Unapproved Drugs

Number 23890
Subject Medical Reporting
Source Associated Press
State NY
Year 2008
Publication Date 11/24/2008
Summary The government is paying millions for risky medications that have never been reviewed for safety and effectiveness but are still covered under Medicaid, an Associated Press analysis of federal data has found. Tax payers have shelled out at least $200 million since 2004 for such drugs. Yet the Food and Drug Administration says unapproved prescription drugs are a public health problem, and some unapproved medications have been dozens of deaths. Millions of private patients are taking them as well, and their availability may create a false sense of security. The AP analysis found that Medicaid, which serves low-income people, paid nearly $198 million from 2004 to 2007 for more than 100 unapproved drugs. Data for 2008 were not available but unapproved drugs still are being sold. The AP checked the medications against FDA databases, using agency guidelines to determine if they were unapproved. The FDA says there may be thousands of such drugs on the market. The medications are mainly for common conditions like colds ad pain. They date back decades, before the FDA tightened its review of its review of drugs in the early 1960s. The FDA says it is trying to squeeze them from the market, but conflicting federal laws allow the Medicaid health program for low-income people to pay for them.
Category Contest Entry
Pages 10
Keywords Medicaid; unapproved medicine; medical reporting; Food and Drug Administration; prescription drugs; medical review
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