A broad group of industry organizations is urging the FDA to delay its quality metrics reporting program, which would require drugmakers to aggregate information on the number of lots started, released for distribution and found out-of-specification, as well as the number of quality complaints reported.
Six organizations — PhRMA, AAM, the International Society for Pharmaceutical Engineering, the Pharma & Biopharma Outsourcing Association, the Active Pharmaceutical Ingredients Committee and the Bulk Pharmaceutical Task Force — signed a joint letter saying the burden of the metrics collection outweighs the benefits, and that more dialogue with the FDA is needed before any further guidance, rulemaking or other actions by the agency.
The groups also submitted comments individually, responding to the FDA’s revised draft guidance published November 2016, which adopted a phase-in approach to reporting, reduced the number of required primary metrics and supported both product and site reports.
Specifically, PhRMA asked FDA to clarify the impact quality metrics would have in inspectional risk management for sites participating during the voluntary phase of the program. The group also proposed, if the agency continues as proposed, to extend the first submission window for 2017 data from the month of January 2018 to the entire 2018 calendar year.
The AAM, formerly GPhA, said the FDA’s proposed timeline is unreasonable—companies would have to currently be collecting their metrics data in order to meet the window, before the agency has addressed industry questions on November’s revised draft guidance. The FDA had previously extended the draft guidance’s comment period, which closed this week.
The AAM also said that, while the FDA describes the program as voluntary and does not have authority to force companies to contribute, the agency’s plans to publish a “Reporter List,” which the AAM said would cause reputational harm to the companies that do not participate.
Following the voluntary phase of the program, the FDA intends to use notice-and-comment rulemaking to develop a mandatory quality metrics program to support its risk-based assessment activities.
Separately, BIO urged the FDA to hold to its position that the submitted data be kept confidential, and exempt from disclosure under the Freedom of Information Act. In the final guidance, the FDA should clearly state the basis for FOIA exemptions, BIO said. In general, the organization said it was supportive of the FDA’s effort to modernize oversight of drug quality.
The way drug and biologics concerns report quality metrics data to the FDA is about to change for good. A regulation nearing finalization will affect every company large and small that manufactures, prepares, propagates or compounds active ingredients or pharmaceutical products produced and sold in the U.S. Submission of Quality Metrics Data: The Why, the When and the What. Attend the live webinar April 28!