Legislation co-sponsored by Congressman Eliot Engel to monitor the safety of drugs after they are on the market passed the House on Wednesday, July 11.
"Until now the focus of the FDA regarding prescription drugs has been to study their safety before they are approved," Engel said to the full House. "There has been a growing concern that, once a drug receives FDA approval, its safety is not monitored. This bill establishes a new program within the FDA to monitor the safety of drugs after they have been approved and marketed."
The bill establishes a surveillance system to track adverse effects of the drug and requires the FDA to conduct a new study of the drug seven years after it goes on the market.
In his capacity as a senior member of the Health Subcommittee of the House Energy and Commerce Committee, Engel added to the bill an amendment to strengthen the Critical Path initiative, originally conceived to make the development and evaluation of drugs more effective.
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