Matheson Says Drug Safety for Utahns Improved in New Bill
Congressman Jim Matheson said bipartisan legislation passed in the House today will toughen safety monitoring of new medicines, even after they have been approved by the Food and Drug Administration (FDA) for sale to consumers. Matheson is a cosponsor of HR 2900- the Food & Drug Administration Amendments Act.
Matheson said there has been growing concern recently that once a drug receives FDA approval, its safety is not being monitored. A recent example is Vioxxa popular arthritis drug linked to fatal heart attacks among some patients for whom it was prescribed. Vioxx was taken off the market in 2004.
"Patients and doctors rely on the FDA's assurance that the medicine they take will help heal, rather than harm them. This bill gives the FDA another tool to regulate drug safety after the drugs are on the market, and being widely prescribed. It also helps the agency track reports of adverse affects and spot any troublesome trends," said Matheson.
The bill increase fines for violating FDA safety standards. It imposes penalties for false or misleading advertising and includes stricter conflict-of-interest provisions, to better ensure that the FDA is acting on information that is objective and not based on opinions of those who would benefit financially from the drug's approval.