Skip to main content Accessibility help
×
Hostname: page-component-848d4c4894-4hhp2 Total loading time: 0 Render date: 2024-06-03T02:35:02.183Z Has data issue: false hasContentIssue false

5 - Private Knowledge for Public Problems

Regulating Pharmaceutical Information

Published online by Cambridge University Press:  05 October 2014

Susan L. Moffitt
Affiliation:
Brown University, Rhode Island
Get access

Summary

Almost every package insert submitted to the FDA for approval is initially burdened with fiction, ranging from vague soft-sell language to outright false claims.... Nothing is more frustratingly prolonged and tortured than controversy over labeling.

J. Richard Crout, 1974

[F]orces were operating to keep those of us who want openness ... to not have our say.

Testimony of Dr. Julia Apter to Senate Hearings, Member of the Cardiovascular and Renal Drugs Advisory Committee, 1974

In the era before the passage of the Federal Advisory Committee Act, public participation in the FDA took a range of forms including: the 1955 Citizens’ Advisory Committee on the Food and Drug Administration; the Medical Advisory Panel on the Accidental Ingestion of Salicylate Preparations that was staffed through a contract with the National Academy of Sciences; informal engagement with professional societies such as the American Academy of Pediatrics; and industry committees that consulted with the American Drug Manufacturers Association and American Pharmaceutical Manufacturers Association. Each of these venues offered a vivid juxtaposition of agency-initiated public participation and relatively closed participatory processes, which ultimately earned the FDA the label of having one of the worst advisory committee transparency records among all government agencies. Participatory bureaucracy for educational assessments faced the challenge of producing “bureaucracy” given long-standing American antipathy toward federal government involvement in public education. Participatory bureaucracy in pharmaceutical regulation faced the challenge of mobilizing participation in ways conducive to democratic accountability: allegations of industry dominance or scientific exclusivity have confronted FDA participatory processes for over half a century.

The passage of the Federal Advisory Committee Act appeared peripheral to the participatory processes for educational assessments. For the FDA, FACA procedures brought more openness than had existed before. Before FACA, the FDA established a range of venues for gathering information from conventionally defined experts. Consistent with expectations for bureaucratic administration, the agency sought this form of advice – for low information/high independence tasks – privately. “Public” access came from the particular information exchanges, between the parties in the room. The FDA also experienced periodic participatory oversight: reviews and reports of the agency delivered to external audiences. When HEW requested these reviews, the reports largely promoted the agency instead of offering accounts that impugned the agency’s expertise.

Type
Chapter
Information
Making Policy Public
Participatory Bureaucracy in American Democracy
, pp. 112 - 127
Publisher: Cambridge University Press
Print publication year: 2014

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Crout, J. Richard, “In Praise of the Lowly Package Insert,” Food & Drug Commission Law Journal 29 (1974): 139–145Google Scholar
Moffitt, Susan L., “Promoting Agency Reputation through Public Advice: Advisory Committee Use in the FDA,”Journal of Politics 72 (2010): 880–893CrossRefGoogle Scholar
Carpenter, Daniel P., Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton, NJ: Princeton University Press, 2010), pp. 167–171
Hutt, Peter Barton, “Investigations and Reports Respecting FDA Regulation of New Drugs (Part 1),” Clinical Pharmacology and Therapeutics 33 (1983): 539–540Google Scholar
Cannan, R. Keith, “Status of the Drug Efficacy Study of the National Academy of Sciences-National Research Council,” Food, Drug and Cosmetic Law Journal (January 1968): 32–35Google Scholar
Whyte, Warren E., “Effectiveness of the NAS-NRC Drug Effectiveness Study,” Food, Drug, Cosmetic Law Journal (February 1970): 91–100Google Scholar
Rettig, Richard, Earley, Laurence E., and Merrill, Richard A. (eds.), Food and Drug Administration Advisory Committees (Washington, DC: National Academy Press, 1992), p. 50Google Scholar
Wolanin, Thomas A., Presidential Advisory Committees: Truman to Nixon (Madison: University of Wisconsin Press, 1975), pp. 15–20Google Scholar
U.S. General Accounting Office, Better Evaluations Needed to Weed Out Useless Federal Advisory Committees (Washington, DC: GAO, 1977)Google Scholar

Save book to Kindle

To save this book to your Kindle, first ensure coreplatform@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Available formats
×

Save book to Dropbox

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.

Available formats
×

Save book to Google Drive

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

Available formats
×