Rationales of delay and difference in regulatory review by Japan, the United States, and Europe among new drugs first approved in Japan

2021 ◽  
Author(s):  
Mototsugu Tanaka ◽  
Mayumi Idei ◽  
Hiroshi Sakaguchi ◽  
Ryosuke Kato ◽  
Daisuke Sato ◽  
...  
Keyword(s):  
United States ◽  
The United States ◽  
New Drugs ◽  
Regulatory Review

Policy Punctuations and Regulatory Drug Review

2003 ◽  
Vol 15 (2) ◽  
pp. 157-191 ◽  
Author(s):  
Stephen J. Ceccoli
Keyword(s):  
United States ◽  
The United States ◽  
New Drugs ◽  
Regulatory Review ◽  
Review Time ◽  
University Center ◽  
The Past ◽  
Percent Increase ◽  
New Chemical Entities ◽  
Drug Review

The FDA has dramatically decreased the regulatory review time for new drugs since the early 1990s. For example, according to the Tufts University Center for the Study of Drug Development (CSDD), which conducts triennial analyses of new drug approvals in the United States, the average FDA review time for approved New Chemical Entities (NCEs) decreased from 35.6 months in 1984–86 to 16.8 months in 1996–98. Thus, in a little more than a decade, the FDA has essentially cut its average review time in half. In addition to the declining review times, the agency's workload, as measured in terms of the number of drugs approved each year, also rose considerably in the 1990s. Specifically, the agency approved a total of 232 NCEs between 1993 and 1999, compared to just 163 approvals during the previous seven-year span—a 42 percent increase. Figures 1 and 2 illustrate the agency's decreased review times and increased workload, respectively. Thus, over the past decade the FDA has approved more drugs and done so in less time than at any other period in history. Simply stated, this change in regulatory performance, especially the declining review times, has been absolutely stunning.

Fake Pharmaceuticals: How They and Relevant Legislation or Lack Thereof Contribute to Consistently High and Increasing Drug Prices

2003 ◽  
Vol 29 (4) ◽  
pp. 525-542
Author(s):  
Merri C. Moken
Keyword(s):  
United States ◽  
Prescription Drugs ◽  
The United States ◽  
Pharmaceutical Products ◽  
New Drugs ◽  
Pharmaceutical Companies ◽  
Brand Name ◽  
Potential Factors ◽  
Counterfeit Pharmaceuticals ◽  
New Applications

The use of pharmaceutical products in the United States has increased more than the use of any other health resource from 1960 to 1990. In excess of 9,600 drugs were on the market in 1984, and the Food and Drug Administration (“FDA”) approves approximately 30 new drugs and countless new applications for alterations of already existing drugs each year. In 2001, the $300 billion pharmaceutical industry sold $154 billion worth of prescription drugs in the United States alone, nearly doubling its $78.9 billion in sales in 1997. With such a rapid increase in market domination and expenditures, the U.S. government and many hospitals have focused their attention on the sales and pricing practices of pharmaceutical companies, as well as other potential factors contributing to these escalating prices. One such cause of the steadily increasing prices of brand name pharmaceuticals is the sale of fake or counterfeit pharmaceuticals (also called “look-alike” drugs).

scholarly journals Shifting from Village-Based Networks to Locally Generated Networks: Undocumented Mexican Agricultural Workers Who Use/Used Hard Drugs

2017 ◽  
Vol 2017 ◽  
pp. 1-13
Author(s):  
Keith V. Bletzer
Keyword(s):  
United States ◽  
Drug Use ◽  
Illicit Drugs ◽  
The United States ◽  
Border Crossing ◽  
New Drugs ◽  
Agricultural Workers ◽  
Economic Success ◽  
Childhood Difficulties ◽  
Hard Drugs

Hardships that face transmigrants working in agriculture include the potential for drug use. Reliant on village-based networks that facilitate border crossing and developing a plan for a destination within this country, transmigrants who try new drugs/alcohol and/or continue on accustomed drugs/alcohol are facilitated in these endeavors through locally generated networks as alternative forms of access and support. Seven cases of undocumented men from Mexico are reviewed to show how use of illicit drugs is minimally affected by economic success and time in the United States, or village-based networks that first facilitated entry into this country. Prior conditions, especially childhood difficulties and search for socioeconomic autonomy, precipitate new and/or continuing drug use within the United States on this side of the border, where both forms of drug use are facilitated by locally generated networks.

