Sunday, December 25, 2011

Control freaks at the FDA forbid free speech

We read:
"The ability of physicians to prescribe approved medicines for purposes not sanctioned by the Food and Drug Administration (FDA) is one of the most important elements of medical care in the United States. These “off-label” uses are perfectly legal, and doctors rely on them extensively. But the agency views off-label prescribing as an attempt to circumvent its control over the nation’s pharmaceutical supply, so a number of regulations make it difficult for doctors to learn about and prescribe drugs off-label.

The most prominent rule entirely forbids drug manufacturers from promoting off-label uses. That might change soon, however, because two different federal courts are now considering lawsuits challenging the constitutionality of the off-label promotion ban. And given a string of recent Supreme Court cases affirming commercial free speech rights, one of those cases may at least partially invalidate the FDA’s restrictions.

Before a drug can be sold in the United States, it must be certified by the FDA as safe and effective for a specific, or “on-label,” use. However, once a drug is approved, physicians may legally prescribe it for any other purpose. And because medical research regularly discovers new treatment options years before the FDA can approve them, off-label prescribing enables patients to benefit from the most up-to-date knowledge.

The practice is ubiquitous in cancer treatment, cardiology, and neurology, and by some estimates, at least 20 percent of all prescriptions written are off-label. The American Medical Association says that many off-label uses are considered “reasonable and necessary medical care, irrespective of labeling.” In fact, doctors can be subject to malpractice liability if they do not use drugs for off-label indications when doing so constitutes the standard of care. That’s one reason most private health insurance plans with prescription drug benefits cover various off-label uses, as do Medicare and Medicaid.

Doctors learn about some off-label uses in medical school, and later by reading medical journals articles or hearing about them from colleagues or at conferences. But the FDA uses its authority over drug labeling and “promotion” (which includes not just advertising but virtually any communication with health professionals or patients) to prevent manufacturers from disseminating information about off-label uses, even to doctors.



D said...

Viagra, as it is prescribed now is "Off Label" from it's original purpose as a blood pressure drug.

Anonymous said...

Is that what it says on the label when you buy it Dsaid?

Anonymous said...

As someone who works in a hospital every day with medical devices (angioplasty stents and balloons) I see off label use every day of these devices. The manufacturers paid a handsome amount for initial studies to prove the effectiveness of their device in a very specific use. If it is used in a very similar and perfectly logical use, it is still called "off label". If the manufacturer wants to market other uses, they have to again pay for vast, multi year studies. This idiocy is courtesy of the FDA. No wonder health care is so expensive here in the US.

Bird of Paradise said...

Abolish buricrats

Anonymous said...

Abolish illiteracy!