FDA Underestimates Burden to Industry to Collect Quality Metrics, Comments Say

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in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance.

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 for which the FDA is asking for as one if its 10 quality data points (DID, July 28).

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pilot program indicated that an average of about 25 hours are required to collect data per product as required by the draft guidance. 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.

The FDA received 77 comments on its quality metrics draft guidance, and while mostly positive, industry has asked the agency to move slowly and offer a phased-in approach to gathering quality metrics.

All four major industry groups — PhRMA, BIO, GPhA and ISPE — have urged a measured approach, allowing companies to prepare and implement any necessary infrastructure changes.

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 FDA.

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

Industry also wants 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, etc., 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 (DID, Aug. 25).

PhRMA suggests that the agency follow a notice-and-comment rulemaking process, which could be completed within the suggested two-year implementation phase.

GPhA agrees that 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 (DID, July 29).

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.

For the product quality complaint rate metric, Amgen asks that the metric 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, a metric that determines active pharmaceutical ingredient and drug product inventory levels. — Kellen Owings

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