Lou Morris is president of Louis A. Morris & Associates, which specializes in regulatory research and consulting. Morris spent 23 years at FDA and is currently a member of FDA’s Drug Safety and Risk Management Advisory Committee. He can be reached at firstname.lastname@example.org or (631) 385-1172.
This letter concerns the FDA press release dated January 18, 2006, entitled "FDA Announces New Prescription Drug Information Format to Improve Patient Safety." The information contained is considered false and misleading, and lacking in fair balance.
Last year, FDA released a series of concept papers that summarized the agency's plans for risk management. One described a new mandate for the pharmaceutical industry: to develop a risk management plan (RMP) for each drug, to be submitted to FDA at the time of the new drug application. The concept papers still need to be finalized and converted into a guidance (a document that explains how companies may comply with FDA regulations), but the mandate is likely to go into effect this year.