Promoting off-label use is too profitable to ignore

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Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

In a special report titled “Big Pharma’s Crime Spree,” David Evans of Bloomberg Markets writes that pharmaceutical companies continue to promote drugs for uses not approved by the FDA, despite paying billions of dollars in fines and penalties.

Pfizer and Lilly lead a parade of U.S. companies that have paid $7 billion in penalties after promoting drugs for uses not approved by the FDA. This unlawful behavior may not end until prosecutors force a drugmaker into bankruptcy.

Even as prosecutors extract promises from the companies’ lawyers to never market off-label uses again, the pharmaceutical giants are doing just that because the revenue is so much greater than the penalties.

Harvard professor Jerry Avorn says “Marketing departments of many drug companies don’t respect any boundaries of professionalism or the law.”

Evans breaks down the numbers to show why drugmakers see off-label prescribing as so essential. He also talks to a former “medical liaison” with Warner-Lambert who grew concerned about his own role in pushing potentially harmful uses of drugs and filed a lawsuit against the company.

He writes that “prosecutors and judges have been unwilling to use the ultimate sanction – a felony conviction that would render a company’s drugs ineligible for reimbursement by state health programs and federal Medicare.” That, as one prosecuter says, is “potentially a death sentence for a drug company.”

1 thought on “Promoting off-label use is too profitable to ignore

  1. Ali

    This is outrageous. We can’t continue to give slaps on the wrist. If the punishment isn’t strong enough then it won’t work.

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