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Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 5 other observers have been increasingly critical of these practices, questioning whether they will be enough to safeguard the United States drug supply. By March 2021, the backlog of drug inspections had already exceeded 1000 facilities. As Mary Denigan-Macauley, GAO's director of healthcare, testified to the US Congress on March 6, that backlog can only grow over time if system- atic steps aren't taken to understand the roots of the backlog and to adopt new approaches to in- spections (3). If the root causes of the problem are not addressed, Denigan-Macauley told Congress, by 2022, 59% of facilities on the FDA's inspection to-do list will not have been inspected in five years and 14% will have never been inspected. Also of concern, Denigan-Macauley testified, is the fact that FDA performed only three offshore site inspections in 2020, even though, as of May 2020, offshore facilities supplied 74% of APIs and 54% of finished drugs sold in the US. In each of 2019 and 2018, GAO reported, FDA had inspected 600 offshore facilities (3). Not only GAO, but public health advocacy groups have criticized FDA's interim inspection practices during COVID-19 as potentially weak- ening FDA's overall inspection efforts. In a March 2021 New York Times news article, Michael Car- ome, director of Public Citizen's Health Research Group, suggested that FDA's pharmaceutical in- spectors be considered "essential workers" and provided with maximal protection so they can perform inspections during the pandemic (4). Others in the legal and business sectors (5–7) have faulted the agency for failing to consider the use of advanced technologies to allow plant in- spections to continue during the COVID-19 pan- demic. As Douglas Farquhar, director at the law firm, Hyman Phelps and Macnamara, pointed out in a January 2021 blog post, the European Medi- cines Agency (EMA) and the United Kingdom's Medicines and Health products Regulatory Agency (MHRA) have been using remote technology such as 360-degree video in some inspections since March 2020 (7). Authorities in Australia, Russia, and Japan are also using the technology (2,6). Denigan-Macauley's March testimony point- edly mentioned the need for FDA to consider the use of novel technologies for inspections. On Jan. 27, 2021, the Parenteral Drug Agency sponsored a webcast (8) that articulated best practices for utiliz- ing some of the technologies available. Speaking on the program were Peter Miller, CEO of Dynamic Compliance Solutions, and executives from two companies that are using remote auditing technol- ogies, including 360-degree video, for site audits. When used correctly, presenters pointed out, new approaches offer a clear window into operations. At this point, FDA is still evaluating potential use of new technologies for inspections (6). Ob- servers hope that the agency will consider using them to step up the pace of facility inspections as the COVID-19 pandemic continues. REFERENCES 1. FDA, History of the FDA, Interview with William C, Hill, June 15, 1982, www.fda.gov/media/81322/download 2. A. Shanley, Pharmaceutical Technology, 45(1), pp 46-49 (2021). 3. US Government Accountability Office, "Testimony before the Senate by Mary Denigan-Macauley, Director of Healthcare," March 4, 2021. 4. S. Kaplan, "Pandemic Forces FDA to Sharply Curtain Drug Inspec- tions," nytimes.com, March 9, 2021. 5. M. Schwartz, "FDA Fiddles with Remote Inspections While Pharma Burns," Bloomberg.com, Dec. 7, 2020. 6. A. Shanley, Pharmaceutical Technology 44 (12), pp 12-16 (2020). 7. D. Farquhar, "Conducting Virtual Inspections: EMA and MHRA, Do It, CDMOs Do It, Why Won't FDA Do it?" FDALawBlog, Jan. 29, 2021. 8. P. Miller, R. Pannala, and P. Sharma, "Effectively Using Technology in Remote Audits," a PDA Webcast, pda.org, Jan. 27, 2021. 9. D. Farquhar, PDA Presentation Slides, fdalawblog.com, January 27, 2021, www.fdalawblog.net/wp-content/uploads/2021/02/PDA-We- binar-Effectively-Using-Technology-in-Remote-Audits.pdf. PT