At the end of the survey, respondents read two descriptions of a drug and were asked which they would take for a life-threatening condition. One description included the word breakthrough and the other did not. More than 90% of people chose the breakthrough drug.
“Given that ‘breakthrough’ is an official designation mandated by Congress, FDA is required to refer to this category of drugs as such,” but the FDA is not required to use terms like “promising,” Dr. Krishnamurti said.
“Breakthrough” is an aspirational term, chosen to help expedite the new drug approval process, which many criticize as slow although there is research indicating that the process is not slow, as Drs. Joseph S. Ross and Rita F. Redberg note in an editorial published with the study.
The term breakthrough “may cause people to have unwarranted confidence about these drugs, which could prevent them from making a fully informed decision about whether to take the drug or not,” Dr. Krishnamurti said.
Simple, clearly worded disclosures can help mitigate some of the incorrect judgments associated with these designations, she said.
“To protect patients from spurious hopes for miracle cures, Congress and the FDA should abandon the adoption of terminology like breakthrough and focus on strengthening the evidentiary requirements for meaningful clinical data to ensure the promise of new drugs and devices,” Ross and Redberg write.
