Executive Order 14293 & FDA Processes

US FDA posted a press release “FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing” ⁽¹⁾ outlining its NEW PROGRAM to strengthen its processes. It proposes a PreCheck in response to EO14293 ⁽²⁾. 

FDA ⁽¹⁾ has suggested TWO steps and they are: 

1.     First, the Facility Readiness Phase provides manufacturers with more frequent FDA communication at critical development stages, including facility design, construction, and pre-production. This phase also encourages companies to provide a comprehensive facility-specific information through a Type V Drug Master File (DMF), such as site operations layout and description, Pharmaceutical Quality System elements, and Quality Management Maturity practices. This facility-specific DMF can be incorporated by reference into a drug application as appropriate. 

2.     Second, the Application Submission Phase centers on streamlining development of the Chemistry, Manufacturing, and Controls section of the application  through pre-application meetings and early feedback.

I am presenting my understanding of FDA’s PreCheck Program processes. I have no financial relationship with any for profit and/or nonprofit organization. 

 

FDA personnel, my conjecture, will never have complete understanding and/or command of each product and process as that is the jurisdiction of the company producing the products. Companies know their manufacturing processes better than anyone else. If they do not then every chemical and pharmaceutical company has a major problem. FDA through this ⁽¹⁾ is suggesting they know more about company’s processes, products and manufacturing. As a regulatory body FDA or for that matter EPA also has to rely on what the company is presenting and saying will do to produce quality product/s. Is FDA suggesting that companies do not understand their product, process and manufacturing processes? With that being the case how FDA personnel, that has minimal and/or no experience in process development, manufacturing and commercialization will be able to advise a company of “facility phase readiness”. FDA just put a CART BEFORE THE HORSE and exposed itself for telling the world that best of the chemical/pharmaceutical companies don’t know much about what they commercialize.   

 

It is my understanding that currently FDA and companies meet to address any questions through in-person meetings. In PreCheck what will be different from the current situation. I would be tempted to call this a case of “sanctioned delays”. 

 

Meeting product’s established quality specification, performance and following cGMP guidelines is company’s responsibility and should be demanded by FDA from every company to produce their products. FDA and or any other regulatory body should have the authority to stop production ⁽³⁾ if they do not deliver expected product quality. FDA should very clearly define the information that each company needs to submit for approval. What FDA has issued is complex and needs simplification. My best postulation is even FDA personnel cannot fill an application. USA needs to adopt and consider processes where NDA(new drug application)/ANDA (abbreviated new drug application) ^(3,4,5) can be approved in 90 days. They have been discussed since 2017 and for EO 14293 to be a success their adoption and implementation is critical ^(3,4,5).  

 

I posted my first reaction about FDA’s PreCheck on LinkedIn ⁽⁶⁾ when I saw the news release ⁽¹⁾. I consider this as an official sanction for the delays. EO 14293 ⁽²⁾ will never come true as there is no timetable to be met. Without any timetable for domestic production for critical drugs, FDA’s processes ⁽¹⁾ are of no value to US population. 

 

We have to recognize that it is company’s responsibility to produce quality drugs and FDA’s responsibility to expedite the approval process. Fact that the Presidents of The United States have issued Executive Orders ^(2,7,8,9) for the expeditious manufacture of critical drugs and it seems no one has taken responsibility for their implementation. It seems they ^(7,8,9) have been ignored and gone by the wayside. How FDA’s PreCheck, a new name for existing practice will promote domestic production?   

 

FDA’s processes need revamp. If not done the issue of critical drugs and shortages will keep rearing its UGLY head every so often. There are many vested interests that will interfere ⁽¹⁰⁾ in the process and need to stay out the way.  

