Is
it or is it not a recall?
Recalls and Wheeling-n-Dealing
with the FDA
Fortunately, for many FDA regulated industries, recalls are something that they either
read about in the FDA enforcement report or hear of through the grapevine. But some
companies are not lucky enough to learn about recalls, they have to live with the reality
of conducting a product recall.
Working with a variety of companies on product recalls, during the last 20 years, I
have seen how companies have had to cope with this occurrence: There are five phases
of dealing with a recall: (1) denial and the decision, (2) deciding how to recall and the
extent, (3) dealing with the FDA, (4) public relations and finally (5) the aftermath.
Phase 1. Denial and the Decision
Ii it or is it not a recall? Most people want to believe that the facts are not what
they appear to be. "It just can't be," or "lets get more information before
we take any action."
Recalls are a traumatic decision for any company to make. Before a company decides to
take this step they must be certain that it is the only route left to them. The Recall
decision is an acknowledgement of several things: we have a major problem, liability
issues, public perceptions and relations as well as the possibility of an FDA regulatory
problem.
One thing to look for is to make sure that problem is, in reality, a recall and not
considered a "product alert." Recently, one of mdi's clients had such an
experience. One key to differentiating between Product Alerts and Recalls can be found in
demonstrating that the problem that your customers have been experiencing in the field,
was being caused by a misuse and that this misuse and it's potential dangers were
addressed in the owner's manual. With this type of a situation, you may have a
Product Alert on your hands and not the more serious product recall.
For product recalls, all information has to be evaluated, investigated and a decision
has to be made as to the necessity of getting the product off the market. At some time
during this investigation, you have to come to the conclusion that the only way to project
the user is to recall the product, no matter how damaging this maybe, a recall has to be
initiated.
Once it has been decided that there is a problem and you must recall the product, now
you have to set things into motion to conduct this recall in the most efficient manner
with the minimum amount of confusion and damage to the product's future sales and the
company's integrity.
Phase 2. How to Recall and the Extent
The next question is, "To what extent should the recall go and what is the best
way to recall the product?"
Of course there are always two forces in a company: One force trying to limit the
recall, while the other force is saying that the recall has to be much more
extensive.
Remember that the decision that you make in deciding the extent of the recall will be
reviewed by the FDA and questioned as to how you made that decision and it's
justification.
The problems with recalls are that you always seem to get back more products than you
hope to get. It appears that your distributors and customers will use this
time to clear their shelves of outdated lots, forgotten products and in some cases even
other company's products.
In trying to limit the recall, you have to take into account many things. Some of the
things to evaluate are: how the product is used, who uses the product, the cause of the
problem, the expected shelf life of the product and finally the potential liability of the
defected product being out in the market after the recall.
Sometimes it is better to "bite the bullet" by extending the recall to cover
the largest area of distribution, down to the user level. You must make sure that you do
not have to conduct the recall several times and keep the recall open longer than you have
too. This could happen if you tried to underestimate the extent of the recall.
Phase 3. Dealing with the FDA
Are you supposed to notify the FDA of a product recall? The FDA is to be alerted of
product field corrections and recalls. This would especially be the appropriate action
when the recall is the result of a death of serious injury.
For medical devices, if your corrective action was done as part of an MDR (Medical
Device Report) you have to submit the MDR in 5 days and you have to notify the FDA of the
corrective action.
From our experience if you don't notify the FDA of your corrective action, the recall,
your competitor probably will. It is very hard to keep a large recall a secret,
particularly when you have a large number of competitors Yes, if you notify the FDA, your
recall will be come "public" knowledge and it will be published in the FDA
enforcement report and possibly the FDA's website. But, by working with the FDA from the
beginning, you will show the agency of your intent to address the problem and you
willingness to do what is necessary to assure the publics safety.
You should contact the local district's recall coordinator and let him/her know that
you are conducting recall. Before you contact the FDA you should have all the information
on the recall including: the product information and labeling, lot numbers, reason for the
recall, the extent of the market of the recalled lot, if there are international sales,
how the product is used and where the product was manufactured if not at your facilities.
Depending on the recall, the FDA will probably send an investigator to follow up with a
site visit to get all the information, the reason for the problem and the corrective
action to assure that the problem has been corrected to prevent from happening again.
Unfortunately, this is where dealing with the FDA could provide troublesome. We must
remember that the FDA is a regulatory agency and they are supposed to enforce the
regulations. The FDA will want to inspect the manufacturing operations to determine the
origination of the occurrence, even if you explain the reason to them. They will try to
determine if there was negligence by the company in shipping an adulterated product.
Remember, if you have a recall because a product failed in the field, the product will be
considered adulterated.
Being up front with the agency during this difficult time may not seem to be a good
idea, but experience has shown that dealing forthright with the agency, before they learn
of the problem secondhand, will be beneficial in the long run.
Phase 4. Public Relations
Now comes the hard part, dealing with your public relations.
This has two parts, (1) customers (2) employees.
It is very important that you let your employees know what is happening concerning the
recall and possible FDA investigations. This is the one way you could prevent rumors and
miss-truths.
An announcement should be made to the employees about the reason of the recall, how
extensive it is and what it means to the company. This information and dealing with your
employees can go a long way for employee moral.
Public relations directed at customers and users must be addressed head on! Being
up-front on your corrective action is a priority. Combining a real explanation of
the problem with details of how the company is correcting the problem and at the
same time assuring the public that it is safe, are critical to the survival of your
company and to maintaining your client base and getting new customers.
There is an old saying that any publicity is good publicity. This may not always feel
right, but dealing with the media head on is an effective tool to be able to assure that
the truth is given out and not speculation. In a recent recall we were involved in, the
President of the company had the opportunity to answer questions to the press but chose to
avoid the situation. This had been a golden opportunity for the company to show that they
were addressing the situation in an immediate fashion and that their main concern was
getting the defected product off the market. Because the company did not use their chance
with the media, the story was slanted away from them.
Phase 5. The Aftermath
Now that the recall has been completed and you need to calculate your loses, both real
and on paper, you should go back over the experience with your management team and see how
good your system worked getting you through this process.
- How did the staff perform?
- Were there better ways to recall the product which would have been faster and better
documented?
- Could the decision to recall be made faster, and if so how?
- How did the Public Relations work and what could be changed to make it more effective?
- How was dealing with the FDA? How could that been handled better?
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A full evaluation with your staff must be made to see how a similar crisis can be
handled in the future. The ideas on improving the recall process must be documented
in the management review meeting and corrective actions taken, if necessary.
Conclusion:
Recalls are among the hardest thing for a company to deal with except for bankruptcy.
Being prepared for this situation is the best way handle such an occurrence. Our
experience in dealing with 100's of recalls has taught us that, usually, the first time a
company issues a recall for a product is the time that the company learns if it is
prepared. This, unfortunately, is the hard way to get your feet wet.
Next Insight Report - "MDRs can be a real pain in the
ASS".
If you have any comments
on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS
that you feel would be of value to other companies, we would be pleased to hear from you
and to discuss them with you and if you allow, we would even put them up on this site for
others to learn from.
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