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Previous Volume 347:1462-1470 October 31, 2002 Number 18

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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When sulfanilamide became available in the 1930s, a liquid preparation that could be taken by small children was needed. Because the sulfa drug did not dissolve easily in water, a chemist at the Massengill pharmaceutical company prepared an "elixir" containing diethylene glycol. At the time, medications had to meet standards for purity and truth in labeling, but their safety did not have to be established before they could be used clinically. Tragically, 107 persons, many of whom were children, died of diethylene glycol poisoning as a result.^1,2,3

Tragedies like the sulfanilamide-related deaths and the epidemic of birth defects associated with . . . [Full Text of this Article]

Background

Scientific Issues

Ethical Issues

Practical Difficulties

The Pediatric Exclusivity Provision

The Effects of Exclusivity

Financial Effects

The Pediatric Rule

The Legal Challenge to the Pediatric Rule

Limitations of Pediatric Exclusivity and the Pediatric Rule

Other Developments

The Future

Related Letters:

Testing Medications in Children
Crawley F. P., Kurz R., Nakamura H., Gurwitz J. H., Steinbrook R.
Extract | Full Text | PDF  
N Engl J Med 2003; 348:763-764, Feb 20, 2003. Correspondence

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