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“Safe”: Many Meanings Complicate FDA Policymaking

FDA Matters is in favor of safe foods and safe medical products. Who isn’t? If you are a consumer, maybe that’s all that matters.

However, being in favor of safe foods and safe medical products is not enough if you are FDA, the media, Congressional authorizers and appropriators, OMB, and industry. It sounds good, but what does it really mean? In the FDA context, “safe” means many things, some of which are barely related to each other.

What are FDA’s safety goals and their means to achieve them? What programs should they strengthen? What people should they hire? Each of these questions has different answers depending on what kind of “safe” is being considered.

In the food area I can think of at least three non-redundant contexts in which the meaning of “safe” is different.

First, we want our foods to be “inherently safe,” a product that is formulated properly and with no negative impact on our health. We do not want to be offered “tomato and arsenic soup.” For this FDA needs food scientists and regulators to determine ingredients that are “generally recognized as safe” and to assure that products conform to standards of identify for specific types of foods.

We also want foods to be “safe from intentional and negligent contamination.” We do not want melamine in milk nor heedless disregard of procedures to prevent botulism, pesticide residues, etc. FDA requires well-trained inspectors, backed by laboratories to perform chemical and biological analysis of otherwise safe foods. Criminal investigators and prosecutors are also part of assuring foods are safe from intentional and negligent contamination.

We also want foods to be “safe from unintentional contamination” by bacteria, insects, fungi, and naturally-occurring toxins. To provide this protection, FDA needs epidemiologists, biologists and health professionals with public health training, along with laboratories that can do sophisticated analysis of pathogens.

Likewise, in the medical products area I can think of at least three non-redundant contexts in which the meaning of “safe” is different.

First, we want medical products (drugs, biologics and devices) to be “safe for use” before they can be marketed. The FDA’s team is composed of scientists and statisticians who can: analyze the chemical and biological foundations of a product; dissect the degree of safety demonstrated in animal and human trials; and work with fellow regulators to determine the balance of risk and benefit.

We also want medical products to be “safe as used” once they are in the marketplace. For this, FDA increasingly needs public health, data and medical analysts who can: evaluate individual case reports and derive usable knowledge from population-based data, such as FDA’s new Sentinel System. I think that post-market safety is often considered a mere extension of pre-approval safety. This won’t be true in five years.

We also want medical products to be “safe as manufactured and distributed.” This requires well-trained inspectors, backed by engineers and manufacturing and supply chain experts. Data systems are needed here, too, to track facilities, shipments, processors, importers, etc. Criminal investigators and prosecutors are also part of assuring safe manufacturing and distribution of medical products.

As can be seen, Commissioner Hamburg’s challenge is much more complex than “hiring more safety people” or “investing more of the agency’s budget on safety programs.” As she defends her priorities, her position would be stronger if it rested on a comprehensive analysis of how the agency is working on all the different meanings of “safe.”


PS: This is a conceptual analysis with strong real-world consequences. There are many situations where the lines I’ve drawn are not as clear as I’ve suggested. Also, I do not want to diminish the abilities of many FDA staff who routinely contribute to more than one type of “safety.”

Improving safety and improving information technology go together. Two earlier columns reflect on this:

The Science Board’s IT Report: Too Technical to Read, Too Important to Ignore October 18th, 2009

Some of FDA’s most difficult tasks are: defining the agency’s role in nanotechnology, creating a pathway for follow-on biologics, implementing a risk-based food safety system, and establishing the right policy for “new media” communications. All rolled together, they are not as complicated or important as transforming information technology (IT) at FDA. Read the rest of this entry »

Turning Data into Knowledge    June 2nd, 2009

Through statute and directive, FDA has been asked to collect, analyze, interpret and utilize massive amounts of data. This includes biological, clinical, adverse event, production and distribution data, medical and food product tracking, and the Sentinel system for early discovery of potential drug safety problems. The systems are not in place to do any of this, at least not at the required level of sophistication. Even if they were, sifting valuable information from background noise is extraordinarily hard. As a result, FDA needs to manage Congressional and public expectations as to “what is possible and when.” Read the rest of this entry »

2 Responses to ““Safe”: Many Meanings Complicate FDA Policymaking”

  1. briut says:

    Insightful post. You’re always a pleasure to read. For me, the question of definition is really just an OPERATIONAL one. A “safe” and effective drug (generally) means two well-controlled studies. For generally recognized as “safe” foods, the standard is basically just showing a good track record. Other unique definitions for “safe” devices (remember breast implants?), “safe” fast-tracking for cancer/AIDS drugs, and so on.

    Frankly, I don’t mind so much that one word means so many things (or, as in Alice in Wonderland, whatever I want it to mean). I just want to know what the standard is so I can show my clients the height of the hurdle. “Tell me the rule, (tell me it’s being applied fairly to my competitors, as well,) and I’ll do it.” Unless, of course, you’d like to write FDA a new lexicon, which wouldn’t be such a bad idea as you seem to suggest…. – Eric Katz

  2. Eric—Thank you. I did write this more from the perspective of the FDA-Congress-media dialog where imprecision about safety has policy consequences. I think the Commissioner and the resource-deficient agency would do better if they articulated how the mandate for safe food and medical products has many parts that must be serviced separately. I would hope that my column would put to rest any notions that the agency would be more effective if it had a safety czar or a safety center or any kind of uber- centralization of safety functions. Some consolidation might be good, but there are far too many parts for which this is not a good idea..

    The manufacturer’s perspective is a useful one. I have written previously “in praise of predictability.” http://www.fdamatters.com/?p=467. For a lot of companies that doesn’t seem to be enough. A significant amount of safety problems seem to be in cases where the company knew or should have known better. This makes me wonder whether there is a degree of operational imprecision internal to companies. When the CEO asks: are our products safe?….he might get a more nuanced answer and better responsiveness if it were three or four questions that focused on different aspects of what makes a product safe. Steven

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