Jun. 13 -Drug labeling by the FDA

Not everyone is happy with changes in drug labeling put into place by the FDA:

Experts say the new labeling system for prescription drugs about to launch in the United States will not radically improve patient safety or the prescribing process.

What’s more, the new rules include a clause, slipped in silently after the public-comment period had closed, that will make it almost impossible for patients to sue drug makers over adverse events, said the authors of a perspective piece in the July 8 New England Journal of Medicine.

“Along with the very modest alterations of drug labeling to be phased in over the next seven years, the changes the FDA [U.S. Food and Drug Administration] begin implementing next month include a regulatory time bomb that could severely limit the accountability of companies that fail to adequately evaluate or report the risks associated with their products,” the authors stated.

New FDA rules outlining an overhaul of the printed-package inserts that accompany prescription drugs are scheduled to go into effect June 30.

The revisions, the first since 1975, will require that inserts include a “prominently displayed summary of key information including indications, usage, dosage and administration,” said FDA Acting Commissioner Dr. Andrew von Eschenbach, when the new rules were announced in January. This summary, or “Highlights” section, will be about a half-page in length, he said.

Health-care professionals can also expect to see a table of contents, patient-consulting information to ease communication between doctor and patient, as well as information on a toll-free number and Internet address for reporting suspected side effects.

See the full article: Forbes.com.