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Groups ask Congress why drug safety isn’t on agenda

Center for Medical Consumers * Center for Science in the Public Interest * Consumers Union * Government Accountability Project * National Consumers League * National Research Center for Women & Families* National Women’s Health Network * Title II Community AIDS National Network * US PIRG

Health, Consumer Groups Urge Congress to Put Prescription Drug, Medical Product Safety on its Priority Agenda for Year

Skimpy FDA budget, failure to consider drug safety bills underscores indifference

Wednesday, Feb. 15, 2006
(Washington, DC) – In light of new safety concerns over attention-deficit disorder drugs, consumer and health groups today strongly urged Congress to immediately hold hearings on prescription drug and medical product safety legislation, and questioned why the Senate and House health committees are not including them among their priorities for the year.
“We’ve seen innumerable deaths attributed to Vioxx, Paxil and now attention-deficit drugs,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports. “The question is, how many more patients must be hurt by medicines they believe are safe before Congress makes drug safety a priority?”
The Senate HELP committee did not include drug and medical product safety among its priorities for 2006, and the committee has failed to hold hearings on bipartisan bills introduced last year by Sens. Charles Grassley (R-Iowa) and Christopher Dodd (D-CT) that would require drug companies make public their clinical trial studies, and give the FDA the authority to make label changes, require drug companies conduct further safety studies, and require advertisements be clearer about risks and benefits (S. 930 and S. 470). The House health committee also has not held hearings on drug safety legislation or legislation aimed at improving the safety of vaccines, implants or other medical products.
Both the House and Senate this week are holding committee hearings on FDA appropriations and health-care priorities. The groups noted that the FY 2007 FDA budget request appears to include an increase of nearly $4 million to improve the agency’s ability to monitor adverse drug events, but most of the funding for this initiative comes from $7 million in cuts to other programs in the Center for Drug Evaluation and Research, including researchers, lab scientists, staff for FOI requests, and laboratory upkeep.
Despite the small overall increase in the center’s budget, the only net staff increase was for positions that review new drug applications — positions funded by drug industry user fees.
“As more and more Americans are relying on prescription drugs, implants and vaccines to stay healthy or become healthier, our government must do more to ensure that the benefits truly outweigh the risks,” said Diana Zuckerman, president of the National Research Center for Women & Families. “Mistakes can be fatal. Improving the safety of medical products has to be a priority this year, not an afterthought.”
Last week, an FDA advisory panel recommended the strongest “black box” warning on ADHD drugs after it was revealed that 25 deaths – mostly children – and 54 serious heart problems occurred in those taking the drug from 1999-2003. The actual number could be higher since there is no mandatory requirement for such adverse event reporting.
“The fact that we’re just now learning about serious cardiovascular events including deaths linked to attention-deficit drugs that happened years ago underscores the need for drug safety reforms,” said Art Levin, director of the Center for Medical Consumers and member of the FDA’s Drug Safety and Risk Management Advisory Committee.
“The FDA’s apparent reluctance to move quickly and decisively to inform prescribers and patients of dangerous drug side effects needs to be replaced by a much more vigilant and pro-active drug safety effort,” Levin added.
Bill Vaughan, CU, 202-462-6262
Alex Dery Snider, NRCW&F 202-223-4000
Art Levin, CMC, 917-836-7596
Alison Rein, NCL, 202-835-3323
Jeff Bloom, Title II AIDS, 202-352-7150
Amy Allina, NWHN, 202-347-1140