FDA to keep better eye on drug safety via industry cooperation
In a move to boost drug safety and effectiveness, the FDA has selected four industry organizations to help it monitor approved drugs once they are on the market, the Minneapolis Star Tribune has reported.
The drug surveillance will include evaluation of huge volumes of electronic patient records. One of the organizations is UnitedHealth Group Inc., which will use its Ingenix division which includes a database of information for 11 million patients. The other contributing organizations are the Oakland, Calif.-based Kaiser Foundation Research Institute,Vanderbilt University out of Nashville, and Harvard Pilgrim Health Care based in Wellesley, Mass.
Each organization will receive amounts in the range of $1.3 million and $1.4 million over the next five years for allowing governmental access to the data for research.
As part of the agreements, the FDA will use the information to analyze drug safety analyses and to move more speedily in the occurrence of public health concerns, the agency said.
Many in the public and media have been critical of the government for not keeping a close eye on drugs once they have gone through initial clinical trials and hit the market. The FDA has not had a robust system for following reactions of approved drugs, relying instead on pharmacists, doctors, nurses and drug manufacturers to file reports on adverse drug reactions.
"The main advantage is speed," said Mark Lindsay, UnitedHealth spokesman, in comments regarding the FDA effort. "A clinical trial usually involves 1,000 or so patients. Now the FDA has access to 11 million."
Lindsay added that now if the FDA gets word of a problem drug, then they can look in the database instead of waiting on providers to chime in about issues.
The drug surveillance will include evaluation of huge volumes of electronic patient records. One of the organizations is UnitedHealth Group Inc., which will use its Ingenix division which includes a database of information for 11 million patients. The other contributing organizations are the Oakland, Calif.-based Kaiser Foundation Research Institute,Vanderbilt University out of Nashville, and Harvard Pilgrim Health Care based in Wellesley, Mass.
Each organization will receive amounts in the range of $1.3 million and $1.4 million over the next five years for allowing governmental access to the data for research.
As part of the agreements, the FDA will use the information to analyze drug safety analyses and to move more speedily in the occurrence of public health concerns, the agency said.
Many in the public and media have been critical of the government for not keeping a close eye on drugs once they have gone through initial clinical trials and hit the market. The FDA has not had a robust system for following reactions of approved drugs, relying instead on pharmacists, doctors, nurses and drug manufacturers to file reports on adverse drug reactions.
"The main advantage is speed," said Mark Lindsay, UnitedHealth spokesman, in comments regarding the FDA effort. "A clinical trial usually involves 1,000 or so patients. Now the FDA has access to 11 million."
Lindsay added that now if the FDA gets word of a problem drug, then they can look in the database instead of waiting on providers to chime in about issues.