Janet Woodcock is the new acting FDA Commissioner – why QbD scientists are hopeful
Janet Woodcock MD, formerly the director of CDER, FDA, has been recently appointed as the acting FDA Commissioner. This isn’t the first time working at the FDA commissioner’s office as she has held several roles there from 2005 until 2008. Here is her announcement to the FDA staff regarding her transition.
Why should we – the QbD scientists – take notice? Because under Dr. Janet Woodcock’s leadership, Quality-by-Design began and has grown ever since.
In 2002, the FDA’s report – State of Pharmaceutical Manufacturing – described a series of ongoing problems and issues in pharmaceutical manufacturing using traditional approaches. The assessment uncovered low process efficiency and effectiveness from waste and rework, high cost of regulatory compliance, and low level of technology compared to other industries.
As a response, Dr. Woodcock launched the “Pharmaceutical Quality for the 21st Century” initiative. Formally known as Pharmaceutical CGMP Initiative for the 21st Century – a Risk Based Approach, the goal was to modernize pharmaceutical product quality and develop flexible regulatory approaches to support continuous improvement in the pharmaceutical industry.
In 2005, at the Pharmaceutical Quality Assessment Workshop (October 5), Janet stated the desired goal as:
“A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drug products without extensive regulatory oversight.”
In 2007, at the Pharmaceutical Quality Initiatives Workshop (March 2), FDA broke down the steps to reach this goal.
- Manufacturers have extensive knowledge about the critical product and process parameters and quality attributes
- Manufacturers control process through quality systems over the lifecycle and strive for continuous improvement
- FDA Role: Initial verification, a subsequent audit
- No manufacturing supplements (may be needed for formulation change)
Of many accomplishments under the Pharmaceutical Quality for the 21st Century A Risk-Based Approach, Quality by Design – QbD – has been the highlight for us, QbD scientists.
Progress of Quality by Design
Some of QbD progresses made during Janet Woodcock’s leadership are:
- Established CDER’s Office of New Drug Quality Assessment (ONDQA) and a risk-based pharmaceutical quality assessment system (PQAS) based on the application of product and process understanding.
- QbD Pilot programs for NDA(New Drug Applications) and BLA(Biologic License Applications)
- Implemented Question-based Review (QbR) Process for CDER’s Office of Generic Drugs. QbR serves a dual purpose of providing guidance to reviewers in preparing consistent and comprehensive evaluations of ANDAs while assessing critical formulation and manufacturing process variables and providing the industry with guidance. More on QbR below:
- Restructuring further with Office of Pharmaceutical Quality
With the ongoing COVID-19 situation, she will most likely focus on urgent matters at the time but we can remain hopeful that QbD will continue to flourish under her leadership.
You can listen to her talking about the progress of QbD here…
UPDATE: April 12, 2021 The new director of CDER FDA is Patrizia Cavazzoni M.D.