Combating drug quality and supply shortages are ongoing concerns for stakeholders throughout the pharmaceutical supply chain, including members of SOCMA’s Bulk Pharmaceuticals Task Force (BPTF). As a means to address these concerns, the U.S. Food and Drug Administration (FDA) is working with the pharmaceutical supply chain on a new Quality Metrics Initiative (QMI). This new initiative, which has been in the works for several years, was a key topic of discussion during the recent DCAT Week 2015 in New York.
The QMI effort is being managed within the FDA’s Office of Pharmaceutical Quality’s Office of Surveillance and aims to create an industrywide metrics reporting scheme that will impact multiple stakeholders. These include finished drug formulators, compounders and packaging firms, active pharmaceutical ingredient (API) and excipient suppliers, as well as quality control labs. It will span all product categories – brand names, generics, biotech and over-the-counter products – as well as encompass all product types – solid oral, liquid and sterile delivery mechanisms. Perhaps the greatest challenge will be to harmonize this effort across a truly global supply chain, with a particular emphasis on the Indian market that dominates global generics.
QMI will focus on clear and simple objective measures. For example, a concerted effort is being made to develop definitions on such terminology as “batch” and “rejection rate.” Multiple stakeholders up and down the supply chain are being consulted, with a keen interest in identifying the most efficient methods of communicating this program to the market.
As part of the DCAT session, representatives from Pfizer and Teva each spoke about the roles they’ve played in helping the FDA create a robust yet pragmatic program that can be easily deployed. As the FDA representative commented, the thinking is to require all stakeholders to report annually on these metrics that are recorded on a quarterly basis. Each company would be graded and provided a “percentile comparison” of its performance against others in its class (much like SAT scores are delivered to students).
Ultimately, the FDA surmises that one of the key objectives is to help the agency identify manufacturing sites deemed of greatest priority for inspection. It is hypothesized that those facilities performing “best in class” may qualify for a reduced inspection frequency. Further, the FDA contends it will be better able to detect variation in product quality and assess the general state of a company’s internal quality system.
The data would be collected under the existing regulation FDASIA Title VII, Section 706. Each company would be required to provide data broken down by product type per manufacturing site.
But many questions remain. For example, does the process segment or dosage form have an effect on the manufacturing site’s overall quality standard? What effect does each metric have on drug recalls and compliance status? Are there correlations that might exist between metrics themselves (with the goal of eliminating “redundant” metrics that correlate closely with others)?
The FDA will provide an update on QMI during an industry stakeholder conference on June 2, 2015, in Bethesda, MD. Attendees will also learn how an industry-sponsored study (commissioned by the Institute of Pharmacological Engineers and McKinzie Consulting) is being evaluated by the FDA.
BPTF, which has advocated for years for greater scrutiny of the drug supply and a level playing field on inspections of foreign drug facilities, is tackling this issue head-on and plans to attend the meeting. For those companies that are not a member of BPTF but would like to get involved and have their voice heard, I encourage you to contact John DiLoreto at firstname.lastname@example.org.