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Inpharma 1472 - 29 Jan 2005 Time for the US FDA to "realize its full potential" It is time for the US FDA to "realize its full potential as both protector and promoter of the public health", says Dr Eve E Slater from the US. As such, "we must envision the FDA as more than a counterpart to the pharmaceutical industry", she contends. Since the introduction of the Prescription Drug User Fee Act in 1992, the FDA has made "appreciable progress" in the efficiency of its drug review process, particularly for drugs awarded priority status, and has "enhanced the scientific quality of its actions", notes Dr Slater. Nevertheless, progress has still been "insufficient", and the FDA "must evolve beyond satisfying the appetite of industry for faster approval of drugs", she maintains. Indeed, the agency’s postmarketing safety surveillance and its oversight of advertising and promotion of drugs must be strengthened, and continual development sought to ensure its capability in emerging areas of science. In addition, and perhaps most importantly, the FDA’s expertise "must be brought to bear in the control of surging drug costs", asserts Dr Slater. She suggests that nationwide, computer-assisted prescribing of barcoded drugs, teamed with an electronic database for personal medical information, would reduce medication errors and "improve the quality of health care and reduce costs". Other means of controlling drug costs available to the FDA include accelerating the conversion of prescription drugs to OTC status, and "more thorough attention to the development and approval of generic drugs", says Dr Slater. Slater EE. Today’s FDA. New England Journal of Medicine 352: 293-297, No. 3, 20 Jan 2005 800996134 1 Inpharma 29 Jan 2005 No. 1472 1173-8324/10/1472-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Time for the US FDA to “realize its full potential”

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Inpharma 1472 - 29 Jan 2005

Time for the US FDA to "realize itsfull potential"

It is time for the US FDA to "realize its full potential asboth protector and promoter of the public health", saysDr Eve E Slater from the US. As such, "we must envisionthe FDA as more than a counterpart to thepharmaceutical industry", she contends.

Since the introduction of the Prescription Drug UserFee Act in 1992, the FDA has made "appreciableprogress" in the efficiency of its drug review process,particularly for drugs awarded priority status, and has"enhanced the scientific quality of its actions", notesDr Slater. Nevertheless, progress has still been"insufficient", and the FDA "must evolve beyond satisfyingthe appetite of industry for faster approval of drugs", shemaintains. Indeed, the agency’s postmarketing safetysurveillance and its oversight of advertising andpromotion of drugs must be strengthened, andcontinual development sought to ensure its capability inemerging areas of science. In addition, and perhapsmost importantly, the FDA’s expertise "must be broughtto bear in the control of surging drug costs", assertsDr Slater.

She suggests that nationwide, computer-assistedprescribing of barcoded drugs, teamed with anelectronic database for personal medical information,would reduce medication errors and "improve thequality of health care and reduce costs". Other means ofcontrolling drug costs available to the FDA includeaccelerating the conversion of prescription drugs toOTC status, and "more thorough attention to thedevelopment and approval of generic drugs", saysDr Slater.Slater EE. Today’s FDA. New England Journal of Medicine 352: 293-297, No. 3,20 Jan 2005 800996134

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Inpharma 29 Jan 2005 No. 14721173-8324/10/1472-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved