Off Label Prescriptions - Despite Reports, FDA Guidelines For Off-Label Promotion Tighten Loophole

It was interesting to read recent media reports incopy also should carry a prominently displayed
such prominent outlets as and the Wall Street Journalstatement disclosing the following:o The uses
about the FDA's plans to set guidelines for the kindsdescribed in the information have not been approved
of literature drug makers can use to support theor cleared by FDA, as applicable to the described
off-label use of FDA-approved drugs. Originally, thedrug or medical device,o The manufacturer's interest
FDA stipulated that drug manufacturers couldin the drug or medical device that is the subject of
disseminate information on unapproved, off-label usesthe journal reprint or reference text.o Any author's
of FDA-approved products, under Section 401 of thefinancial interest in the product or manufacturer.o The
Food and Drug Administration Modernization Act thatfunding source for the study, ando Any significant
expired on Sept. 30, 2006. It took a while but on Feb.risks or safety concerns the manufacturer knows
15, 2008, the agency announced new guidelines underabout concerning the unapproved use that are not
the title "Good Reprint Practices."discussed in the journal article or reference text.
The whole idea is that while the FDA recognizes thatIt Remains Illegal to Promote Off-Label Use
off-label use is common, and indeed quite legal, drugFinally, it should be recognized that it is illegal for a
companies need strict guidance on what theydrug company to promote off-label use for a drug or
disseminate regarding those uses. Contrary to whatdevice, that constitutes a "new use" for that drug or
some of those news reports suggest, the FDA is notdevice. If such promotion is carried out, then the FDA
opening the door for drug companies to promoteretains legal authority to decide upon the condition of
off-label uses of drugs. Instead, it puts very preciseunapproved "new use" and whether the distribution
rules and standards in place for what the companiesof an article or publication constitutes promotion of a
can use as supporting evidence, such asnew use. In some cases these decisions can result in
peer-reviewed publications.a product being deemed misbranded or adulterated
In general, the FDA approves drugs only for certainunder the federal Food, Drug and Cosmetic Act.
indications, and this information is contained in theGiven that healthcare professionals can legally
FDA label for the product. However, there is nothingprescribe drugs for off-label use, the FDA guidelines
illegal about healthcare professionals prescribingrepresent a significant advance in this whole area. I
FDA-approved drugs for non-indicated uses, such asfind it puzzling to read comments in the press and in
administering an anti-epileptic drug to treat bipolaronline blogs about how this is going to open up the
disorder, for instance. Indeed, it is estimated thatarea of unapproved, off-label use and thereby put
around 20 percent of all drugs are prescribed forthe public's safety as risk because the FDA is now
off-label uses, particularly in the psychiatric arena.going to completely endorse publications promoting
However, it is illegal for manufacturers to activelysuch use. If anything, this proposal sets very strict
promote drugs for non-indicated uses.and sensible boundaries for promoting off-label use.
Limiting What Companies Can DistributeAs Randall Lutter, an FDA deputy commissioner, said
The new guidance recommends that individuals (suchin a news release referring to the publications for
as drug company representatives) who disseminateoff-label use, they "can contribute to the practice of
literature in support of off-label use, use only lettersmedicine and may even constitute a medically
to the editor, publication abstracts, and reports ofrecognized standard of care."
Phase 1 trials in healthy subjects from peer-reviewedMedia Fuss Side Effect
journals with recognized editorial boards. It also allowsOne side effect of the media fuss was that
for reference publications that contain little or noDemocratic Rep. Henry Waxman of California wrote
substantive discussion of the relevant investigation orto the FDA suggesting that it rethink the guidance.
data. The publications should be generally available inHe said he was worried that it would create a large
bookstores or other independent distribution channelsloophole in the laws against off-label promotion.
where medical textbooks are sold, according to theActually, it tightens loopholes.
guidelines.In the end, it is the doctors and healthcare
The guidelines also suggest that the articles shouldpractitioners who must decide on how to use a drug
not be edited, abridged, marked, or highlighted in anyfor a given condition. If an FDA-approved
way, and that reprints or copies should beanti-epileptic drug has been shown to significantly
accompanied by the FDA-approved labeling and animprove a bipolar disorder in independent and
extensive and comprehensive bibliography. Thepeer-reviewed studies, then doctors and healthcare
articles should not be physically attached to anypractitioners are the ones who are going to be in the
promotional material by sales representatives, norbest, and only, position to determine how best to
should they constitute a subject of discussion duringtreat the patient, on a case-by-case basis. With
sales presentations. Similarly, sales representativesthese guidelines in place, the promotion or advocacy
should not distribute these reprints at conferences.of off-label use by drug-or medical device-companies
Lastly, the FDA recommends that a journal reprint oris likely to be severely restricted.