More than a decade ago, Congress allowed pharmaceutical companies to distribute peer-reviewed medical journal articles to physicians describing alternative, "off-label" uses of federally approved drugs. Currently the Food and Drug Administration (FDA) has to approve these reprints before they are circulated. But as the 1997 law authorizing the reprints expires, the FDA is mulling a plan to drop the approval requirement altogether, allowing companies to disseminate unabridged reprints of "truthful and non-misleading" medical journal articles more easily.
Apparently operating on the assumption that patients are best served when doctors are unaware of the latest medical information, Rep. Henry Waxman (D-Calif.) says the proposal "would open the door to abusive marketing practices." Waxman, who chairs the House Committee on Oversight and Government Reform, is trying to block the change.
These reprints are the only way pharmaceutical companies can legally market their products for off-label uses. Such prescriptions are routine for cardiac drugs (46 percent of all prescriptions), anticonvulsant drugs (46 percent), asthma medications (42 percent), and cancer treatments (33 percent). Waxman, age 68, may be unwilling to take off-label cardiac drugs, but millions of his fellow Americans have benefited from doing so.