Move over right-to-try: FDA looks at improving clinical trial enrollment
From the article:
The FDA’s bar for “breakthrough” designation may be too low, Harvard Medical School policy researchers argue in the New England Journal of Medicine. The designation was created by Congress in 2012 for new drugs that preliminary evidence suggests provide substantial improvement over existing treatments for serious or life-threatening conditions. It gives sponsors access to early FDA meetings, more timely communication to promote efficient trial designs and interaction with top agency officials to try to expedite patient access to promising medicines.
But many breakthrough drugs didn’t show “substantial improvement” over existing options after approval, write Jonathan Darrow, Jerry Avorn and Aaron Kesselheim. One reason is that the breakthrough designation suggests they can meet the necessary technical requirements when they still are early in development. The products may go on to demonstrate only modest effectiveness — a problem, the authors write, because the designation often leads to promotion of the drugs as dramatically better than existing treatments, sometimes even as “cures” or “miracles.” They suggest Congress “eliminate the potentially misleading term ‘breakthrough’ along with the separate designation" and incorporate key features into the fast-track program. Meanwhile, "FDA could raise the low baseline of comparison by broadening the definition of ‘existing therapies.'"
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