The FDA has increasingly found itself in a delicate balancing act when it comes to the approval and oversight of medications and vaccines. Drugmakers frequently complain that the agency's approval process is long and cumbersome and that its red tape denies patients desperately needed medications; however, the agency's advisory committees and scientists have sometimes criticized it for fast-tracking approvals, seemingly under political or industry pressure. At the same time, the FDA, lacking resources to monitor the safety and proper use of drugs once they're on the market, frequently shoulders the blame when harmful effects later arise.
Consider the schizophrenia drug Zyprexa. In January 2009, the maker of Zyprexa, Eli Lilly & Co., pleaded guilty to a federal misdemeanor charge of illegally marketing the antipsychotic medication to treat dementia in elderly patients. Internal company documents unsealed in May revealed that Eli Lilly urged doctors to prescribe Zyprexa off-label to dementia patients, despite company research that showed Zyprexa didn't reduce symptoms of Alzheimer's or dementia and that death rates among elderly patients taking Zyprexa were significantly higher than in patients who didn't get the drug.
Eli Lilly has already paid out more than $1 billion to settle more than 30,000 plaintiffs' claims stemming from the marketing of Zyprexa for uses not approved by the FDA. The drugmaker also paid the state of Georgia $6 million in a multimillion-dollar settlement involving dozens of other states in lawsuits brought by insurers claiming that Eli Lilly hid Zyprexa's side effects, including weight gain and increased risk of diabetes.
"Compared to its peer agencies in other parts of the world, the FDA has arguably failed consumers and physicians by over-relying on pharmaceutical companies to provide supporting research for new drug application," wrote U.S. District Court Judge Jack Weinstein in ruling on one Zyprexa case in 2008. "The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for Zyprexa."
Commissioner Hamburg has pledged to beef up enforcement by the FDA under her watch. One of the toughest safety actions the FDA can take, for instance, is to require a "black box" warning on drugs known to carry serious or life-threatening risks. In April 2009, FDA officials mandated black-box labeling on the antiwrinkle drug Botox and similar products, which the agency said have the potential to spread from the injection site to other parts of the body, causing breathing or swallowing difficulties. The move resulted from reports of deaths and hospitalizations associated with the use of botulinim toxin, particularly to treat muscle spasms in children with cerebral palsy (no serious side effects have been confirmed in patients using botulinim toxin for cosmetic purposes). The FDA's black-box warning came two years after the European Union issued similar warnings about Botox. "Although this action could have been taken by the previous Administration, we hope this warning indicates that the winds of change are blowing at the FDA," said Dr. Peter Lurie, head of the consumer-advocacy group Public Citizen, which has been calling for the warning since 2008.
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