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Introduction
The issue of Pediatric Drug Testing (PDT) has been a matter of controversy in recent years. ... With the United States Senate now wanting to restore a 1998 Food and Drug Administration (FDA) regulation known as the "Pediatric Rule" that was overturned in October 2002 , the debate of whether or not the Pediatric Rule should be passed has resurfaced. ...
Background
Pediatric Drug Testing refers to the process where drugs that have already been proved fit for consumption in adults are tested for their suitability and effectiveness in children. Such a testing aims to reduce the usage of “off-label” drugs; drugs that are safe and effective for use on adults but not on children because of the absence of testing done to clarify its effectiveness and safety. ...
Popular sentiments from pro-PDT groups: An analysis
In the article , “Pediatric Drug Testing May Prove Unhealthy”, the Competitive Enterprise Institute (CEI), a prominent group lobbying against the passing of the Rule claimed that PDT “could actually endanger public health by delaying the introduction of new drugs”. In stating this, they imply that when drugs are tested, there is a delay in their release due to the research and testing that has to be done on children before they are approved. Testing and research take up both time and money and that it is the delay of the drugs in the market that may “endanger the public health”. ...
The article further argues that the drug approval process would result in “fewer new drugs overall. ... The credibility of this statement is undermined by the lack of information pertaining to how much “riskier” and “costly” PDT really is in the drug approval process. ... PDT can be costly, with the provision of pediatric exclusivity used as an incentive to urge companies carry out PDT by helping to cover costs incurred by clinical trials. This is done by allowing drug companies to be free from generic competition while it conducts its tests by granting it a six-month patent extension. FDA estimates that over 20 years, pediatric exclusivity will cost consumers an additional US$13. ... Over this time, according to the FDA’s projections, brand-name drug makers will gain US$29. ... The Alliance for
Human Research Protection (AHRP) challenges the passing of the Pediatric Rule on the basis that the “FDA refused to provide the data about adverse events from pediatric trials”. In 1999 the FDA acknowledged that the post-FDA Modernization Act policy change "led to an increasing number of proposals for studies of safety and pharmacokinetics , including those in children who do not have the condition for which the drug is intended.
Approximate Word count = 1985
Approximate Pages = 7.9
(250 words per page double spaced)
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