Off-Label Marketing Lawyers
Off-label marketing is a form of healthcare fraud that endangers millions of patients. As government efforts to crack down on healthcare fraud are higher than they have ever been, you could be vulnerable to facing charges if you are in the business of manufacturing medications.
Our criminal defense attorneys have spent their careers defending healthcare professionals against allegations of fraud. Our firm boasts an impressive array of successes, from jail-free plea deals to complete acquittals.
We hope that you will not delay in contacting us for a strictly confidential, 100% risk-free consultation. Our criminal lawyers will get to the bottom of your story in order to fully advise you of your rights and responsibilities under the law.
What is Off Label Marketing?
To understand how off-label marketing works, we need first to address the process by which drugs are legally made available to the public.
As a drug manufacturer, you know that you must obtain FDA approval in order to create and sell your products. The FDA will only approve a drug for public consumption if it can determine that the benefits outweigh the known and potential risks.
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What is the approval process?
The approval process first involves an analysis of the condition the drug is intended to treat. This is because it is only after understanding the nature of the illness and the consequences of leaving it untreated that the risks and benefits can be properly assessed.
Drug manufacturers generally submit the results of at least two clinical trials as evidence that the proposed treatment’s benefit to sufferers of the relevant illness outweighs the attendant risks and side effects.
When the FDA approves the drug, it does so for the specific treatment of the disorder the drug was manufactured to treat. Uses, side effects, risks, and warnings must be outlined on an FDA approved drug label, which is distributed to consumers when they fill their prescriptions.
Off-label marketing then essentially occurs when drug manufacturers market the drug for a different use than the FDA approved it for.
The following are just a few examples:
A medication approved specifically for the treatment of high blood pressure is marketed as an effective pain reliever.
An SSRI approved for the treatment of depression is marketed as a muscle relaxant.
An antipsychotic approved for the treatment of Bipolar Disorder is promoted to treat sleep disorders.
Botox injections improved for elective cosmetic enhancements are promoted for the treatment of headaches.
What often occurs is that drug manufacturers identify helpful side effects of a particular medication, and thus recognize an opportunity to promote their drug to an additional market.
Are there any problems for approval?
The problem is that the FDA approval process hinges on the effectiveness of the specific drug with respect to a particular illness. Meaning the risk/benefit analysis is conducted on the basis of the illness the drug is proposed to treat.
While the risks generally remain the same regardless of what the drug is used for, the benefit aspect of the analysis depends on the nature of the targeted condition.
What are the Pros and Cons for approval?
Think of it this, Chemotherapy essentially poisons the body and has resulted in many deaths. The FDA has approved chemotherapy for the treatment of cancer because untreated cancer results in far more deaths than chemo does. That is, the benefits outweigh the risks.
However, chemotherapy would not likely be approved for the treatment of a less life-threatening condition than cancer. While weight loss might be a common side effect of chemotherapy, the FDA is unlikely to approve it for the treatment of obesity anytime soon.
Even though obesity can potentially be life-threatening, there are many less risky treatments available, such as Gastric Bypass Surgery, prescription medications, etc., that make the risks of treating obesity with chemotherapy outweigh the weight loss benefit.
That brings up another aspect of the analysis—the availability of less harmful treatments. While chemotherapy is not the only available cancer treatment, it is statistically the most effective response to a life-threatening condition.
Thus the benefit of chemotherapy is that it greatly reduces the cancer patient’s chance of death, even though death is among the risks of the treatment itself.
So while other treatments might be less risky in and of themselves, the fact that they are less effective makes them more dangerous in this context. With that being said, physicians have far more freedom in prescribing medications that drug manufacturers do in promoting them.
The chemotherapy example is extreme and unlikely to happen in reality. However, the medical community could theoretically begin studying the use of chemotherapy on obesity patients to develop a new accepted medical community standard around its use.
This could then lead to the FDA approving chemotherapy as an obesity treatment. But until such approval occurs, drug manufacturers are not permitted to market the treatment to physicians for that particular purpose.
So in summary, off-label marketing occurs when drug manufacturers market a drug for a purpose beyond its FDA approved use. Off label marketing can take place in face to face meetings with physicians, or pamphlets distributed to patients.
The danger is that doctors rely heavily on pharmaceutical marketing in their prescribing decisions. The FDA approval process is set up in awareness of this fact, and off-label marketing compromises its integrity.
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Off-Label Marketing Under the Law:
Drug manufacturers who engage in off label marketing can be subject to both civil and criminal penalties. The Department of Justice prosecutes off-label marketing through the Labeling and Misbranding provisions of the Food Drug and Cosmetic Act (FDCA).
These provisions require manufacturers to abide by strict guidelines in order to legally distribute their products. Under both the FDCA and the False Claims Act (FCA), it is a crime to introduce drugs into interstate commerce in violation of the protocols established by these provisions.
