Senate Passes Drug Safety Legislation

Bill Will Protect Patients From Unsafe Medicines

RIPIRG

Washington, DC — In a victory for consumers, the Senate today passed the “Food and Drug Administration Revitalization Act” sponsored by Senator Ted Kennedy (D-Mass.) by a vote of 93 to 1.

The bill attempts to please both the powerful pharmaceutical industry and consumer groups.  It increases the amount of money the FDA receives in fees from drug makers to speed the approval of new drugs, and includes language to protect consumers from unsafe prescription drugs.

Over the next five years, the bill will increase by $225 million the amount of drug industry user fee money dedicated to drug safety.

“Congress is telling the FDA that they must put safety first,” said U.S. PIRG Consumer Health Care Advocate Paul Brown. “The American public will no longer tolerate dangerous and deadly drugs like Vioxx, Paxil, and Accutane approved by an agency that has been much too cozy with the industry it is supposed to be regulating.”  

The Senate bill gives the FDA new powers to issues fines to drug companies if they fail to do follow-up safety studies, or if they air false or misleading TV ads.  In a rebuff to the drug industry, an amendment by Senator Charles Grassley (R-Iowa) to substantially increase those fines passed by more than a two to one margin.  Unfortunately, an amendment by Senators Richard Durbin (D-IL.) and Jeff Bingaman (D-NM) to reduced conflicts-of-interests on FDA advisory committees failed to pass on a tied vote, 47 to 47.

“Even without the stronger conflict-of-interest amendment, this bill is a step in the right direction,” said Brown.  “For too long the ‘D” in the FDA has stood for ‘dysfunctional’.  This legislation will begin to change that by refocusing the agency on its original mission of ensuring that American consumers receive safe medicines.” 

The drug safety provisions were added to must-pass prescription drug user fee legislation that provides nearly $400 million or 20 percent of the Food and Drug Administration’s $1.5 billion budget.

The House is scheduled to debate similar legislation in the Energy and Commerce Subcommittee on Health by the end of May, and both Houses are expected to pass drug safety/prescription drug user fee legislation by the end of July.