Food And Drug Administration | FDA Consultant

The Food and Drug Administration (FDA) Commissioner, Dr. Robert Califf, recently testified in front of a Senate Appropriations subcommittee about core programs for the 2025 budget process. Executives at FDA are asking for a $341 million increase in the annual budget (currently proposed at $7.22 billion) compared to the previously approved FY 2024 budget.

Drug Shortage

One topic that received significant interest was drug shortages. Dr. Califf confirmed there are still over 200 drugs classified as in shortage. FDA has requested over $12 million to help rectify the problem and bring greater predictability to supply chain problems. Additionally, the ability to clarify pharmaceutical manufacturing problems that may arise appears to be a priority to FDA.

Regulatory Affairs

The Office of Regulatory Affairs (FDA ORA) has asked for an additional $2.7 million to be added to the proposed budget. Specifically, ten new full-time employees are proposed as headcount to address issues with both drug shortages and problems inside the supply chain. $3 million is specifically proposed to recruit new FDA inspection resources who can help identify these types of scenarios in advance during routine FDA inspections.

Further, continued growth in regulatory applications for both medical device manufacturing and biologic manufacturing facilities was mentioned as critical to keep pace with the industry’s need for FDA approval inspections. For life science industry employees, the slowdown in FDA inspections has had mixed reactions.

Michael Rogers, associate commissioner for regulatory affairs at the FDA’s Office of Regulatory Affairs, has also recently commented about the need for more FDA auditors due to investigators who have recently retired. According to Rogers, FDA investigators “have been underrecognized and underappreciated”, which may have led to attrition over time at the agency.

Avian Influenza Virus

Dr. Califf continued the discussion with lawmakers about the potential dangers of avian influenza (or bird flu) and vaccine production. Commentary revolved around how prepared the United States government is in responding to virus mutations if bird flu could spread to humans. Further, Dr. Califf elaborated on how investments in personal protective equipment (PPE) & funding for vaccine manufacturing could help the potential problem.

Finally, short-term solutions focused on the safety of dairy workers if the virus infected the U.S. milk supply, and new research options to study how quickly the avian influenza virus may evolve.

IT Infrastructure

Finally, FDA has requested over $8 million to improve critical infrastructure and upgrade technology across the agency. The goal is to modernize many of the legacy workflows the regulatory agency uses and increase the analytical potential of data analysis.

The entire presentation can be found at this link.

Pharmaceutical Consultant & Pharma Consulting Services

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Combination Products

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21 CFR Part 11
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About Regulatory Compliance Associates

food and drug administration Regulatory Compliance Associates^® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

Founded in 2000
Headquartered in Wisconsin (USA)
Expertise backed by over 500 industry subject matter experts
Acquired by Sotera Health in 2021

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health^®.

Sotera Health Company, along with its three best-in-class businesses – Sterigenics^®, Nordion^® and Nelson Labs^®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Commitment to Quality

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

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