Tuesday, April 29, 2008

Freedom to elect has finally come to pharma marketing

It is election season and voters across the US are being asked their opinions. Who will you vote for? The politicians are doing their best to see to it that we have the facts (all versions).

After all, this is America. The fundamental assumption is that we are (for the most part) all born intelligent human beings and we are (again, for the most part) each capable of making intelligent and informed decisions. This is not only the American way--this is what makes us American. “Man is basically good” as British philosopher John Lock (1632-1704) wrote about the tenants of democracy. In short, man is capable of self-governance, self determination—and in making his own decisions.

Let’s fast-forward a few hundred years and focus on pharmaceutical marketing for a moment. “DTC”—direct to consumer pharma marketing. That’s what we call our newly evolved form of pharmaceutical marketing. The sector alone is responsible for tens of thousands jobs—and they have all been born in the last decade. It used to be that a doctor was only qualified to interpret what might be suitable for drug consumers to learn. This being the case, pharmaceutical marketers would only market to this small group of “deciders.” Today, the FDA has allowed these marketers to market “DTC.” The decision now is directed one step beyond—to the end consumer.

At last! What I do not understand is what took us so long to break this barrier? What took the FDA so long to tell us that we are safe to learn about the drugs that are being prescribed to us?

This is not a free for all. Checks and balances have been created to maintain order. Now the FDA provides detailed regulations and guidance for advertising efforts aimed directly at consumers. Pharmaceutical companies are required to follow these directives when preparing such direct-to-consumer ad campaigns. In general, such ads must include information about the medication's side effects (we know all about that), contraindications (situations in which it should not be taken), and its effectiveness. Companies are required to submit their direct-to-consumer advertising materials to the Division of Drug Marketing, Advertising, and Communications (DDMAC) at the FDA's Center for Drug Evaluation and Research (CDER). However, DDMAC does not provide approval for each and every advertising effort. Sometimes, companies will submit materials to the FDA before they implement certain marketing campaigns. This gives the FDA the opportunity to offer helpful feedback and suggestions.

True freedom can only happen with laws, rules and regulations. The freedom to elect has finally come to pharma marketing.

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