Serious Side Effects and Other Safety Issues Would be Discovered Sooner

In an effort to reduce delay in the issuance of FDA safety recalls of drugs, Medicare wants to create a massive electronic database of patients’ prescription histories by partnering with drug benefit managers, Medicare chief Mark McClellan said yesterday, May 11.

The new drug-safety database could be used by researchers to quickly discover potential serious side effects and other safety issues during the period after a drug has been approved by the FDA and while it is being used by patients.

Medicare chief McClellan said he hoped this drug-safety database project would result in fewer FDA recalls such as the high-profile removal of Merck’s Vioxx painkiller from the market in September 2004.  "If the FDA’s got concerns that a drug may have a risk, we’ll now have the data capability to provide much more complete evidence on whether there’s a problem," added McClellan, who headed the FDA before becoming administrator of the Center for Medicare and Medicaid Services in 2004.

McClellan observed that people are frustrated with the current drug-safety monitoring system because they feel it takes too long before potentially fatal side effects are noticed by the FDA.  Accordingly, there is a costly delay in getting increased warnings put on drug package inserts, e.g., black-box warnings, or having an unsafe drug recalled from the market. 

McClellan made his comments in a speech to the Pharmaceutical Care Management Association, an industry group, on May 11.

(Posted by: Tom Lamb)