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Experts Fault New FDA Drug Label Changes

By Amanda Gardner, HealthDay Reporter
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They won't help patients, but could shield drug makers from legal action, researchers say

However, these issues become almost irrelevant in light of the new, last-minute provisions. Language was added to the final ruling stating that any FDA-approved label, "whether it be in the old or new format, preempts... decisions of a court of law for purposes of product-liability litigation."

That addition, Shrank said, was in response to a comment made during the five-year comment period. He did not know who had made the comment.


WEDNESDAY, June 7 (HealthDay News) -- 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.

The initiative is intended to reduce the number of preventable "adverse events" -- now estimated at 300,000 annually -- that occur in hospitals in the United States, officials said.

New drugs will automatically be covered by the new format. Drugs approved within the past five years will ultimately be required to abide by the changes. Drugs older than that will not be subject to the requirements, but manufacturers are being "encouraged" to update their inserts.

According to the perspective piece authors, the highlights section and new table of contents are the only pieces that will be even moderately helpful to prescribers.

"They re-jiggered a label that's hard to access and hard to read and not that useful in the clinical process for doctors," said Dr. William Shrank, co-author of the article and an instructor of medicine at Harvard Medical School. "They should have considered how the information is delivered to doctors, not just re-jigger the way the label looked."

Instead, doctors need better access to updated risk/benefit information, ways to compare various drugs quickly and, overall, a better synthesis of information, he said.

"I don't think it should be understated what an opportunity the FDA missed," Shrank added. "They didn't really alter the delivery system of these labels. The delivery of risk and benefit information is a real failure."

However, these issues become almost irrelevant in light of the new, last-minute provisions.

Language was added to the final ruling stating that any FDA-approved label, "whether it be in the old or new format, preempts... decisions of a court of law for purposes of product-liability litigation."

That addition, Shrank said, was in response to a comment made during the five-year comment period. He did not know who had made the comment.

Attempts by HealthDay to reach the FDA for comment were unsuccessful.

According to the perspective piece, several members of the U.S. House of Representatives and Senate have already voiced their objection to the provision, and to the lack of debate preceding it.

Court challenges, the authors stated, are likely.

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