Currently, under federal law, manufacturers can (1) respond to questions posed by physicians regarding products, (2) share peer-reviewed articles and (3) sponsor continuing education courses.
Two bills proposed by Congress
Congress is seeking to expand that freedom of exchange in the following ways:
H.R. 1703: the legislation would allow for more sharing of clinical data, that is, scientific, non-promotional off-label information about drugs.
H.R. 2026: the legislation would allow drug manufacturers to share preclinical data regarding unapproved uses to review committees to help support future FDA-approval regarding off-label use.
Both bills would require the manufacturer to disclose that the FDA had not approved the information.
So while these bills would substantially expand the ability of manufacturers to communicate with physicians regarding off-label uses, they would still not permit off-label “marketing” per se.
Further, while off-label marketing may become decriminalized in time, first amendment protections will likely not extend beyond truthful statements made regarding the drug’s effectiveness. And if the legislative changes outlined are any indication, “truthful statements” would probably be limited to those backed by clinical data.
Additional changes to Federal Law
States are making increasing efforts to broaden laws regulating off label marketing. For example, Arizona passed the Free Speech in Medicine Act in 2017, which permits communication regarding off-label uses.
However, the law does not permit off-label promotional statements.
All of this means that while the restrictions on off-label marketing are loosening, it is on track to remain a strictly regulated practice.
Most important to understand is that it remains a crime to market your product for any purpose beyond that which the FDA has approved it for. So if you have engaged in off-label marketing, you need the assistance of a well-qualified criminal attorney.
Penalties for off-label marketing depend on a number of factors. They increase substantially when the practice results in the submission of false statements to a government benefit program.
Government benefit programs are funded by taxpayer dollars and provide need-based financial assistance to individuals. Examples Include Medicare, Medicaid, No-Fault Insurance Programs, and Veterans Benefit Programs.
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Private insurance might cover a wide variety of services, including counseling and massage therapy. Government benefit programs are generally more limited in their coverage. Certain forms of physical therapy following an accident might be covered, for example, while acupuncture would generally not be covered.
So let’s say a Medicare recipient is suffering from debilitating migraines. Medicare would likely provide coverage for their migraine treatment, because without coverage that individual might not be able to hold down their job or take care of their children.
Perhaps there are a number of FDA approved headache treatments available, but a Botox manufacturer has been selling the patient’s physician on the notion that Botox is amongst the most effective migraine treatments on the market.
Alternatively, the patient may have seen a commercial or read in a pamphlet about Botox’s success in treating migraines, inducing that patient to request the treatment specifically.
The botox manufacturer may be incentivizing the physician to prescribe it by offering financial or other types of perks, known as kickbacks, or the marketing techniques might be persuasive to convince the doctor that Botox is the best remedy available.
Either way, the doctor prescribes Botox to the patient and submits a claim to Medicare for reimbursement. The claim diagnoses the patient’s migraines and designates Botox as the appropriate therapy.
In this scenario, the drug manufacturer could be held criminally liable under the False Claims Act, which in relevant part prohibits both:
- Knowingly causing to be presented a false claim for payment, and/or
- They are knowingly causing a false statement material to a fraudulent claim to be made.
It is easy to see why from this example. The Botox manufacturer, whose target market was limited by the FDA to those willing to pay for elective surgery, could now essentially get its expensive cosmetic enhancement procedures covered by a program that is supposed to provide coverage only in cases of legitimate medical need.
Depending on the circumstances, criminal liability may also be imputed to the physician for upcoding or receiving kickbacks, but the legal obligation is still on drug manufacturers to refrain from contributing to the cycle of fraud.
What do you call this Penalty?
Penalties under the False Claims Act include fines are triple the government’s actual damages plus $11,000 per false claim submitted.
So in the above example, if the Botox manufacturer’s off label marketing resulted in 1000 claims for Botox being submitted to Medicare, and the government reimbursed $500 per claim, the government would have paid out $500,000, but the penalty on the manufacturer would extend up to $12.5 million.
Drug manufacturing companies are generally incorporated, which means that liability for the actions of some members of the company can be imputed to the organization as a whole. Although the entire corporation would not be sentenced to prison, those in positions of control, such as the President or CEO, would be vulnerable to facing jail time.
Whistleblower Protections & Incentives:
One of the most significant sources of government detection regarding off label marketing comes from whistleblowers.
The False Claims Act contains not only protections for those who report off-label marketing (it imposes criminal sanctions on defendants who retaliate) but also incentives, in that the act entitles whistleblowers to a portion of the financial recovery obtained in the civil suit.