 

Girish Malhotra, PE

 

EPCOT International 

 

References:

 

1.    FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing August 7, 2025

2.     EO14293  Regulatory Relief To Promote Domestic Production of Critical Medicines, May 5, 2025

3.     Malhotra, Girish: ONE PAGE Road Map to Reduce Drug Shortages, Assure Quality and Improve Affordability Profitability through Simplicity, December 6, 2019

4.     Malhotra, Girish: What Is Needed for a Regulatory Approval of NDA/ANDA Filings in 90 Days? Profitability through Simplicity, October 24, 2018

5.     Malhotra, Girish: Simplified Roadmap for ANDA/NDA Submission and Approval will change Pharma Landscape, Profitability through Simplicity, November 25, 2018 

6.     LinkedIn August 7, 2025

7.     Executive Order 13588 Reducing Prescription Drug Shortages, October 31, 2011

8.     Executive Order 13944 Ensuring critical medicines are made in US August 14, 2020

9.     Executive Order 14017  America’s Supply Chains Feb. 24, 2021

10.  Malhotra, Girish: Most Favored Nation Pricing & Bringing Pharmaceutical Manufacturing Home, Profitability through Simplicity, July 13, 2025

  

Roadmap to Reduce Drug Shortages and Bring Pharma Manufacturing Home (US):

Just the thought of drawing a road map to minimize drug shortages and bring pharma manufacturing home to US has been, can be and is a daunting task in the current environment. It can give all of us shivers. US is excellent to accept any challenge that has come its way. However, it has failed miserably to minimize shortages and put forth policies to bring at least generic and essential drug manufacturing home. Our inaptitude is very evident from the fact that we have been discussing these issues for more than TEN years and done nothing. Executive Orders have been ignored ^{(1, 2, 3)}. Roadblocks are our current systems and ways drugs are sold under a mutually subsidized healthcare system. 

 

I am proposing a pathway to overcome these challenges, obstacles and resolve conflicts. I am confident that improvements can be made to assure drug shortages are alleviated and pharma manufacturing comes home. My conjecture is that a totally outlandish outlier effort is needed.

 

I propose that the application filed for a generic drug be granted or denied in 90 days of filing. This is bold and very different from the current unknown time that could be anywhere between 3-4 years. Unless such steps are taken to resolve the issue of drug shortages and bringing manufacturing home, the current landscape is not going to change. Details are discussed later. 

 

Proposed plan is of significant value to pharmaceutical companies as they will have start having return on their investment compared to multiple years it takes now. This will allow companies to meet the challenge and eliminate shortages. This program could be used by the companies to invest in new manufacturing technologies and methods ^(4,5) to improve their profits and compete for market share as is done in any free economy. Companies will have tested their manufacturing processes and systems to start production of quality products as soon as they receive FDA approval. 

 

I have no vested interest in the outcome of the effort other than minimizing agony of fellow citizens to have food and staying healthy rather than making a choice between either ⁽⁶⁾. 

 

Again, we as a country, have done nothing to eliminate drug shortages and bring their manufacturing home. Vested interests and the current participants/players including legislators have prevented anything meaningful to happen. No one wants to jeopardize their profits and vested interests. It is time we act as one country. Even with this effort profits are not going to go away. They will get just get redistributed. 

 

Food and Drug Administration (FDA), Federal Trade Commission (FTC), US Legislators and other regulatory bodies will have to spearhead, support to create systems and implement what is necessary for the 90 day plan to work. Unless these entities act together in US’s national interest with the mission to eliminate shortages and bring manufacturing home, we will continue to have legislative hearings that are meaningless (too many to cite). 

 

Across the board team effort would be needed to adopt the suggested system. Trust between the regulated and the regulators to supply approved quality drugs is critical. Any company that participates in the outlined effort should be trusted to supply FDA approved drugs. Any failure would be a cause for they not be able to supply generic drugs to the US market for the next five years. 

 

Effort made here is not perfect but is a start. I am not against profits but in the current landscape drugs are distributed through selected channels with no open competition. No one knows the real price of drugs they use is THE problem. It has to change. In US’s mutually subsidized healthcare system price truth is lost and patients suffer. My conjecture is that the current drug distribution practices are THE bottleneck and THE problem.

 

ROADMAP:

 

For success of the proposed alternate pharma companies will have to commit to participate for at least five years. If they fall short on delivering product quality and/or stop supplying drugs within the year of their approval and/or collude with any other company (manufacturing or distributor) they will be barred from supplying drugs to the US market and/or establishing a manufacturing plant in US and its territories for the next five years even if they are a current supplier to the US market. With higher than current profits and US’s open market and size companies will be continually vying for entry. This will be an excellent opportunity for generic pharma companies. Purpose of short filing and approval times is necessary as it will minimize shortage time and companies will realize faster and higher return for their investment.

