Quality is Number One, Even When Trying to Address Supply Chain Issues

Quality Executive Partners (QxP) attended the AAM/IGBA meeting in Orlando, Florida in February.  The event was simultaneously informative, thought-provoking, and challenging. The audience listened to industry experts describe the roadblocks that the generics industry faces (particularly in the U.S.) and it gave everyone a reason to pause, consider the problems, and try to find ways to reach common ground.   

Given the complexities involved in the processes of bringing these life savings drugs to American patients and current market dynamics, it’s no wonder that cost to manufacture has become a race to the bottom for the generics industry.  

The pharmacy benefits managers (PBMs), insurance companies, and distribution lanes add costs to these medicines. And though the generics industry is essentially pricing at cents per pill, the American patient still pays too much for the medicines they need and without transparency as to why. This, in turn, causes the generics industry to race to the bottom to charge even less per pill so that their products can be written into formularies and be accessible in our country.  

We are approaching a significant problem in our healthcare system. U.S. cost structures do not incentivize generics manufacturers to sell here and in turn, exacerbate access problems to these medicines that are desperately needed to treat the American patient.  This is a significant risk to the supply chain of medicines for our country. 

As I reflect on the sessions, including Mark Cuban’s fireside chat on his Cost Plus Drug Company, and many SVPs and CEOs of large generic manufacturers like Teva, Sandoz, Amneal and Dr. Reddy, the one topic that was not mentioned explicitly was quality.  

Quality is essential in the algorithm of cost and more importantly, the value that generic drugs deliver.  When you don’t include quality in the equation, the American patient assumes that they are getting medicines from their pharmacy that are as labeled:

  • The medicine is pure (free of impurities)
  • The medicine is at the strength prescribed and needed
  • The medicine is effective. 

I contend that quality means doing things right the first time:  

  • There are no compromised shortcuts
  • There is efficiency in manufacturing
  • There exists no repeating steps or reworking of product (all of which increase time and money to make) 

We have started to witness significant U.S. regulatory action at foreign manufacturing sites due to a general lack of quality in manufacturing practices. Issues exist around data integrity, cleaning procedures/validation, hold times, and stability. The ability to get your product into US commerce is getting harder, as the race to the bottom is reinforced. This is yet another issue to consider when discussing the challenges of the U.S. supply chain of generic medicines. 

We all know the saying, “If you do not have time and money to do it right the first time, you will always find time to do it again the right way”.  If you, as the head of a global generics manufacturer, need or want to take a step back and have your manufacturing system evaluated for quality and efficiency, please reach out, I would love to have a discussion.  

A discussion that centers on quality will not solve everything in this industry, but it is a step forward and one all companies should take. Paraphrasing a dynamic leader and speaker at the conference, Cynthia Meiners, SVP Strategic Program Development Officer at Good Rx: “Ensuring public health by strengthening the medicine supply chain is one of the single most important and personal needs we have.”

Click through to https://www.qualityexecutivepartners.com/ and uncover how our QxP teams are creating roadmaps to the future for pharma. Creating Roadmaps to the Future for Pharm


QxP Vice President Christine Feaster is a 20+ year veteran in pharma quality assurance. Prior to joining QxP, Christine was a vice president of U.S. Pharmacopeia.  
 

The Crucial Nexus: Data Integrity in Pharmaceutical Manufacturing

Christine Feaster
May 17, 2024

Pharmaceutical Industry Trends for 2024 So Far

Christine Feaster
April 24, 2024

Decoding the Technical Transfer Process in Biotech Manufacturing

Sarah Boynton
April 23, 2024

Quality Executive Partners - IACET Accreditation

Ken Mead
April 9, 2024

Coaching and Correcting: A Focus on Behavior Over Blame

Sarah Boynton
November 1, 2023

The Importance of Roles and Responsibilities in Biotech Manufacturing & Human Error Prevention

Sarah Boynton
October 26, 2023

Remote cGMP Inspections and AI in Drug Manufacturing

Michelle Fishburne
October 11, 2023

4 Best Practices for Effective Investigation into Deviations

Sarah Boynton
September 19, 2023

The Art of Viral Vector Manufacturing: 4 Essential Controls to Prevent Cross-Contamination

Sarah Boynton
September 13, 2023

Practicing Risk Acceptance

Mark Roache
August 28, 2023

Annex 1 – Can we all take a deep breath now?

