DeLauro Statement on New Study Highlighting Safety of Approved Drugs

WASHINGTON, DC (May 11, 2017) — Congresswoman Rosa DeLauro (CT-03) today released the following statement regarding a new study showing that nearly one-third of the U.S. Food and Drug Administration's (FDA) approved drugs had safety issues. The study, published this week in the Journal of the American Medical Association, demonstrates the urgent need to address the safety of drugs, highlighting the number of withdrawals and black box warnings issued after a drug goes to market, as well as the lapse time it takes for the FDA to act.

"Millions of Americans across the country rely on the FDA to ensure the safety and effectiveness of the drugs they take every day. Unfortunately, things can go wrong and the FDA lacks the fundamental authority to recall potential life-threatening drugs once they are on the market.

"This new study highlights just how significant this issue is, with almost a third of drugs cleared by the FDA posing safety risks that are identified after their approval. Further the study found that the median time for the FDA to act is more than four years. This is absolutely unacceptable and the FDA must do its job in ensuring that drugs are safe before they hit the market.

"When American lives are on the line, we cannot afford to wait until someone falls sick or dies for the FDA to guarantee a drug's safety. Congress should pass my Recall Unsafe Drugs Act to give the FDA the authority to step in and issue a mandatory recall of drugs that have been found to cause serious adverse health consequences or death."

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