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Healthy Skepticism Library item: 9393

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

FDA user fees approved.
Clin Pharm. 1993 Jan; 12:(1):3


Abstract:

The approval of the Prescription Drug User Fee Act of 1992, a plan for the Food and Drug Administration (FDA) to charge fees to pharmaceutical companies for review of their new drug applications, is announced. Initially, the fee charged for each new drug application is $100,000; 5 yr from now, it will be $233,000. The legislation will also require manufacturers to pay FDA an annual fee for every drug they have on the market; the fee is $6,000 now and will rise to $14,000 in 5 yr.

Keywords:
Drug Approval* Drug Industry/economics* Drug Industry/legislation & jurisprudence Fees and Charges* Humans Prescriptions, Drug/economics Time Factors United States United States Food and Drug Administration/legislation & jurisprudence*

 

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Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963