FDA documents for most-popular drugs not online

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

Nancy Watzman, writing for the Sunlight Foundation Reporting Group, has found that, because the Food and Drug Administration only makes approval background documents available for drugs approved after 1997, safety and efficacy information for nine of the 25 most-prescribed drugs is not available online.

The article points out that doctors base their treatment decisions on information in peer-reviewed articles, where drug companies have little incentive to publish negative information. The studies the FDA uses to make approval decisions, however, may have more complete and balanced information that would be useful to doctors and consumers.

Watzman reports that the FDA apparently receives such documents electronically, then prints them out, redacts them by hand (using white out!) and then scans them and saves them as PDF documents that are not searchable.

The report includes a list of the 25 most-prescribed drugs and highlights those for which FDA review documents are available online.

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