Doctors widely agree that aspirin helps prevent heart attacks and estrogen helps prevent ovarian cancer in postmenopausal women. But the Food and Drug Administration prohibits drug manufacturers from disseminating information about such accepted medical uses for these and other FDA-approved drugs because the uses aren't mentioned on the FDA-approved labels. The FDA takes this stand despite the facts that:

• Many "off-label" uses of FDA-approved drugs are routine and safe, as documented in standard medical reference works.

• In the treatment of cancer, the drug of choice usually requires off-label uses.

The FDA makes no distinction between off-label uses accepted within the medical community and completely untested uses, although it admits that off-label uses are a necessary component of health care.

Nevertheless, in recent years the FDA has expanded its definition of "labeling" to include any dissemination by a manufacturer of information on off-label uses, even if the manufacturer is making no claim of its own. The FDA has even pursued criminal prosecution of drug company personnel.

As a result, drug companies no longer provide medical texts to doctors or substantial financial support for medical education.

Research published in medical journals and experience in use of drugs inevitably outpaces the lengthy clinical trials required for a manufacturer to get FDA approval for a particular use. Sometimes a manufacturer determines that the clinical trials needed to get such approval are not economically justified.

In a pending lawsuit, the Washington Legal Foundation is challenging FDA drug approval policy on First Amendment grounds.

Source: Richard A. Samp, "FDA Censorship Threatens Patient Medical Care," Consumers' Research, Vol. 77, No. 12, December 1994.