The government can’t make a criminal out of a medical sales rep for speaking truthfully about his or her product.
That’s the 2-1 split panel verdict of a U.S. Court of Appeals in the case of U.S. v. Caronia and seriously questions the basis for prohibiting off-label marketing of medical products.
This all began in 2005 when a government sting operation caught Alfred Caronia discussing an unapproved uses of a drug with a doctor. On November 30, 2009, he was convicted for conspiring to “introduce a misbranded drug into interstate commerce.”
By December 3, 2012, the U.S. Appeals Court panel in New York overturned his conviction. The panel’s decision came as either a shock or relief, depending on where you sit and, according to the dissenting judge, “calls into question the very foundations of our century-old system of drug regulation.”
Caronia’s lawyer, Jennifer McCann, told OTW that she believes the panel’s ruling also applies to medical device companies.
Off-Label Costs
The specter of off-label communications informs every interaction between physicians and medical device and drug makers. FDA staffers comb the aisles of every major device and drug meeting looking for off-label violations. Companies are frequently sent warning letters about misbranding products.
Industry spends significant resources to comply with FDA rules related to off-label marketing. The government goes to great lengths to assure drugs and devices are only marketed for the indications on the labels and the plaintiff’s bar uses the off-label use of a product in lawsuits against physicians and companies. Insurers have denied payments for off-label use and the Justice Department has used off-label use in pursuing false claims cases.
The restrictions are there to fulfill the government’s role of protecting the public from unproven and unsafe products.
However, off-label use by physicians is not prohibited by law because it’s considered the practice of medicine. Only manufacturers and their employees are prohibited from speaking about off-label uses.
“The Sting”
The Caronia “sting operation” involved the government wiring up an informant and physician named Stephen Charno, M.D. to catch Caronia telling him about legal and truthful off-label uses of his company’s product.
Think about that for a minute. The government went through the time and expense to wire up a physician to catch a drug rep providing truthful information about his product.
Caronia was not convicted for off-label marketing. He was convicted for saying something (truthful) about his product that was not specifically noted on the product’s label. Thus, misbranding. The government said it wasn’t prosecuting Caronia for his speech, but that the speech demonstrated intent to cause the misbranding. The Court didn’t buy that.
Violation of Free Speech
Caronia asked “Why me?” Why can everyone, except a company and rep speak truthfully about a product?
The Appeals Court panel answered, there was no good reason and prohibiting only Caronia from speaking was a violation of his First Amendment right to free speech and actually got in the way of public health.
Here’s what the Court had to say:
As off-label drug use itself is not prohibited, it does not follow that prohibiting the truthful promotion of off-label drug usage by a particular class of speakers would directly further the government’s goals of preserving the efficacy and integrity of the FDA’s drug approval process and reducing patient exposure to unsafe and ineffective drugs.
Second, prohibiting off-label promotion by a pharmaceutical manufacturer while simultaneously allowing off-label use “paternalistically” interferes with the ability of physicians and patients to receive potentially relevant treatment information; such barriers to information about off-label use could inhibit, to the public’s detriment, informed and intelligent treatment decisions.
In fact, in granting safe harbor to manufacturers by permitting the dissemination of off-label information through scientific journals, the FDA itself “recognizes that public health can be served when health care professionals receive truthful and non-misleading scientific and medical information on unapproved uses” of approved drugs.
FDA Fears
Washington insider Steven Grossman writes on fdamatters.com on December 12 that if doctors can legally prescribe a particular drug for a specific use (albeit off-label), then companies ought to be able to provide “truthful and not misleading” information that they possess. “Arguably, they can do so now (via reprints of scientific articles), but only in response to a physician’s request. This is a very limited means of disseminating information.”
It is in the public interest for off-label uses to become on-label indications and, says Grossman, the FDA would like to see every off-label use get the scrutiny necessary to assure it is safe and effective.
