New drugs under clinical evaluation in the United States

1978 ◽  
Vol 1 (1) ◽  
Author(s):  
StephenK. Carter
Keyword(s):  
United States ◽  
Clinical Evaluation ◽  
The United States ◽  
New Drugs

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.

Pharmaceuticals, Patents, and Politics: Canada and Bill C-22

1993 ◽  
Vol 23 (1) ◽  
pp. 147-160 ◽  
Author(s):  
Joel Lexchin
Keyword(s):  
United States ◽  
Research And Development ◽  
Patent Protection ◽  
The United States ◽  
New Drugs ◽  
Compulsory Licensing ◽  
High Drug ◽  
Drug Prices ◽  
Future Demands ◽  
The Impact

In response to high drug prices, the Canadian government amended the country's patent act in 1969 to allow for compulsory licensing to import pharmaceuticals. As a result of the legislation, by 1983 drug costs in Canada were over $200 million lower than they would otherwise have been. The multinational drug industry was strongly opposed to compulsory licensing, despite any evidence that its economic position had been harmed. Restoration of patent protection for drugs was one of the key U.S. demands during free-trade negotiations between Canada and the United States in 1985–1987. The result was Bill C-22, which gave new drugs protection from compulsory licensing for seven to ten years. This article analyzes the impact of Bill C-22 on the generic industry, the creation of jobs in research and development, drug prices, and research and development expenditures. It concludes with an examination of future demands from the pharmaceutical industry.

scholarly journals National trends in prescription drug expenditures and projections for 2021

2021 ◽  
Author(s):  
Eric M Tichy ◽  
James M Hoffman ◽  
Katie J Suda ◽  
Matthew H Rim ◽  
Mina Tadrous ◽  
...  
Keyword(s):  
United States ◽  
Prescription Drug ◽  
Pharmaceutical Expenditure ◽  
The United States ◽  
New Drugs ◽  
Drug Spending ◽  
Cancer Drugs ◽  
Pharmaceutical Expenditures ◽  
Drug Expenditures ◽  
New Policies

Abstract Purpose To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2021 in the United States, with a focus on the nonfederal hospital and clinic sectors. Methods Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2021 were reviewed—including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, generics, coronavirus disease 2019 (COVID-19) pandemic influence, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2021 were based on a combination of quantitative analyses and expert opinion. Results In 2020, overall pharmaceutical expenditures in the United States grew 4.9% compared to 2019, for a total of $535.3 billion. Utilization (a 2.9% increase) and new drugs (a 1.8% increase) drove this increase, with price changes having minimal influence (a 0.3% increase). Adalimumab was the top drug in 2020, followed by apixaban and insulin glargine. Drug expenditures were $35.3 billion (a 4.6% decrease) and $98.4 billion (an 8.1% increase) in nonfederal hospitals and clinics, respectively. In clinics, growth was driven by new products and increased utilization, whereas in hospitals the decrease in expenditures was driven by reduced utilization. Several new drugs that will influence spending are expected to be approved in 2021. Specialty and cancer drugs will continue to drive expenditures along with the evolution of the COVID-19 pandemic. Conclusion For 2021, we expect overall prescription drug spending to rise by 4% to 6%, whereas in clinics and hospitals we anticipate increases of 7% to 9% and 3% to 5%, respectively, compared to 2020. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.

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