US FDA launches overarching Office of Pharmaceutical Quality

In a media briefing on Monday, Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told reporters that the goal of the new OPQ is to bring together disparate programs within CDER to provide a clearer and more predictable way to measure drug quality.

The office wants to continue to ensure that patients receive high quality products and that industry understands “clear standards for inspection and enforcement action​,” Woodcock said, noting that the agency will advertise “very soon for the director of the office​.”

Office of Surveillance​

“We’re trying to use a risk-based approach to look at what things could negatively influence the performance of a product​,” Woodcock added. The agency will be tasked with adding new performance metrics by which it will evaluate industry, though any shift in metrics will come with new draft and final guidance.

Within the OPQ, the agency will create an Office of Surveillance, which will be tasked with creating new quality metrics, and will let OPQ inspectors know if they need to inspect manufacturing facilities during an NDA (new drug application) review.

After a new industry range of metrics is published, she added that FDA will take “the first two years to make sure we’re measuring apples and apples​” and allow facilities to see where they stack up against competitors.

The agency will undergo the “same type of work but new inspection protocols will be​” standardized and help industry understand how pre-approval and surveillance inspections can be done, Woodcock said.

“Once we get this rolling, we hope to work on an international level – hope to move to a more quantitative, objective way to get more predictability​,” Woodcock added.

Modified Release Problems​

Though she stressed the creation of the OPQ is “not a direct response to any one issue​,” Woodcock did mention that modified release dosage forms “are the biggest problem​” in terms of quality.

She added that under certain conditions, modified release tablets can morph, and dissolution tests are “not an appropriate control mechanism​,” and the agency “can’t do a bioequivalence test on every lot​.”

Woodcock also called out compounding facilities as being particularly difficult to oversee. “Compounding is hard in general – the quality of the operations are at a level that require a lot of oversight and there are a lot of problems​,” she added.