FDA Launches Pharma Quality Office To Improve Drug Manufacturing, Agency Teamwork
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
We should expect to see even more attention lavished on pharmaceutical quality in 2015. This week, the FDA announced the launch of its long planned-for Office of Pharmaceutical Quality (OPQ). This office will be responsible for setting quality standards for both brand name and generic drugs to ensure that pharma manufacturing firms maintain quality control during the manufacturing process, Reuters reports.
Back in 2012 when Woodcock first announced the plans to launch OPQ, she said, "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. We must be strategic and have systems in place to identify and respond to quality issues before they become problems.” She highlighted the importance of this as the pharmaceutical industry and the drugs it proffers are manufactured more regularly outside of U.S. borders and become more heavily reliant on global raw materials.
In recent years, quality has been a prime concern, and a number of media sources waste no time in filling their headlines with news of the latest recalls, drug bans, and FDA “crack-downs,” both domestically and abroad. However, the OPQ was not created to address a lack of quality in the industry, but rather to ensure manufacturing is more systematic.
Indeed, drug recall numbers in recent years suggest that quality is improving. According to Reuters, the number of drug recalls went down by 20 percent between 2013 and 2014, and dangerous class I recalls were reduced by 30 percent. Overall, 2013 to 2014 boasted recall stats that suggest the industry is making progress with quality. From 2013 to 2014, the total number of recalled units stood at 70 million, as opposed to the annual average of 225 million units between 2010 and 2012.
One big order of business the new OPQ plans to tackle is addressing the quality of extended release drugs. These drugs, developed to be slowly released through the body, have been put in the spotlight because of their difficulty to test and because they could require different standards compared to other drugs, Bloomberg reports. Recalls for this particular type of drug have often been spurred by improper dissolution or because the drug lacks the efficacy of the brand-name product.
In the OPQ, there are 30 people employed to monitor modified-release drugs and investigate their efficacy in what Woodcock is describing as a “huge scientific effort.” Lawrence Yu, deputy director of OPQ, says the office plans to work closely with researchers to help determine the best methods and standards for testing the ways extended-release drugs are absorbed when introduced in the body.
The OPQ also plans to review generic and brand name drug applications in an effort to open up communication between reviewers and inspectors, Yu revealed in an interview with the Wall Street Journal blog. Companies submitting drug applications in the future will send them to the OPQ for review. Naturally, review time is a concern for the industry, but Yu believes that the 10 month goal for NDAs and the six month goal for breakthrough therapies will be met, especially because “it will be easier [for staffers] to communicate with each other… Let’s say a reviewer found some issues [with a manufacturing process referenced in an application], but the inspection was done already and we had to go back and check again at the last minute. Maybe there are three weeks left before the [review date]. In the future, we’re hoping such last-minute situations will be minimized, because reviewers can find potential issues and verify them by working with inspectors,” Yu told the WSJ blog.
The launch of the OPQ also means that drug companies can expect a future guidance that will establish quality metrics for drug manufacturers, however there has been no indication as to when this will be released for industry comments.