Position your company as a partner rather than
operating from a position of fear and distrust
Chris Harvey, Stericycle Expert Solutions
How to Partner with
Regulators During a
Pharmaceutical companies operate in an industry where in- creasing 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 research 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 last 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 automati-
cally 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