Grossman writes that one of FDA’s great fears is that off-label prescribing will become dominant in clinical medicine. “FDA is concerned that companies will receive approval for a first use, then (directly or subtly) encourage doctors to prescribe off-label. If this strategy is profitable, FDA worries that fewer and fewer companies will commit the time and money to gain approval for additional indications. If a company can’t promote off-label, then it is more likely to invest in clinical trials to gain approval of the additional indications.”
He added, “Unrestricted promotion of off-label use would definitely undercut FDA. In such an environment, I believe that many companies will ‘game’ the system by finding a comparatively easier first use for approval, then let sales for other uses build off-label. Nor do I think companies are universally concerned about ‘litigation commenced under states’ product liability laws for ineffective products and the resulting reputational harm from such lawsuits.’”
Now What?
So what happens now? What if the full Appeals Court affirms the panel’s decision and ultimately, the U.S. Supreme Court decides to hear the case and upholds the decision?
New Clinical Data
Jason Hannon is the executive vice president and general counsel for NuVasive, Inc. Hannon said companies spend significant time and money on protocols to assure that all company communications comply with existing labeling requirements. Most of that effort takes place at the commercial point of contact with surgeon customers. All literature has to be scrubbed and nothing can be sent without a review process.
How much a company could save in reduced compliance costs isn’t known, but Hannon says the real costs is to physicians and patients who lose potential communications about legal, off-label uses. “Upholding the free speech argument would likely cause new interest in generating clinical data related to off-label use.
Companies should think about the possibilities if this ruling becomes the law of the land, says Hannon. But cautions, “Nobody should be meaningfully changing their practices right now.”
Paul Anderson: A Surgeon’s Perspective
Paul Anderson, M.D., professor of orthopedic surgery at the University of Wisconsin talked to OTW about those possibilities and what it would mean for the advancement of science in orthopedics.
Anderson says current off-label rules stifle innovation. For example, he says he can’t get devices from companies for unapproved uses for studies or CME approved courses. As an example, he noted the recent meeting of the FDA’s orthopedic panel to reclassify pedicle screws for use in the cervical spine. The screws were not specifically approved for that use. However, the standard of care had long moved past the antiquated wire and hook method for stabilizing the spine and screws were being used successfully. Anderson could only train surgeons one at a time while he was performing an actual procedure on a patient.
He also said IRBs (Institutional Review Boards) are less likely to approve studies if off-label use is required. He noted his difficulty in trying to do studies with BMP-2 products.
“We need company involvement in these studies, ” said Anderson. The companies are needed because their instrumentation is required for surgeons to be able to perform “hands-on” procedures during training. “We’re holding back education and innovation.”
Protecting Patients
Anderson is quick to point out that we need rules to protect patients from ineffective or unproven devices.
Here is how the appeals panel addressed that issue:
The government could pursue several alternatives without excessive First Amendment restrictions.
The government could develop its warning or disclaimer systems, or develop safety tiers within the off-label market, to distinguish between drugs.
The government could require pharmaceutical manufacturers to list all applicable or intended indications when they first apply for FDA approval, enabling physicians, the government, and patients to track a drug’s development. To minimize off-label use, or manufacturer evasion of the approval process for such use, the government could create other limits, including ceilings or caps on off-label prescriptions.
AAOS: Nothing Changes
The American Academy of Orthopaedic Surgeons’ (AAOS) outside counsel Katie McDermott told us that this decision will likely not change the legal relationship between surgeons and device companies. “Surgeons always want truthful information, ” said McDermott.
She also noted that this was only a three judge panel with a 2-1 split in one court district in New York. There is no telling how the entire Appeals Court bench will rule. “Nothing here changes the AAOS’ position on off-label use.”
McDermott also said there are over 700 sealed whistleblower cases pending against drug and device makers for False Claims and the Justice Department is not likely to back off because of a change in off-label rules. This case deals with criminal activity while the whistleblower cases are civil.
Neither the FDA, AdvaMed nor the Medical Device Manufacturers Association would comment on the case.
We don’t know yet what the FDA will do. We learned that the agency has filed for a 30-day extension to consider appealing the decision.
