Postgraduate Medicine
ISSN: 0032-5481 (Print) 1941-9260 (Online) Journal homepage: http://www.tandfonline.com/loi/ipgm20
Will more drug control be more effective? Allan J. Ryan To cite this article: Allan J. Ryan (1977) Will more drug control be more effective?, Postgraduate Medicine, 62:6, 19-19, DOI: 10.1080/00325481.1977.11714692 To link to this article: http://dx.doi.org/10.1080/00325481.1977.11714692
Published online: 07 Jul 2016.
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Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ipgm20 Download by: [Australian Catholic University]
Date: 07 August 2017, At: 01:38
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editorial • Sen Edward Kennedy and other advocates oflegislation to control more rigidly licensing of pharmaceutical products and monitor the ir development and sale seem unaware of what has happened-or more correctly what has not happened-since the Toxic Substances Control Act was signed in 1976. If they are aware of the history of this legislation, which was debated for five years, they are in the dangerous position ofthose persons described by Santayana who because they are unable to remember the past are condemned to repeat it. The act gives the federal govemment authority to review the safety of ali existing chemicals and requires producers to show that new products are not dangerous and to hait production of substances deemed to be injurious to health or the environment. However, as John Vinocur bas pointed out (The New York Times, Oct 30, 1977), the law has so far accomplished virtually nothing except to create confusion and anxiety among chemical producers. Estimates of the annual cost of compliance range from $100 to $400 million by the General Accounting Office to $2 billion by a spokesman for the Dow Chemical Company. Failures to act were listed by Vinocur as follows: • An inventory of chemicals marketed in the United States, which will serve as a data base for ali future regulatory action, is running ten months behind schedule. • The Office of Toxic Substances of the Environmental Protection Agency has not yet produced a strategy document to outline its general approach. The same office bas been unable to pro vide a definition of the test data required from industry before new chemicals can be marketed, a major provision of the law. • No risk assessment has been made thus far by the Office of Toxic Substances on 13 notices filed by manufacturees, in compliance with the statute, stating that they are dealing with substances with suggested toxicologie problems. • No statement bas been issued as to what will be designated as a small business, a question of major importance to manufacturees who may be able to forego sorne testing requirements if they are so classified. This subject is important because of the
Vot 62 • No. 6 • December 19n • POSTGRADUATE MEDICINE
will more drug control be more effective? Allan J. Ryan, MD
gradually emerging concept that a majority of human cancers may be caused by toxic substances in our environment. With the exponential multiplication of chemical substances in the past 20 years, hardly a month goes by without reports of new threats of cancer from substances used in manufacturing or present in consumer products. Present legislation bas helped control risks associated with certain dyes used in cosmetics and food products; tris, a chemical used to reduce flammability of children's sleepwear; vinyl chloride; and asbestos. The Food and Drug Administration bas taken action against artificial sweetners and is testing a number of other substances to determine whether their use should be banned or restricted because they produce cancer in laboratory animais. FDA Commissioner Donald Kennedy has made sorne progress in his term of office, but much remains to be done if the full potential of the age ney for benefiting the public is to be realized and the mistakes of the recent past are to be corrected. The imposition of whole new are as for Kennedy to administer, as contemplated under proposed legislation, would simply result in the development of further bureaucratie apparatus, in greater delays, and in more frustrations for physicians as weil as pharmaceutical manufacturees. Kennedy and his department need a chance to catch up on their present responsibilities and to rationalize their operations before a situation is created which will hamper-and perhaps paralyze-their actions, as bas happened with the Toxic Substances Control Act. Perhaps the FDA can even generate sufficient respect so that Congressj as in the case of saccharin, will not feel called upon to do its own regulating of possibly dangerous substances, and so that state legislatures, as in the case of laetrile, will not feel called upon to become arbiters of medical treatment. •
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ISSN: 0032-5481 (Print) 1941-9260 (Online) Journal homepage: http://www.tandfonline.com/loi/ipgm20
Will more drug control be more effective? Allan J. Ryan To cite this article: Allan J. Ryan (1977) Will more drug control be more effective?, Postgraduate Medicine, 62:6, 19-19, DOI: 10.1080/00325481.1977.11714692 To link to this article: http://dx.doi.org/10.1080/00325481.1977.11714692
Published online: 07 Jul 2016.
Submit your article to this journal
View related articles
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ipgm20 Download by: [Australian Catholic University]
Date: 07 August 2017, At: 01:38
Downloaded by [Australian Catholic University] at 01:38 07 August 2017
editorial • Sen Edward Kennedy and other advocates oflegislation to control more rigidly licensing of pharmaceutical products and monitor the ir development and sale seem unaware of what has happened-or more correctly what has not happened-since the Toxic Substances Control Act was signed in 1976. If they are aware of the history of this legislation, which was debated for five years, they are in the dangerous position ofthose persons described by Santayana who because they are unable to remember the past are condemned to repeat it. The act gives the federal govemment authority to review the safety of ali existing chemicals and requires producers to show that new products are not dangerous and to hait production of substances deemed to be injurious to health or the environment. However, as John Vinocur bas pointed out (The New York Times, Oct 30, 1977), the law has so far accomplished virtually nothing except to create confusion and anxiety among chemical producers. Estimates of the annual cost of compliance range from $100 to $400 million by the General Accounting Office to $2 billion by a spokesman for the Dow Chemical Company. Failures to act were listed by Vinocur as follows: • An inventory of chemicals marketed in the United States, which will serve as a data base for ali future regulatory action, is running ten months behind schedule. • The Office of Toxic Substances of the Environmental Protection Agency has not yet produced a strategy document to outline its general approach. The same office bas been unable to pro vide a definition of the test data required from industry before new chemicals can be marketed, a major provision of the law. • No risk assessment has been made thus far by the Office of Toxic Substances on 13 notices filed by manufacturees, in compliance with the statute, stating that they are dealing with substances with suggested toxicologie problems. • No statement bas been issued as to what will be designated as a small business, a question of major importance to manufacturees who may be able to forego sorne testing requirements if they are so classified. This subject is important because of the
Vot 62 • No. 6 • December 19n • POSTGRADUATE MEDICINE
will more drug control be more effective? Allan J. Ryan, MD
gradually emerging concept that a majority of human cancers may be caused by toxic substances in our environment. With the exponential multiplication of chemical substances in the past 20 years, hardly a month goes by without reports of new threats of cancer from substances used in manufacturing or present in consumer products. Present legislation bas helped control risks associated with certain dyes used in cosmetics and food products; tris, a chemical used to reduce flammability of children's sleepwear; vinyl chloride; and asbestos. The Food and Drug Administration bas taken action against artificial sweetners and is testing a number of other substances to determine whether their use should be banned or restricted because they produce cancer in laboratory animais. FDA Commissioner Donald Kennedy has made sorne progress in his term of office, but much remains to be done if the full potential of the age ney for benefiting the public is to be realized and the mistakes of the recent past are to be corrected. The imposition of whole new are as for Kennedy to administer, as contemplated under proposed legislation, would simply result in the development of further bureaucratie apparatus, in greater delays, and in more frustrations for physicians as weil as pharmaceutical manufacturees. Kennedy and his department need a chance to catch up on their present responsibilities and to rationalize their operations before a situation is created which will hamper-and perhaps paralyze-their actions, as bas happened with the Toxic Substances Control Act. Perhaps the FDA can even generate sufficient respect so that Congressj as in the case of saccharin, will not feel called upon to do its own regulating of possibly dangerous substances, and so that state legislatures, as in the case of laetrile, will not feel called upon to become arbiters of medical treatment. •
19
