Regulatory Focus™ > News Articles > Study: Are FDA's Expedited Approval Pathways Worth the Risk?

Study: Are FDA's Expedited Approval Pathways Worth the Risk?

Posted 05 September 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has long been at the center of a passionate debate between industry and patient safety advocates: Is the agency too slow at approving new products, leaving patients to go without needed medications, or is it going too fast, placing those same patients at risk of injury from potentially dangerous products?

A new research piece in the Journal of the American Medical Association (JAMA) weighs in on the latter side of the above question, opining that FDA's expedited drug development pathway is subjecting unwitting patients to under-tested and riskier products.

"Although enabling new drugs with a favorable benefit-to-harm balance to become available to patients more rapidly is a laudable goal, the underlying question is what public health risks are taken when drugs are approved for widespread use while important safety questions remain unanswered," write co-authors Thomas Moore, AB and Curt Furburg, MD, PHD.

In 2011, the authors note, FDA approved 16 of its 35 new drugs using one of its several expedited approval programs: priority review, fast track, and accelerated approval. However, these quicker review periods are in some cases missing serious safety issues, they write. Three drugs-Caprelsa, Gilenya and Pradaxa-all of which were approved using expedited procedures, were cited by the authors as having safety issues such as toxicity and bleeding risks that the authors contend would have been understood had the products gone through further testing.

FDA Hits Back

FDA's top drug regulator, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), hit back at the piece, saying the benefit:risk paradigm for these drugs is not based on a single perspective. "I'd like to stress that where there are unmet medical needs, the public has told us they are willing to accept greater risks," Woodcock said. "The cancer community in particular says we haven't used accelerated approvals enough."

In a separate statement provided to Pharmalot, FDA also noted expedited approval is only an additional, and not the final, step in an ongoing review process that transcends the product's entire lifecycle.

"Once a drug is approved, we continue to monitor its performance throughout its life cycle," wrote FDA. "Importantly, these [expedited review] programs do not change the statutory standard for approval but rather allow some flexibility in meeting that standard."

Read more:

JAMA - The Safety Risks of InnovationThe FDA's Expedited Drug Development Pathway

Pharmalot - Is The FDA Sacrificing Safety For Speed?

WSJ - Article Says Agency Let Risky Drugs Hit Market

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