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I'm a little tired of reading about "off-label" promotion of
prescription drugs, especially in the context of whistleblower
instigated fraud cases and lawyer/patient driven product liability
cases. I'm not a lawyer but here are some solutions that
would discourage inappropriate "off-label" promotion and would
consume far fewer resources and certainly cost a lot less than is
being spent now on litigating these types of offenses.
First, Pharma companies should not promote products for uses
that are not approved by the FDA. If a company is found
guilty of "off-label" promotion, in addition to any corporate fines
(which should equal total product revenues during the time of
illegal promotion) , responsible individuals should be held legally
accountable and convicted, with personal fines, disgorgement of
incentive compensation during the time of illegal activities, and
even incarceration if warranted. No corporate
settlements. It is very likely that criminally charged front
line employees directed or even trained to promote for off-label
uses may be more than willing to offer up and provide evidence
against culpable higher level executives who encouraged or approved
of the promotion. I'm pretty sure this would increase
executive management oversight to ensure compliance.
To remove the financial incentives for "off-label" promotion,
government programs (Centers for Medicare and Medicaid Services and
states) should not reimburse for unapproved uses of prescription
drugs. If the patient wants to pay for the unapproved use of
a prescription drug that a physicians has prescribed, that should
be their choice. At the same time, that choice carries the
liability that if something should go wrong; the only legal
recourse for the patient should be to hold the prescribing
physician and perhaps their healthcare provider accountable.
Because "off-label" use is an informed decision, neither the
patient nor the physician (or healthcare provider system) could sue
the pharmaceutical company for any negative consequences resulting
from the unapproved use. Physicians who prescribe for
unapproved uses but post a diagnosis that aligns with approved uses
just so the patient can get it reimbursed would face fraud charges
and be held personally liable. Similarly, there would be no
need for federal or state litigation against pharmaceutical
companies for False Claims that inappropriately causing taxpayers
to fund unapproved uses.
If physicians and patients have made a choice to use a product
"off-label" and private payers (insurance companies, employers, or
PBMs) choose to pay for the unapproved use then they should assume
the same liabilities as stated above. They are making an
informed decision and the payer is agreeing with that choice by
reimbursing for the unapproved use. The patient could sue the
prescribing physician, healthcare system, and perhaps the payer,
but they would have no legal recourse against the pharmaceutical
company should a harmful event occur from the unapproved use.
But what about all the "medically established" unapproved uses
in treating things like cancer? The same rules and legal
liabilities should apply. Physicians have the choice to
prescribe, patients have the choice to take, and payers have the
choice to reimburse for the unapproved use if they want to assume
the liabilities with the inability to sue the pharmaceutical
company. If the medical experts, patient advocacy groups, or
government programs and insurance companies feel a prescription
drug should be approved and reimbursable for a particular use, they
should petition the FDA and submit their clinical proof of efficacy
and safety to obtain an FDA approved label claim for the
product.
While preserving physician, patient, and payer choice these
recommendations remove a major financial incentive (reimbursement)
for pharmaceutical companies and increase the legal consequences
for individuals who inappropriately promote for off-label uses of
prescription drugs. More importantly, it appropriately shifts
product liability for unapproved uses to healthcare providers and
payers.
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