Regulatory Perspectives: One Academic Viewpoint From the United States

2003 ◽  
Vol 15 (S1) ◽  
pp. 277-281
Author(s):  
Peter Whitehouse
Keyword(s):  
United States ◽  
Cognitive Impairment ◽  
Vascular Dementia ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States ◽  
New Drugs ◽  
Vascular Pathology ◽  
Vascular Burden ◽  
The Brain

The development of new drugs to treat vascular dementia and other conditions in which cognitive impairment is due at least in part to vascular pathology will require future interaction among academic, industry, and government regulatory clinicians and scientists. This article offers the author's perspective on the positive involvement of the Food and Drug Administration in development of conceptual frameworks and practical approaches to treatment of conditions characterized by vascular burden of the brain.

scholarly journals 484. Metallo-β-Lactamase-Positive Carbapenem-Resistant Enterobacteriaceae and Pseudomonas aeruginosa in the Antibiotic Resistance Laboratory Network, 2017–2018

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S237-S237
Author(s):  
Allison C Brown ◽  
Sarah Malik ◽  
Jennifer Huang ◽  
Amelia Bhatnagar ◽  
Rocio Balbuena ◽  
...  
Keyword(s):  
United States ◽  
Pseudomonas Aeruginosa ◽  
Antibiotic Resistance ◽  
The United States ◽  
New Drugs ◽  
Carbapenem Resistant ◽  
Laboratory Network ◽  
Therapeutic Decisions ◽  
Carbapenemase Gene ◽  
Carbapenem Resistant Enterobacteriaceae

Abstract Background Infections with metallo-β-lactamase (MBL)-producing organisms are emerging in the United States. Treatment options for these infections are limited. We describe MBL genes among carbapenemase positive carbapenem-resistant Enterobacteriaceae (CP-CRE) and Pseudomonas aeruginosa (CP-CRPA) isolates tested during the first two years of the Antibiotic Resistance Laboratory Network (AR Lab Network). Methods State and local public health laboratories tested CRE and CRPA isolates for organism identification, antimicrobial susceptibility, and PCR-based detection of blaKPC, blaNDM, blaOXA-48-like, blaVIM, and blaIMP carbapenemase genes. All testing results were sent to CDC at least monthly. Results Since January 2017, the AR Lab Network tested 21,733 CRE and 14,141 CRPA. CP-CRE were detected in 37% of CRE; 2% of CRPA were CP-CRPA. Among CP-CRE, 9% (686/8016) were MBL-producers (NDM, VIM, or IMP). Among MBL-producers, a blaNDM gene was detected most often (81%; 551/686). blaNDM were most common among Klebsiella spp. (47%; 261/551), blaIMP were most common among Providencia spp. (53%; 40/75), blaVIM was most common among Enterobacter spp. (19%; 25/62). Twelve percent (96) of MBL CP-CRE contained more than one carbapenemase gene. Among CP-CRPA, 73% (218/300) were MBL producers and blaVIM was the most common gene (62%; 186). Three (1%) MBL CP-CRPA contained more than one carbapenemase. Conclusion Increased testing of CRE and CRPA isolates through the AR Lab Network has facilitated early and rapid detection of hard-to-treat infections caused by MBL-producing organisms across the United States. The widespread distribution of MBL genes highlights the continued need for containment strategies that help prevent transmission between patients and among healthcare facilities. To support therapeutic decisions for severe infections caused by MBL-producing organisms, the AR Lab Network is now offering rapid susceptibility testing against aztreonam/avibactam, using digital dispenser technology. This testing program aims to close the gap between the availability of new drugs or drug combinations and the availability of commercial AST methods, thereby improving patient safety and antimicrobial stewardship. Disclosures All authors: No reported disclosures.

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