BioPharm International - March 2021

BioPharm International - Regulatory Sourcebook - March 2021

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Page 4 of 47 March 2021 eBook BioPharm International 5 INTERIM MEASURES SEEN AS INADEQUATE Once it suspended routine inspec- tions, FDA took steps to ensure that it could still supervise opera- tions without sending inspectors onsite such as the review of doc- uments, or accepting recent notes from inspections performed by PIC/S member agencies. Howe ve r, t he Un ite d St ate s Government Accountability Office (GAO) and other observers ques- tion whether these practices will be enough to safeg uard the US drug supply. By March 2021, the backlog of drug inspections had already exceeded 1000 facilities. As Mary Denigan-Macauley, the GAO's director of healthcare, testi- fied to the US Congress in March, that backlog can only grow over t ime if systemat ic steps a ren't ta ken to u ndersta nd t he roots of the backlog and to adopt new approaches to allow inspections to resume as the COVID-19 pandemic grinds on (3). If root causes for the backlog, beyond the impact of the pandemic, are not examined and addressed, Denigan-Macauley told Congress, by 2022, 59% of facili- ties on the FDA's inspection to-do list will not have been inspected in five years and 14% will have never been inspected. A l s o o f c o n c e r n , D e n i g a n - Macauley testified, is the fact that FDA performed only three offshore site inspections in 2020, one in Canada, another in Germany and a third in India, even though, as of May 2020, offshore facilities sup- plied 74% of APIs and 54% of fin- ished drugs sold in the US, and most of them are in China and India. 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 weakening FDA's overall inspec- tion efforts. In a March 2021 New York Times news article, Michael C a r o m e , d i r e c t o r o f P u b l i c Citizen's Health Research Group, suggested that FDA's pharmaceu- t ica l i nspec tor s b e considered "essential workers," and provided with maximal protection so they can perform inspections during the COVID-19 pandemic (4). Others in the legal and busi- ness sectors (5 –7) have faulted the agency for undue conserva- tivism in failing to consider the use of advanced technologies to allow plant inspections to con- tinue during the COVID-19 pan- d e m ic . A s D oug l a s Fa r qu h a r, director at the law firm Hyman Phelps and Macnamara, pointed out in a January 2021 blog post, the European Medicines Agency (EMA) and the United Kingdom's Medicines and Health products Regulatory Agency (MHRA) have been using remote technology in inspections since March 2020 (7). Also using the technology are reg- ulatory authorities in Australia, Russia, and Japan (2,6). Denigan- Macauley's testimony pointedly mentioned the need for FDA to weigh in, formally, on the use of novel technologies such as remote video for pharmaceutical plant inspection (3). FROM AUDITING TO INSPECTIONS On Jan. 27, 2021, the Parenteral Dr ug Agency sponsored a web - cast (8) that addressed a number of these issues from a technical perspective and articulated best practices for utilizing some of the technologies available. Although the presentation discussed audit- ing, some of the concepts discussed could be ported directly to facil- ity inspections. Speaking on the program were Peter Miller, CEO of Dynamic Compliance Solutions, and exec utives from t wo phar- maceutical companies that are using remote auditing technolo- gies: Raghuram Pannala, quality control exec utive w ith Sciegen Pha r maceut ica ls, a nd P rasha nt Sharma, chief technical officer of Cadilla Healthcare. [FDA Law Blog has updated Farquhar's post with a direct link to the webcast power- point slides (9)]. As Miller pointed out on the program, best practices must gov- ern use of the technolog y such as no recording, and ensuring a live stream. When used correctly, though, presenters say the new methds can provide a clear window into operations. At this point, FDA is still evalu- ating findings from pilots studying remote technologies in food and medical devices inspections (6). However, many industry observers express hope that FDA will leverage new technologies and approaches that will help the agency 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. 2. A. Shanley, Pharmaceutical Technology, 45(1), pp 46,48, and 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 Inspections,", March 9, 2021. 5. M. Schwartz, "FDA Fiddles with Remote Inspections While Pharma Burns,", Dec. 7, 2020. 6. A. Shanley, Pharmaceutical Technology 44 (12), pp. 12-14 (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. BP Regulatory Sourcebook Quality

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