 

Companies who participate in eliminating shortages and producing generic drugs in US will have to abide by extremely strict code of conduct and compete in open market. Like any other competitive business only the best will survive. They will use internal cost and profitability analysis ⁽⁴⁾ to determine their participation. Companies will compete for the customers through open market competition i.e. competitive pricing and drug efficacy. Use of innovative technologies and their application and methods ^(4,5) will guarantee them cost advantage. Knowledge and creativity of company personnel could be put to test. Companies will have to shed technologies that have been used for the last 60+ years ^(4,5). No one would like to admit this but the current manufacturing methods are mortar and pestle technologies of yester years and  need to be upgraded. It is time and challenge here might get them there.  

 

Use of drug tier ⁽⁷⁾ system, an unnecessary bureaucracy, is a needless drug segregation system. It limits competition between companies who produce FDA approved drugs. It needs to be abolished. Direct competition between companies to cure the same disease will keep the quality high and prices competitive. Again better manufacturing technologies and creativity will be a win for the patients. 

 

Generic drug producers will sell directly to the patients through mail order or similar channels thereby bypassing the existing channels that are controlled by limited distribution companies. Use of existing distribution channels is company’s choice. 

 

US’s mutually subsidized healthcare system camouflages the real drug price to patients. We have to remember that the mission of the current channels is to maximize their profits at the expense of patients. Affordability and shortages are not a consideration. 

 

Information exchange between companies and regulators:

 

Implementation of the proposed program could be a challenge for the regulators and the regulated.  For its success, current ways, methods and information required by FDA and submitted by each individual company may have to be modified. Participating companies will have processes that will deliver quality product as soon as their submission is approved in 90 days ^(8,9,10,11). This approval time is the KEY to the success of the proposed program. Process information and methods submitted will be used to produce the approved product.

 

90 day approval requirement is a quantum change from the current practices. USFDA might have to modify its current ways and methods for the companies to submit information about their drug manufacturing methods, their efficacy and performance. There could be significant resistance within FDA and pharmaceutical companies. However, these changes are necessary if US wants to minimize shortages and wants to bring pharmaceutical manufacturing home. We have procrastinated for too long and overlooked needs of its population and national security. 

 

For program’s success information required by FDA and/or other regulators has to be such that its personnel (chemists, chemical engineers, quality control) based on their experiences can envision every detail of the process (process, equipment, operating instruction, test methods and product quality specs etc.) without visiting the production site. FDA might have to create information templates ^{(10, 11)}. These will make the basis for complete information and may allow FDA to ask for any additional information within 10 days of submission of the application. FDA will have 90 days to grant and/or deny from the date of filed application with clear explanation of every denial. Any falsified information submitted by the company will be grounds for barring the company to be in the US market for five years.  

 

FDA (Food and Drug Administration) publishes performance standard for each drug’s dispensable form. They should be available to every manufacturing entity who would like to produce and supply the drugs to the US market. 

 

It is expected that company’s staff is proficient in process development, manufacturing practices and product quality requirements from the onset. Same is expected at every filing company. Each  participating company would have to test its chemistry, process and methods so that the production of quality product is flawless. In their application they will have to include process equipment, manufacturing process, operating instructions, test methods, product specifications and other quality information etc. for their active pharmaceutical ingredient (API) manufacture and formulation methods and proof that the product meets FDA established finished performance standards. Again, information submitted by the company should be sufficient, clearly stated and would be used for every individual generic drug approval submission. Good Manufacturing Practices have to be followed.

 

It is critical that every manufacturing company provides necessary details that will allow the application reviewer adequate information so that the s/he can envision the process, the equipment and various test methods to grant and/or deny the filed application. If the information asked and provided does not provide the necessary data, it could result in denial of commercialization of the drug. An oversupply of information is always helpful.  

 

Using the filed information regulators from day of receipt will have 10 days to respond for every submitted application to the company for its completeness. If all of the information is not submitted from the onset, application most likely would be rejected in 10 days from the day of receipt. Thus, it is very critical that FDA creates near perfect information submission system that companies will use for application submission and evaluation. If complete 90 days from the filing date FDA will have to grant and/or deny their application. It will have to give definitive reasons for rejection. 

 

If the company is to produce the same drug at more than one site, it has to submit individual application and the results of the produced product from each site in their application. Any inaccurate information that will influence approval of the application will become ground for rejection and bar the company from any subsequent filing for the same drug to USA for ONE year. 

