How FDA’s Program Alignment Initiative Will Impact Clinical Trials

November 9, 2017

By Angela Woodall, Healthcare and Environmental Reporter.

In 2015, several pharmaceutical manufacturing companies inside and outside the United States received a warning from the U.S. Food and Drug Administration that their manufacturing standards were deviating from good practices. Some problems related to data controls, others to anti-contamination procedures. Enforcement of the standards, known as CGMP, is one of the multiple roles required of the FDA and one that may see a sharpening of focus as the result of the agency’s program alignment initiative.

Launched in May 2017, the most immediate change that clinical trial sponsors and CROs may  see as a result of the realignment is the way oversight duties are grouped by product rather than by geography. Inspectors and compliance staff will specialize in five commodity types. The category that covers clinical trials is called the Office of Bioresearch Monitoring Operation, or OBIMO:

On May 15, 2017, as part of the broader agency Program Alignment initiative, the U.S. Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA) will implement a program-based management structure that aligns staff by FDA-regulated product. This organizational approach replaces a management structure based on geographic regions.

This is meant to deepen their expertise about, among other things, relevant protocols, test result data and production quality, according to a legal reading of the FDA decision. That’s good for the safety of products but may mean that sponsors and CROs need to anticipate inspectors with more detailed questions when they get to the trial or the manufacturing site. They can also watch for changes in guidance documents and standard procedures by the FDA as a result of the realignment.

The restructuring comes on the heels of a similar 2015 realignment measure, which resulted in the Office of Pharmaceutical Quality as well as a boost to user fee programs (UFAs).  So the FDA expects the two initiatives and funding taken together to point in the direction of investigators with deeper expertise, resulting in more pointed questions and more stringent reviews. On the flip side, the new arrangements could could save time and money encouraging different interactions between both sides.

The question is when the impact will be felt. The realignments originate from a 2013 directive that called on staff to find ways the agency could cut costs, streamline operations and improve inspections. But, more than four years later, when or how the impacts will be felt in labs is uncertain because of tumult in Washington, D.C: Scott Gottlieb took his seat as the new commissioner within days of the release of details on the restructuring.

Angela Woodall, Healthcare and Environmental Reporter

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