INSIGHT REPORT
Vol 4  #1 
January-February
2001

INSIGHT REPORT

I

N

S

I

G

H

T

For the past three years mdi has been providing, via our Insight Reports, information on various topics of interest that we felt were important to you.  These insights have been written using the firsthand knowledge and experience gained from situations in which we have been involved.

In the past year mdi’s staff has been engaged in: 

• a FDA criminal investigation for fraud

• a six-month FDA inspection of a company

• numerous FDA inspections in the USA and Foreign

• various Warning Letter replies

• obtaining over 30 510(k) applications and conducting several face to face meetings with the FDA on behalf of our clients.

Our staff has become very familiar with the FDA's patterns and concerns. We have also become familiar with the strategies companies can best employ in order to address and even avoid FDA issues.

We are constantly re-evaluating the Agency’s policies, determining both why it is that companies get into trouble and also ways that companies can avoid those pitfalls and still maintain a viable business.

Our insight reports are made up of information obtained from first hand experiences. However, there is one thing that we have been having a hard time getting across to our clients, perhaps because it is somewhat subjective -- and this can be the main reason that certain companies get into real FDA trouble. This reason can be spelled out in one word, arrogance.

The FDA, as well as the other regulatory agencies, is supposed to be a consumer protection agency. They report to the US Congress for their actions and their budget. If their numbers concerning compliance issues were down, there would be no reason to increase their budgets.

Statistically, if the FDA inspect a certain number of companies they are going to find some of these companies to be out of compliance, thus making them actionable (FDA 483, Warning Letter or even and Injunction). This is very similar to the fact that on any given day a Highway Trooper would be able to issue a speeding ticket to a certain amount of cars on the highway. The Troopers cannot ticket all the cars they may see speeding. But, watching a car being ticketed along side a highway is a very strong reminder of the results of your actions.  

Regulated companies are very much like those speeding cars driving down the highway, they will take as much liberty as they feel they can get away with until the FDA visits them or they are spotted by that Highway Trooper, so to speak.

Working with hundreds of companies over the years and meeting with their top executives, or their executive committees, while decisions are being made - we have learned a great deal about the problems of doing business and staying profitable. We have also seen the outcome of the wrong decisions, although we usually enter the picture after the damage has already been done.

What steps can be taken to try to maximize the effect of the decisions taken by companies to actually show good intentions? Here are a few ideas that you maybe able to use to help you in your decision making process:

1. The use of an FMEA (Failure Mode Effect Analysis) exercise. This very powerful tool ought to be used more often than at present. It should be used to determine if an already adopted corrective action will be effective in addressing a problem. Though it is usually used when designing a new product, it is should be used when making changes to a product as well.
    

2. Management Review notes should be comprehensive and fully document the “management decision-making” process. These can be valuable pieces of documentation to have available in the event that a problem is investigated and you are trying to show that the decision was made through a formally documented process.
    

3. The use of “Preventative Actions” by management after reviewing quality data. This shows that management is not just reviewing data but taking a pro-active approach in seeing how they can effectively improve the product, the operations and even the profitability of their company.
    

4. When Corrective Actions are taken, such as a product recall, get the FDA involved in the recall process. This is now a regulatory requirement when safety issues are of concern. In these cases, being up front with the agency is the best available strategy.
    

5. Remove “arrogance” from your posture when dealing with the agency.  In trying to protect your company from the utmost wrath of the regulatory agencies - this is probably the one area that cannot be ignored.

You must be aware that what may appear as weakness from the FDA in the form of a slow regulatory response as a result of a problem found in your company, may soon turn into a quagmire of legal proceedings. Thinking that the FDA’s shortcomings in their lack of immediate response means that you got away with something would be the wrong way to interpret the Agency’s commitment to enforce the Act. The government doesn’t always travel the logical path. To believe that the FDA has decided to put the past behind them as it relates to your company’s problems would not be wise. This would most definitely be a sign of “arrogance” and this most definitely is not the way you need to be perceived.

So, for the new year, the best advice I can arm you with is to look at how you are presently operating, review your organization, set up policies and procedures that are easy to implement and monitor and most importantly, be careful on how you deal with the Regulatory Agencies. It is your responsibility to assure compliance. Lastly, remove “arrogance” from  your every thought process.

Remember, as you drive home from work today and you spot that Highway Trooper and make that quick impulse responsive look down at your speedometer -  what a deep and pleasant sigh of relief you could breathe if you could look down and see that you were already driving within the speed limit.

Next Insight – TBA

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.
e-mail INSIGHT