Adaptive licensing – How are regulators supporting innovation?

By Johan Strömquist Published in Mednous May 2014


This commentary by NDA CEO Johan Strömquist on the development of novel regulatory pathways such as the FDA breakthrough designation and the EMA adaptive licensing concept, was published in the May issue of MedNous.

Drug development has become an increasingly timeconsuming and costly exercise. In fact, the cost of new medicines is continuing to escalate just as the public is becoming more aware of the need to have new agents to treat serious diseases. The pressure is therefore on to find new ways to deliver innovation – and to deliver it efficiently.

The drug regulator stands in a pivotal position in this debate. Regulators have a legal responsibility to protect the public health by making sure that new medicines meet rigorous standards of safety and efficacy both before and after market launch. Recently, both the European Medicines Agency and the Food and Drug Administration have been employing some vision to try and facilitate innovation as well. Thus far, the US has been the most pro-active.

In July 2012 the FDA introduced a new regulatory pathway called the ‘breakthrough therapy designation’ that builds on a pre-existing pathway called the ‘fast track designation.’ Both pathways allow the faster review of products with a potential for treating serious or life-threatening conditions. Of the two, the breakthrough designation is clearly targeted at innovation.

In order to obtain breakthrough status, a company must provide preliminary clinical evidence that its drug may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoint, such as showing substantial effects of treatment during clinical development. Similarly fast track designation is intended for drugs that would fill an unmet medical need.

However fast track drugs need only show some advantage over available therapies – not the substantial improvement required for breakthrough designation. This is a subtle but important difference.

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