We are continuing a discussion today that be began in our last post. Pharmaceutical companies in the United States have very deep pockets and enormous lobbying power – both of which are being utilized to weaken public-safety regulations. Specifically, drug companies are now seeking to assert their “right” to market prescription drugs for uses other than those approved by the Food and Drug Administration.
This practice, known as “off-label” prescribing, is something only doctors are legally allowed to do. Unfortunately, pharmaceutical sales representatives often skirt ethical and legal boundaries in an attempt to convince doctors to write off-label prescriptions. Relaxing this regulation would only make it easier for drug companies to essentially bypass both the authority of the FDA and the discerning judgment of physicians.
Why is it problematic for pharmaceutical companies to have such free access to American consumers? For starters, they already have far more access than nearly anywhere else in the world. The United States is one of just two countries where pharmaceutical companies are allowed to engage in direct-to-consumer advertising that includes claims about the products. These commercials and other advertisements convince consumers to pressure their doctors for prescriptions which may not be necessary or safe.
Second, we need to always keep one simple but important fact in mind: Science and marketing are not the same thing. Science takes time, careful study and objectivity. This is why the FDA drug-approval process is often lengthy and expensive. Pharmaceutical companies need to prove that their drugs are relatively safe and effective for specific types of patients and specific uses (the ones for which they are seeking FDA approval).
Certain drugs may be safe/beneficial for off-label uses, but that determination should not in any way be influenced by the potential for profit. It should be made by doctors influenced only by scientific research.
Sadly, pharmaceutical companies have already found ways to encourage off-label prescribing by busy doctors who may not have time to read studies. We should not be making this process any easier for them.
There are countless examples of why we need more pharmaceutical industry regulation, not less. Dangerous and defective drugs harm far too many Americans, many of whom were not warned about the specific risks ahead of time. Unless we rein in the free-marketing “rights” of drug companies, this problem will almost certainly get worse rather than better.