Researchers Ask FDA to Stop Using the Word "Breakthrough"

When referring to new drugs on the market, the Food and Drug Administration (FDA) commonly uses the word “breakthrough” to describe them in its review process. But a group of researchers have now asked the agency to stop using the the word because it could be misleading to the general public.

In a study published in the journal _JAMA Internal Medicine, r_esearchers from Dartmouth College and Carnegie Mellon University found that patients may be misinterpreting the FDA’s usage of the word because they often don’t understand the FDA’s review process.

“Breakthrough therapies” are classified by the FDA if they meet certain criteria, such as its use to treat life-threatening conditions or that it may work better than other drugs. These drugs are the moved through the review process quicker, and the actual effectiveness of the drugs is studied later.

The study found that when 600 Americans read actual FDA press releases on a hypothetical new lung cancer drug, 10 percent of people thought the drug sounded promising based only on the facts. When the word “breakthrough” was added into the press release, however, 22 to 25 percent of people thought it sounded promising.

Also, belief in the supporting evidence for the drug increased from 43 percent to nearly 60 percent once "breakthrough" was added.

The researchers have asked the FDA to use more neutral terms.

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Sourced from:, Doctors to FDA: Don't Call Them 'Breakthrough' Drugs