Drug Problems: Dangerous Decision-Making at the FDA

Number 27333
Subject Medicine
Source Project on Government Oversight (Washington, DC)
State
Year 2015
Publication Date Oct. 15, 20, Nov. 12, 20, 30, Dec. 9, 23, 2015
Summary The public depends on the U.S. Food and Drug Administration to ensure that medicines are safe and effective, but through many months and almost 30,000 words of reporting, POGO’s ongoing “Drug Problems” investigation has revealed dangerously lax FDA oversight of prescription drugs. We found that the FDA has set low standards, approved drugs based on flawed clinical trials, taken a toothless approach toward doctors who violate standards of clinical research, allowed misleading marketing, provided inadequate warnings about drug hazards, slighted reports of drug-related deaths and injuries, withheld important information from the public, and made other dubious judgments that advanced the interests of pharmaceutical companies while putting patients at potentially deadly risk. Among other developments detailed in our package: After we exposed a potentially crippling flaw in the testing of a blockbuster drug, the FDA and its European counterpart said they were reexamining the clinical trial upon which they had based the drug’s approval.
Category IRE Contest Entry
Pages
Keywords FDA: safety; standards; lax; prescriptions; violations
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