancy in the distribution of payments by categories. Royalty or License Fees, Compensation, and Consulting Fees are the primary transferring channels of single large payments. The massive transfer from industries to surgeons has a strong “apical dominance” and excludability. Further research should focus on discovering the fundamental driving factors for the strong concentration of certain medical devices and how these payments will affect the industry itself.

Presence of Indian Pharmaceutical Industries in US Market: An Empirical Analysis

2009 ◽  
Vol 6 (4) ◽  
pp. 333-344 ◽  
Author(s):  
Jena Deepak Kumar ◽  
Vishwajeet Mohan ◽  
Padmanabhuni Venkata Appaji ◽  
Lanka Srinivas ◽  
Poduri Balaram
Keyword(s):  
Drug Application ◽  
Active Pharmaceutical Ingredient ◽  
The United States ◽  
The Us ◽  
Pharmaceutical Industries ◽  
Export Destination ◽  
Complex Chemistry ◽  
New Drug Application ◽  
Total Type ◽  
Comprehensive Study

The United States is the largest pharmaceutical market in the world with generic sales accounting for US$58.5 billion and is India's largest export destination. India accounts for one out of every four Abbreviated New Drug Application (ANDA) approvals in the years 2007 and 2008, ranks first in total Type II active Drug Master Files (DMFs) with US Food and Drug Administration and it also received 31 per cent of all tentative approvals (as on 11 December 2008). In 2008, the exports of formulations from India to top 28 regulated countries surpassed Active Pharmaceutical Ingredient (API) exports firmly demonstrating the shift in credibility and Quality Compliance. India has rich vendor base with 3.75 DMFs per molecule and has filed more than 450 different APIs. Has India tapped the US market to its fullest potential? Where do the opportunities for further growth for India lies in this market? To answer this question, a comprehensive study of DMFs and ANDAs filings by their therapeutic categories, dosage forms, strengths, companies, countries and other key parameters like patents was undertaken. The study reveals that ANDAs from India are confined to small number of highly competitive molecules, and has to move into the new orbit of working in complex chemistry, Biotech-based medicines, and advanced formulations.

scholarly journals Poverty, Obesity, Diabetes: Are They the By-Products of Liberalization of Global Economy?

2016 ◽  
Vol 19 (4) ◽  
Author(s):  
Sharaf N. Rehman
Keyword(s):  
Paradigm Shift ◽  
Global Economy ◽  
Paper Briefly ◽  
Obesity And Diabetes ◽  
The Us ◽  
Pharmaceutical Industries ◽  
By Products

The paper briefly describes the causes of a global rise in obesity and diabetes. In so doing, it establishes links between (1) poverty and obesity, and (2) obesity and diabetes. The paper also presents data from a survey (N=147) conducted in a depressed economy in Texas where cases of obesity and diabetes are among the highest in the US. The paper argues for a paradigm shift in viewing the role of policymakers in regards to food and pharmaceutical industries, both locally and globally.

Industrial Change and Regional Development: The Case of the US Biotechnology and Pharmaceutical Industries

1998 ◽  
Vol 30 (10) ◽  
pp. 1757-1774 ◽  
Author(s):  
M Gray ◽  
E Parker
Keyword(s):  
Drug Development ◽  
Research And Development ◽  
Competitive Advantage ◽  
Regional Development ◽  
Biotechnology Industry ◽  
Marketing Channels ◽  
Industrial Change ◽  
The Us ◽  
Development Experience ◽  
Pharmaceutical Industries

We examine the arguments surrounding the location and organization of innovative firms and examine the prospects for industry renewal and regional rejuvenation. We examine the effect of technological breakthroughs in the biotechnology industry on the organization and location of production with respect to mature and emergent regions. We find that, despite losing much of their preeminence in research and development, traditional firms in mature regions have managed to ‘capture’ a substantial amount of manufacturing and marketing. The drug-development experience, manufacturing capabilities, and marketing channels of more established companies in mature regions are turning out to be major sources of competitive advantage.

The Eleventh Circuit Holds that Agreements in which Pharmaceutical Companies Pay Generic Companies Not to Compete May be Valid

2004 ◽  
Vol 32 (1) ◽  
pp. 181-184
Author(s):  
Amy Garrigues
Keyword(s):  
Pharmaceutical Companies ◽  
Court Decisions ◽  
Patent Holder ◽  
Trial Court ◽  
Court Of Appeals ◽  
The Us ◽  
Antitrust Laws ◽  
Per Se ◽  
Appeals Court ◽  
Two Sides

On September 15, 2003, the US. Court of Appeals for the Eleventh Circuit held that agreements between pharmaceutical and generic companies not to compete are not per se unlawful if these agreements do not expand the existing exclusionary right of a patent. The Valley DrugCo.v.Geneva Pharmaceuticals decision emphasizes that the nature of a patent gives the patent holder exclusive rights, and if an agreement merely confirms that exclusivity, then it is not per se unlawful. With this holding, the appeals court reversed the decision of the trial court, which held that agreements under which competitors are paid to stay out of the market are per se violations of the antitrust laws. An examination of the Valley Drugtrial and appeals court decisions sheds light on the two sides of an emerging legal debate concerning the validity of pay-not-to-compete agreements, and more broadly, on the appropriate balance between the seemingly competing interests of patent and antitrust laws.

Relation of Statistically Significant, Abnormal, and Typical WAIS-R VIQ-PIQ Discrepancies to Full Scale IQs

2000 ◽  
Vol 16 (2) ◽  
pp. 107-114 ◽  
Author(s):  
Louis M. Hsu ◽  
Judy Hayman ◽  
Judith Koch ◽  
Debbie Mandell
Keyword(s):  
Graphical Method ◽  
The United States ◽  
Full Scale ◽  
True Score ◽  
Absolute Value ◽  
Normative Population ◽  
The Us ◽  
The Mean ◽  
And Performance ◽  
Quadratic Models

Summary: In the United States' normative population for the WAIS-R, differences (Ds) between persons' verbal and performance IQs (VIQs and PIQs) tend to increase with an increase in full scale IQs (FSIQs). This suggests that norm-referenced interpretations of Ds should take FSIQs into account. Two new graphs are presented to facilitate this type of interpretation. One of these graphs estimates the mean of absolute values of D (called typical D) at each FSIQ level of the US normative population. The other graph estimates the absolute value of D that is exceeded only 5% of the time (called abnormal D) at each FSIQ level of this population. A graph for the identification of conventional “statistically significant Ds” (also called “reliable Ds”) is also presented. A reliable D is defined in the context of classical true score theory as an absolute D that is unlikely (p < .05) to be exceeded by a person whose true VIQ and PIQ are equal. As conventionally defined reliable Ds do not depend on the FSIQ. The graphs of typical and abnormal Ds are based on quadratic models of the relation of sizes of Ds to FSIQs. These models are generalizations of models described in Hsu (1996) . The new graphical method of identifying Abnormal Ds is compared to the conventional Payne-Jones method of identifying these Ds. Implications of the three juxtaposed graphs for the interpretation of VIQ-PIQ differences are discussed.

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