Industry Criticizes FDA for Underestimating Quality Metrics Collection Burden

The FDA has underestimated the burden that would be imposed on drug manufacturers in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance.

The agency received 77 comments on the guidance. While most comments were positive, industry has asked the agency to move slowly and offer a phased-in approach to gathering quality metrics.

PhRMA points out that while much of the reportable information already is collected by many companies, practices for tracking quality metrics vary widely.

For example, some organizations have centralized release and stability testing facilities, so they don’t collect out-of-specification data separately from each manufacturing site — data the FDA is asking for as one if its 10 quality data points.

ISPE adds that preliminary data from its own quality metrics pilot program indicated that an average of about 25 hours are required to collect data per product as required by the draft guidance. The FDA’s own estimate was 10.6 hours per product. Additionally, costs for adjusting internal IT systems and incorporating additional review and retention of data should be factored in, industry says.

Assessment Period

BIO encourages the FDA to implement a two-year assessment period during which data are collected from industry, and open dialogue to determine a set of metrics and definitions that will provide optimal value to the agency.

That two-year period also would allow the agency and industry to pinpoint any unintended consequences of metrics collection.

Industry also wants the FDA to be more transparent about data assessment, particularly how outcomes and conclusions gleaned from data are determined and communicated, ISPE says.

The FDA should provide more details on how data will be used to make risk-based inspectional decisions, BIO says. The group recommends that manufacturers be informed of how they fall within their peer groups. Definition of a peer group, such as company size, type of products and number of products also is welcomed, the group adds.

Despite the comments, industry groups still questioned whether the FDA has the legal authority to request the metrics from industry.

For example, GPhA says the program exceeds the agency’s statutory authority. It adds that manufacturers would need to make changes to collect the data, disrupting the manufacturing process and potentially causing supply shortages.

As for the metrics themselves, ISPE reiterates its stance that the “annual product review” or “product quality review on time rate” metric be deferred as a potential future metric, and the FDA should begin with only lot acceptance rate, product quality complaint rate and invalidated out-of-specification rate.

PhRMA agrees that the metric has limited value and could produce unintended consequences, encouraging firms to sacrifice substance in the interest of meeting deadlines. The group suggests tweaking it to focus on the content of the reports instead of timeliness.

Complaint Metric

For the product quality complaint rate metric, Amgen asks that it be determined by dividing the number of complaints by the number of units distributed, rather than the number of lots released. Because the number of units per lot varies between sites and companies, an analysis of the data between similar product types would be unachievable, the company says.

PhRMA adds that because complaints may be received at any time over the shelf life of a lot, an annualized number, reported by quarter, should be required.

Finally, Amgen proposes the addition of a metric to help predict drug shortages — for example, one that determines active pharmaceutical ingredient and drug product inventory levels.

Stay up to date on regulatory stories like this one by subscribing to the Drug GMP Report. For over 20 years, drug manufacturers have relied on DGR for the latest on FDA’s interpretation and enforcement of cGMPs and the Quality Systems Regulation — information you need to stay in compliance.