Congressman Doyle Praises Drug Safety Bill

Legislation Includes Doyle Provision to Make Medical Devices Safer

Washington, DC – September 19, 2007 – U.S. Representative Mike Doyle (PA-14) today hailed the passage of important drug safety legislation in the U.S. House of Representatives today and expressed satisfaction that his provision requiring unique identifying codes for all new medical devices produced.

“The Food and Drug Administration Amendments Act of 2007 will significantly improve the safety of our prescription drugs and medical devices,” Congressman Doyle said this afternoon.  “I’m pleased that I was able to help write this important legislation.” 

The Food and Drug Administration Amendments Act of 2007 establishes the most sweeping drug safety provisions in years, creating a new program to monitor the safety of drugs after they go on the market.  Up until now, the FDA has concentrated its efforts on ensuring the safety of new prescription drugs before they receive approval to be marketed.  There has been growing concern however that, once a drug receives FDA approval, its safety is not monitored.  The shortcomings of this approach became clear once problems with the prescription drug Vioxx were reported.  This bill establishes a new program within the FDA to monitor the safety of drugs after they have been approved and marketed.  

“This legislation is sorely needed to restore the public’s confidence after the Vioxx scandal,” Congressman Doyle observed.  “But the bill goes far beyond just fixing the Vioxx problem.”

The bill also increases the fines of up to $10 million for violating FDA safety standards.  The bill also imposes tough new fines for false or misleading advertising.  It also creates publicly available databases to track the clinical trials of new prescription drugs seeking FDA approval.  Making this type of information available to the public, including academic experts and other independent observers, will dramatically increase the likelihood that safety concerns raised by the data are not overlooked.   The bill also increases FDA staffing levels in order to provide faster approval of promising new drugs, and it includes several provisions to encourage the development of pediatric drugs and devices.  

“The Food and Drug Administration Amendments Act also includes a provision I wrote that requires medical devices to carry a unique identifier, like a barcode or an identification chip,”  Congressman Doyle noted.  “Giving medical devices a unique ID will make it easier for doctors and hospitals to determine whether a patient is affected by a medical device recall and reduce the amount of time needed to notify him or her.  In addition, it would reduce medical costs by improving supply chain management.”

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