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Two high-ranking House Republicans have accused the US Department of Health and Human Services of delaying eagerly awaited guidelines for off-label marketing of drugs and devices. And the charge comes amid growing frustration among companies that the US Food and Drug Administration is squelching their free speech-rights.

In a letter sent Thursday to HHS Secretary Sylvia Burwell, the lawmakers wrote they are “perplexed” the FDA has not yet issued new guidelines covering off-label marketing or held a promised meeting. And they worry that court rulings will, instead, become the basis for determining policy. Then they claimed the delay is the result of disagreement between HHS and FDA leadership.


“It is our understanding that HHS has not allowed FDA to issue its completed draft guidance addressing the scope of permissible ‘scientific exchange,’” of useful information about drugs and devices, wrote Fred Upton, a Republican from Michigan and Joe Pitts, a Republican from Pennsylvania. They also attached a draft bill that would allow companies to market products for unapproved uses.

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  • This is exactly the types of legislation that Industry Insiders would come up with. If they were not all in the pocket of the industry they would be working on real issues. There is a reason that this kind of deceptive marketing used to be illegal in the US. The foxes are in the hen house!

  • Does anyone seriously believe that if HHS/FDA don’t go Pharma’s way they won’t battle this in court? Of course, they will–and they’ll blame the agencies for the cost of Jones & Day et al. So the expressed respect for an FDA ruling, if they don’t like it, strikes me as pure hypocrisy. I dare the industry to pledge they won’t challenge an HHS/FDA ruling if not to their liking. Sextuple dare. Let’s put sincerity to a test.

  • When there is no proof that a drug or device will do what the innocent salesman says it will do…
    It’s not science.
    We believe the doctor who believed the salespeople who tell the truth and are not misleading…
    After all, they’re not guilty!
    I love the choice: either the courts are going to decide
    the FDA must hurry up and make guidelines for this unconscionable practice.
    The Off-Label Belief System
    What could go wrong?

    • Off label free speech allows us to promote without statistically significant proof of efficacy. I’ve always believed the P value of 0.05 was arbitrary anyway. Even FDA can’t tell us how it was derived. This is how new discoveries are made. Someone makes an observation and then a company does a following. Study. I would also like to see those “coming soon” ads reinstated instead of promoting a drug only after approval. Makes sense to let the medical world know.

    • This would never affect the patient, if a physician would: have some ethics, moral responsibility, keep “First do no Harm, and give conscious informed consent. However, if a patient prefers keeping their medical records private, then perhaps off label is the way to go, but never without their conscious informed consent. They need to know the side effects of the drug for the condition that they are taking it for.

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