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Working Paper No. 28. Do Off-Label Drug Practices Argue Against FDA Efficacy Requirements? Testing an Argument by Structured Conversations with Experts

PublikationWorking paper
Daniel Klein, Företagandets villkor, Liberalisering
Working paper No. 28
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Sammanfattning

The Food, Drug and Cosmetics Act of 1938 with amendments in 1962 is inconsistent regarding FDA certification of a drug’s efficacy. The act requires efficacy certification for the drug’s initial (“on-label”) uses, but does not require certification before physicians may prescribe for subsequent (“off-label”) uses. Are there good reasons for this inconsistency? Using a sequential online survey we carried on a “virtual conversation” with some 500 physicians. The survey asked whether efficacy requirements should be imposed on off-label uses, and almost all physicians said no. It asked whether the efficacy requirements for initial uses should be dropped, and most said no. We then gently challenged respondents asking them whether opposing efficacy requirements in one case but not the other involved an inconsistency. In response to this challenge we received hundreds of written commentaries. This investigation taps the specialized knowledge of hundreds of physicians and organizes their insights into challenges to the consistency argument. Thus, it employs a method of structured conversations with experts to test the merit of an argument. Is the consistency argument a case of “foolish consistency,” or does it hold up even under scrutiny?

Klein, D. & Tabarrok, A. (2003). Do Off-Label Drug Practices Argue Against FDA Efficacy Requirements? Testing an Argument by Structured Conversations with Experts. Ratio Working Paper No. 28.

Baserat på innehåll

Working Paper No. 28. Do Off-Label Drug Practices Argue Against FDA Efficacy Requirements? Testing an Argument by Structured Conversations with Experts
Working paperPublikation
Klein, D. & Tabarrok, A.
Publiceringsår

2003

Sammanfattning

The Food, Drug and Cosmetics Act of 1938 with amendments in 1962 is inconsistent regarding FDA certification of a drug’s efficacy. The act requires efficacy certification for the drug’s initial (“on-label”) uses, but does not require certification before physicians may prescribe for subsequent (“off-label”) uses. Are there good reasons for this inconsistency? Using a sequential online survey we carried on a “virtual conversation” with some 500 physicians. The survey asked whether efficacy requirements should be imposed on off-label uses, and almost all physicians said no. It asked whether the efficacy requirements for initial uses should be dropped, and most said no. We then gently challenged respondents asking them whether opposing efficacy requirements in one case but not the other involved an inconsistency. In response to this challenge we received hundreds of written commentaries. This investigation taps the specialized knowledge of hundreds of physicians and organizes their insights into challenges to the consistency argument. Thus, it employs a method of structured conversations with experts to test the merit of an argument. Is the consistency argument a case of “foolish consistency,” or does it hold up even under scrutiny?

Working Paper No. 28. Do Off-Label Drug Practices Argue Against FDA Efficacy Requirements? Testing an Argument by Structured Conversations with Experts
Working paperPublikation
Klein, D. & Tabarrok, A.
Publiceringsår

2003

Sammanfattning

The Food, Drug and Cosmetics Act of 1938 with amendments in 1962 is inconsistent regarding FDA certification of a drug’s efficacy. The act requires efficacy certification for the drug’s initial (“on-label”) uses, but does not require certification before physicians may prescribe for subsequent (“off-label”) uses. Are there good reasons for this inconsistency? Using a sequential online survey we carried on a “virtual conversation” with some 500 physicians. The survey asked whether efficacy requirements should be imposed on off-label uses, and almost all physicians said no. It asked whether the efficacy requirements for initial uses should be dropped, and most said no. We then gently challenged respondents asking them whether opposing efficacy requirements in one case but not the other involved an inconsistency. In response to this challenge we received hundreds of written commentaries. This investigation taps the specialized knowledge of hundreds of physicians and organizes their insights into challenges to the consistency argument. Thus, it employs a method of structured conversations with experts to test the merit of an argument. Is the consistency argument a case of “foolish consistency,” or does it hold up even under scrutiny?

Ratio Working Paper No. 349: Industrial conflict in essential services in a new era – Swedish rules in a comparative perspective
Working paperPublikation
Karlson, N.
Publiceringsår

2021

Publicerat i

Ratio Working Paper

Sammanfattning

This paper examines whether the Swedish regulatory system of dealing with industrial conflicts that affect essential services need an update or reform. Are the existing rules effective in a world where many essential services are upheld by many interdependent agents in complex systems where every single node becomes critical for the functioning of the system, and where the essential service activities could be either private or public? A comparative study is conducted with the corresponding regulatory systems of the United Kingdom, Germany, and Denmark.
The conclusion is that Sweden is a special case. The Swedish protection against and readiness in dealing with societally harmful industrial conflicts in essential services is weaker than in the countries of comparison. Just as in relation to other threats to essential services, it is not sustainable to claim that just because such a threat is not currently present, there would be no need for preparedness.
There are many alternative ways to handle this. Desirable methods should both prevent harmful conflicts from erupting and end conflicts that have grown harmful to society at a later stage. The labour market organisations should have a mutual interest in reforming the rules.

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