- August 29, 2019
FDA issued draft guidance at the end of April on voluntary recalls’ initiation process under 21 CFR part 7 subpart C.
“We know that in order for a recall to be effective and timely, it’s crucial that companies be prepared in advance to take all necessary steps for when a recall is initiated,” says FDA Associate Commissioner for Regulatory Affairs Melinda Plaisier. For this reason, work around voluntary recalls “is also keenly focused on guiding companies on steps needed to ready their facilities and staff for possible recall situations.”
The draft guidance aims to clarify how manufacturers can prepare, plan and work with agency staff, with the goal of helping to ensure that voluntary product recalls are initiated properly and in a timely manner. The proposed recommendations fall under three categories — proper personnel training, thorough and organized record-keeping and adequate recall initiation procedures. They include using modern record-keeping approaches like “blockchain technology” and maintaining recall initiation procedures to avoid overlooking necessary actions and minimizing disruption on operations, among other recall elements.
The new draft guidance document is the culmination of the work for “proactive and systemic improvements to FDA’s recall processes” over the past 18 months, adds Plaisier. It follows on the heels of FDA final guidance on the use, content and circumstances regarding public warnings and public notifications for either firm-initiated recalls or FDA-requested recalls, including for product corrections.
Plaisier says efforts to improve recall processes “have resulted in more timely information being available to consumers, allowing them to protect themselves and their families.” She cited voluntary recalls of angiotensin II receptor blocker drugs, such as valsartan, losartan and irbesartan, and that of Roche Diagnostics’ test strips for home-use Warfarin monitoring, as some examples of these results.
Of note, the Agency is authorized to issue mandatory recalls of devices but not of drugs. Its voluntary malfunction summary program and “hidden database” for devices and combination products recently came under fire over media reports that underscored lapses in regulatory oversight of adverse events.
Under part 7 subpart C, the Agency has authority to intentionally delay public notifications of recalls for certain drugs and devices if, in its judgment, these notifications would lead to “unnecessary and harmful anxiety in patients and that initial consultation between patients and their physicians is essential.” FDA intends to “refine and improve” its ability to disseminate this information, Plaisier notes.
REFERENCE: RAPS Regulatory Focus; 23 APR 2019; Ana Mulero