What the FDA Does

Through the activities of the then new—since November 2002—but since departed commissioner of Food and Drugs, Mark B. McClellan, M.D., Ph.D., the FDA had recently launched five major initiatives for Efficient Risk Management, Better Informed Consumers, Patient and Consumer Safety, Counterterrorism, and to build a Strong FDA.  

At the simplest level, drug companies seek FDA approval to do anything that involves the testing of therapies in humans. The FDA authors and publishes manuals and other publications that establish the guidelines for Best Clinical Practice which insurers such as HMOs use to guide their own activity of reimbursement of medical bills, and so on. 

Many experts flaunt their FDA panel expert status, which means that they are often called to judge new diagnostic and treatment evaluation in a condition matched to their expertise. Companies like to have people who know how the arguments are laid out at the FDA and what are the issues to be addressed up front, as long as this leads to safer medicines faster and cheaper. So far this is the case. 

The more chronic trial-regulating activities of the FDA can thus be leisurely learned and appreciated by drug companies. The FDA also has an acute set of actions that companies do not wish to learn the hard way. It is responsible for initiating and enforcing drug and food recalls, market withdrawals, and safely alerts. They have even recalled a particular water used in manufacturing drugs. 

All of the FDA s correspondence is public and can be obtained on its web site. One of the worst letters for a Pharma executive— besides the letters from its board of directors (BOD) and major investors— to receive is a warning letter. Threads of disputes can be followed from complaints to actions on http //www.fda.gov/foi/waming.htm. Most frustrating for company executives is that these complaints often start with the alleged misrepresentation of a dmg s efficacy for too broad a range of indications without due reference to its contraindications made by the company s representatives at a trade show. The text may read something like the following  

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