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Impact of user fees on changes withi...

Lawson, Gary W.

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Impact of user fees on changes within the Food and Drug Administration (FDA).

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Impact of user fees on changes within the Food and Drug Administration (FDA)./
作者:	Lawson, Gary W.
面頁冊數:	211 p.
附註:	Source: Dissertation Abstracts International, Volume: 66-08, Section: A, page: 3089.
Contained By:	Dissertation Abstracts International66-08A.
標題:	Political Science, Public Administration. -
電子資源:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=3184791
ISBN:	0542262967

Impact of user fees on changes within the Food and Drug Administration (FDA).
Lawson, Gary W.

Impact of user fees on changes within the Food and Drug Administration (FDA). - 211 p.

Source: Dissertation Abstracts International, Volume: 66-08, Section: A, page: 3089.

Thesis (D.P.A.)--University of La Verne, 2005.

Problem. In 1992, to expedite the drug approval process, Congress authorized the Food and Drug Administration (FDA) to collect money from the brand-name drug industry for one 5-year period. This law has since been extended twice, and the FDA now collects more than

ISBN: 0542262967Subjects--Topical Terms:

1017438
Political Science, Public Administration.

Impact of user fees on changes within the Food and Drug Administration (FDA).
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245 1 0 $a Impact of user fees on changes within the Food and Drug Administration (FDA).
300 $a 211 p.
500 $a Source: Dissertation Abstracts International, Volume: 66-08, Section: A, page: 3089.
500 $a Adviser: Jack Meek.
502 $a Thesis (D.P.A.)--University of La Verne, 2005.
520 $a Problem. In 1992, to expedite the drug approval process, Congress authorized the Food and Drug Administration (FDA) to collect money from the brand-name drug industry for one 5-year period. This law has since been extended twice, and the FDA now collects more than $2 00,000,000 per year---nearly a fifth of its total budget---from the companies that it regulates. The purpose of this study was to evaluate if this new private industry revenue source is an asset or detriment in the agency's pursuit of its primary mission to protect and safeguard U.S. citizens.
520 $a Theoretical framework. Drawing on principal-agent and capture theories, this study examines if the FDA experienced a shift in fundamental principal-agent relationships as a result of the new revenue source.
520 $a Methodology. This study used a research model based on 11 research questions. Secondary data sources and descriptive statistic methodologies were used.
520 $a Findings and conclusion. Four major findings were established: (a) continuation of user fees creates suspicion as to the FDA's motives related to prescription drugs and thus, impedes the FDA's ability to maintain the public trust; (b) public agencies are held to a higher moral, legal, and ethical standard, and therefore, even the slightest appearance of having a conflict of interest must be eliminated; (c) since user fees were initiated, the FDA has made internal policy and procedure changes that may be viewed as serving the drug industry; and (d) to maximize public safety and ensure the public trust, the FDA needs a better system of checks and balances related to prescription drugs.
520 $a Recommendations. The FDA should go further to make known all financial relationships with the drug industry. Citizens need to be aware that financial interests compete with safety, efficacy, and humanitarian considerations. To better protect consumers and offer citizens a more comprehensive system of checks and balances, an independent office of prescription drug safety and efficacy must be established.
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