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.
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
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.
Help Stop Off-Label Marketing - Call Us Today
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.
FREE consultation about a potential off-label marketing case, please
contact our firm today at (832) 384-9783!