Until a few months ago, few if any senior executives had personal experience managing a company during a pandemic. Making matters more difficult, there’s really no recent history to consult to determine what perils lie ahead, which processes work and how to plan for recovery once the crisis passes.
Unfortunately, this uncertain environment seems likely to continue for the foreseeable future. We don’t know what will happen when businesses start to re-open, safety inspections resume, and regulatory enforcement discretion and emergency authorizations come to an end.
When it comes to following strict manufacturing practices and minimizing health risks, the pharmaceutical industry may be the most well-equipped business sector to respond to the types of challenges presented by the coronavirus. In fact, we’re looking to them to emerge as heroes in this crisis as they strive to develop effective treatments and vaccines for COVID-19.
But that doesn’t mean there’s no risk. In fact, their work may inadvertently open the door to more recalls and regulatory enforcement down the road. Why?
- Current Good Manufacturing Practices (cGMP) deviations have been the #1 reason for drug recalls for the last four quarters. In fact, cGMP deviations accounted for 26.9% of all recalls and 55% of all recalled units in the first quarter of this year. Those numbers include at least 14 recalls linked to NDMA impurities – an issue we know is still hot as we await metformin recall announcements.
- Current regulatory oversight activities are significantly limited. But when FDA inspectors return to their offices and can get back on the road, we expect an increase in recalls and enforcement.
- Increased supply, demand, and workforce issues make supply-chain management and risk-management more challenging than ever before.
- The reputational risk has never been higher for companies facing safety issues – especially those companies whose response is perceived as falling short. Social media, conscientious regulators and aggressive plaintiffs’ attorneys remain ready to pounce and to compound any problems facing a pharmaceutical company.