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Widow tells Senate drug safety reforms needed

Tuesday, March 13, 2007

First Major Senate Hearing Wednesday on Prescription Drug Safety; Minnesota Widow Urges Tough Reforms to Protect Consumers

(Washington, DC) – A Minnesota woman who lost her husband to prescription drug side effects will represent the consumer voice Wednesday at the first major Senate hearing this session on prescription drug safety.
Kim Witczak, whose husband Woody died within five weeks of being prescribed the antidepressant Zoloft for insomnia, will tell her story and urge the Senate Health committee to include strong drug safety provisions in its reauthorization of the Prescription Drug User Fee Act, or PDUFA.
“Never once did we question the drug. Why would we? It was FDA approved and heavily advertised as safe and effective,” said Witczak, who has lobbied for FDA reform in 25 trips to Washington since her husband committed suicide in 2003.
Since his death, antidepressants have been required to carry a blackbox warning for adults and adolescents under the age of 25 about the increased risk of suicidality, but there is still no warning for older adults.
“Unfortunately, my story is not an isolated case,” Witczak said. “I have been working with many other families who have lost loved ones due to unsafe drugs and they could tell similar stories.”
Click here to read Witczak’s written testimony, which includes several specific recommendations to PDUFA as well as proposed drug-safety legislation (S. 484).
Congress first passed PDUFA in 1992 to speed up drug approvals by having the industry help fund the approval process. The original act has been extended twice and is slated to expire this year unless Congress reauthorizes it (PDUFA IV).
The proposal calls for the drug industry to pay $393 million annually to the FDA, and critics say having industry fund the same agency that regulates it is a conflict of interest that has led to many drugs with questionable safety problems being rushed onto market.
“We all want life-saving drugs approved quickly, but the FDA is out-of-balance and must give more attention to post-approval safety,” she said.
Bill Vaughan, Susan Herold, 202-462-6262
Kim Witczak, WoodyMatters.org