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COVID’s Impact on Pharmaceutical Compliance

The pharmaceutical and medicine manufacturing industry is one of the most heavily regulated industries in the country. The FDA is charged with ensuring the safety of all medicines available to people of the United States. This alone is an incredibly difficult task. And with the advent of the COVID-19 pandemic, it’s only become more challenging. 

New FDA requirements (and lack of progress) have pushed remote monitoring and inspections to the forefront of the discussions of federal regulation and patient health.

Pharma companies must keep up with this rapidly changing landscape. Those that invest in technology and talent aimed towards the future will find themselves reaping the benefits of forethought. 

With this in mind, let’s take a look at the impact of COVID and remote mentoring technology on the pharmaceutical industry.

Clinical Trials

The COVID-19 pandemic has disrupted clinical trials around the world. Many have had to be put on hold or canceled. Others have had to readjust to new regulations geared towards the safety of patients and healthcare workers. And a huge percentage have been restructured towards researching COVID itself. We have already seen profound effects, and these will undoubtedly last long into the future of medical science.

Clinical trials are a necessary part of testing and validating pharmaceutical drugs. New drug development and approval depend on them. New subject enrollment in clinical trials had seen a 74% decrease worldwide as of September 2020. (1) 

There are several reasons for the sharp decrease in new enrollments and stalled trials, including:

    • Concerns over patient safety
    • Social distancing and occupancy restrictions
    • Staff furloughs
    • Financial losses and subsequent budget cuts

The FDA has been issuing guidance on the conduct of clinical trials of medical products during the COVID-19 public health emergency, and it’s no surprise that remote monitoring is playing a huge role in the effort to keep clinical trials going.

According to the FDA:

“If planned on-site monitoring visits are no longer possible, sponsors should consider optimizing use of central and remote monitoring programs to maintain oversight of clinical sites

Some clinical outcome assessments (COAs)36 can be conducted remotely in clinical trials during the COVID-19 public health emergency, including COAs for performance outcome (PerfO), interview-based clinician-reported outcome (ClinRO),37 patient-reported outcome (PRO), and observer-reported outcome (ObsRO).

FDA regulations require sponsors to monitor the conduct and progress of their clinical investigations. The regulations are not specific about how sponsors must conduct such monitoring and are therefore compatible with a range of approaches to monitoring that may vary depending on multiple factors. Therefore, certain aspects of site monitoring visits may be done remotely if technically feasible.” 

Food and Drug Administration, Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards, Published March 2020, Updated January 27, 2021 (2)

Concern over patients’ ability to safely and effectively travel and receive care at research centers was one of the top reasons for clinical trial shutdowns. Remote monitoring can help create safer environments for both patients and doctors. This eliminates the need for travel, allows for social distancing measures to be enforced, and can stimulate an increase in trials and therefore company growth.

Remote monitoring has already been implemented in many clinical trials, and as technology and techniques advance, it’s clear that it’s only going to increase in usefulness and effectiveness. 

GMP Inspections 

The effects of the COVID-19 pandemic have reached far beyond clinical trials. GMP inspections have also seen a major shift.

In March 2020 the FDA announced that it was temporarily postponing all domestic and foreign routine surveillance facility inspections. In July they issued an announcement that they were going to began working towards resuming “prioritized domestic inspections.” (3)

According to PharmTech, the number of drug facility inspections performed dropped by over 50% from 2019 to 2020 from 779 to 349. Biologics plant inspections dropped even more dramatically, from 116 to 28. Many of the prioritized inspections were done at sites dealing with COVID-19 and vaccine research. (4)

This data shows a need for a swift modernization of GMP inspection protocol. The FDA has slowly begun taking steps towards utilizing modern technology. In October of 2020, they announced that they were testing the use of live video on food investigations. (5) 

However, they have been moving sluggishly compared to other regulators around the globe. According to PharmTech:

“The European Medicines Agency (EMA), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada, the Therapeutic Goods Administration (TGA) of Australia, Japan’s Pharmaceutical and Medical Devices Agency, and the Russian Ministry of Health—are all using some forms of remote technology for remote inspections.” (4)

Many regulators have found success in remote inspections. The European Federation of Pharmaceutical Industries and Associations (EFPIA), based in Brussels, “sees  added  value  in retaining  these  practices  beyond  the  pandemic  situation,  as  enabler  for  reliance  and recognition.” (6) The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) have already issued a “Best Practices for Virtual Inspections” living document.

Even though the FDA has shown reluctance in adopting a virtual inspection model, remote inspections will be prevalent in the future beyond the COVID-19 pandemic.

Implications for Pharmaceutical Companies

Pharmaceutical companies have been forced into a difficult position due to the COVID-19 pandemic. However, in many ways, these difficulties have only expedited the need for changes in approach when it comes to inspections and compliance. 

Many pharma companies take a straightforward rule-based approach in their compliance programs. However, the checklists and standard operating procedures that have been in place for years are not going to be enough to stay agile in this modern digital era.

The skillset for compliance departments is changing. Companies without strong collaboration between tech and compliance may find themselves in non-compliance in the near future. Companies that invest in new technology and training will find themselves in the right position when remote inspections become commonplace.

AVATOUR is ready to work with compliance departments to prepare for the future of remote inspections. Our 360° mobile technology allows hosts and guests to interact as if they were on-site together.

An AVATOUR session is much more than a simple video call. Guests are fully immersed in the site and can control their view in complete 360° vision. Our platform takes real people to real places, and allow you to maintain quality, compliance, and safety in a dynamic industry.

If you’d like to learn more about how AVATOUR can help your pharmaceutical company equip yourselves for the present and prepare yourself for the future, schedule a demo with us.

Sources:

(1) Sathian, Brijesh et al. “Impact of COVID-19 on clinical trials and clinical research: A systematic review.” Nepal journal of epidemiology vol. 10,3 878-887. 30 Sep. 2020, doi:10.3126/nje.v10i3.31622 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7538012/ 

(2) U.S. Department of Health and Human Services, Food and Drug Administration. “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards.” Mar. 2020, www.fda.gov/media/136238/download. Updated January 27, 2021

(3) U.S. Department of Health and Human Services, Food and Drug Administration. “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers. Guide for Industry.” Aug. 2020, https://www.fda.gov/media/141312/download. Updated January 29, 2021 

(4) Shanley, Agnes. “FDA Inspections Remain Stalled During the COVID-19 Pandemic.” PharmTech.com Advancing Development and Manufacturing, Pharmaceutical Technology, 2 Jan. 2021, www.pharmtech.com/view/fda-inspections-remain-stalled-during-the-covid-19-pandemic

(5) McMeekin, Judith. “Remarks at the Food and Drug Law Institute Annual Conference.” U.S. Food and Drug Administration, Food and Drug Law Institute, 6 Oct. 2020, www.fda.gov/news-events/speeches-fda-officials/remarks-food-and-drug-law-institute-annual-conference-10062020.  

(6) MQEG inspection topic team. “Alternative  GMP/GDP  Inspection  Practices  in  a  Pandemic  Situation (COVID‐19) and Beyond.” EFPIA.eu, European Federation of Pharmaceutical Industries and Associations, 28 May 2020, www.efpia.eu/media/547487/alternative-gmp-gdp-inspection-practices-in-a-pandemic-situation-covid-19-and-beyond.pdf

(7) IFPMA. “Points to Consider for Virtual GMP Inspections – An Industry Perspective.” IFPMA.org, International Federation of Pharmaceutical Manufacturers & Associations, 5 Feb. 2021, www.ifpma.org/wp-content/uploads/2020/07/Best-Practices-for-Virtual-Inspections_Feb21.pdf

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