Public Meeting About Communicating Drug Risks to be Convened in December 2005
In early October 2005 the FDA announced that it has contracted with several large health insurance companies to gain access to their database of prescription drug claims in order to search for emerging drug-safety issues. The health insurance company databases that will be available to the FDA are those created and maintained by UnitedHealth's unit Ingenix Inc., the Kaiser Foundation Research Institute, Vanderbilt University, and privately held Harvard Pilgrim Health Care Inc.
With access to the respective health insurance company databases, FDA researchers will examine medical claims related to a patient's prescription drug use in an attempt to identify possible serious side effects from drugs already on the market -- with the aim being to do so sooner than the FDA has been able to in the past. Starting with the Vioxx recall in September 2004, many FDA critics have charged that the agency has been too slow to recognize serious side effects that emerge after drugs are approved by the FDA.
"These kinds of methods, I think, provide a lot of opportunities. It's something we will probably be doing a lot more of," said Scott Gottlieb, the deputy FDA commissioner for medical and scientific affairs.
In addition to the health insurance database review project, the FDA announced a December 2005 "public meeting" for the purpose of getting input on how best to communicate newly discovered drug risks with doctors and patients. An FDA statement about the scheduled December 2005 public hearings includes this comment: "FDA believes it is critical that risk communication be timely, accurate, and easily accessible, and it must recognize health literacy limitations and include the needs of a multicultural population."
In more detail, according to an October 3, 2005 letter by Steven Galson, Director of the FDA's Center for Drug Evaluation and Research, there will be public hearings on December 7 and 8, 2005 in Washington, D.C. on the topic "FDA's Communication of Drug Safety Information".
(Posted by: Tom Lamb)