SUMMARY

A high-ranking FDA official acknowledged in an appearance before the Institute of Medicine that the agency's system for ensuring the safety of drugs is "pretty much broken down" and it has known for a long time it needed to improve its system. Recently the FDA published guidelines for a Drug Watch program to provide emerging drug safety information to the public. However, Senator Grassley and others have criticized the FDA's new drug safety board, which is tasked with determining which drugs will be included in the program.

The Drug Risk Survey posed questions about the FDA's proposed Drug Watch program as well as a Drug Risk Advisory System proposed by John Mack, publisher and editor of this newsletter (see "A Proposal for a Drug Risk Advisory System"). This article will provide an edited summary of the results with additional commentary.

Topics covered include:

• Criticism From All Sides
• Is FDA Backing Off?
• Goldhammer's (PhRMA's) Statement to the IOM
• Drug Watch Site Proposal Summary
• Drug Risk Survey Results Regarding FDA's Drug Watch Proposal:
  • Do you believe that a Drug Watch site such as proposed by the FDA is necessary?
  • Is the Drug Watch program proposed by the FDA Too Cold (doesn't go far enough), Just Right, or Too Hot (goes too far).
  • Do you think the Drug Safety Oversight Board proposed by the FDA is independent enough and properly constituted with the right mix of experts?
• Drug Risk Advisory System
• Drug Risk Survey Results Regarding Drug Risk Advisory System Proposal:
  • Chart of Responses

PMN46-04
Issue: Vol. 4, No. 6: June 2005
Word Count: 1888
TOPICS: Strategy/Planning | Direct-to-Consumer (DTC) Advertising & Marketing | Corporate Compliance/Government Regulation/Industry Guidelines