Why FDA Needs a New Search Engine
The FDA’s Transparency Task Force is holding hearings into how it can improve its openness to the public. In addition to the hearings, it’s collecting comments from citizens. Adorably, it also has a transparency blog which is run by Erik P. Mettler, FDA’s “Transparency Blog Managing Director.” Your tax dollars at work!
The best thing that the FDA can do to make its operations more transparent is to organize its web site so that searches for information within it actually produce meaningful results.
FDA’s web site is massive. It was recently redesigned and the new design is a vast improvement. But the information within it is not organized in a way that makes anything easy to find.
Try this: Go to FDA.gov to look for all documents the FDA has published on the Pfizer drug Lipitor. On the homepage, Lipitor is not listed under the alphabetical “L” section at the top of the site, so it seems sensible to start with the “Drugs” section and drill down. There you will find that FDA’s information is not organized by drug but by issue, such as approvals, safety, news and so on. There is no section for all the FDA’s information on Lipitor.
You might be tempted to use the FDA’s search engine to pull up every page that mentions Lipitor but all that does is produce 10 pages of disorganized results. One of those pages looks like it contains everything you might need to know about FDA’s Lipitor database, but it does not. It doesn’t include this warning letter over false or misleading marketing of Lipitor from 2002, which is contained in a different section of the site.
So, FDA, please consider organizing your database by drug as well as by issue.
The call came from the Pew Prescription Project’s Allan Coukell. He pointed out that doctors already use drugs for off-label purposes, and that if the FDA thinks a drug’s label should not be expanded then those docs need to know why so they can stop writing dangerous prescriptions.
Coukell used the example of Takeda’s ciglitazone, an abandoned and ultimately unapproved drug for diabetes. FDA later approved a similar drug, rosiglitazone, (GlaxoSmithKline’s Avandia), which later was found to increase cardiovascular risks in its patients. Coukell:
Knowing the adverse event profile of ciglitizaone and other products in the same class, might have caused clinicians and drug safety experts – and the applicant – to look earlier and more closely for these adverse events. Lives might have been saved.
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.
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