The FDA Should Stop Letting Drug Companies Skip Steps

Recent headlines have highlighted the Food and Drug Administration’s accelerated approval program for new drugs, sowing doubt that treatments approved this way actually work. While the program has expedited many life-saving treatments for terminal and rare diseases, there are serious challenges ensuring the mandatory confirmatory clinical trials are completed after approval. What can we do to get these trials back on track? I wrote about this in The Boston Globe today:

“When drugs receive accelerated approval, they go to market and companies immediately start profiting. The Office of the Inspector General found that Medicare and Medicaid spent over $18 billion in three years on drugs with accelerated approval but incomplete confirmatory clinical trials.”

Read the whole piece here.

Research for this article was supported by Arnold Ventures.

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