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Pharmaceutical Medicine
Published in: Pharmaceutical Medicine 1/2008

01-01-2008 | Current Opinion

Drug Approval Times and User Fees

An International Perspective in a Changing World

Author: Professor Joel Lexchin

Published in: Pharmaceutical Medicine | Issue 1/2008

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Abstract

On the surface it would seem that everyone — industry, patients and regulators — would be in favour of faster drug approvals. Approval times in developed countries vary significantly. One major cause of slow approval times is resource availability. In the face of government reluctance to increase funding to regulatory agencies through tax dollars, user fees (payments from industry) have been adopted in many countries. In the US, user fees were accompanied by a commitment to faster approvals, whereas in other countries there seems to have been a tacit agreement between industry and the regulator that approval times would become shorter. Information from the US, Australia and Canada shows that user fees have resulted in more rapid drug approvals and a greater percentage of new drug applications being approved. To the extent that new drugs improve health outcomes, patients have benefited, and there is some contested evidence that an increase in the use of new drugs leads to better health but the large majority of new drugs do not offer any significant therapeutic gains. At the same time as improving drug approval times, user fees have also resulted in the shunting of agency resources into the approval system and away from other regulatory functions, such as postmarketing surveillance. Furthermore, for the US Food and Drug Administration, the introduction of user fees also seems to have led to increased workloads for agency staff and lower staff moral. There is a major ongoing debate about whether or not faster approvals subsequently lead to more drug withdrawals for safety reasons. There is a body of evidence that seems to indicate that this is not the case but other metrics, such as the fate of drugs that are approved just prior to legislated deadlines, show higher rates of withdrawals for this group of drugs. Finally, many prominent doctors and academics believe that user fees have fundamentally changed the relationship between regulators, the public and industry, and there are calls in the US for the abolition of user fees.
Footnotes
1
1In the late 1990s, the length of time a new drug application spent in the review process was just over 300 days, significantly under Health Canada’s target of 355 days, but there was an additional 350 days of waiting time before the review started.[5]
 
2
2The TPD approves and monitors prescription and nonprescription drugs derived from chemical manufacturing and medical devices; the Biologics and Genetic Therapies Directorate (BGTD) is responsible for biological and radiopharmaceutical drugs including blood and blood products, viral and bacterial vaccines, genetic therapeutic products, tissues, organs and xenografts. While responsible for different types of products both the Directorates function in an almost identical manner, and for the purposes of this article, the term TPD will be used for both
 
3
3The relevant parts of the FDA for the purposes of this paper are the Center for Drug Evaluation and Research, which regulates drugs derived from chemical manufacturing, and the Center for Biologics Evaluation and Research, which regulates blood and blood products, vaccines and allergenic products and protein-based drugs
 
4
4The pharmaceutical industry also had a significant role to play in the long approval times. In many cases, the initial files sent to the FDA had major inadequacies and companies took prolonged periods of time to respond to FDA queries.[8]
 
5
5The TGA is the Australian equivalent to the FDA and the TPD
 
6
6The Medicines Control Agency is now the Medicines and Healthcare products Regulatory Agency (MHRA)
 
7
7‘ Priority’ review drugs are those thought to have the potential for significant therapeutic gains
 
8
8Olson[18] makes the point that the increase in hospitalizations and deaths due to ADRs needs to be balanced against the benefits of quicker access to new drugs
 
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Metadata
Title
Drug Approval Times and User Fees
An International Perspective in a Changing World
Author
Professor Joel Lexchin
Publication date
01-01-2008
Publisher
Springer International Publishing
Published in
Pharmaceutical Medicine / Issue 1/2008
Print ISSN: 1178-2595
Electronic ISSN: 1179-1993
DOI
https://doi.org/10.1007/BF03256677

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