David R. Henderson  

Hooper and Henderson on Out-of-Control FDA

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Then there's the issue of off-label promotion. A drug's "label" is the drug's FDA-approved prescribing information--those complicated package inserts that we've all seen. Any approved use is on-label, while any use not listed on the insert is considered off-label, even though the off-label use may effectively treat a medical condition. Although the FDA tolerates off-label usage, it forbids pharmaceutical companies from promoting such uses.

Promotion is really just communication. So the ban on promotion means that your doctor is prohibited from getting any useful information from the company that manufactures the drug he is preparing to inject into your veins, if he is using the drug for off-label purposes. This prohibition on communication does real harm to real people, to say nothing of the harm that it does to the First Amendment. And it isn't just Forest that has fallen afield of this rule; over the last three years, Pfizer was hit with an eye-popping $2.3 billion settlement; Eli Lilly paid $1.4 billion; Novartis paid $422 million; Allergan paid $600 million; Elan paid $204 million; and GlaxoSmithKline has set aside $3.4 billion for its settlement.


This is from Charles L. Hooper and David R. Henderson, "The FDA's War on Drugs," published at the Hoover Institution's Defining Ideas.


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COMMENTS (7 to date)
John Goodman writes:

It is estimated that over half of cancer drugs being used today are "off label." So this is no small matter.

Also the communication ban includes making it illegal to send a doctor an article out of a medical journal describing the off label use, even if the doctor subscribes to the journal.

John Papola writes:

I wonder how many people died because the FDA forbid the promotion of aspirin as a preventative medicine for people at risk for heart attack. What an institution.

David R. Henderson writes:

Thanks, John and John,
John P., might make a good rap video. :-)

Shangwen writes:

Drug companies aren't perfect, but forcing them to look for profits in a relatively narrow number of pipelines has a range of harmful consequences. We have to separate their many rent-seeking behaviors from the fact that, in the end, they produce useful medicines.

If governments are serious about controlling health costs, they should ease up on pharma regulation. Over the last two decades, the costs associated with cardiac surgery have dropped in many regions because interventional procedures such as medication have surpassed surgical innovations by a long shot, thus reducing the need for risky heart surgeries and making cardiac treatments both more accessible and affordable. If drugs can displace heart surgery and get better outcomes, surely that is a reason to ease up on it in many other diseases.

GabbyD writes:

"I wonder how many people died because the FDA forbid the promotion of aspirin as a preventative medicine for people at risk for heart attack. What an institution."

but this is no longer true.

Costard writes:

Regulation is a moral enterprise, not a practical one. And really it is a testament to progress that our human sacrifices are almost entirely bloodless.

Heather writes:

I thought that you can still request those articles from Med Info scientists, just not sales who may know all about the product, but not as much about disease state/medicine/etc. to be qualified to talk about it in an "off-label" context. I think it's a matter of who requests the information- it has to come from the doctor, not pushed by the drug reps.

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