PhRMA Steps Up Campaign to Delay Quality Metrics

Pharmaceutical and Research Manufacturers of America (PhRMA) is urging FDA to slow down on its initiative to use quality metrics as part of its risk-based inspection paradigm. In the first of what it says will be a series of blog posts on the topic, PhRMA says it “strongly recommends” that the agency “adopt a phased-in approach to rolling out this ambitious program. The phased-in approach would span five years with an initial two year voluntary period and include milestone reviews against predetermined criteria. This approach would alleviate concerns around transparency and confidentiality, operability and legal authority.”



 

Last year, FDA released a draft guidance on “Request for Quality Metrics” that outlined the data FDA plans to request from pharmaceutical and biologic manufacturers as part of the risk-based inspection program. The initial quality metrics FDA intends to request will help it calculate the following:Lot Acceptance Rate = 1 –x (x = the number of specification-related rejected lots in a timeframe divided by the number of lots attempted by the same establishment in the same timeframe).Product Quality Complaint Rate =the number of product quality complaints received for the product divided by the total number of lots of the product released in the same timeframe.Invalidated Out-of-Specification (OOS) Rate = the number of OOS test results for the finished product invalidated by the establishment divided by the total number of OOS test results divided by the total number of tests performed by the establishment in the same timeframe.Annual Product Review (APR) or Product Quality Review (PQR) on Time Rate = the number of APRs or PQRs completed within 30 days of annual due date at the establishment divided by the number of products produced at the establishment.

“While FDA recognizes the value of quality metrics, we also recognize that individual data points and metrics are not solely indicative of the state of quality of the establishment or products,” the guidance said. “Rather, FDA intends to use quality metrics data in context with other sources of quality data... FDA intends to use quality metrics data to further develop FDA’s risk-based inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve the efficiency and effectiveness of establishment inspections, and to improve FDA’s evaluation of drug manufacturing and control operations. FDA expects that the initial use of the metrics will be to consider a decreased surveillance inspection frequency for certain establishments.”



In comments on the guidance, PhRMA said that a phased-in approach would “prevent any unintended consequences that can arise when embarking on such an innovative and transformative approach to regulation. Moreover, any mandatory program subject to enforcement action could be implemented only via formal rulemaking. PhRMA strongly suggests that FDA engage in such rulemaking processes—failure to do so makes the quality metrics program unnecessarily vulnerable to legal challenge after PhRMA member companies have invested millions of dollars and countless hours in preparing to meet the program’s requirements. PhRMA also strongly encourages FDA to publicly state its commitment to carefully balancing the benefits of transparency in how quality metrics data are analyzed and used with the need to protect confidential commercial information.”