Since the Mid-2010s FDA Drug and Biologic Guidelines have been Growing at a Faster Clip than Prior Years: Is it Time to
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COMMENTARY
Since the Mid‑2010s FDA Drug and Biologic Guidelines have been Growing at a Faster Clip than Prior Years: Is it Time to Analyze Their Effectiveness? Iraj Daizadeh, PhD, MBA1 Received: 9 August 2020 / Accepted: 9 October 2020 © The Drug Information Association, Inc 2020
An Food and Drug Administration (FDA; Agency) guideline (which may include Guidance Document, Compliance Policy Guide (CPG), Small Entity Compliance Guide, Information Sheet, Good Review Practices, Special Controls Document, Industry Letter, Concept Paper, Manual or Memorandum)1 was instituted to present the Agency’s ‘current thinking around a certain topic (see 21 CFR 10.115,2,3).’ From an industry perspective, these guidelines have been an important set of documents that may decrease the regulatory uncertainty (risk) around specific aspects of the drug discovery, development and delivery (DDDD) process. The content of these guidelines has varied, including recommendations on specific conditions/diseases, modalities, and compliance matters. Since the first recorded drug or biologic FDA guideline (based the FDA data-repository that houses guidelines) was issued in September 1977, there has been an uptick in the number of issued guidelines (see Fig. 1 and Appendix for supportive data and analysis [2–10]). The increase in the number of guidelines may be due to several factors including the concomitant rise in the sophistication of science and technology supporting the DDDD process or the COVID-19 crisis, among others. On a per annum basis, time will tell if the total number of drug and biologic guidelines in 2021 will exceed the values in 2018 (132) or 2019 (145). The number of COVID-19-related guidelines has also contributed to the recent upswing.4 From a guideline perspective, starting on March 18, 2020 and until Aug 06, there were 21 COVID-19-related FDA drug and biologics guidelines. Interestingly, this number may seem comparable with the 20 and 22 drug and biologic guidelines in the prior months (Jan and Feb, respectively), though the
pre-COVID-19 guidelines covered an assortment of disease, platform and/or conduct of certain DDDD activities. Albeit efforts have been underway to empirically test if guidelines facilitate approval of medicines, it is challenging to use statistical tests to ascertain true causality between the two (see [1]). Anecdotal evidence appearing in the literature suggest the importance of guidelines to the DDDD process. While there are reports critical of these guidelines (see, e.g., [12, 13]), and those advocating an opportunity for collaboration between developers and the FDA (see, e.g., [14]), there are examples of general successes in clarifying forward pathways (see, e.g., [15–17]). In some cases, there are explicit calls for guidelines; e.g., on endpoint selection for cancer cachexia [18, 19], or performing studies in cancer in the geriatric population [20]. Given the general interest and importance to the DDDD process, it is surprising that—to the author’s knowledge— there has not been a robust investiga
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