Then in 2015 a federal judge in New York issued a preliminary injunction against the FDA, permitting Amarin Pharmaceutical to share information about the off-label use
of its fish-oil drug Vascepa.
According to the First Amendment critique of the FDA's off-label promotion regulations, if the FDA is concerned about off-label use
of a prescription drug, the agency should regulate off-label use
itself, thereby limiting off-label prescribing without infringing on freedom of speech.
The Food and Drug Administration (FDA) is announcing the establishment of a docket to assist with our evaluation of our policies on communications and activities related to off-label uses
of marketed products, as well as communications and activities related to use of products that are not yet legally marketed for any use, we would like to obtain comments and information related to scientific exchange.
The FDA, armed with better information about the extent of off-label use
and its adverse effects, would be in a better position to require postmarket testing and to discourage off-label use
with new types of warnings if manufacturers failed to provide sufficient, timely evidence of safety and efficacy in that particular extrapolation.
Historically, the FDA has claimed that prohibiting pharmaceutical manufacturers from promoting off-label use
of their products achieves three important government interests: promoting the health and safety of the public, ensuring that physicians receive accurate and unbiased information regarding prescription choices, and preserving the effectiveness and integrity of the FDA's drug approval process.
The complaint further alleged that Medtronic aggressively promoted off-label uses
of its device utilizing journal articles, advertising media, sales representatives and consultants and paid leading physicians to urge the use and purchase of Infuse.
an institutional drug committee approved the off-label use
Faced with online testimonials pertaining to off-label uses
of its product,--for example, a Wikipedia entry that has been edited by others to provide information that is not compliant with existing advertising and labeling rules or public social media comments incorrectly attributing off-label use
of a product to the manufacturer--a company would be understandably confused, and rightfully concerned about FDA's reaction (possible regulatory enforcement action) to any public response on the one hand, and a potential increase of liability for failure to warn, and so on, on the other.
So, once a drug or device is placed on the market, physicians may legally prescribe it for any safe and effective off-label use
, governed only by professional medical standards and the licensing authority in each state.
At the most basic level, one may wonder why off-label use
of drugs is permitted at all.
Although plaintiffs pointed to information in the complaint regarding the global sales of the drug and the estimated percentage sold for off-label use
, these details did not supply particularity regarding fraud.
The use of drugs like gabapentin for purposes not approved by the FDA is referred to as off-label use