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Washington, D.C. --- U.S. Rep. Frank Pallone, Jr. (D-NJ), Chairman of the Health Subcommittee of the House Energy and Commerce Committee, issued the following statement in response to the U.S. Food and Drug Administration's (FDA) plan to ensure the safety of drugs and other medical products. FDA's report came in response to a set of recommendations from the Institute of Medicine (IOM). The New Jersey congressman plans to address the issue of drug safety during reauthorization of the Prescription Drug User Fee Act (PDUFA) this year.
"I'm pleased by FDA's announcement today. For far too long the FDA has been hampered by an uncoordinated organizational structure, severe resource constraints, and a limited ability to protect the public health once a drug has reached the market. While the reforms proposed by FDA today are a step in the right direction, they hardly address all of these issues.
"Congress will have to step in and ensure that FDA has both the enforcement mechanisms and resources it needs to guarantee the safety and efficacy of a drug throughout its lifecycle. It is my intention to address some of these issues in the upcoming PDUFA reauthorization." |
