Drugs

3 Ways to Speed Drug Approvals

David McFarland

— 1 min read
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Two consultants say that it usually is not FDA that slows the approval process for NDAs and BLAs. Writing in a Stat opinion piece, Certara CEO William Feehery and vice president Julie Bullock, a former FDA clinical pharmacology reviewer, say the main reason for delays and extensions is that sponsors submit their applications too soon.

“The culprit is pressure,” they write. “We’ve seen drug developers move quickly but without all of the data needed to take them through to approval. If they rush forward, urged on by their various stakeholders, they can experience delays when FDA requests additional data to fill gaps. This pressure to submit affects the drug approval journey in ways that can be anticipated and avoided.”

They say developers should take three steps to move the approval process along with speed but not haste: 

  •          don’t cut corners on data collection;
  •          share information as soon as possible with FDA reviewers; and
  •          communicate with regulators.

The article also lists ways the process can be improved from the regulators’ side. The authors say the agency has worked to be more visible and approachable through meetings and workshops. They say it would be good if FDA were cleared to share lessons from previous trials in a confidential, non-specific way. “If regulators transparently published their rationale for rejecting a new drug application, or published a bi-yearly document explaining why applications were rejected, that would be more beneficial,” they say. “Sponsors should also be encouraged to publish what they learn from failed trials or programs so others can learn from their experience — for the ultimate benefit of patients — though we understand that many companies may be reluctant to share information, based on competitiveness or proprietary information and other legal concerns.”

The authors conclude that drug developers should take time to be thorough early in the process, lest they pay for it later when they can least afford it. “Though seemingly time-consuming, obtaining timely, robust data and communicating early and often with regulators will diminish delays later in development and approval,” they say. “Clinical trials take place, patients participate, and programs move forward. But if data are not collected and information isn’t shared because companies believe it will slow down approval timelines, they are making the wrong call.”

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