Drug Recall & Remediation Planning In Asia – Strategic Considerations
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Abstract: When necessary, drug recalls require the company (i.e. product owner, licensee or manufacturer) to effectively implement its drug recall & remediation plan, in accordance with relevant regulatory procedures, in a timely manner, without undue delay, transparency and clarity. Given the multi-jurisdiction and differences across Asia, this is quite a challenge but needs to be mastered – out of necessity. This article provides a high-level overview of the strategic considerations and roadmap for companies when designing an effective plan.
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Introduction:
Mismanaging a drug product recall can be costly with potential fines, sanctions and legal action, as it impacts hard-earned trust and reputation, and provides an in-road for competitor products to step in. It is imperative therefore, for pharma and biotech companies (i.e. product owner, licensee or manufacturer) to have a ready-to-go and thorough drug/medicine product recall plan and team, in every market that the product is registered for sale.
A senior vaccine veteran once quipped, “A proper drug usage monitoring and recall plan is the backbone of assurance to healthcare professionals, patients, their families and regulators. It is a standout advantage that builds trust, which is critical for market entry and adoption.”
Key Consideration: Having A Ready-To-Go Plan
However, in dealing with the sector for 16 years across Asia, I observe most companies fall short when it comes to drug recall readiness. While established players often do have somewhat of a drug recall procedure or plan, it’s not rigorous, updated, localized or well-practiced – this is especially so, with staff reductions, turnover and the complexity of multi-territory regulatory updates. Given the multiple jurisdictions across Asia, differing languages, regulatory frameworks and cultural nuances, the established players face an uphill task to ensure their plans are ‘ready-to-go’ at the local level. Also, most drug recall plans tend to overlook the speed of social media and the prevalence of online misinformation. For smaller players and their appointed distributors, drug recall readiness is not a competency, as the distributors are not staffed or trained to undertake a recall for their designated territories. Such players rely on external parties that are only engaged and brought up to speed, when the crisis is full-blown and past statutory timelines. Another key observation is that many companies often do not have meaningful patient feedback monitoring systems, that is critical towards attaining timely product feedback, including adverse reactions or product integrity issues. Often, this information channel is not scrutinized and analyzed in real time. This can be easily resolved with the use of simple technology tools. The lack of timely quality patient usage feedback is a severe handicap that cripples the inflow of incident-reporting.
Drug Recalls – Types & Classifications
When necessary, drug recalls require the company (i.e. product owner, licensee or manufacturer) to effectively implement its plan professionally, without undue delay, transparency and clarity.
What constitutes a recall and when it is necessary?
A drug recall is necessary when a product is found to be defective in some way and removing it from the market is the only way to safeguard patient safety. Often, drug recalls result from the following discovery streams (a) via the company – self-discovers product formula, logistics, supply-chain, labelling and packaging integrity issues through its own QA processes; (b) via patient adverse reactions or complaints; (c) via regulator-audit discoveries.
What are the types of recalls?
Recalls are usually voluntary (i.e., undertaken by the manufacturer or distributor) or compulsory, driven by the regulator. It is not uncommon for local regulators to follow recall notices issued by significant national regulators (e.g. USFDA, UK MHRA, PMDA Japan, EMA EU, HSA Singapore etc.).
Depending on the potential risk/hazards – drug recalls are generally categorized as either Class 1, Class 2 or Class 3 recalls:
- Class 1 recalls are when the product poses a life-threatening situation to patients;
- Class 2 recalls are when the product may cause temporary or medically reversible adverse health consequences; and
- Class 3 recalls are when the product is unlikely to cause serious harm, which may include packaging, patient information or labelling errors.
Drug Recalls – Notifying the Regulator
Upon discovery and knowledge of a drug-related issue that requires a drug recall, the company (i.e. product owner, licensee or manufacturer) must act in a timely manner – to notify the regulator often within the first 24 hours of discovery. The drug recall issue, classification and recall plan should be discussed with the regulator. Managing the regulator is demanding – the company will have to demonstrate its seriousness when presenting a thorough drug recall plan, which factors in remediation and effective communications.
