A Proposal for a Drug Risk Advisory System Survey Results
Drug Risk Advisory System Recently the FDA published guidelines for a Drug Watch program to provide emerging drug safety information to the public. While it is laudable that the FDA intends to make this kind of information available on its web site, the public may not be aware that a drug has been added to the list unless they proactively visit the web site.

It is essential that the information from the FDA about drug risks and side effects get out to consumers as quickly as possible and that the risks are communicated effectively.

Taking a page from the Homeland Security Advisory system, the author proposes a color-coded system for notifying the public about drug risks and links the levels of risk with levels of restrictions on DTC advertising.

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Update (December 2011): See the blog post and article below for a follow up on this issue. Also, to address a requirement of the 2010 Patient Protection and Affordable Care Act (Affordable Care Act), FDA may be required to revisit this issue (see “FDA Summary of Drug Benefits vs Risks“).

PMN45-01
Issue: Vol. 4, No. 5: May 2005
Word Count: 1924

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