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Senate drug safety bill good first step toward protecting consumers

Friday, Aug. 4, 2006

Bipartisan Senate Drug Safety Bill Good First Step in Dealing with Unsafe Medicines

CU urges more openness, tougher fines and more control of DTC advertising

(Washington, D.C.) — The drug safety bill introduced Thursday by Senate health committee leaders is a good first step toward protecting consumers from dangerous prescription drugs, and Consumers Union will work along with drug safety activists from across the nation to strengthen the bill so regulators have the necessary tools to stop companies from gaming the system.
“This bill sets up a basic drug safety framework, and gives the FDA more power to deal with risky medicines, rather than letting the drug companies take the lead as they do now,” said Bill Vaughan, senior policy analyst with Consumers Union, publisher of Consumer Reports.
“We hope to work with Senate health leaders to strengthen this legislation even more and ensure drug safety in this nation is an open and public process,” Vaughan said of the bipartisan bill introduced by Senators Enzi and Kennedy, chairman and ranking member of the Senate Health Committee.
“We will try to make sure the voices of drug safety victims are heard in the debate so Congress understands that we can’t afford to repeat the tragedies caused by our current system,” he added.
Consumers Union cited as major positive steps a requirement that some clinical drug trials and their results be made public, and the ability to impose monetary fines on drug companies that fail to comply with certain risk management requirements. CU wants to strengthen those sections so that all clinical trials also are made public, trial results are reported in a timely manner, and trials completed before the legislation are made public. CU also wants to increase the penalty amounts so drug companies will take violations much more seriously.
The legislation also would allow the FDA to prohibit direct-to-consumer advertising for two years for those new drugs that have outstanding safety questions. While this is a major improvement, CU supports a three-year moratorium on marketing of these new drugs so enough information can be collected on whether the medicines are safe.
CU would like the legislation to address concerns raised in a recent survey of FDA scientists who said they were pressured by the drug industry and supervisors within the FDA to downplay or ignore safety concerns. Providing public access to negotiations between the drug industry and regulators would improve that climate.
“We would like the safety process to be open and public, so FDA scientists feel free to debate safety concerns without fear of retaliation,” Vaughan said.
Vaughan also urged Congress to increase user fees on the drug industry to fully fund FDA drug safety efforts, including clinical trials and computer modernization, and to ensure those fees aren’t tied to new drug approvals.
“With some amendments, this good bill can be made a great bill for American consumers.”
For more information on CU’s drug safety efforts, go to ConsumersUnion.org
Contact: Bill Vaughan, Susan Herold