FDA’s Lax Ways

Despite increasing calls for transparency at the FDA, the agency’s sloppy performance continues to put consumers at risk both medically and financially.

On October 26, 2009, the Government Accountability Office (GAO) released a report indicating the FDA has often allowed drugs to remain on the market after follow-up studies showed a lack of any benefit. The “fast-track drug-approval process,” which the FDA instituted in 1992, was the ready-set-go! for drugs to be rushed to market on the basis of meager, preliminary laboratory study. For example, Viagra, tested in just two studies on 200 volunteers, was approved by the FDA and soon prescribed to millions of patients. Adverse reactions and deaths associated with the use of the drug were noted only when Viagra was prescribed to many more patients than those who had participated in the original clinical trials. A number of drugs designed to treat cancer and HIV were approved in a similar fast-track fashion with the proviso that the manufacturers conduct follow-up trials to document their drugs’ effectiveness. And yet, the FDA often fails to police this requirement. Equally distressing is the fact that FDA, rather than insisting on independent, third-party studies, uses the manufacturer’s own data to determine effectiveness.
Congressional investigators have revealed that the federal law directing the FDA to bar researchers already convicted of fraud from engaging in further research is all but ignored. A congressional report released October 22, 2009, noted that the FDA pays “so little attention to its responsibilities to ban researchers convicted of fraud and is so disorganized about carrying them out that its actions take an average of four years to complete”. The GAO’s analysis of 18 proceedings regarding researchers convicted of fraud found that the FDA took between one and 11 years to complete the process. Congressman Joe Barton, R-Texas, has promised to introduce legislation to give the FDA more power to ban convicted researchers. Why is there no pressure on the agency to enforce existing federal law?
The standardization of food-labeling by the FDA is all over the news. For example, USA Today has publicized criticism leveled at the nation’s largest cereal maker, Kellogg’s, whose box of Cocoa Krispies trumpets: “Now helps support your child’s IMMUNITY”. A careful review of the label reveals this claim to be misleading, even fraudulent, because Kellogg’s is referring not to the cereal but to an added ingredient. Kelly Brownell, Ph.D., of Yale University’s Rudd Center for Food Policy and Obesity, notes: “By their logic, you can spray vitamins on a pile of leaves and it will boost immunity.”
Shame on the FDA for being so lax when it comes to important issues affecting consumer safety!