According to a Government and Accountability Office report released in April, the FDA does not maintain a “clear and effective process” for monitoring the safety of previously approved drugs. The report was requested in 2004 by Senator Chuck Grassley and Representative Joe Barton. In the study, researchers examined the agency’s handling of four controversial drugs: Baycol, Bextra, Arava, and Propulsid. It was concluded that there is a lack of listed qualifications for the determination of what safety concerns to address and when to take action. Of the four drugs observed, all but Arava were eventually taken off the market due to safety concerns, which means that the defective products were allowed to circulate among the masses freely for quite some time before their danger had been addressed.
Additionally, the report finds that while the FDA does on occasion request postmarket studies as a condition of approval, only about 25% of the drugs released to market between 1991 and 2003 had completed such studies. Many dangerous drugs are more than likely to be still flowing in the market today, based on this data.
If you or someone you know has been injured due to defective drugs, please contact a personal injury lawyer. In the Columbus, Ohio, area, contact Robert W. Kerpsack, Co, LPA.
