Misunderstanding of Drug Approval Process Common

Many people believe that drugs given the go-ahead by the Food and Drug Administration are safer than they have to be to get approval, according to a study. Researchers found that in the first few years after a drug is approved, there are still questions about how well it will work.

The 3,000-person web-based survey found that one quarter believed that the FDA only approves drugs without serious side effects. Another 39 percent thought that only “extremely effective” drugs were granted approval. Survey respondents were also asked to choose between a hypothetical cholesterol drug that had been shown to lower cholesterol and another that decreased the risk of a heart attack. Only 59 percent chose the drug with a clear effect on heart attacks. In another case, participants could choose between a newer or older heartburn drug that worked equally well and had the same side effects. Just 34 percent picked the older heartburn drug.

Researchers also gave study participants a short statement including the idea that newer isn’t always better, because researchers may not have had enough time to investigate safety issues. After reading the statement, seventy-one percent took the cholesterol drug with clear clinical benefit, and 53 percent picked the older, thoroughly vetted heartburn drug.

According to the study authors, people may be better informed about the drug approval process if the FDA creates a one-page fact sheet clearly stating the harms and benefits of each drug.

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