Patients receive medications every day that are safe and useful for treating their medical ailments. Unfortunately, there are also instances in which patients are given prescriptions that cause more harm than good, as is the case when drugs are given for unapproved uses. And in many of these “off-label” prescription cases, the drug's manufacturer knows there is risk, but fails to share those risks with doctors or patients.
Before a prescription drug is approved by the FDA, pharmaceutical companies must submit the drug for clinical testing specific to its intended use. Unless a drug is approved for a specific use, it cannot be marketed for that use, even if there is anecdotal evidence it is safe for treating other issues. The same is true if a drug is not approved for a specific type of patient.
Doctors can legally prescribe medications for off-label use, but manufacturers cannot promote or advertise it for that use. Many off-label uses of drugs are not approved for payment through government-funded medical programs, though Medicare recently changed its rules allowing for wider coverage of off-label uses of cancer drugs. Submitting claims to Medicare or Medicaid for unapproved purposes can violate the False Claims Act and constitute fraud.
Despite the laws and limitations against off-label marketing, pharmaceutical manufacturers regularly face accusations of doing so. There are several ways manufacturers are able to accomplish off-label marketing schemes, including training sales reps about uses and dosages, providing sales reps with literature to distribute to doctors, providing financial incentives or kickbacks to doctors for prescribing drugs for off-label uses, and paying doctors to promote medications for off-label uses in medical literature or when they speak to the public.
The simple fact is doctors are seen as authorities by the general public and their opinion concerning a drug carries greater weight than others, including the drug's manufacturer or government officials. There is incentive for drug companies to reward doctors for pushing their drugs, even if it means being penalized. Many drug manufacturers are more than happy to take the hit to their reputations and wallets because the financial reward for expanding their customer base is so great.
Are Doctors to Blame?
There have been instances in which doctors have promoted drugs knowing that doing so was risky, but in many cases, doctors share information about drugs with the best intentions. They face a fine line between providing useful information and illegally promoting a drug.
If a doctor knows a medication is safe and effective for off-label use – that a drug could help a patient with a medical condition and not prescribing the drug would cause more harm than good – that doctor has an obligation to provide information to the patient about the drug. Off-label prescriptions are legal and often the best option on a patient-by-patient basis.
Problems occur when doctors over-prescribe off-label prescriptions and/or receive benefits from a drug's manufacturer for these prescriptions. As a patient, it is within your rights to question your doctor and determine his or her reasons for recommending a drug to you if it is yet-to-be-approved for the given use.
There are also concerns about doctor education. Research has shown many doctors think a medicine is FDA approved for something when it is not, just because it is so frequently prescribed for that off-label use. Misinformed doctors prescribe the medication based on false assumptions, further perpetuating the drug's off-label use without investigating data associated with that use. Drug manufacturers do nothing to encourage doctors to investigate and learn more about medications, even if they are not guilty for outright rewarding the doctor for off-label prescriptions.
What Can You Do?
Off-label medications can be beneficial and even lifesaving, but in most cases there is little to no scientific evidence they work. Many consider off-label use to be problematic because of the lack of data regarding safety and effectiveness. There are also concerns about how best to regulate drugs for off-label use. Some in the medical community believe there should be stricter rules for off-label prescriptions, but others are concerned more rules will prevent access to helpful drugs for many patients.
Until laws regarding off-label use change, you have the right as a patient to take responsibility for the medications you are given. Doctors are not required to disclose a prescription is off-label if they are not asked, but you have a right to request more information. Questions that can help you decide whether off-label use is worth the risk include:
• Is this prescription off-label?
• On what information/research did you base your decision to give me this prescription?
• Why do you believe this medication will benefit me? What is your percentage of certainty?
• Are there any clinical trials in progress regarding this use of this medication? Am I eligible to enroll?
If enrollment in a clinical trial is not an option or you prefer not to enroll in one, it is a good idea to check with your insurance company before accepting an off-label prescription – some are unwilling to offer coverage.
If you or a loved one has experienced any illness or injury after taking a drug that you believe was promoted illegally by its manufacturer, we can help. For more information, contact the attorneys at Andrus Wagstaff law firm at 866.534.5014.