FDA PROPOSES NEW RULES MAKING 'OFF-LABEL' DRUG USE EASIER

WASHINGTON (CNN) -- The U.S. Food and Drug Administration said Friday it is
proposing new rules that would make it easier for drug companies to tell
doctors and insurers about "off-label," or unapproved, uses of their
products.

Under the current system, once a drug or device is approved by the FDA for
any use, physicians can prescribe or use them for other ailments or
procedures in what is called "off-label" use.

Drugs approved to treat one form of cancer, for instance, are often used
for other types of cancer, and a cancer drug known as hydroxyurea is
sometimes used to treat sickle-cell anemia and HIV infection.

However, until now, the companies could not officially inform physicians,
pharmacists or insurers of the other potential uses. The new rules would
allow the companies to do so.

Also under the proposal, the companies would not have to wait for FDA
approval of the additional uses before giving out information.

The information, however, must meet certain criteria. It must:

- - Concern a drug or device that already has been approved by the FDA for at
least one use.

- - Be peer-reviewed scientifically or published in a medical journal.

- - Not pose a risk to public health.

- - Not be false or misleading.

- - Enclose information saying the use is not approved by the FDA.

The proposed rules will allow companies to tell doctors, pharmacy benefits
managers, health insurance companies, group health plans and government
agencies about off-label uses of their products.

FDA must have 60 days notice

"This information can only be disseminated for 'off-label' uses which have
been, or will be, studied and submitted for FDA approval," it said in a
statement. "It must also be reliable and balanced."

The companies also must alert the FDA 60 days before they begin sending out
the information.

William Schultz, the FDA's deputy commissioner for policy, said that in the
past the agency worried that letting a company talk about off-label uses
would reduce any incentives to test its products carefully for those uses.

The FDA now requires companies to prove a proposed new drug or device is
safe and actually works for the specific disease or condition for which it
is being licensed.

Reuters contributed to this report.

Checked-by: (Joel W. Johnson)