In the largest health care fraud settlement ever, GlaxoSmithKline has agreed to pay the whopping sum of $3 billion, the U.S. Justice Department announced earlier today. The reason? GlaxoSmithKline was caught marketing two popular antidepressant drugs — Paxil and Wellbutrin — for populations and indications they were never approved for.
In the U.S., the Food and Drug Administration (FDA) must approve all prescription medication uses and who they can be marketed to, based upon scientific studies the pharmaceutical must develop, fund and publish. Pharmaceutical companies then have to ask for permission to add those uses or populations to the drug’s existing approval.
Many drug companies, including GlaxoSmithKline (GSK), have sought to cut corners in getting these additional formal approvals, because all of that additional research costs time, money and effort on their part. So in the past, they’ve “soft marketed” these drugs for these additional uses through the salespeople who try and sell the drug to individual psychiatrists and physicians.
Perhaps, finally, drug companies will get the message. You may get away with such marketing practices for awhile, but eventually some whistleblower is going to (thankfully) turn you in.