USFDA Audit Team and their responsibility: A Overview

USFDA team working and monitoring in a almost all the domain to ensure the safety of the subjects as well as patients rights and quality of the pharmaceutical products products. It is one of the best regulatory team in the world to ensure that doing compliance assessment in Health Domain as well as related domain.

The following tree diagram shows that the USFDA offices and related Key personnel's. 

Source of the image:  USFDA website.

Now,we can discuss different department works under the USFDA, their mission and their responsibilities in shorts.

Following are the major departments,

There are five body working under one director for USFDA, Cynthia Schnedar J.D is a managing director in USFDA.

Five teams are working and checking compliance for sectors in pharmaceutical as well as in research filed.

1.    Office of Prescription Drug Promotion Letters

2.    Office of Compliance/Immediate Office 

3.    Office of Manufacturing Quality Letters

4.    Office of Scientific Investigations Letters 

5.    Office of Drug Security, Integrity and Recalls

1.    Office of Prescription Drug Promotion Letters (OPDP)

OPDP works with the mission “"To protect the public health by ensuring that prescription drug information is truthful, balanced, and accurately communicated.  This is accomplished through a comprehensive surveillance, enforcement, and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers." (Source : USFDA Website).

Many of the NDA products were launch in the year before that the provided product information and labeling contents of the particular product is very important thing to has to be compliance with the regulatory or not. Product summary and its content, instruction to the patients, side effects and contraindication etc are the some points to be captured in the labels.

It’s very important to have control on the advertisement information and promotion letter which are provided by the pharmaceutical company.  

OPDP personnel are responsible for the reviewing prescribed drug advertisement and labeling content to ensure that provided information is false or misleading. OPDP engaging the many of the other task with other department / division of the FDA on the issue related the labeling and the promotional contents. Some of responsibilities are as follows;

A.   Providing written comments to pharmaceutical sponsors on proposed promotional materials to ensure clear and unambiguous communication of the laws and regulations relating to prescription drug promotion.

B.   Reviewing complaints about alleged promotional violations.

C.   Initiating enforcement actions on promotional materials that are false or misleading.

 

OPDP Organization

Director's Office

Thomas Abrams, Director

Mark Askine, Deputy Office Director

Michael Sauers, Staff Supervisor

Catherine Gray, Senior Consumer Safety Officer

Jean-Ah Kang, Special Assistant

Robyn Tyler, Regulatory Counsel Team Leader

Julie Chronis, Regulatory Counsel

Holli Kubicki, Regulatory Counsel

Kathryn Aikin, Social Science Team Leader

Kevin Betts, Social Science Analyst

Amie O'Donoghue, Social Science Analyst

Helen Sullivan, Social Science Analyst

Barbara Chong, Training and Support

Sheila Ryan, Health Science Policy Analyst Team Leader

Elizabeth Pepinsky, Health Science Policy Analyst

Diane Nhu, Regulatory Project Manager

Olga Salis, Regulatory Project Manager

Becki Vogt, Regulatory Project Manager

Michael Wade, Regulatory Project Manager 

Sabrina Smith, Administrative Officer

Sharon Smith, Technical Information Specialist

Division I

Andrew Haffer, Director, Division I

Lisa Hubbard, Deputy Director

Elaine Cunningham, Evidence Review

Janet Daly, Program Specialist 

Team 1 – Neurology, Psychiatry

Mathilda Fienkeng, Team Leader

• Aline Moukhtara, Reviewer
• Susannah O’Donnell, Reviewer
• Dhara Shah, Reviewer

Team 2 – Hematology/Oncology (blood cancers)

Katie Davis, Team Leader

• Ray Conklin, Reviewer
• Jim Dvorsky, Reviewer
• Wendy Lubarsky, Reviewer 
• Nisha Patel, Reviewer

Team 3 – Oncology (solid tumors)

Jessica Cleck-Derenick, Team Leader

• Carole Broadnax, Reviewer
• Nazia Fatima, Reviewer
• Nick Senior, Reviewer
   

Team 4 – Addiction, Analgesics, Anesthetics, Antivirals

Sam Skariah, Team Leader

• Kemi Asante, Reviewer
• Jessica Fox, Reviewer
• Koung Lee, Reviewer
• Shenee Toombs, Reviewer

Division II

Robert Dean, Director, Division II

Twyla Thompson, Deputy Director

Nneka Onwudiwe, Evidence Review

Lisa Champion, Administrative Officer

Team 5 – Osteoporosis, Reproductive, Urology

Matthew Falter, Team Leader

• Jina Kwak, Reviewer
• Carrie Newcomer, Reviewer
• Lynn Panholzer, Reviewer
• Brian Tran, Reviewer

Team 6 – Dental, Dermatology, Metabolic & Endocrine

Melinda McLawhorn, Team Leader

• Ankur Kalola, Reviewer
• Charuni Shah, Reviewer
• Tara Turner, Reviewer

Team 7 – Allergy, Gastroenterology, Pulmonary, Rheumatology

Katie Klemm, Team Leader

• Adewale Adeleye, Reviewer
• Meeta Patel, Reviewer
• Roberta Szydlo, Reviewer

Team 8 – Anti-Infective, Cardiovascular, Medical Imaging, Ophthalmology, Renal, Transplant

Amy Toscano, Team Leader

• Adam George, Reviewer
• Zarna Patel, Reviewer
• Meena Ramachandra, Reviewer
• Puja Shah, Reviewer

Source: Organization Chart reference (Click link for more Information)

2.    Office of Compliance (Click here for more)

Office of compliance engage in the in the activity to ensure the safe effective and high quality of drugs in the public health domain. These teams also promote and protect the public health to ensuring the quality of the approved pharmaceutical drugs in the huge pharmaceutical markets.

