During the past two years, the FDA has been repeatedly questioned in very public ways as to whether or not it is acting to protect public health. A consequence of that fact is that the agency must appear ever vigilant in public demonstrations of its ability to protect public health. That means, among other things, the issuance of Warning Letters.
The DDMAC Warning Letter is usually issued in response to a communication by a company that promotes a drug not yet approved as safe and effective. Remember always that a drug is not safe and effective, despite stellar results from clinical trials, until the agency says that it is safe and effective by means of an approval letter.
Sales representatives are paid by companies to promote and sell drugs, and they earn a commission that reflects their ability to do so. One can’t blame them then for being overzealous and promoting the drugs they are selling as being the best.
But, one of the most common causes of Warning Letters issued by CDER/DDMAC is in response to sales efforts of staff, usually at medical meetings. The communication is usually oral. It usually involves a booth representative who is talking big and says something about an unapproved drug, or an unapproved indication for an already approved drug that is outside the regulatory bounds set by the agency. Standing on the receiving end of this oral communication is an FDA representative. The result is a Warning Letter.
Some companies seem to wear Warning Letters as a badge of honor. Others abhore them. If you fall into the latter category, here is some advice.
A good sales force is a valued commodity. Part of that value is knowing what to say and how to say it and to whom. Therefore, it would be prudent to not only train a sales force on the regulatory guidelines about what they say, but to incentivize them for saying it. In other words, they should be indoctrinated as to what is out of bounds and be rewarded for giving balance in their sales efforts. There should be checks and balances installed in the process to see if they are doing a balanced job, and if they do, they get rewarded for that financially in the same way they get rewarded for their sales. Failure to communicate balance would result in a penalty.
This will save wear and tear on a company while at the same time, saving the FDA postage.