How To Find Documents On The FDA Site
3 CommentsBy Ed Silverman // December 21st, 2007 // 10:57 am
The news that Merck and Schering-Plough failed to publish some studies about the Zetia cholesterol med and liver damage is the latest example of an issue that plagues the pharmaceutical industry - a failure to be transparent. The problem was underscored by the fact that The New York Times noted that partial results of the studies (look here) were alluded to in documents on the FDA web site.
So for those who want to play detective, The Annals of Pharmacotherapy (subscription required) published a handy step-by-step primer to locate hard-to-find documents on the agency site. The cheat sheet should help you find briefing documents - the reams of supporting paperwork submitted by a drugmaker when seeking FDA approval for its med. It was compiled by a professor and students at the Lake Erie College of Osteopathic Medicine’s School of Pharmacy.
To get started in locating an approval package for a drug, follow the path by folks who regularly visit the FDA site, www.fda.gov. First, click on ‘drugs’ on the left side and then click on ‘Drug@FDA’ on the right side. Of course, you have to then enter the name of the drug in the search box. From there, you’ll see a highlighted line - ‘approval history, letters, reviews and related documents.’ Then click on ‘reviews.’
The rest is rather lengthy and the journal has it summarized nicely.
Tom
The FDA web site certainly contains a wealth of information, if you know how to find it and evaluate it in the correct scientific and regulatory context. The good news is that FDA has put much effort into soliciting stakeholder feedback on its homepage and has said it plans to increase user-friendliness considerably. For comparative perspectives on drug safety issues, there are four top-tier health authority websites that also offer a huge trove of data and assessments to sift through. They are the European Medicines Agency, Health Canada, UK Medicines Agency, and Australian Therapeutic Goods Administration. Just my opinion, but I think EMEA does the nicest job of remembering that a drug risk has to be assessed against the benefit, not in a vacuum. Health Canada offers both a health professional and a patient version of all safety communications - a useful feature for consumers who may not understand medical jargon.
http://www.emea.europa.eu
http://www.hc-sc.gc.ca/index_e.html
http://www.mhra.gov.uk/
http://www.tga.gov.au/
By the way, anyone who wants to learn more about the significance of liver enzyme elevations in clinical trials might appreciate the new FDA draft guidance on this topic http://www.fda.gov/Cder/guidance/7507dft.htm
Lisa Van S
Ed,
You are gonna need a larger magnifying glass than that..
donna
What’s being done about the combination of childhood vaccines shutting down the pancreas if given together to get a child caught up on vaccinations, ie for school attendance or travel?