When one hears bad news, it is essential to determine what one is dealing with and if it is a question, issue, problem, or crisis. We all know individuals who have a propensity to exaggerate the magnitude of an issue and to lead people to think that there is a large problem or even a crisis when, in fact, there is none. There is also a group at the other end of the spectrum where people downplay legitimate problems and are slow to acknowledge the existence of a major problem or incipient crisis. These personality traits are usually easy to recognize.

There is a hierarchy of concern about the topics one deals with. The first step is to consider whether the information one receives means that there is a question or an issue that needs to be addressed. If the matter is serious, it may be a real problem, or there may be an actual crisis. This may be better viewed as a spectrum of seriousness and importance, because there is a continuum from question to issue to problem and to crisis. This framework of determining if the matter should be identified as a question, issue, problem, or crisis helps to orient oneself to understand the magnitude of the matter being considered and assess what level of concern is appropriate. If one is dealing with a simple question, it should not be described and dealt with as an issue or problem, because the latter two categories require a different level of consideration, attention and action or response.

The people within a company who must be involved in addressing each of these levels often vary. Many professionals have a habit of talking about drug development “problems” that are really “issues” that have to be discussed and an action plan developed. In such situations, no real problem per se exists; although, there is often the potential for the issue to turn into a
problem, but it is not a problem at the moment. Likewise, some development problems can turn into a crisis if not dealt with appropriately and promptly. Of course, there are also problems that are dealt with by the media that turn into crises because of how they are discussed or interpreted. These are media-generated crises that have to be dealt with in the same way as other crises external to the media (e.g., some patients have adverse events that may have resulted from using the company’s drug).

A problem certainly requires more emotional involvement in responding to it than does an issue, which should be relatively neutral in the amount of concern invested. A problem may not necessarily have a short time frame in which it has to be settled, even though it should usually be promptly addressed. For example, a toxicological finding may be a real problem for a company, but the correct way to address it may be to (a) decide to conduct a repeat or new toxicological trial that may last several months, (b) promptly inform the regulatory authorities of the approach chosen, and (c) discuss it with the regulatory authorities. While the terms concern and commitment suggest a level of emotional involvement, problems and crises must be addressed objectively and coolly.

Addressing issues involves a great deal of choice in how one approaches them, to what depth and in what time frame. A true problem is a situation that may allow choice in the depth it is addressed and how it is addressed, but the problem itself is real and may not be ignored. The need to deal immediately with crises is clear. To do so most efficiently requires that a plan already be in place, so that everyone is not running around asking what they should do when a crisis arises. A good crisis plan clearly defines for the organization what is a crisis, a problem, an issue, or merely a question and gives clear steps for handling those in the crisis category. It should identify the persons within the organization to be notified, the timeline in which they should be notified, and other relevant steps to ensure the crisis at hand is addressed to minimize its impact on patients and on the viability of the company.

Several categories of crises are discussed—internal corporate personnel crises, internal production crises, and crises from an external source. Internal corporate crises include those primarily affecting the company and its ability to manage its affairs or to even survive. Examples include the death of one or more senior corporate officers (e.g., in an airplane or automobile accident), using all the company’s financial resources, or learning that a senior executive is committing fraud.

Internal production crises include problems in the manufacture and shipment of drugs possibly caused by a strike, major fire, flood, earthquake, tornado, or other natural disaster, sabotage, or other human-instigated disaster. Other examples include quality control problems on a major product in which it is found to be defective in any of many ways or an inability to obtain starting materials or development of major equipment problems.

Crises from external sources include an attempt at a hostile takeover of the company, tampering with a product, recall of a product, major lawsuit, or boycott against one or more of the company’s products. These crises may arise for many reasons (e.g., falling stock price, purported adverse events that are serious, development of politically sensitive drugs such as contraceptives or abortifacients). Another example includes a major Food and Drug Administration action against the company.

Tables 26.1 and 26.2 illustrate aspects of corporate crises, and examples of product crises are listed in Table 26.3. Clearly, these types of crises overlap to a significant degree. It is also important to note that, while a particular corporate crisis may affect some products more than others, all product crises affect the company.

The occurrence of a crisis may or may not come as a surprise to a company. Some crises brew for a period of time before they occur (e.g., problems with certain manufacturing equipment, threatened boycotts), whereas others occur without warning (e.g., tornado, sabotage, tampering). A company often feels a partial loss of control when a sudden crisis occurs and may lack enough information, initially, to deal with it adequately.