Amid heightened debate over a regulatory program for speeding the approval of some medicines, a new government analysis finds extensive delays in the clinical trials that drug makers are required to conduct after approvals.
At issue is accelerated approval, which the U.S. Food and Drug Administration established in 1982 in an effort to get medicines for hard-to-treat diseases to patients sooner than they might under the usual pathways to the marketplace. As a condition of approval, a pharmaceutical company must confirm the effectiveness of its medicine through one or more clinical trials by a certain date.
Through the end of 2021, the FDA approved 278 medicines under this program, but the new analysis found drug companies do not always hold up their end of the bargain. More than one-third — or 104 — of the required clinical trials remain incomplete. And of those, one-third — or 35 — are past their completion date, the analysis found. On average, those trials were about 1.5 years past their original planned completion dates.
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