 

Compiling information can be a challenge but in the interest of customer safety and product performance, accuracy is a MUST. Perfection of information is expected as life depends on them when used. Regulators will have no hand holding meetings with companies as it is done today.  

 

To assure companies are producing and distributing drug per their approved filing FDA would randomly check the distributed finished drugs against the quality claims of each company. Independent labs can be used to test products that is being sold. Any deviation/discrepancy will be grounds for disbarment for supplying drugs to the US market for the next FIVE years. Regulators will randomly perform unannounced inspection of the facilities producing drugs being distributed in USA. Company cannot prevent unannounced inspections in their respective countries. 

 

For the outlined roadmap to succeed it is extremely critical that the information exchange between the regulator and the regulated is very accurate. This will allow each side to have an accurate understanding of the process being used to produce the desired product. There cannot be any ambiguity as inaccurate information will not allow approval of the process and significant monies will be lost. Core competencies and perfection of each team would be tested. 

 

Distribution:

 

Each pharmaceutical company that can supply approved drugs should use distribution channel of their choice to compete and sell the drugs to the directly to patients. Direct sales are the key to the success of the proposed plan. Each finished drug product manufacturer like automobiles, smart phones or laptop computers that have equivalent functioning will compete on performance and price. Current distributors can participate but cannot prevent entry of others distribution channels as long as USFDA approved products are being distributed. 

 

Since there will be no drug tier ⁽⁷⁾ system competition between drug companies for the sale of their FDA approved product/s, patient with the advice of their healthcare provider and product price can decide on the drug they want to use. 

 

Collusion:

 

If any company is found to be colluding with any other drug producer, distributor or channel to limit availability of the drug and/or increase the selling prices each would be barred from supplying drugs to the US market for the next FIVE years. FTC and each US state can investigate. Companies being investigated cannot distribute or sell any approved drug/s during the course of investigation. Companies for every frivolous investigation would be reimbursed equivalent of ONE year’s revenue for that drug. Use of ombudsman might be necessary for any conflict resolution.

 

US Production: 

 

Companies opting to produce/establish manufacturing facilities in USA using the FOUR State Model ⁽⁸⁾ should be given preference. 

It is expected that the companies who compete directly for the customers will innovate their manufacturing technologies ⁽⁴⁾ and methods and compete based on product quality. Open competition will benefit US population. My conjecture is that it will lead to manufacturing technology innovation, higher profits and higher quality products for the producing companies. This will be for US in general as it will bring new employment to the selected areas. 

 

My speculation is that what has been proposed here could be strongly objected by FDA, FTC, drug conglomerates and members of current distribution system. Legislators should back and take a lead for such proposal. I expect that in an open market, quick approval and competitive drug distribution system, drug efficacy and price would level the playing field, reduce shortages, bring pharmaceutical manufacturing home and make drugs affordable. US being the largest generic market, companies would compete on the basis of drug quality, performance and price. It will be a win for US patients and best of the generic pharmaceutical manufacturing companies. Procrastination and meaningless talk about drug shortages and bringing manufacturing home has to end. It is TIME. 

 

Girish Malhotra, PE

 

EPCOT International

 

References:

 

1.     Executive Order 13588 Reducing Prescription Drug Shortages, October 31, 2011, Accessed August 31, 2020 

2.     Executive Order 13944 https://www.govinfo.gov/content/pkg/FR-2020-08-14/pdf/2020-18012.pdf Accessed April 26, 2022

3.     Executive Order on America’s Supply Chains https://www.whitehouse.gov/briefing-room/presidential-actions/2021/02/24/executive-order-on-americas-supply-chains/ Feb. 21, 2021 Accessed May 30, 2022

4.     Malhotra, Girish: Active Pharmaceutical Ingredient Manufacturing: Nondestructive Creation Accessed February 28, 2022

       Malhotra, Girish: Chemical Process Simplification: Improving Productivity and Sustainability John Wiley & Sons, February 2011 

6.     Malhotra, Girish: Drug Prices: Food vs. Medicine - A Difficult Choice for Some Profitability through Simplicity June 16, 2011

