In the comments to my previous article I had said I would tackle the topic of how Pharmaceutical Products are marketed and how the FDA is involved in that process. Then I managed to get a new job with a different company, and have been busy getting up to speed. I still do the same thing, but with a different company and more responsibility. All of that aside, I am now up to speed, and had the good fortune to be browsing the FDA’s website when I came across, the following article: “FDA issues warnings to marketers of unapproved ‘chelation’ products”. This seemed to me a good lead in to discuss the situation down at the FDA and why it is beneficial to have an outside party look at your marketing materials before you present them to the public.

In general, the promotional review process at the FDA works as follows. A Pharmaceutical, or CAM Company decides upon an advertisement they wish to have for their product. They review it internally to ensure compliance with the regulations as they understand them, then they send it to the FDA either as an informational piece or requesting a formal review. Which one they choose is dependent on how much of a risk they feel they are willing to take, which can also come down to the risk/benefit profile of the product in question. There is a group in each Center for the FDA which handles this. For the two Centers I have primarily dealt with on these issues, it is DDMAC (Division of Drug Marketing, Advertising and Communications) in CDER (Center for Drug Evaluation and Research) and APLB (Advertising and Promotional Labeling Branch, also pronounced “Apple-Bee”) in CBER (Center for Biologics Evaluation and Research). Now this is where the path between legitimate Pharmaceuticals and CAM takes a massive divergent twist.

Pharmaceuticals have a distinct disadvantage when it comes to marketing their products. For a Pharmaceutical advertisement to be acceptable, it must have three major parts to it, not including the biggest piece of all, FDA approval as a Marketable Product. The first of these, although it seems fairly obvious, is the Drug Name. After all, the consumer must know what product it is they are seeing information about. At this point both Pharmaceuticals and CAM are still relatively similar. The next two points is where divergence occurs.

The second most important tenet in Drug Marketing is having a truthful summary. This can be explained simply as the portion of the ad where the manufacturer tells you what the product does, and conforms to the product label. This is actually a good time to draw some attention to that word, “label”. In Regulatory terms, the label refers to not only the label on the actual medical packaging, but also that neatly folded origami-looking piece of paper that you get with your pill bottles, known as the Prescribing Information. The information contained in this label details the circumstances under which a drug should be prescribed, what adverse events are known and expected, effects on geriatric populations, pediatric populations, and pregnant populations. The list goes on, and it is all in the nice piece of paper. That label limits what claims can be said about a Pharmaceutical product.

For example, you cannot say, with a Pharmaceutical product for nasal decongestion that it cures cancer, as it is not in the label. Now, if there have been clinical trials done, and it shows that it does have effects on certain types of cancer, then you could make the claim, but you need accepted and peer-reviewed Science to back the claim. The same is not true for CAM. This is why, if you are a chronic insomniac like myself and you stay up way too late, you see products promising to cure every ill you may have from foot fungus to dehydration (water has been known to do this of course) to impotence.

It is telling that in some cases, these companies do get sued for their deceptive claims. One need only go so far as to look at Berkeley Neutraceuticals, the makers of Enzyte to see this. What they were really sued for was the false promise of “Double your money back” which they offered in their ads, however, it was entered during the trial that the product really did not perform as promised. I wonder if “Smiling Bob” is still smiling?

Another very key point to Pharmaceutical Advertising is what is known as fair balance, and here is where CAM comes up 100% deficient. The key to this is understanding that fair balance tells a complete picture of the story. It gives you both the negatives and the positives in your product. I am sure many of you have seen a drug advertised on television and been wondered about all those negative things that are mentioned. That is part of the fair balance, and it is required that Pharmaceutical companies tell you this. As most CAM is regulated under the Nutritional side of the FDA this fair balance does not exist. They are not under any obligation to say, for example, “Oh, my product contains only water, so while it may quench your thirst, it will not cure your cancer.”

This fair balance must also be clear and not misleading. This became a major issue back in 2008 when Robert Jarvik, M.D. began promoting Lipitor in television commercials. In the commercials, he used the line, “I’m glad I take Lipitor, as a doctor, and a dad.” This is a very very fine line that the FDA eventually stepped in on. Robert Jarvik is, indeed, a Medical Doctor. He did complete Medical School. What he did not do, and has never claimed to have done, is completed his medical internship/residency and is not licensed to prescribe. The FDA’s fear is that, since the advertisement began with the genial line of “I’m  Doctor Robert Jarvik, inventor of the Jarvik Artificial Heart.” that people would rely fully on Dr. Jarvik’s recommendation. After Pfizer was made aware of these concerns, they eventually pulled the advertisement. This is a beautiful case study on how one should always be careful not only of the message one is delivering, but also how that message is delivered.

As with everything where regulations are concerned, there are grey areas. This is where trained Regulatory Professionals come in, and we work to ensure that companies stay on the straight and narrow as much as is possible.


21 CFR 201

21 CFR 202


Posted by Martin A. Lessem, J.D.

A regulatory attorney working as a Director of US Regulatory Affairs in the Pharma Industry with ten years experience in Regulatory Affairs in both Clinical and Post-Marketing areas. Martin has planned US Regulatory Strategies and managing the Regulatory Activities in the US for a multi-national company. Currently he is working on Labeling for Biological products with another multi-national company.