Office of compliance have mission with “To promote and protect public health through strategies and actions that minimize consumer exposure to unsafe, ineffective, and poor quality drugs.” with the through excellence in risk- and science-based policy, surveillance, and enforcement, and they prevent consumer exposure to unnecessary risk from drugs throughout their lifecycle”.

The team assuring the  CDER mission assuring the safe and effective drugs are in Americans people hand. Team having following responsibility:

.

1.    Addressing public health risks associated with legal violations.

2.    Developing and overseeing drug compliance programs designed to reduce consumer exposure to risks of unsafe and ineffective drugs.

3.    Monitoring the quality of human drugs through inspectional coverage, product testing, and other pre- and post-market surveillance activities.

4.    Advising the Center Director and other Agency officials on regulatory and enforcement issues involving human drugs.

5.    Coordinating Center-Field relations and providing support and guidance to field offices on case development and regulatory actions.

6.    Ensuring uniform interpretation of standards.

7.    Developing policies and compliance strategies to ensure that over-the-counter and prescription drugs are of high quality, properly labeled, safe, pure, and meet applicable drug approval requirements.

8.    Developing policy and standards to achieve high product quality through application of current good manufacturing practice requirements. We accomplish this by coordinating surveillance and pre-approval inspections.

9.    Coordinating evaluation and classification of drug recalls and working with field offices for implementation of recalls.

10. Monitoring resolution of drug shortage situations involving compliance issues.

11. Implementing programs and projects to identify, assess, and prioritize the public health significance of legal violations.

12. Developing and using innovative enforcement strategies to reduce public health risks associated with legal violations.

Office of Manufacturing Quality:

 

     Office of manufacturing quality (OMQ) engaged in the activity to assure the quality of the manufacturing of pharmaceutical product. The assurance of the good manufacturing quality is most important part of the drug manufacturing cycle.

      As per the USDFA site OMQ doing the inspection with the vision of the “assures that quality medicines are available to the American public.”

      With the mission “Quality will be a global benchmark for regulation of pharmaceutical quality.”

The following is the OPQ structure

•                     Office of Operations

•                     Office of New Drug Products

•                     Office of Lifecycle Drug Products

•                     Office of Process and Facilities

•                     Office of Surveillance

•                     Office of Testing & Research

•                     Office of Biotechnology Products

•                     Office of Policy

     The OPQ involved in the various stream of activity like to directs overall regulation of pharmaceutical quality submission review, manufacturing facility assessment, and surveillance of the quality of marketed pharmaceutical products which are submitted to USFDA as new drug, ANDA or any other related.  

      Plans, develops, and directs the office strategy research, new technology, policy, and regulatory support for the various functions of subsidiary offices

       Encourage creative thinking, collaboration, and transparency

    Leads and coordinates partnerships between offices, centers, and agencies includes international harmonization and collaboration

     Evaluates and assesses product quality aspects of IND and NDA submissions, and API information supporting Abbreviated New Drug Applications (ANDAs)

• Conducts team-based reviews that include cross-OPQ collaboration and participation in inspection where necessary.

• Conveys risk-informed recommendations on approvability

•  Responsible for the communication of product-specific residual risk identified in the premarketing arena.

•                     Serve as a liaison to CDER’s Office of New Drugs.

Assessment of the CMC information in an application, including but not only: Drug substance/API information supporting INDs, NDAs, and ANDAs

•         Product quality standards, including: Formulation/product design

•         Product characterization

•         Clinically-relevant specifications, including those related to bio-pharmaceutics

•         Container/closure system

•         Stability

•         Product-related post-marketing requirements/commitments.

In the summary, OPQ having most attention on the manufacturing plants as well as those are submitted NDA and ANDA submission.

Following is the organization personnel who acting leader:

Office of Pharmaceutical Quality Offices and Leadership

The following individuals serve as office leaders:

Director: Michael Kopcha, Ph.D., R.Ph.
Deputy Director: Lawrence Yu, Ph.D.

• Office of Program and Regulatory Operations (OPRO): Giuseppe Randazzo (Acting)
• Office of Policy for Pharmaceutical Quality (OPPQ): Ashley Boam (Acting)
• Office of Biotechnology Products (OBP): Director: Steve Kozlowski
• Office of New Drug Products (ONDP): Sarah Pope Miksinski (Acting)
• Office of Lifecycle Drug Products (OLDP): Susan Rosencrance (Acting)
• Office of Testing and Research (OTR): Director: Lucinda (Cindy) Buhse
• Office of Process and Facilities (OPF): Robert Iser (Acting)
• Office of Surveillance (OS): Russell Wesdyk (Acting)

      Dear guy's our next department is "Office of Scientific Investigation". We will discuss in detail about this department. Because this is directly related to our CRO auditing and many more. Why this department was establish and what is mission of scientific investigation committee. I will posted very soon.