Pharmaceutical companies operate in an industry where increasing regulatory scrutiny is the norm. So it is understandable when a pharmaceutical company is about to initiate a drug recall, regulators may seem like the enemy—ready to pounce at the slightest misstep.
But the reality is typically quite different, and assuming an adversarial perspective from the start can actually make the situation worse. A better approach is to work closely with regulators and position your company as a partner rather than operating from a position of fear and distrust.
After all, the key objective of the U.S. Food and Drug Administration (FDA) is the same as the manufacturers’—to resolve the problem as quickly as possible for the safety of patients and consumers. Punishment is not the FDA’s aim. It would prefer to work cooperatively with manufacturers to get potentially unsafe products out of the marketplace as quickly and efficiently as possible.
The following are six principles pharmaceutical companies can follow to establish trust and a productive working partnership with regulators to achieve better recall outcomes.
1. Be transparent. No matter how quickly a pharmaceutical company alerts the FDA about an issue, it won’t help if they aren’t upfront about the true nature of the situation.
Pharmaceutical companies need to understand they are not the first drug company to experience a recall; it is endemic in the industry. They should be prepared to divulge the potential hazard and how it was discovered, the likely scope and scale of the issue, and any reported injuries or adverse reactions—even if it is unclear that the product is the true source of those reports.
Transparency is particularly urgent in today’s environment because trends show that the risks are higher. Extended research1 reveals that Class I pharmaceutical recalls—those that the FDA defines as posing the most serious adverse health consequences—have been rising steadily over the past several years.
2. Speed matters. Perhaps the most frequent—and serious—mistake pharmaceutical companies make is waiting too long. If a potential issue occurs, it is critical to understand that alerting the FDA and other relevant regulatory bodies doesn’t automatically trigger a recall. And if a recall is necessary, it almost certainly can’t be avoided, only delayed.
Delaying action can lead to distrust, additional scrutiny, and ultimately, hefty fines. Reporting the hazard quickly demonstrates to regulators a company’s concern and commitment to making things right, and there is no better way to begin the relationship.
Also keep in mind that the longer a manufacturer delays executing a drug recall, the more its business and reputation may suffer.
3. Ensure your actions match your words. A robust plan is vitally important. But it is also meaningless without follow-through. To demonstrate they are true partners, pharmaceutical companies must act on their plans efficiently, knowing that the FDA will be watching closely—even looking at response rates to determine whether additional steps are necessary.
4. Be prepared. Pharmaceutical companies need to develop a notification plan. The number one concern in any potential recall situation is consumer safety. To protect the public, companies should ensure their notification plans are as robust as possible and hold periodic mock recalls to test for various scenarios and identify any gaps in their procedures.
Direct notification only to those impacted is best, but when that is not possible, widespread announcements are necessary. Regulators expect to see a plan that meets, and ideally exceeds, their requirements. The FDA has specific guidance defining how it expects a company to alert the public about a recall, and what kind of information to provide, such as details about the potential hazard and what customers should do with the affected product. Following its guidance closely will demonstrate your commitment to the partnership.
5. Offer an appropriate remedy. There’s no doubt that recalls can be expensive. But trying to stem losses through short-term cost cutting measures usually are more harmful than helpful. This is particularly troublesome with over-the-counter (OTC) drug makers. They may try to get by with an insufficient replacement or partial refund. In some cases, regulators may reject these proposals right from the start. In other instances, companies are forced to expand or alter remedies when the first ones prove insufficient.
Instead, pharmaceutical companies should consider the perspective of their customers, be they healthcare providers, distributors, patients, or OTC consumers. What would inspire them to take action? What remedy options would make it clear the recall is serious? By looking at it from the customer’s point of view, companies are better able to satisfy regulators as well. Regardless of who is affected by the recall, pharmaceutical companies should also make their instructions as clear and easy to follow as possible.
6. Know the mandates—or work with someone who does. When it comes to regulatory compliance, the devil is in the details. This is often the greatest source of apprehension when a pharmaceutical company faces a recall.
Even small, geographically-limited recalls involve highly complex regulations. When recalls expand to a nationwide or even global level, the complexity is compounded. Pharmaceutical recalls can be particularly vexing because there are few good ways to pull back the products of certain manufacturing lots. Mandates under the Drug Supply Chain Security Act (DSCSA) must be followed for removing stock from shelves and inventories, for example. Every form, piece of data, and step in the process must be managed with painstaking care. That requires a thorough understanding of mandates from the various regulators who may be involved at every level.
A recall—or even the prospect of a recall—can be frightening. But by confronting the fear head on and embracing the role of the regulator, pharmaceutical companies can position themselves for recall success. Those who embrace a partnership and act swiftly to get unsafe products out of the marketplace faster will build good will with regulators. Positive partnerships with regulators also tend to head off negative fallout from being in the media spotlight, which further protects reputations.
About the Author
Chris Harvey is Director of Recall Solutions at Stericycle Expert Solutions. Throught his career, he has managed more than 1,000 recalls, including hundreds of high-profile recalls and withdrawals for the nation’s largest pharmaceutical and CPG companies.
This article also can be found in the INTERPHEX 2018 Show Daily: Tuesday, April 17.