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PV / Drug Safety Crises

This is a follow up to the previous posting on PV Stress Tests.

During every PV person’s career, a “PV crisis” will arise. PV “crises” can occur in clinical trials or during marketing and may be of varying degree and type; so let’s define them first.

Although the following are not always crises, often they are:

These are only some of the possible examples. As you can see, some are predictable to a degree (e.g. a Warning Letter after a bad inspection) and others are not. Some may be (to use the tennis term) “unforced errors” and others are beyond anyone’s control.

But however one arrives at a crisis point, the company and the PV department must be ready to act immediately to protect the public health and to resolve the safety issue as rapidly as possible.

Several things must be in place in the company in order to ensure that the risks to public health and the possible damage to the company are minimized.

A leader to take charge 24/7. This person should be senior and empowered. He/she should have the mandate to convene the appropriate personnel to define, investigate and respond to the issue. This usually takes the form of a safety committee and, in fact, the senior safety committee that handles all other safety issues (e.g. labeling, stopping trials etc.) may be the committee designated to handle crises. This committee should be chaired by the leader noted above. Some companies will form an ad hoc committee either reporting to the safety committee or separate from it to handle the particular crisis.

The members should include: the head of drug safety, the head of regulatory, a legal representative, quality/compliance, a project manager (or someone to handle the administrative work), subject matter experts, business partners if appropriate, representatives from the company’s affiliate or subsidiary if they are the focus. If there is a GMP issue, a representative from manufacturing should be a member. A company expert on media/social media should also attend. Usually some database searches or other IT reports will be needed so an IT member should attend. This is not a complete list and the chair should designate additional members including external consultants or experts as needed. Commercial representatives (e.g. marketing and sales) may attend but it must be clear to all that the primary focus is on public health and safety and not commercial matters. Each representative attending the meeting should also be empowered and able to make decisions at the meeting rather than having to clear an action with his/her hierarchy.

An up-to-date list of all the needed personnel with 24/7 contact information.

A meeting should be called ASAP, with distant or traveling members attending by phone or webcast.

Every situation and “crisis” is different and there is no one-size-fits-all response. The company must put in place a mechanism to deal with the issue. It must be flexible enough to respond to changing events as occurs in “the fog of war” (if you will forgive the military analogy). Things change rapidly and the company’s responses must be cogent, ethical and aimed primarily at protecting the public health.

For the PV personnel involved, these episodes become subsequent “war stories” that will be recounted over the years!

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