Off-Label Marketing

Houston Off-Label Marketing Lawyer

Federal False Claims Act Lawsuits

A burgeoning area of health-care fraud is the off-label marketing of prescription drugs by manufacturers. The Federal Food and Drug Administration (FDA) must approve all prescription drugs sold in the United States. Upon application, the FDA reviews a proposed drug’s safety and efficacy. The FDA then will approve that drug for an indication. Once approved for a particular indication, the manufacturers must market the drug for only that use.

Off-label marketing is carried out by the following actions:

  • Direct solicitation for off-label use
  • Using false statements for off-label use
  • Providing illegal kickbacks for off-label use

If you suspect that off-label marketing is taking place in your workplace, you should not hesitate to contact a Houston off-label marketing attorney from our firm, Correro & Leisure, P.C. We have extensive experience dealing with whistleblower litigation and federal False Claims Act cases.

The Problem of Off-Label Promotion

Problems arise when the cost of the drug far exceeds the market demand. The low demand may be due to the low occurrence of the disorder in the population. At this point, drug companies will attempt to expand the market for their product by marketing it as a treatment for disorders that are more common. The bottom line is always the same—money. Some unscrupulous drug companies will throw caution to the wind in order to recoup the tremendous amount of money that was spent on research and development. However, if a governmental Medicaid or Medicare program pays for these non-approved uses, a false claim arises.

FDA Requirements

The dissemination of information on off-label drugs must meet certain requirements. A manufacturer may disseminate information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling in extremely limited situations. Failing that, the drug is misbranded. Although physicians are free to prescribe a drug for an off-label use, the FDA prohibits distribution of “misbranded” drugs, including drugs which have been distributed while accompanied by literature urging doctors to use the drugs in non-approved ways. Whether a drug is FDA-approved for a particular use will largely determine whether a prescription for that drug will be reimbursable under the Medicaid program. Reimbursement by Medicaid is, with only one rare exception, prohibited if the drug is not being used for a medically accepted indication.

Basically, once the FDA approves a drug for a certain use, it must be promoted by the manufacturer for that use, not a financially preferred use. For example, assume a drug manufacturer, ABC Pharmaceuticals Inc., obtained a FDA indication for the use of X-CREAM to treat a rare skin disorder. Even though that market is very small, ABC must promote X-CREAM for the treatment of only that skin disorder. If a physician wanted to prescribe X-CREAM for the treatment of a very common allergic reaction, then he is free to do that. However, ABC may not freely promote X-CREAM as a treatment for the allergic reaction, because that is not what it is indicated to treat. If in conversations with drug representatives, the physician first asks about alternative uses for X-CREAM, then ABC may, under the above conditions, briefly discuss other studies. However, the studies that ABC uses must meet the above requirements. The same is true in a CME setting. ABC must meet the above requirements, or it may only promote X-CREAM for the treatment of the skin disorder—regardless of how much the drug cost to develop or how small the skin disorder market.

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Drug companies and medical manufacturers reap incredible profits from drugs and devices which are not only used for their approved uses, but also for other, unapproved uses. This is not only illegal, but it can become quite dangerous to patients and those who use these products. Fight back against fraudulent healthcare practices by calling us today.

For a FREE consultation about a potential off-label marketing case, please contact our firm today at (832) 384-9783!

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