Healthy Skepticism Library item: 6477

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

Walsh CJ.
FDA efforts to control the flow of information at pharmaceutical industry-sponsored medical education programs: a regulatory overdose
Seaton Hall Law Review 1994; 24:1325-1369

Abstract:

There are several serious flaws in the Food and Drug Administration’s proposed regulations for industry-sponsored educational and scientific programs, flaws that are the result of faulty underlying assumptions. In order to correct these flaws, the FDA should re-focus its criteria for assessing whether an activity should be regulated as advertising to turn on the question of the industry sponsor’s actual degree of control over the content. By concentrating on the presence of control, rather than mere involvement, the resulting regulations would send a clearer message both to drug companies and continuing medical education providers about what sort of behaviour is objectionable. Under a control test, false or overly biased information coming from unscrupulous sponsors would be regulable byt he FDA, without restricting the exchange of scientific information. Rewriting its enforcement policy in this fashion would also remedy the First Amendment problems by removing the most serious restrictions on drug company and third party speech. In short, although the Draft Concept Paper and the Draft Policy Statement represent a legitimate effort to remedy perceived abuses, they must be refocused to achieve the FDA’s objective without interfering with socially valuable speech.

Keywords:
*analysis/United States/Food and Drug Administration/FDA/regulation of promotion/unlabeled indication/quality of information/continuing medical education/CME/ sponsored symposia & conferences/ commercial free speech/ conference speakers/ corporate funding/ATTITUDES REGARDING PROMOTION: REGULATORS AND GOVERNMENT/PROMOTION DISGUISED: CONFERENCES AND MEETINGS/PROMOTION DISGUISED: SUPPORT FOR CME/PROMOTIONAL TECHNIQUES: UNLABELED INDICATIONS/REGULATION, CODES, GUIDELINES: DIRECT GOVERNMENT REGULATION