off-label

How to Stop “Off-Label” Marketing and Sales of Prescription Drugs

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.   www.PharmaReform.com

  • Kimberly

    This would be very effective in stopping off-label promotion. The portion that has to do with promotion should happen tomorrow. I am, however, concerned that by restricting the ability of physicians to prescribe drugs as they see fit we could stunt innovation. What do you think?

  • http://www.pharmareform.com Mike Wokasch

    Kimberly,
    Thanks for the good question. I don’t believe this has anything to do with stunting innovation. In no way is physician prescribing inhibited or limited in this scenario. I am merely proposing that physicians, patients, and payers assume responsibility and accountability for their choice to prescribe, use, or pay for an unapproved use. I feel this is fair and appropriate. It has been too financially rewarding, incentivized and encouraged by reimbursement, to keep Pharma Companies from engaging in “off-label” promotion. As I state, that doesn’t make it right and Pharma Companies should not be promoting their products for unapproved uses. At the same time, it has been too easy for the government and patients to use “off-label” promotion as the basis for litigating to multimillion dollar awards and settlements despite the fact that three other entities (physician, patient, and payer) all made choices to use a product for the unapproved indication. It’s almost as if Pharma companies are being blamed for forcing physicians to prescribe, forcing patients to take to the drugs, and forcing payers to reimburse for the unapproved use. Although Pharma Companies benefit from “off-label” use, they have no capacity to prescribe, to make patients take drugs, or to approve payer reimbursement. mike@pharmareform.com

  • Kimberly

    That makes perfect sense. Well thought out and stated. Thank you!