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Insight Report Vol. 6 No.4

The FDA cannot be your consultant!

It surprises me to find companies that are unable to grasp or that do not understand the FDA’s mission. In the early 70’s, when I joined the FDA, I didn’t know who the FDA was or what they did. But back then there was an excuse, the FDA was not a household name or a daily headline event, where they were involved in a new drug application or a recall notice.

What Is the FDA?

The FDA is the Federal Regulatory Agency which has been given the mission to enforce the laws of the land as they pertain to foods, drugs, medical devices, and blood banks. .

Though the FDA should not be looked on as an enemy of these industries nor should it be thought of as a friend. The FDA has a very important job to perform and it does not include acting as a consultant.

My first days as an investigator with the Agency, in 1972, involved indoctrination into what the FDA’s mission was and the role of the investigator. The investigator is considered the eyes and ears of the FDA and it is the investigator’s role to go out to the various industries to make sure that they are in compliance with the regulations. It is the investigator’s responsibility to enforce the regulations that are based on the laws enacted by the US Congress.

Investigators are trained not to provide guidance! That is not the investigator’s role.

Now, as I look back over the past 30 years I find that there are still far to many companies wondering why the FDA cannot guide them on how to comply with the regulations. What is by far my most surprising discovery is the trend of new companies being started by entrepreneurs who think that they know everything they must to raise capital, design and manufacture a product but, when it comes to one of the most crucial areas of their future survival ? compliance with the regulatory agency that controls their products ? they know far too little.

This is not to say that the FDA doesn’t provide some services to assist the industry to better understand the regulatory requirements. One of these offices is DSMA, the Division of Small Manufacturers Assistance. This office sets up educational seminars around the country, and even internationally, to provide information on newly formed regulations or industry concerns. This office consists of FDA field investigators who have been in companies and have an understanding of the regulations and how they are to be applied.

The one problem with DSMA is that what they say is not always binding on the FDA. There have been situations in the past that using DSMA’s advice to implement some system for compliance was not acceptable to an FDA investigator during an inspection.

The FDA is available to assist companies; however this must be done before the FDA initiates an inspection. Once an inspection is started all avenues of assistance are off.

Recently, there was an article in one of those published FDA newsletters titled “The FDA is not in the consulting business, says compliance official.” The article goes on to say, “Helping device makers comply with the quality system regulations or any other laws governing devices is not the responsibility of the FDA.”

This article was provoked by a small medical device company asking the FDA for help in designing a corrective action play after receiving a Form 483 during an inspection.

The FDA turned down the request and instead issued the company a warning letter for several deviations found during that inspection.

Is it the Agency’s role to assist the company to comply with the regulations or just to make sure that the company is in compliance? The FDA cannot play both roles. The problem with helping a firm set up “corrective action system” or for that matter any addressing any other part of the quality system, is that if the FDA recommends fixes that don’t work to correct the problem, the FDA will have no legal recourse. Why? Because any assistance that the FDA may provide could only be based on information supplied by the company. What happens if that information is incomplete and the FDA does not have the knowledge that it is incomplete and thereby makes recommendations based on that incomplete information? The ugly head of conflict of interest is raised because the FDA has been placed in an adverse position to take additional regulatory actions, since the agency originally advised the company on what to do.

As you see, it is impossible for an FDA officer of compliance to provide a company assistance on how to comply with the regulations while they must, by necessity, look at the possible legal actions that must be against the company.

Therefore, it is the responsibility of each company to determine their own path toward compliance, was the article's conclusion.

Why this is surprising to any company that is regulated by the FDA is beyond normal business understanding: What is not so surprising is how unevenly the FDA regulations can be interpreted between investigators from the same FDA office. And this is the crux of the situation.

There have been times when a company was audited by the FDA with no deviations observed and then a few years later, with no changes to the operations, products or personnel, the company is again inspected and is handed with an extensive list of observations which could result in the issuance of a warning letter.

Who was right, the first investigator or the second one?

Unfortunately, the FDA does not get involved in that obvious discrepancy. The FDA is not here to explain why one inspection turned out the way it did and the next one was completely different. Not only does the FDA not have to explain, you must be able to deal with the situation as it exists.

The FDA’s responsibility is to be able to support that investigator’s finding and to back up any possible regulatory action. The first inspection cannot be used as an excuse of the second inspection’s findings. That there were no problems found during the last inspection is not a good defense.

Usually the differences can be written off to the fact that investigators are people and people are not all equal in how they operate, though one would hope that such a divergent view of the same process would make someone wonder who was right and who was wrong. In either case the company is inevitably stuck in the middle.

So, while dealing with the FDA is not an easy task, the understanding of the Agency and its role as an enforcer of the laws is imperative to the success of your business. Comprehending the laws and how to apply them is vital to keep the FDA at bay. It is up to you to decide If you want FDA assistance. And, if you do, you must ask for it prior to finding the FDA at your front door uninvited.

Please remember the FDA may not be your friend but they certainly don’t have to be your enemy. The best way to be successful in dealing with both friends and enemies is in understanding them. Understanding the FDA would be the best way to avoid potential problems.

Next Insight Report - to be announced.

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