In an October 17, 2016 “CONSUMER ALERT” issued by the New Jersey Office of the Attorney General (NJOAG), the State warned that “Any physician found prescribing Subsys to patients not qualified for the treatment will be subject to disciplinary action . . . We will not allow patients’ lives to be endangered by prescribers who disregard the federal restrictions placed on this drug.” A close-reading of the article reveals that the NJOAG has apparently taken the peculiar position that the U.S. Food and Drug Administration has done something that the agency has never before done – establish a national “standard of care” to be followed by physicians with regard to the prescribing of a medication. This reading is supported by subsequent disciplinary actions taken by the Board of Medical Examiners which, at least in part, address the alleged improper prescribing of Subsys as a deviation from the standard of care.
“TIRF REMS” refers to the Transcmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation Mitigation Strategies (REMS) program, established by the FDA in an effort “to ensure informed risk-benefit decisions before initiating treatment . . . and [to further ensure] appropriate [patient] use of TIRF medicines.” It is an important program, requiring that both prescriber and patient inform themselves of the risks and benefits associated with TIRF REMS medications, such as Subsys. As a precondition to prescribing TIRF REMS medications, the program requires, among other things, that prescribers review the “TIRF REMS Access Education Program,” the “Full Prescribing Information” for each TIRF medication and execute a “Prescriber Enrollment Form.” Indeed, prior to prescribing any TIRF medicine, the prescriber and patient must execute a “Patient-Prescriber Agreement Form,” which, again, works to ensure that both prescriber and recipient are fully aware of the dangers associated with these powerful drugs.
What the TIRF REMS program does not appear to do, however, in contrast to the apparent position taken by the NJOAG, is to create a medical “standard of care” that would prohibit TIRF REMS qualified prescribers from prescribing the medication for off-label use, even if such off-label use falls within medically appropriate standards of care. This is not surprising, as the FDA has long made clear, through agency rules and bulletins, that it was not in the business of interfering with a physician’s professional medical judgment. This stance is further reflected in the terms and conditions of the TIRF REMS Access Program itself, which do not include an express prohibition on the prescribing of TIRF REMS medications off-label. Regardless, prior to dispensing TIRF REMS medications, it is critical that prescribers are in full compliance with the TIRF REMS Access program and prescribe strictly in accordance with all applicable medical standards of care.
If you are a provider and have received a subpoena, complaint or other legal document from the Office of the New Jersey Attorney General, New Jersey Board of Medical Examiners or the Division of Consumer Affairs in connection with the prescribing of a TIRF REMS medication, it is important you speak with a qualified healthcare attorney immediately, given the highly aggressive stance the State has taken in relation to these drugs and its ability to penalize you in a variety of ways, including licensure suspension and revocation. Frier Levitt has a deep knowledge of TIRF REMS related issues and can help. Contact us today to speak to an attorney.
