GlobalData tracks 40 yrs of innovation in USFDA review designations

Regulatory authorities, particularly the US FDA, have played a crucial role in accelerating and incentivising the development of innovative treatments through review designations. Since the first designation in 1984, the FDA has seen a substantial rise in the number of designations granted, reaching 694 in 2020. This surge reflects key pharmaceutical milestones, including the biotech boom and the advent of groundbreaking scientific advancements over the past four decades, observes GlobalData

Jasper Morley, Pharma Analyst at GlobalData, comments, “To date, the FDA has implemented seven different types of review designations, which accelerate and incentivise drug development. Each designation offers specific benefits to the drugmakers. For example, the orphan drug designation (ODD) is granted to drugs intended to treat a rare condition providing tax credits for qualified clinical trials, exemptions from user fees, and a potential of seven years market exclusivity following approval.”

GlobalData’s report, “Pharmaceutical Review Designations – Trends and Industry Insights,” reveals that the FDA awarded its first 22 designations, consisting solely of ODD, in 1984. From 1984 to 1997, it awarded an average of only 23 designations per year, indicating limited adoption of review designations. However, between 1998 and 2012, an average of 93 designations were awarded yearly, and in 2012, the 182 review designations awarded was over 10 times the number awarded in 1997.

This finding is aligned with the Modernization Act of 1997, whereby the FDA sought to speed up the approval of new drugs which saw the introduction of the fast-track and priority review designation types, in 1998 and 1999, respectively. Furthermore, this period also coincided with the advent of the biotech industry, whereby the 2003 completion of the human genome project catalysed gene therapy developments.

The period between 2012 and 2020 saw another rapid increase in the annual numbers of review designations awarded. Over this period, annual designations awarded by the FDA increased almost four-fold. This period included the implementation of novel designation types: qualified infectious disease product designation (in 2012), breakthrough therapy (2013), rare pediatric drug designation (2014), and regenerative medicine advanced therapy designation (2017).

Morley adds, “The introduction of these specific designation types reflects the booming biotech industry, and embracing of novel technologies to develop advanced biologics, which began entering clinical development.”

In 2020, the number of designations awarded reached a peak of 694. This reflected heightened pharmaceutical activity and investment during the COVID-19 pandemic, which accelerated the development of critical therapies and vaccines. Since 2020, the number of review designations has declined from this heady peak, with only 506 awarded in 2024. This decline is attributed to the return to the post-pandemic normality, whilst still maintaining historically high levels of activity compared to earlier decades.

Morley concludes, “Since the introduction in 1984, the FDA has overseen increases in the annual awarding of review designations. This trend mirrors the evolution of the pharmaceutical industry, in terms of investment and utilisation of novel technologies. Today, seven review designations remain an integral part of the FDA’s toolkit, expediting the approval of critical therapies and ensuring that life-saving drugs reach patients as quickly as possible.”