7.     Understanding Drug Tiers Accessed October 22, 2023 

8.     Malhotra, Girish: ONE PAGE Road Map to Reduce Drug Shortages, Assure Quality and Improve Affordability,Profitability through Simplicity December 6, 2019

9.     Malhotra, Girish: US’s Self Sufficiency for Generic Drugs: A Supply Dilemma and Potential Solutions, Profitability through Simplicity March 31, 2022 

10   Malhotra, Girish: Can the Review and Approval Process for ANDA at USFDA be Reduced from Ten Months to Three Months? Profitability through Simplicity, March 25, 2017

       Malhotra, Girish: Strategies to Increase Generic Drug Competition and Bring Manufacturing to The United States of America, Profitability through Simplicity, March 16, 2020 

Comments & Feedback to USFDA on Distributed and POC Manufacturing (FDA-2022-N-2316)

USFDA has sought feedback on Distributed and Point-of-Care Drug Manufacturing. It makes the following statement for Distributed and POC Manufacturing ⁽¹⁾. Focus of DM and POC is US based. Perspective and comments presented are my own and not influenced by any profit and non-profit making organization.  

 

“Pharmaceutical manufacturers have generally produced drugs at large fixed-location facilities, but some are now developing smaller, mobile drug manufacturing processes that can be deployed to multiple locations, including at the point of care, such as at a hospital or clinic. These novel distributed manufacturing (DM) and point-of-care (POC) manufacturing technologies have the potential to improve the reliability and robustness of the drug supply chain. The U.S. Food and Drug Administration is keenly interested in these technologies because they could potentially provide flexibility for drug manufacturers to enable rapid and localized response to changing demand and increase timely access to quality drugs for U.S. patients.”

 

Underlying question is that using FDA’s current review and approval scenario how much time it would take to set up and fill the “rapid and localized response”. What would be considered reasonable and who is going to be held accountable? There are questions and comments that need to be addressed/considered. 

 

1.    Has USFDA considered and reviewed the patient volume need for such manufacturing and distribution in USA from company’s business perspective? It is critical that it be done. 

2.    Who would prioritize the drugs and their quantities? Who would manufacture the prioritized drugs? What would it take? What if due to lack of profitability no company wants to produce the drugs. What has FDA done or do to expedite availability ^(2,3) of the needed products? 

3.    What has USFDA done for the companies to facilitate avail such business opportunities i.e. has it simplified its approval processes from multiple years to few months ^(2,3)? 

4.    DM and POC opportunities have existed for a long time. What has stopped companies from capitalizing on such profit making opportunities? Is it the regulations or the investment each company has to make for each specific drug (limited volume) for them to have sufficient return? 

5.    Since there are not very many generic API production facilities in US, DM and POC business opportunities will be limited. Has USFDA considered this limitation? Approval times and regulations will have to be simplified ^(2,3).  

6.    For the brand drugs (API and their formulation) being produced in US, why would the companies not use their existing facilities to serve the DM and POC needs. No additional manufacturing plant would be needed. No one wants to have additional “white elephants” that will be used sparingly ⁽⁴⁾. This holds true for the generic drug producers also. 

7.    Cost of drugs produced at USA located DM and POC will be higher than the current prices. This will be due to higher overall costs compared to China and India and PBMs (pharmacy benefit managers) and associates wanting to retain their profit margins. Only direct distribution to patients would lower prices ⁽⁵⁾. PBM et.al. will strongly oppose such move. Alternate business models and proposals discussed ⁽⁶⁾ can be searched (key word: alternate business) and need to be considered. 

8.    Based on review of the discussion paper for DM and POC post ⁽⁷⁾ it seems that the filing and approval requirements for even for limited quantity DM and POC business would be the same as they are for the current NDAs and ANDAs. This will be an obstacle as the drugs will not be available when needed, even in emergencies. Drugs could be available by bringing DM and POC manufacturing home. This could be done by significantly reducing NDA (new drug application) and ANDA (abbreviated new drug application) approval times. Pathways are available ^(2,3). It is recognized that drug safety and efficacy cannot be compromised but to bring pharma manufacturing home approval time reduction is critical. Companies need to be held responsible and if do not comply there could be business consequences. 