Shire Pharmaceuticals paid $56.5 million for FCA violations after an executive in the company reported them for off-label marketing of the psychoactive drug Vyvanse, which had been FDA approved to treat ADHD.
For three years, Shire advertised a number of false claims regarding the drug, including that it turned children into better students and that it was not vulnerable to abuse like other stimulants.
The company also alleged that their drug Adderall XR was clinically superior to other ADHD medications in that it made users indistinguishable from non-ADHD peers. These claims were entirely unsubstantiated.
The executive who came forward against the company claimed to be motivated by his moral objection to the overprescription of amphetamines to children. He also received $5.9 million of the recovered $56.5 million in the suit.
This example should serve to demonstrate the degree to which employees of your company and others with knowledge of your marketing practices could be persuaded to report you.
As mentioned above, most states have adopted their version of the False Claims Act, along with the attendant whistleblower protections and incentives.
Our criminal defense attorneys will help you determine which specific laws apply to your conduct and the types of charges you might face.
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Other Detection Sources:
However, whistleblowers are far from the only source of off-label marketing detection. Healthcare fraud costs the government billions of dollars per year, which is why efforts to eradicate it are only rising.
Accordingly, detection efforts are becoming increasingly vigilant and sophisticated.
While regulatory agencies are tasked with analyzing an enormous number of claims, advances in technology such as data analysis can identify deviations from accepted medical patterns.
So if a number of non-cosmetic doctors you are marketing to start prescribing Botox suddenly, that will likely draw attention, if not immediately then eventually.
Many defendants do not realize they are under investigation until enough evidence has been gathered to justify an arrest warrant. At that point, a search warrant might also be obtained, entitling investigators to access to internal documents and other data that could provide the necessary evidence of intent.
An excellent source of evidence too often comes right from the mouths of suspects, who are so overwhelmed by the sudden shift in events that they tell obvious lies or spill truths they had no legal obligation to share.
What is the Advantage of having an Attorney?
It is so imperative that you retain a criminal defense attorney, regardless of whether your conduct has, to your knowledge, been detected. Our criminal lawyers will fully inform you of your rights and responsibilities so that you know how to answer questions and protect yourself in the event you are caught off guard by law enforcement.
Even if you have already been arrested and fear you have said too much, it is not too late to reap the indispensable benefits of qualified counsel. Our criminal attorneys will assess the damage and formulate an immediate strategy to both lessen the consequences of your past decisions and create new opportunities for a favorable outcome.
You may feel that you are in an impossible situation. However, a criminal case is rarely as black and white as it seems to be at first glance. While we are not magicians, you will be amazed at the options that open up for you when we are on your side.
Our criminal lawyers have many years of experience defending clients against liability for off label marketing. While the specifics of our approach vary depending on the situation, the winning strategy we always employ is grounded in a combination of effort, intelligence, and goodwill.
Our criminal defense lawyers are not about cutting corners. We believe there is no substitute for hard work and dedication, and we are proud that our reputation for diligence sets us apart.
We also remain dedicated students of the law, remaining perpetually up to date regarding the latest legislation and legal precedent that could be used to our client’s advantage. We draw on our many years of varied experience in every decision we make on your behalf and remain alert to all possibilities your specific situation presents.
Our commitment to criminal defense is fueled by our passion for justice. We understand that good person make mistakes, which is why we do everything in our power to prevent our clients from suffering lifelong consequences for their past decisions.
This spirit emerges in every conversation with prosecutors, as we patiently work to paint you in their mind the way we see you; as a valued member of your community who deserves a second chance. The ultimate goal of our approach is to get your case dismissed, which puts an end to the time and money defending yourself requires.
But understanding that dismissals are never guaranteed, our approach pursues that goal by preparing your case as if it is going to trial. This alerts prosecutors to the fact that succeeding against us will be a challenge, incentivizing them to at least strengthen your plea deal if not dismiss your case.
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Developing a Defense Strategy:
Our lawyers have experience in identifying all evidence gaps and potential loopholes to dismantle a case. Should a case reach trial, we use every tool possible to demonstrate that the prosecution has failed to raise enough evidence establishing each necessary element beyond a reasonable doubt.
As intent is a necessary element, we will endeavor to show that even if the evidence does indicate you acted knowingly, it is not conclusive enough to meet the required standard of proof.
Recent litigation regarding off-label marketing has been centered around the argument that prohibiting this conduct is a First Amendment violation. As detailed above, our attorneys are legal experts with a minute to minute awareness of unfolding precedent and are prepared to raise all arguments that might provide the basis for your acquittal.
Facing criminal charges is an enormously stressful experience, but hopefully, we have provided you with the information and encouragement you need to get into action.
With the right criminal defense attorneys behind you, you are armed with all the tools you need to transform your worst nightmare into a manageable obstacle.
We look forward to assisting you.