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8 records – page 1 of 1.

An antibiotic's journey from marketing authorization to use, Norway.

https://arctichealth.org/en/permalink/ahliterature286114
Source
Bull World Health Organ. 2017 Mar 01;95(3):220-226
Publication Type
Article
Date
Mar-01-2017
Author
Christine Årdal
Hege Salvesen Blix
Jens Plahte
John-Arne Røttingen
Source
Bull World Health Organ. 2017 Mar 01;95(3):220-226
Date
Mar-01-2017
Language
English
Publication Type
Article
Keywords
Anti-Bacterial Agents - economics
Costs and Cost Analysis
Drug Approval - organization & administration
Drug Resistance, Bacterial
Drug Utilization
Health Policy
Humans
Insurance, Health, Reimbursement
Marketing - organization & administration
Norway
Practice Guidelines as Topic
Private Sector - organization & administration
Abstract
Here we describe in detail marketing authorization and reimbursement procedures for medicinal products in Norway, with particular reference to nine novel antibiotics that received marketing authorization between 2005 and 2015. The description illustrates that, in places like Norway, with effective antibiotic stewardship policies and an associated low prevalence of antibiotic-resistant bacterial infection, there is little need for newer, more expensive antibiotics whose therapeutic superiority to existing compounds has not been demonstrated. Since resistance begins to emerge as soon as an antibiotic is used, Norway's practice of leaving newer antibiotics on the shelf is consistent with the goal of prolonging the effectiveness of newer antibiotics. An unintended consequence is that the country has signalled to the private sector that there is little commercial value in novel antibiotics, which may nevertheless still be needed to treat rare or emerging infections. Every country aims to improve infection control and to promote responsible antibiotic use. However, as progress is made, antibiotic-resistant bacteria should become less common and, consequently, the need for, and the commercial value of, novel antibiotics will probably be reduced. Nevertheless, antibiotic innovation continues to be essential. This dilemma will have to be resolved through the introduction of alternative reward systems for antibiotic innovation. The DRIVE-AB (Driving re-investment in research and development and responsible antibiotic use) research consortium in Europe has been tasked with identifying ways of meeting this challenge.
Notes
Cites: Lancet. 2005 Feb 12-18;365(9459):579-8715708101
Cites: J Antimicrob Chemother. 2015;70(6):1604-725673635
Cites: J Antimicrob Chemother. 2013 Sep;68(9):2144-5323674762
Cites: Lancet Infect Dis. 2016 Feb;16(2):161-826603172
Cites: Antimicrob Agents Chemother. 2010 Sep;54(9):3564-820547788
PubMed ID
28250535 View in PubMed
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Canadian drive to curb drug expenditure.

https://arctichealth.org/en/permalink/ahliterature193432
Source
Lancet. 2001 Aug 25;358(9282):648
Publication Type
Article
Date
Aug-25-2001
Author
W. Kondro
Source
Lancet. 2001 Aug 25;358(9282):648
Date
Aug-25-2001
Language
English
Publication Type
Article
Keywords
Canada
Cost Control - methods
Drug Approval - organization & administration
Drug Costs
Drug Prescriptions - economics
Humans
PubMed ID
11530167 View in PubMed
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Diffusion of innovation I: Formulary acceptance rates of new drugs in teaching and non-teaching British Columbia hospitals--a hospital pharmacy perspective.

