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Industry appears to be making a concerted push to pressure the FDA to relax what they believe to be overly restrictive policies concerning the off-label promotion of drugs, an effort that began picking up steam following a 2012 court decision in which a sales reps conviction was overturned on the grounds his "truthful, non-misleading" conversations about off-label use of a drug was protected under the First Amendment. (See ViewPoints: FDA responds to calls to relax off-label marketing rules - is change becoming inevitable?)
The FDA, with help from the US Justice Department, has been vigilant about punishing companies deemed to have run afoul of its rules against off-label promotion of drugs. The American Medical Association estimates that the industry has coughed up more than $16 billion over the past decade in settlements related to off-label promotion cases.
Over the past few years, however, drug companies have started taking a more offensive stance. A coalition called the Medical Information Working Group (MIWG), founded by a number of big pharma players - Eli Lilly, GlaxoSmithKline, Johnson & Johnson and Pfizer among them - has filed multiplecitizen petitions with the FDA requesting additional clarity on its policies related to off-label promotion activities.
The pressure on the FDA to act has thus been building for a while, and the agency has signalled some willingness to work with drugmakers to relax the rules a bit in specific circumstances, such as dissemination of published studies and clinical practice guidelines that include references to off-label use of drugs.
Some companies clearly feel the agency is not being flexible enough. On May 7, Amarin filed suit against the FDA alleging that the agency is infringing the companys First Amendment rights by prohibiting it from discussing certain clinical data related to its dyslipidaemia drug Vascepa.
Mindful that pressure has been building, and that there are strong feelings held by various stakeholders who argue both for and against loosening the rules, the FDA announced last week a plan to hold a public meeting this summer to discuss the issue.
To gain better understanding about the views of doctors on the possibility of relaxing restrictions prohibiting off-label promotion of drugs, FirstWord PLUS is polling US-based general practitioners, neurologists and oncologists and asking them
- In your estimation, are the FDAs rules on off-label promotion of drugs too restrictive?
- How often do you prescribe drugs for uses that would be considered off-label?
- How often do you find yourself in a situation where you have questions about off-label uses of a drug but are unable to find helpful information?
- In general, what proportion of sales representatives conform to current off-label legislation when promoting prescription drugs in your area of specialty?
- If the FDA were to relax its rules on off-label promotion of drugs, do you think it would benefit or harm public health?
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