Communicate Strategically – Keeping Stakeholders Updated
When recalls are in process, the company should utilize all mass communication media available to disseminate the required drug recall information to the public – this is especially so, for Class 1 and sometimes Class 2 recalls.
The company should also undertake periodic reporting to the regulator on the status of the product recall, investigation and quarantine inventory updates, including timely interim and final reports. Also, the company should provide timely progress updates to the press, patients and relevant healthcare professionals. The challenge, however, is that while communications is required, most companies in Asia tend to shy away from updating relevant stakeholders, which leads to damaging speculation that the prevailing product recall has yet to be resolved.
All communication must be timely, meaningful and factual, with corporate legal approval. The alignment of the company’s legal and corporate positioning is important and may evolve over time.
The Recall Roadmap
When initiating a product recall planning process, it is critical to have the following guiding principles:
- Be Timely, the shot-clock has started
- Involve the right internal (clinical affairs, QA, legal, marketing & comms) and external (agencies) partners
- Speedy identification and classification of the ‘product quality’ issue
- Finalize and implement the Recall Plan (not draft the plan)
- The remediation of the issue should be detailed
- Appoint spokesperson, for all communications
- Ensure timely and relevant communication
- Engage & Communicate with Regulators and channel partners
In terms of process, there are generally six phases of a product recall. Companies need to ensure they have a ready-to-go product recall plan and team, have the right level of decision-making and are well-rehearsed, as a collective unit.
Summary
To recap, every company (i.e. product owner, licensee or manufacturer) in the Life Sciences sector needs to have a ready-to-go drug recall and remediation plan. The relevant executives and partners need to be familiar and competent with the plan. Yes, the multi-jurisdiction in Asia makes it challenging, but the company needs to be prepared. Having the right senior team and partners, who are well-versed with Drug Recall and Remediation Plan is paramount.
Should your life sciences company require any assistance, please contact our Life Sciences team at info@corpmediapl.com
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About the Author
Dennis Susay is a senior partner at Xp2, co-leading the firm’s counsel across two sector – Life Sciences (Pharma, Biotech & Medtech) and Global Banking & Markets and Corporate Professional Services sectors. He has more than 25 years of Asia Pacific and international leadership experience – across marketing, brand, communications and BD with top ranked brands including Bank of America Merrill Lynch, Baxter Healthcare, Yahoo!, Nike and Johnson & Johnson Medical.
In the area of Life Sciences communications counsel, Dennis worked for leading global agencies Hill & Knowlton and Porter Novelli, where he headed the regional Life Sciences practice serving multiple mega life sciences brands across pharma, vaccines and medtech. Dennis has valuable medtech start-up experience, where he was part of the cofounding team. Across these sectors, Dennis is well versed in working alongside regulatory, compliance and legal partners With his experience in high-regulated sectors, Dennis is well versed with working alongside regulatory, compliance and legal partners. He has specific case experience (in-house and as an advisor) with life sciences product recalls, risk assessment preparedness and corporate litigation & disputes.
About cmXp2
cmXp2 (“Xp2”) is a strategy advisory firm dedicated to supporting organizations operating in high-regulated sectors, specifically: Food & Nutrition, Agriculture & Agri-Food/Aquaculture, Life Sciences, and Global Banking & Markets, Institutional & Corporate Banking.
For organizations in these sectors, Xp2 helps them navigate complex and dynamic regulatory, legal and ethical parameters to define and execute strategies that generate meaningful value, shape opinions, enhance reputation and drive market impact. Our senior partners’ deep sector leadership expertise across these high-regulated sectors is well-placed to help clients succeed.
Xp2 is a division of the award-winning Corporate Media Services Pte Ltd (CorpMedia) that has over 32 years of experience. The firm is headquartered in Singapore and serves the Southeast Asia region.
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