https://arctichealth.org/en/permalink/ahliterature216734
Source
Can J Hosp Pharm. 1994 Dec;47(6):254-60
Publication Type
Article
Date
Dec-1994
Author
M M D'Sa
D S Hill
T P Stratton
Author Affiliation
Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver.
Source
Can J Hosp Pharm. 1994 Dec;47(6):254-60
Date
Dec-1994
Language
English
Publication Type
Article
Keywords
British Columbia
Canada
Diffusion of Innovation
Drug Approval - organization & administration
Drug Industry
Formularies, Hospital - standards
Hospitals, Teaching
Humans
Pharmacy Service, Hospital - organization & administration
Pharmacy and Therapeutics Committee
Time Factors
Abstract
Lag times in the diffusion of new drugs in the hospital setting have both patient care and pharmaceutical industry implications. This two-part series uses diffusion theory to examine differences in the adoption rates of new drugs in British Columbia teaching and non-teaching hospitals. Formulary addition of a new drug by a hospital's Pharmacy and Therapeutics Committee was considered the adoption indicator. Time for adoption was defined as the difference between a drug's Canadian market approval date and the date of formulary addition. Surveys were mailed in September 1990 to 41 hospital pharmacies (response rate = 88%), asking respondents to provide formulary inclusion dates of 29 drugs marketed between July 1987 and March 1990. A significant difference (Mann-Whitney U Test, p
PubMed ID
10139270 View in PubMed
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Hear no secrets, see no secrets, speak no secrets: secrecy in the Canadian drug approval system.

https://arctichealth.org/en/permalink/ahliterature202879
Source
Int J Health Serv. 1999;29(1):167-78
Publication Type
Article
Date
1999
Author
J. Lexchin
Source
Int J Health Serv. 1999;29(1):167-78
Date
1999
Language
English
Publication Type
Article
Keywords
Canada
Confidentiality
Consumer Product Safety
Drug Approval - organization & administration
Government Agencies - organization & administration - standards
Humans
Information Services
Management Audit
Observer Variation
Personnel Downsizing
Privatization
Abstract
Systemic bias in the form of a lack of transparency in the operation of the Canadian drug regulatory agency, the Health Protection Branch, seriously undermines our knowledge of how well the agency is functioning. In recent years this secrecy has combined with deregulation, downsizing, and privatization to compromise safety and could lead to deleterious consequences in the way that drugs are being used. Finally, these forces are threatening the ability of the Health Protection Branch to set priorities for the overall system of drug regulation. This article provides concrete examples of each of these problems. The author then discusses why secrecy is so firmly entrenched in the regulatory approval system, and offers some suggestions on how to tackle this issue.
PubMed ID
10079402 View in PubMed
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No longer "if," but "when": the coming abbreviated approval pathway for follow-on biologics.

https://arctichealth.org/en/permalink/ahliterature146808
Source
Food Drug Law J. 2009;64(1):115-48
Publication Type
Article
Date
2009
Author
Jeremiah J Kelly
Michael David
Author Affiliation
Whiteford, Taylor & Preston, LLP, Baltimore, MD, USA.
Source
Food Drug Law J. 2009;64(1):115-48
Date
2009
Language
English
Publication Type
Article
Keywords
Biological Products
Canada
Clinical Trials as Topic
Drug Approval - organization & administration
Drugs, Investigational
Economic Competition
Europe
Government Regulation
Guidelines as Topic
Humans
Investigational New Drug Application - organization & administration
Legislation, Drug
United States
United States Food and Drug Administration
Abstract
Abbreviated approval of follow-on biologics involves answering complex scientific, legal, and policy questions. The Food and Drug Administration (FDA or the Agency) asserts that it lacks the statutory authority to approve follow-on versions of biologics licensed under Section 351 of the Public Health Service Act (PHSA). Despite persuasive arguments to the contrary the one hundred and tenth Congress entertained four legislative proposals to give FDA this authority, each markedly different. It is no longer a question of "if," but "when" FDA will receive authority to review and license abbreviated applications for follow-on biologics. Any legislation in the one hundred and eleventh Congress must determine: (1) if FDA should be granted authority to develop an abbreviated pathway through rulemaking or guidance; (2) if human clinical trials should be mandatory or discretionary; (3) the feasibility of interchangeability determinations in light of patient safety concerns; (4) the duration of marketing exclusivity for associated products; (5) which products are eligible for follow-on approval; and (6) the degree to which uniformity is achievable between the FD&C Act and the PHSA. This paper recommends the one hundred and eleventh Congress strike a balance between patient safety, incentives for product innovation, price competition, and the need for a flexible, transparent process that capitalizes on FDA's growing expertise with follow-on biologics approvals under Section 505(b)(2) of the FD&C Act.
PubMed ID
19998743 View in PubMed
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Switching omeprazole in Sweden and the United States.

