Posted 13 January 2015
By Alexander Gaffney, RAC
More than two years after first proposing the creation of a quality-focused office, the US Food and Drug Administration (FDA) has finally launched its new Office of Pharmaceutical Quality (OPQ) in a bid to standardize and centralize how drug quality is overseen by regulatory officials.
The creation of OPQ was first announced in September 2012 during a larger reorganization of the Center for Drug Evaluation and Research (CDER) by longtime director Janet Woodcock.
"Quality is the underpinning of everything we do, and it is imperative that we have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety," said Woodcock in a 2012 memo to FDA staff. "We must be strategic and have systems in place to identify and respond to quality issues before they become problems. This is especially critical due to the global nature of drug manufacturing and the sourcing of raw materials outside of the US."
OPQ was envisioned as a way to oversee drug quality throughout the product lifecycle, instead of the fragmented pre-market/post-market approach now taken by FDA. Accordingly, Woodcock announced that the Office of Pharmaceutical Science (OPS), Office of Generic Drugs (OGD), Office of Manufacturing and Product Quality (OMPQ) and Office of Compliance (OC) would all be ceding some of their quality functions to OPQ.
OPQ is also meant to address several endemic problems in the pharmaceutical sector, Woodcock has explained. Chronic drug shortages and a lack of manufacturing modernization have both factored into FDA's decision to create OPQ, Woodcock told the press at a 12 January 2015 media briefing.
OPQ Officially Launches
Now the real fun begins for regulators and industry alike. OPQ is now operational and an integral part of the drug review process, Woodcock told reporters.
Effective immediately, all new drug applications—both for new drugs and generic drugs—will be reviewed by OPQ under its new "unified approach to quality."
And that, Woodcock said, will mean some changes to how the agency accepts and reviews data about how a drug is manufactured. The idea of a "quality scorecard" was frequently mentioned during Woodcock's remarks. As envisioned by OPQ, the scorecard will include information generated by a sponsor to illustrate that their operations are compliant with good manufacturing practices and that they are on the lookout for potential problems. The idea is to match known or potential issues to quality metrics, Woodcock explained.
No Guidance… Yet
Crucially, this data will need to be transmitted to FDA during the review process. While a guidance document explaining what FDA will be looking for is under development, no release date has yet been confirmed. Woodcock also confirmed to Regulatory Focus that the agency will eventually require sponsors to submit quality metrics data in a standardized form so that its information technology systems can make better use of the information provided.
The agency does not plan to publish the quality metrics, and at several points during the conversation Woodcock opined that she believed the public would not benefit from having access to drug quality information. "Any drug that we allow to remain on the market will have good performance to the extent of our knowledge," she said, indicating that OPQ will enforce a strict dichotomy.
However, Woodcock said she did anticipate drug quality being a key piece of data drug purchasers might ask for in the future.
Potential Benefits (and Problems)
One potential problem for OPQ may well be the number of decisions it will have to process. By combining the quality functions of new drugs and generic drugs—including post-approval supplemental applications—Woodcock said the office will have to make more than 10,000 decisions each year. If the center can't recruit enough staff, that raises the prospect of potential backlogs.
However, Woodcock was eager to stress the potential benefits to industry if it complies with FDA's new quality approach. Companies with better approaches to quality should see more predictability in their drug applications, more manufacturing "up-time," and even fewer inspections by FDA. Woodcock also stressed that quality is often a stumbling block in accelerated drug reviews, such as for breakthrough designation products, and that more quality data might be able to speed up approvals.
Smaller companies may find it more difficult to implement these changes, Woodcock noted. "If you're a big company, you probably already have quality metrics that you collect," she said. Companies will be expected to both collect and send those metrics to FDA for review. Smaller companies, however, will need to start collecting those metrics—a process that may involve additional time or even staff.
But for Woodcock, the benefits to FDA are tremendous. "We only get to certain facilities every one, two, five years. The question is, 'What's going on in between [those inspections?’ We'd like to have some quantitative information on how they're doing."
The data OPQ collects from drug manufacturers will allow the agency to get a specific sense of how the industry is doing beyond "just an episodic basis," Woodcock added.