In late November, FDA issued a revised draft of its guidance on the submission of quality metrics data. The initial draft of the guidance, issued in July 2015, had announced FDA’s intent to require the submission of quality metrics data using, among other things, its relatively new authority to request certain records or information in advance or in lieu of an inspection: Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA), added by Section 706 of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA). The Agency’s proposed approach met with some pushback from various stakeholders, who raised both technical issues and concerns that FDA lacks the legal authority to compel the submission of quality metrics data as described in the draft guidance.
More than a year later, FDA has published a substantially revised version of the draft quality metrics guidance. Here are five key takeaways from the revised draft guidance:
1. Submission of quality metrics will be voluntary until FDA undertakes rulemaking
In the revised draft guidance, FDA announces its intent to initiate a “voluntary phase” of the quality metrics reporting program. The Agency reiterates its authority to require the submission of quality metrics data under Section 704(a)(4) of the FDCA, but does not intend to exercise that authority in implementing this voluntary phase of the reporting program. FDA also notes that it does not intend to take enforcement action based on errors in a quality metrics submission made as part of the voluntary phase of the program, provided the submission is made “in good faith.”
FDA anticipates accepting the voluntary submission of data through an electronic portal starting in January 2018. After evaluating the results of the voluntary phase of the quality metrics program in 2018, the Agency intends to engage in the rulemaking process.
2. FDA is focusing on a more limited set of metrics
In the draft guidance published in July 2015, FDA sought the submission of four primary metrics and three optional metrics. In the revised draft guidance, FDA has pared that down to three primary metrics: lot acceptance rate, invalidated out-of-specification rate, and product quality rate. The Agency notes that it intends to use this voluntary phase of the program to learn more about this limited set of quality metrics and associated analytics, and that related metrics may be added as the program evolves.
3. All types of manufacturing establishments can participate
FDA focused on reporting at the product (active pharmaceutical ingredient (API) or finished dosage form (FDF)) level in the initial draft guidance. Product-specific submissions were to include data for each manufacturing establishment. FDA now states that it continues to encourages the submission of product reports segmented by manufacturing site but revised the draft guidance to contemplate submission of either (a) product reports segmented by site or (b) site reports segmented by product. FDA also provides that all types of drug manufacturing establishments (e.g., manufacturers of excipients) can participate in the voluntary phase of the reporting program.
4. FDA intends to publish a tiered list of reporter categories to incentivize the submission of quality metrics data
As an incentive for the submission of quality metrics data during the voluntary phase of the program, FDA intends to publish a list of five “recognition categories” of product and site reporters, ranked by whether the reporter has submitted some or all the requested data. For example, the category “Product Reporter Top Tier” will include product reporters that submit all the requested data for all covered establishments in the supply chain for the product for the full year reporting period. “Product Reporter Mid Tier” includes product reporters that identify all covered establishments in the manufacturing supply chain for the product and submit all requested data for at least one of those establishments for the full year reporting period.
5. FDA continues to have high hopes for the quality metrics program
Despite FDA's decision to downshift to a voluntary reporting program, the revised draft guidance reflects the Agency's continued belief in the value of quality metrics data to inform its risk-based decisionmaking. During the voluntary phase of the program, FDA intends to use quality metrics reporting to inform its surveillance inspection risk-based model and share how that reporting has reduced the frequency of inspections. FDA also expects to use the submissions collected on a voluntary basis to facilitate early resolution of potential quality problems, reduce the likelihood of disruptions in the drug supply, address potential drug shortages, help FDA prepare for and hone the focus of its inspections, and encourage manufacturing improvements across the drug lifecycle.
FDA intends to expand on these goals during its “fully implemented” quality metrics program, after rulemaking is complete. This implementation process is likely to take years, and the probability of it moving forward apace remains to be seen under the new administration. The burdens and benefits experienced by reporters during the voluntary phase of the program likely will affect the scope and timing of any future rulemaking process.