https://arctichealth.org/en/permalink/ahliterature75509
Source
Am J Ther. 2003 Sep-Oct;10(5):370-6
Publication Type
Article
Author
Joshua Cohen
Author Affiliation
Tufts Center for the Study of Drug Development, Boston, Massachusetts 02111, USA. joshua.cohen@tufts.edu
Source
Am J Ther. 2003 Sep-Oct;10(5):370-6
Language
English
Publication Type
Article
Keywords
Anti-Ulcer Agents - economics - standards - therapeutic use
Comparative Study
Decision Making, Organizational
Drug Approval - organization & administration
Drug Costs - standards
Drugs, Non-Prescription - economics - standards - therapeutic use
Enzyme Inhibitors - economics - standards - therapeutic use
Humans
Omeprazole - economics - standards - therapeutic use
Prescriptions, Drug - economics
Quality Assurance, Health Care
Sweden
United States
United States Food and Drug Administration - standards
Abstract
This article compares the Swedish Medical Products Agency's (MPA) decision to switch omeprazole from prescription (Rx) to over-the-counter (OTC) status with the US Food and Drug Administration (FDA) advisory panel's decision not to authorize the switch. The agencies' differing perspectives on efficacy, safety, labeling, and clinical trial requirements are evaluated with regard to the Rx-to-OTC switch process in general and omeprazole's case in particular. The FDA and MPA regulatory policies on switches are substantially divergent. The FDA maintains a stricter set of switch guidelines and requirements than the MPA. One could infer from this that the FDA is more risk-averse than the MPA. Nevertheless, the omeprazole switch in Sweden appears to be an exception in that it contrasts with the MPA's historical reluctance to switch the Rx status of medications. Cost considerations appear to have triggered the omeprazole switch, making it a special case. The lessons to be drawn from this case study are both specific and general. At the specific level, this case study suggests the MPA's decision to switch omeprazole was prompted by economic considerations, whereas the FDA's mandate did not allow cost to affect its decision on omeprazole. At a general level, this case study indicates that the differences between the FDA and MPA with respect to their regulatory policies on switches and their mandates apply not only to omeprazole but also to the dozens of switches currently under consideration by the respective regulatory agencies.
PubMed ID
12975722 View in PubMed
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Transparency in drug regulation: mirage or oasis?

https://arctichealth.org/en/permalink/ahliterature177289
Source
CMAJ. 2004 Nov 23;171(11):1363-5
Publication Type
Article
Date
Nov-23-2004
Author
Joel Lexchin
Barbara Mintzes
Author Affiliation
Emergency Department, University Health Network, School of Health Policy and Management, York University, Toronto, Ont. joel.lexchin@utoronto.ca
Source
CMAJ. 2004 Nov 23;171(11):1363-5
Date
Nov-23-2004
Language
English
Publication Type
Article
Keywords
Access to Information - legislation & jurisprudence
Antidepressive Agents - therapeutic use
Bias (epidemiology)
Canada
Cardiovascular Diseases - chemically induced
Clinical Trials as Topic - standards
Cyclooxygenase Inhibitors - adverse effects
Drug Approval - organization & administration
Drug Industry - legislation & jurisprudence
Hormone Replacement Therapy - adverse effects
Humans
Publishing - standards
Pyrazoles
Sulfonamides - adverse effects
Notes
Cites: JAMA. 2001 Nov 21;286(19):2398-40011712925
Cites: Lancet. 2000 Feb 12;355(9203):566-910683020
Cites: JAMA. 2000 Sep 13;284(10):1247-5510979111
Cites: JAMA. 2001 Nov 21;286(19):2398; author reply 2399-40011712924
Cites: BMJ. 1997 Jul 19;315(7101):149-539251544
Cites: JAMA. 2002 Jul 17;288(3):321-3312117397
Cites: BMJ. 2003 May 31;326(7400):1171-312775615
Cites: BMJ. 2004 Feb 28;328(7438):518-2014988197
Comment In: CMAJ. 2005 Jun 21;172(13):1664; author reply 1664-515967953
PubMed ID
15557590 View in PubMed
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8 records – page 1 of 1.