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1 million penalty for violating FDA rules?

Dickinson, James D

Medical marketing & media, 1994-12, Vol.29 (12), p.18

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Título:
1 million penalty for violating FDA rules?
Autor: Dickinson, James D
Assuntos: Advertising ; Ethics ; FDA approval ; Fines & penalties ; Law enforcement ; Marketing ; Medical device industry ; Medical equipment ; Pharmaceutical industry ; Prescription drugs ; Product recalls ; Regulatory agencies ; Violations
É parte de: Medical marketing & media, 1994-12, Vol.29 (12), p.18
Descrição: The Food and Drug Administration's (FDA) present armory of weapons to fight advertising and promotional violations is not doing the job, testified FDA Deputy Commissioner and Senior Advisor Mary K. Pendergast to the House Subcommittee on Regulation, Business Opportunities and Technology. Most commonly, FDA resolves regulatory issues involving promotion by issuing non-public Notice of Violation letters and then, if these do not work, by going public with formal Warning Letters. FDA does have injunction, seizure, and criminal prosecution powers, but uses these only rarely because they are time-consuming and resource-intensive. While FDA's present powers are usually sufficient to cause a company to cease unlawful promotional activities, Pendergast said that the potential financial rewards for violative promotional activities, such as the promotion of off-label uses, are great, and the risk of serious sanction, minimal.
Editor: New York: Haymarket Media, Inc
Idioma: Inglês

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