Revance Therapeutics Inc (RVNC)

[floblu14]

Everything you want to know about "off label" usage, but were afraid to ask -

AMA JOURNAL OF ETHICS:

Excerpts -
The FDA does not prohibit physicians from prescribing drugs off-label [4], and Congress has repeatedly taken legal steps to prevent the FDA from interfering with the practice of medicine [4]. Although many malpractice lawsuits have been filed on behalf of patients arguing that they did not give informed consent to take a drug because they were not informed that use for their particular condition was actually off-label, the law has generally sided with physicians in finding that they have no legal duty to inform patients of a drug’s regulatory status [3, 4]. Such rulings enforce that off-label is an FDA regulatory term that denotes nothing about clinical risks or benefits [4]. The physician’s duty is to provide clinical information and some have argued that taking the time to explain the legal complexities of FDA approval versus off-label drug use could distract from shared clinical decision making [3, 4].

Conclusion
Off-label prescribing is a common and legal practice in medicine. This practice is justified when scientific evidence suggests the efficacy and safety of a medication for an indication for which it does not have FDA approval and when the practice is supported by expert consensus or practice guidelines. Through shared decision making, patients and families are equal partners in clinical decision-making processes, which can help a physician carefully weigh risks and benefits of a given treatment according to the patient’s unique circumstances.

Read more:
https://journalofethics.ama-assn.org/article/prescribing-label-what-should-physician-disclose/2016-06