Quality Management Efforts: 2017 CDER Guidance Agenda Impact
Former FDA Chairman Robert Califf
Former FDA Chairman Robert Califf, M.D. stepped down on January 20, President Trump’s Inauguration Day. It’s not always easy to predict what CDER, or any FDA agency, will accomplish under a new Chairman.
What’s the impact of a new FDA Chairman?
Many rumored candidates seem to indicate that they would reign in the FDA in significant ways. The CDER’s guidance agenda and other activities, including inspections, could be impacted. On the other hand, any perceived threat to consumers, such as a serious drug recall, could always force the FDA and CDER to step up pharmaceutical manufacturer enforcement activities.
CDER taps Enforcement Director Ashley
While life sciences manufacturers await word of who will run the FDA, CDER installed Donald Ashley as the Director of the Office of Compliance on January 9. He brings more than twenty years of compliance and enforcement experience in criminal and fraud investigations to help steer FDA enforcement policy.ties.seem to indicate that they would reign in the FDA in significant ways. The CDER’s guidance agenda and other activities including inspections could be impacted. On the other hand, any perceived threat to consumers, such as a serious drug recall, could always force the FDA and CDER to step up pharmaceutical manufacturer enforcement activities.
Will Enforcement Director Ashley have more of an impact than new FDA Chairman?
Ashley previously worked at the U.S. Embassy in Manila, Philippines. Additionally, he served as the Associate Director for the Justice Department’s Office of International Affairs in the District of Columbia. His background suggest he will be a strong advocate for meeting FDA compliance regulations. He could ultimately have more impact on the CDER than an incoming FDA Chairman. The new FDA Chairman will certainly be adjusting to a considerable amount of required administrative duties.
Official CDER 2017 Guidance Agenda
There are more than a dozen promised guidances that pharmaceutical manufacturers should keep an eye on. Many of the prospective guidances demand strong document control, change management, and easy access to erecords.
Guidance Agenda highlights
Among the most important potential guidances in 2017 are those focusing on:
- Postmarketing Safety Reporting for Human Drugs and Biological Products
- Format and Content of a Risk Evaluation and Mitigations Document, Revised Draft
- Standardized Format for Electronic Submission of NDS and BLA Content and Planning and Conduct of Bioresearch Monitoring Inspections for Submissions to CDER
- Providing Regulatory Submissions in Electronic Format – Submission of Manufacturing Establishment Information
- Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards
- Providing Regulatory Submissions in Electronic Format – Standardized Bioanalytical Data
- Field Alert Report Submission related to Pharmaceutical Quality/Manufacturing Standards (CGMP) Risk Management Guidance: Cybersecurity
Optimize your quality management efforts
Clearly, after reviewing the planned 2017 guidances, the key to FDA compliance for pharmaceutical manufacturers must include having a firm grasp on the document management process. An automated document management solution that is part of a versatile quality management system (QMS) like AssurX is a necessity in 2017.
Some things will not change. Period.
Given an uncertain 2017 for the FDA, experts advise life sciences manufacturers to take the steps they can without waiting around to see what the FDA will do. For example, even the most stripped down FDA is still going to tell FDA inspectors to look at corrective and preventive action (CAPA) programs. That simply will not change. Same for the document management process. Ditto the overall quality management system (QMS).
Never underestimate the impact of a black swan
Finally, never underestimate the impact of a black swan on quality and compliance management. A black swan is an unforeseen event that can blindside an industry, e.g. a drug tampering case such as Tylenol in the 1980s.
Be proactive with your quality and compliance management efforts
Of course, it is always important to have some sense of what the FDA will do next — especially when it comes to deciphering FDA inspection and enforcement trends. That said, it’s dangerous to sit back and wait for the FDA to tell you how to run your business. Instead, be proactive. Develop your own plan. Be ready to defend it.
The result? You’ll be less susceptible to how the wind blows at the FDA in 2017 and beyond.