FDA’s 37 breakthrough designations in 2013 ‘were little help’ to small biotechs

A report from analysts has suggested that while the FDA granted 37 ‘breakthrough designations’ in 2013, most “favoured big pharma and big biotech – despite the fact that the FDA’s promise to provide assistance on clinical trial design and guidance on development was aimed at small, cash-strapped biotechs“.

The FDA defines the approval system as a fast-track for unmet needs, stating: “Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.” The report, however, from financial analysts EP Vantage, questions its effectiveness.

“Although many companies have been quick to play up the potential advantages of a breakthrough designation, the fact is that no one actually knows what these are in practice.

“Little can be gleaned from the three products to have already received US approval, and many uncertainties still abound.”

Jacob Plieth, senior editorial analyst, EP Vantage.

 

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Reference links:

FDA grants 37 breakthrough designations in 2013 (EP Vantage press release at BusinessWire).

Frequently asked questions: breakthrough therapies (FDA).

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