Vanessa Figueroa
August 24, 2023

In Cell and Gene, Good Science is Necessary, But Not Sufficient

Mark Roache
August 21, 2023

6 Ways To Achieve Manufacturing Audit And Inspection Readiness

Sarah Boynton
August 14, 2023

Experience is What You Get Just After You Needed It, Part 2

Mark Roache
August 10, 2023

Experience is What You Get Just After You Needed It, Part 1

Mark Roache
August 10, 2023

Sterility Assurance Matters to This ONE

Greg Gibb
August 8, 2023

Enhancing Quality and Safety: 3 Essential Human Error Prevention Tools for cGMP Manufacturing

Sarah Boynton
August 3, 2023

Asia-Pacific Happenings: Samsung Bioepis Implements QxP Virtuosi®

Michelle Fishburne
August 2, 2023

CDMOs – Selecting the Right One for Each Manufacturing Stage

Christine Feaster
July 24, 2023

3 Types of Human Error and Potential CAPAs to Prevent Them

Sarah Boynton
July 20, 2023

Drug Shortages: Causes & Solutions

Christine Feaster
July 10, 2023

The 5 Questions You Need to Ask After a Human Error Event Occurs

Sarah Boynton
July 5, 2023

Understanding How Adults Learn

Mike Levitt
June 30, 2023

Annex 1 and Ensuring Filling Technologies Fit the Need

Natasha Howard
June 21, 2023

How to Solve Pharma’s Skilled Workforce Deficit

Jeff Roy
June 20, 2023

ChatGPT Told Me AI is “Imperative” in Pharma Manufacturing

No items found.
June 18, 2023

Get Ready: FDORA’s Unannounced Foreign Inspection Pilot Program is On!

Crystal Mersh
June 6, 2023

Nitrosamines Impurity Challenges

Christine Feaster
June 2, 2023

All You Need to Know About Contamination Control Strategies, Parts 1 and 2

No items found.
June 1, 2023

When is ISO 8 Not ISO 8?

Bob Ferer
May 30, 2023

Cost Of Quality: Worth Every Cent In Bio/Pharmaceutical Manufacturing

Crystal Mersh
May 24, 2023

Pharmaceutical Quality is NOT a Spectator Sport

Mike Levitt
May 22, 2023

The Six Keys for Effective Deviation Investigators

Mike Levitt
May 18, 2023

There Has to be a Better Way to Train

Tyler DeWitt, Ph.D.
May 15, 2023

Cell and Gene: Article Series on CGT’s Key Drivers

Mark Roache
May 8, 2023

Bacterial Endotoxin Testing is on the Move

Christine Feaster
May 5, 2023

Top 20 Pharma Company Chooses QxP Virtuosi® Platform

Vanessa Figueroa
May 3, 2023

Crystal Clear: Controls Are Not Enough

Crystal Mersh
April 22, 2023

Myth #1: Complying with Regulations and Product Specifications

Brian Duncan
April 20, 2023

Myth #2: Proactively Remediating Bad Inspection Outcomes: What’s the benefit?

Brian Duncan
April 20, 2023

Is it Time to Outsource Internal Auditing?

Mike Levitt
April 18, 2023

Don’t Be a Daredevil When Retrofitting Your Facility, Part 2

Bob Ferer
April 10, 2023

Don’t Be a Daredevil When Retrofitting Your Facility, Part 1

Bob Ferer
April 10, 2023