PALLONE COMMENDS PRESIDENT BUSH FOR SIGNING FDA REVITALIZATION ACT OF 2007 INTO LAW
"President Bush should be commended for signing a bill into law today that will restore public confidence in the FDA's ability to protect the public health. This is a great victory for American consumers. The FDA Revitalization Act of 2007 gives the FDA the financial resources and authorities necessary to ensure patients have timely access to safe and effective therapies.
"First and foremost the FDA Revitalization Act is about drug safety. In order to empower the FDA to protect the public from harmful drugs, we are giving the agency new authority to compel important labeling changes. This is a significant improvement over current policy, where FDA must haggle with drug companies in protracted negotiations that put patients and consumers at risk.
"The FDA will also be better equipped to force drug manufacturers to fulfill their responsibility to the American public and complete post-market study commitments, which are critical to ensuring a drug is safe. In addition to these important new authorities, the law authorizes the collection of $225 million in new user fees, a significant increase in the amount of funds dedicated for the use of drug safety activities.
"The FDA Revitalization Act also provides for commonsense improvements to our nation's food safety system, such as more stringent ingredient and labeling standards, establishment of an adulterated food registry, and improvements in public notification.
"Patients will be happy to know that the law also requires greater transparency of drug makers by calling for clinical trials to be registered in a database monitored by the National Institutes of Health (NIH), along with basic results data. Finally, the law would make significant progress in reducing the number of conflicted experts who serve on advisory committees."