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Marketing Pharmaceuticals in today’s Regulatory Environment

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.
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Posted in: Pharmaceuticals, Politics and Regulation

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The FDA for the Average SBM Consumer

How the Food and Drug Administration came to be is a story that is filled with death, intrigue and dubious characters. It also, like most stories, has its share of heroes and vindications. The list of those who have died to bring us the agency we know today is long, but even today, the death-toll continues. Now this is not the horrible thing it may at first seem. People are all born with a terminal disease known as life, and they will die. The goal of Medicine is to forestall that death as long as possible and to give people good, long, healthy and safe lives. This is where the Food and Drug Administration comes into play. They help guide the pharmaceutical world in the safest manner possible.

The legal quagmire that is the Food and Drug Administration (FDA) is a result of a series of laws which it behooves the Science-Based Medical community, to understand. Many of these laws were a result of deaths, which were themselves the result of either poor safeguards, or, as we will see in one case, lack of information on the part of a company. It began with the Division of Chemistry inside the U.S. Department of Agriculture. The original concern of this group was the misbranding and adulteration of both food and drugs. The first of the laws which came into effect, to give the Bureau of Chemistry as it became known, was the Biologics Control Act of 1902. As is so often the case with FDA regulations, this was a result of deaths in the populous.
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Posted in: History, Politics and Regulation

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