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Michael Causey

FDA Compliance

New CDER Guidance Could Affect Quality Management Efforts

Be proactive in anticipation of new leadership and direction at the FDA

Published: Tuesday, February 28, 2017 - 13:03

Former FDA Chairman Robert Califf, M.D., stepped down on Jan. 20, 2017, and it’s not always easy to predict what the Center for Drug Evaluation and Research (CDER), or any FDA agency, will accomplish under a new chairman. Efforts at quality management could be affected by what appears to be an aggressive guidance agenda for 2017 from the CDER.

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 affected. 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 Donald Ashley

While life sciences manufacturers await word on who will run the FDA, on Jan. 9, 2017, the CDER installed Donald Ashley as the director of the Office of Compliance. He brings more than 20 years of compliance and enforcement experience in criminal and fraud investigations to help steer FDA enforcement policy.

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 suggests 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 e-records.

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

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) 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 effect of a black swan

Finally, never underestimate the effect 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 had to deal with during 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.

First published Feb. 14, 2017, on the AssurX blog.


About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.