18) But the prohibition only applies to manufacturers and their agents-any other speakers (physicians, medical journals, ordinary people) are "free to say whatever [they] want about the off-label use
encouraging bloggers to write about off-label uses
of a product.
Particularly in such situations where the off-label use
represents the medically accepted standard of care, "it may be unethical to conduct the necessary study" because doing so requires some patients to be randomized into the control arm of the trial, in which subjects are given a placebo or are treated with a product known or believed to be less effective.
10) All of these reforms would help increase the safety of off-label use
1) Drug manufacturers must have filed an application for FDA approval of the new use of the drug before that off-label use
can be discussed in medical literature to be distributed to health professionals; 2) Medical literature must be submitted to the FDA for review before the information is distributed to medical professionals; and 3) Drug manufacturers must biannually prepare and submit a list of all the articles and references on the new use that were disseminated to health professionals, and a list of the categories of providers that received the literature pertaining to the new use.
Physicians learn of off-label uses
from medical research and experience conveyed by peer-reviewed publications, newsletters, lecture presentations, conferences, and conversations with trusted colleagues.
It was both advocating and discouraging off-label uses
by pregnant women.
Even when the off-label use
is similar to the labeled use, the FDA requires a "supplemental new drug" application and, just as with new drugs, supplemental applications require extensive clinical trials.
At that hearing, some of the FDA's own medical experts recommended that the ban remain in effect, saying they feared that the drug would become too widely available through off-label use
Judge Denny Chin's opinion for the 2-1 majority of the 2nd Circuit noted that while the FDCA does not expressly prohibit the marketing of drugs for off-label use
, the FDA has concluded in draft guidance that an "approved drug marketed for an unapproved use (whether in labeling or not) is misbranded because the labeling of such drug does not include 'adequate directions for use.
On the one hand, off-label use
of prescription drug and devices gives rise to a series of major problems for the FDA.
of medical therapies is legal in the United States (although companies marketing their products for off-label uses
is not), but researchers are concerned that "augmentation beyond instrumentation and autograft bone grafting in pediatric spinal arthrodesis" is unnecessary.