9.    Pharmaceutical companies who want to establish manufacturing facilities in USA and participate in DM and POC or any similar opportunity, based on the current landscape, will have to internally prove their innovative methods (e.g. continuous or modular or mobile ^{(8, 9)} ) to assure the product quality will be as designed. They will be challenged for time to commercialize as each process will have to be proven internally and then to USFDA. This would pose an enormous burden on acquiring experienced chemists and chemical engineers and time. Brand companies due to patent expiry time limitations do not have the time for such process developments unless they start such effort from the onset ⁽⁹⁾. Batch processes will stay as the routine method. To use continuous or mobile processes business model change would be needed ⁽⁹⁾ and need to be considered Generics will have to review their short and long term business model for each product but will be similarly challenged. Another serious question of confidentiality will be there and it is why FDA personnel should be taught the details of confidential chemistries and methods as long as the company guarantees quality product.  

10. Introduction of every new processing method at companies and USFDA, based on recent six years needed for Continuous Direct Compression ⁽¹⁰⁾ from FDA, suggests that innovation incorporation at companies will be a tough sell internally and no company will innovate. Every process could include different unit operations and that means it will delay approval. Companies do not have such time luxuries. Question is why the companies have to go through such processes if they guarantee product quality and consistency and have fast approvals of NDA and ANDA. Companies innovate but teaching USFDA the technologies they use should not be needed. Product quality , efficacy and consistency should the underlying requirement.

If USFDA can address, simplify and shorten its processes ^(2,3) not only it will make Distributed and Point of Care manufacturing possible but also would set an environment to bring pharmaceutical manufacturing home, comply with the Executive orders ^{(11,12, 13)} and alleviate shortages. This along with direct selling to patients will lower drug prices. All this will require an alternate business model that could lead to “net zero emissions” in pharma ⁽¹⁵⁾.  However, to these to happen two entities (USFDA and PBMs) will put significant resistance ^(5,14).   

 

Girish Malhotra, PE

 

EPCOT International 

References 

 

1.     FDA Seeks Feedback on Distributed and Point-of-Care Drug Manufacturing https://www.fda.gov/news-events/fda-voices/fda-seeks-feedback-distributed-and-point-care-drug-manufacturing October 14, 2022 Accessed November 15, 2022

2.     Malhotra, Girish: Can the Review and Approval Process for ANDA at USFDA be Reduced from Ten Months to Three Months? Profitability through Simplicity, March 25, 2017 Accessed November 10, 2022 

3.   Malhotra, Girish: What Is Needed for a Regulatory Approval of NDA/ANDA Filings in 90 Days? Profitability through Simplicity, October 24, 2018  

4.     Benchmarking Shows Need to Improve Uptime, Capacity Utilization, Pharmaceutical Manufacturing, September 7, 2007 Accessed November 12, 2022  

5.     Malhotra, Girish: Improving Drug Affordability for the United States Populous through Alternate Business Models, Profitability through Simplicity, May 4, 2018, Accessed November 10, 2022

6.     Malhotra, Girish: Profitability through Simplicity Accessed November 14, 2022 

7.   Distributed Manufacturing and Point-of-Care Manufacturing of Drugs, Discussion Paper, October 18, 2022 Accessed November 4, 2022

8.     Continuous production Cambridge Dictionary, Accessed November 19, 2022 

9.     Active Pharmaceutical Ingredient Manufacturing: Nondestructive Creation De Gruyter.com Accessed June 10, 2022

10.  ETP Graduates its First Technology February 22, 2022 Accessed November 16, 2022  

11.  Executive Order 13588 Reducing Prescription Drug Shortages, October 31, 2011, Accessed August 31, 2020 

12.  Executive Order 13944 https://www.govinfo.gov/content/pkg/FR-2020-08-14/pdf/2020-18012.pdf Accessed April 26, 2022

13.  Executive Order on America’s Supply Chains https://www.whitehouse.gov/briefing-room/presidential-actions/2021/02/24/executive-order-on-americas-supply-chains/  Feb. 21, 2021 Accessed May 30, 2022

14.  Malhotra, Girish: Innovation in Pharmaceuticals Manufacturing Technologies, Distribution & Regulations: Are they Easy or a Challenge? Profitability through Simplicity, September 26, 2022 Accessed November 10, 2022  

15.  Malhotra, Girish: Climate Change and Greening of Pharmaceutical Manufacturing Profitability through Simplicity January 24, 2022 Accessed November 15, 2022