Feds Target Drug Executives

The U.S. government is stepping up its use of the so-called "responsible corporate officer doctrine" to hold pharmaceutical company executives personally and criminally responsible for violations of FDA laws. (Here is one example.) This enforcement approach doesn't require the executives to be personally responsible for an offense or even to be aware that an offense was committed. As we know, all Americans are supposed to be innocent until proven guilty, which requires prosecutors to prove criminal intent and criminal behavior. With the responsible corporate officer doctrine, prosecutors simply need to prove that a law was broken somewhere in the company and it follows that the executive(s) at the top of the organization are guilty.

One conviction is worse than merely a fine and jail time; it can mean the end of that executive's career because the government is also trying to ban convicted individuals from doing business with Medicaid and Medicare. No drug company can afford to forego those segments of its business and therefore no drug company would ever hire such an employee. Welcome to "one strike and you are out."

Sometimes the violation might be due to bad luck if, for instance, a raw ingredient is later found to be tainted. Perhaps most amazing, however, is that some of the FDA's rules--violations of which can end an executive's career--actually harm patients. These supposed "crimes" actually have clear beneficiaries.

Consider off-label prescribing. Off-label prescribing is a legal and common way for physicians to provide the best medicines for their patients. When a new medicine is approved by the FDA, it is approved for a particular disease or diseases. Usage for these disease(s) is called on-label prescribing. If the disease isn't listed on the product's package insert, that prescribing is called off-label.

Off-label prescribing is legal, widely practiced, and is actively encouraged by Congress, the National Institute for Health, Medicare, the Veterans Administration, and the National Cancer Institute. However, the company that markets that medicine can't encourage off-label prescribing in any manner whatsoever because the FDA considers such promotion illegal. The prescribing itself is legal; it is the communication that is illegal. This prohibition on communication for legitimate medical conditions does real harm to real people, to say nothing of the harm to our First Amendment rights.

Consider the following case. A pharmaceutical sales representative reads a peer-reviewed science journal article that recommends an off-label use of the company's product. This enterprising sales rep then gives a reprint of that article to an interested doctor and that doctor prescribes the drug for that condition. The cost of the drug is reimbursed by insurance companies and Medicare. Patients get better. The doctor receives kudos. The federal government then sues the drug company and the top executives, forcing them to pay fines and serve prison time. When they are later released, they are unable to find any employment in the pharmaceutical industry. Why? Because one of their employees was trying to help patients and physicians.

Pharmaceutical companies are energetically trying to find better ways to help patients and physicians--that's their whole business model. Treating company executives as criminals with a "one strike and you are out" doctrine won't help a single patient fight breast cancer or Parkinson's disease.

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