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Page: << Prev | 1 | 2 Another drug, the multiple sclerosis medication Tysabri, was pulled from pharmacy shelves in early 2005 after several patients in clinical trials developed a rare but deadly viral infection in the brain. Tysabri was returned to the market in 2006, but under much stricter guidelines.
On Tuesday, the FDA proposed to strengthen the drug safety system with three basic efforts.
First is strengthening the science supporting the FDA's medical product safety system, including new ways to detect and predict adverse events and reassess drug benefits and risks.
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"We can move from just counting side effects to actually preventing and controlling them," said Dr. Janet Woodcock, FDA's deputy commissioner and chief medical officer.
This effort also includes a pilot project to assess the safety of new drugs after they've been on the market for 18 months.
"We'll assess this pilot program for wider implementation after we've run several products through it," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research (CDER).
Consumers Union, however, pointed out that most safety problems don't become apparent until a drug has been on the market for five to seven years.
"Reviewing drugs for safety after 18 months is a good start, but we need periodic, consistent reviews of drugs on the market to catch these major safety issues," Vaughan said.
Galson also announced a new data-sharing agreement with the Veterans Administration to "improve patient safety through better access to data." The agreement is expected to be one of several.
The second part of the overall effort involved improving communication among all parties involved in the drug safety process.
Finally, the recommendations called for changing CDER internal culture and instituting organizational and managerial changes.
"We agree with the IOM about the need to improve the culture at FDA and CDER throughout the life cycle of drugs we regulate," Galson said.
Lutter said the agency would issue a report a year from now on how the recommendations are being implemented.
More information
You can view the full report at the FDA.
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