Important Takeaways from the PDA/FDA Joint Regulatory Conference Highlights from the Second Plenary Session

With over 800 members in attendance on the first day of the PDA/FDA Joint Regulatory Conference, Milind Ganjawala, Director of the Division of Drug Quality 2 , Office of Manufacturing and Product Quality and Office of Compliance for the U.S. Food and Drug Association’s (FDA) Center for Drug Evaluation and Research (CDER), took the stage as the moderator for the crowd-favorite session, “P2: Center of Office Updates.”

This session featured four distinguished speakers from the FDA: Peter Marks, PhD, Director of Biologics Evaluation and Research; Douglas Throckmorton, MD, Deputy Director of Regulatory Programs; Matthew Lucia, PhD, Director of the Office for New Animal Drug Evaluation; and Michael Rogers, MS, Associate Commissioner for Regulatory Affairs.

The speakers elaborated on how the FDA continues to optimize its strategies and actions to safeguard the quality, safety and effectiveness of medicines for patients, even amid current manufacturing and supply challenges.

CBER’s Three Key Areas of Focus: COVID-19 Vaccination, Infectious Disease Prevention and Advancing Gene Therapies for Rare Diseases

Peter Marks outlined the three primary areas of focus for the Center for Biologics Evaluation and Research (CBER) for the remainder of this year and the upcoming year:

1. COVID-19 Vaccine Composition for 2024-2025
2. Updates to human tissue guidance to reduce infectious disease transmission risk
3. Advancing the development and availability of gene therapies for rare diseases

CDER’s Response to Confronting Drug Manufacturing and Information Systems and Information Exchange Challenges

Dougals Throckmorton discussed the challenges around pharmaceutical quality.

Currently, he explained, “we are in an age of quality,” in contrast to the 1970s and 2000s, which focused on efficacy and safety in pharmaceuticals. When asked why quality is now the front and center of all decision-making, Throckmorton noted a number of evident reasons for this shift.

One of the outcomes of pharmaceutical quality challenges is drug shortages, Throckmorton said, which continue to plague the industry and impact patients. He explained that there are currently 111 drugs facing shortages, many of which are common ones.

How can the industry address this? Communication is key. Throckmorton emphasized that “through communication with the industry, the number of prevented shortages continues to grow, while the number of new drug shortages remains steady.”

Center for Veterinary Medicine's One Health Approach Advances Animal and Public Health Through Innovation, Antimicrobial Stewardship and Global Harmonization

Matthew Lucia provided insight into the Center for Veterinary Medicine's (CVM) One Health approach, which aims to protect the health of people and animals in a shared environment. He highlighted several key areas of this strategy:

• User fee reauthorization
• The Animal and Veterinary Innovation Agenda
• Zootechnical animal food substances
• Animal biotechnology
• Antimicrobial resistance strategy
• International harmonization

In the final minutes of his presentation, Lucia discussed the FDA’s work on antimicrobial resistance and international harmonization. Regarding antimicrobial resistance, the FDA is following an updated five-year plan (2004-2008) with three main goals:

1. Align antimicrobial drug product use with the principles of antimicrobial stewardship
2. Foster stewardship of antimicrobial use in veterinary settings
3. Enhance monitoring of antimicrobial resistance and antimicrobial drug use in animals

Lucia noted that the FDA is also working on plans to finalize guidance on the duration of antimicrobial use, stewardship of antimicrobial use in companion animals and a long-term strategy for collecting antimicrobial use data in the next two years.

Lastly, Lucia briefly mentioned the FDA’s international efforts to harmonize global standards for animal and public health by collaborating with global partners to solve shared issues.

Transformation of FDA’s Office of Regulatory Affairs into the Office of Inspections and Investigations

The final presenter of the day was Michael Rogers. Rogers began by announcing that the Office of Regulatory Affairs will now be known as the Office of Inspections and Investigations (OII). He explained that this name change reflects cross-programmatic decisions that have led to the transformation.

OII will focus on its core operations: inspections and investigations and import operations and emergencies. The change will involve dedicated inspectorates for human and animal drugs, foods, biologics, bioresearch monitoring, devices and radiological health, and tobacco. Only a small group of inspectors will be assigned to cosmetics, inspections in that area are based on consumer complaints. Rogers also discussed his work on investing in what he said is the FDA’s “most important resource," investigators. Due to a high attrition rate among investigators, he explained, “there is a significant cost to the Agency when you lose a trained investigator.” He added that much of the FDA’s work depends on the efforts of investigators on the frontlines. To address this, steps will be taken to improve domestic and international travel for investigators, as well as to modernize their training.

Finally, Rogers emphasized the importance of OII communicating its role in the industry. For example, he detailed that OII’s regulatory activities contribute to the removal of approximately one billion unsafe products from the market every year.

Conclusion