Many small pharmaceutical companies and biotech manufacturers continue to struggle with FDA approval delays that have developed over the past several years. Even internationally, regulatory guidelines have evolved to the point of being outright onerous in some countries. Many companies are adding substantial numbers of regulatory affairs personnel, preferably of the very experienced variety, to deal with the increased issues.
|By Jacob Presson,
However, FDA hasn’t just been adding regulations without offering a hand to pharma. In recognition of some of the delays, FDA has begun to shorten the evaluation windows for many submissions, so that products can move more quickly through the various regulatory stages. There are also accelerated timelines that serve this purpose, particularly for those drugs treating “serious diseases,” a term left loosely defined by the FDA statement.
Accelerated approval allows companies to use surrogate endpoints to demonstrate a product’s efficacy. A surrogate endpoint is an alternative measurement that is an indirect indication of symptom improvement or survival. Rather than spending extra time on trials to conclusively show that a drug has the specific desired effect, if companies demonstrate the validity of surrogate endpoints, then the FDA will grant the drug approval contingent on the successful outcome of confirmatory trials.
Why then are companies still struggling with these timelines? Larger companies are doing fairly well, with most expecting shorter timelines over the next few years. It’s the smaller companies that still struggle with the FDA approval process, even those offering products that fit into the serious disease category eligible for regulatory fast tracking.
What slows these companies down is a lack of experience in dealing with regulators and the inability to retain a rapport with the FDA at all stages of the approval process. Personal relationships are critical in pushing through a product in order to get on the fast track or get a surrogate endpoint approved. Small companies have a hard time retaining experienced regulatory affairs personnel because larger companies often lure them away. As a result, despite the FDA’s best efforts to smooth the process, small pharma ends up without much recourse in terms of expediting regulatory approval.