5 things we learned at the PDA/FDA Joint Regulatory Conference 2024

Last week, Qualio attended the 2024 PDA/FDA Joint Regulatory Conference for a fact-finding mission in Washington, D.C.

The flagship conference, shared between the Parenteral Drug Association and the Food & Drug Administration, was hosted for the 33rd time in September 2024.

The PDA FDA conference theme? cGMP: quality through science and innovation.

As an event designed for the regulated pharma and biotech companies that Qualio serves, we couldn't miss it!

Here's what we learned across the 3 days.

1. Biggest-ever FDA shake-up incoming

On October 1, 2024, the FDA will go through the biggest reorganization in its history.

Over 8000 people will be affected as the Office of Regulatory Affairs becomes the Office of Inspections & Investigations, with its 5200 headcount cut to around 3600.

The move comes as part of a broader initiative which will also streamline compliance functions within the Center for Drug Evaluation and Research (CDER), and present a new model for field operations.

At the same time, the FDA is grappling with high amounts of attrition in the workforce. New pay bands, an improved travel experience for inspectors, and a first-of-its-kind training program partnership with North Carolina State University are all fresh initiatives aimed at attracting and retaining new talent.

The takeaway:

The FDA insists its reorganization won't affect its relationship with the industry, and shouldn't be felt by life science companies.

Nor does the move suggest any scaling back of inspection or auditing activity. The FDA plans to conduct the same amount of inspections within a tighter and more efficient operating structure.

Other regulatory ingredients like RRAs, product samples, recall histories and international info-sharing will continue to complement inspections and give the FDA a picture of how companies are operating in the industry.

2. Remote inspections still on the rise

COVID-19 has driven an irreversible change in how the FDA regulates life science companies.

In short? The FDA is going hybrid.

Where physical inspections were once part and parcel of FDA practice, the clear shift to 'remote regulatory assessments' and information requests that took place in 2020 doesn't seem to be going anywhere post-pandemic.

In fact, where on-site inspections drove 100% of warning letters in 2019, that figure is almost a quarter lower this year.

At the same time, almost a quarter of 2024 warning letters have been triggered by remote requests, or failure to respond to them - and the brief reliance on physical sample-taking during the pandemic seems to have completely faded away.

The takeaway:

The FDA is relying more and more on remote inspections and record requests to keep tabs.

Ensure you have the operational ability to respond to these new inspection demands: digital, cloud-based QMS information looks increasingly expected.

3. 'BC' quality hasn't returned yet

ORA Program Director Alonza Cruse referred to BC ('Before COVID') as a clear boundary in terms of industry quality perception. 

An industry-wide dip in quality and compliance has been apparent since the pandemic, and has yet to rebound.

Though the causes are myriad, the FDA pinpoints a widespread lack of proactive, preventive quality best practice as a key factor.

The takeaway:

COVID has placed new pressures on life science companies, which many are failing to consistently adapt to.

Rather than the oscillation between compliance and non-compliance which the FDA is seeing, the agency is actively pushing prevention-focused quality programs which allow at least a baseline of compliance to be maintained.

And for this, increased leadership engagement and support is critical.

4. Data integrity a consistent weakness

Data integrity has continued to act as a banana skin for regulated companies.

For the past 5 years, around a fifth of cGMP warning letters on average have referenced data integrity as an area of non-compliance.

The FDA is keen for pharma and biotech companies to tackle this issue, again pushing its guidance document on the subject as a key reference point. 

And data integrity isn't the only compliance issue consistently popping up in inspections.

Other recurring areas of concern include:

• Sterility assurance
• Aseptic processing
• Selection of ingredient suppliers
• Ingredient testing
• Contract manufacturing quality management

The takeaway:

Without the baseline of high-integrity, controlled data, your other quality efforts will be weaker and less consistent.

Pay attention to data integrity and how to maximize it with appropriate processes, tools and systems.

5. New guidance

The world of quality and regulatory never stands still.

The conference was a great way to touch base on upcoming guidance documents and updates for life science companies to dive into.

New draft guidance documents

May 2024: Platform Technology Designation Program for Drug Development

July 2024: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products

New final guidance documents

June 2024: Facility Readiness: Goal Date Decisions Under GDUFA

July 2024: Container Closure System and Component Changes: Glass Vials and Stoppers

September 2024: Control of Nitrosamine Impurities in Human Drugs

FDA documents coming soon

• Pharmaceutical Quality/CMC – omnibus legislation
• Framework for Regulatory Advanced Manufacturing Evaluation (FRAME)

International updates

• Improved ICH guidelines related to the Common Technical Document (M4Q) and stability (Q1/Q5C)
  
  
• ICMBRA collaborative pilot: joint FDA-EMA approval system with a mixture of on-site and remote inspections for faster, simultaneous US/EU approvals 

The takeaway:

Keep abreast of current best practice, expectations and programs by visiting the FDA, ICH and ICMBRA websites

The PDA FDA 2024 conference was a great way to keep on top of the latest challenges, trends and patterns unfolding in the pharmaceutical and biotech industries.

Thanks to PDA and FDA for hosting us!