Magazine article Drug Topics

FDA Moves to Overhaul Package Inserts, Cut ADEs

Magazine article Drug Topics

FDA Moves to Overhaul Package Inserts, Cut ADEs

Article excerpt

The Food & Drug Administration is proposing a new "userfriendly" format for prescription drug package inserts that it estimates could save nearly $4 billion a year in hospital costs by reducing adverse drug events (ADEs). Other benefits of the regulation seen by the FDA include less time needed by health professionals to find the information they need and more effective treatments.

"This proposal is particularly valuable because it will make important information available in a clear, consistent, and readable format that is essential to proper prescribing practices," said Jane E. Henney, FDA commissioner. Jeffrey Trewhitt, a spokesman for the Pharmaceutical Research & Manufacturers of America, said the drug industry agreed that package inserts, also known as the approved labeling, need to be improved. "It is important to pursue new efforts to provide more precise and understandable prescribing information," Trewhitt said. He added that at first look, the proposal "sounds encouraging, but now we've got to get into the details. The devil is always in the details."

One major change in the format is creation of a new, introductory "highlights" section covering dosage, side effects, and contraindications that the FDA believes will decrease ADEs caused by incorrect prescribing of the Rx. It calculated that about $3.8 billion annually in hospital costs associated with ADEs are potentially preventable through better labeling, although it noted that the actual amount could not be predicted with certainty.

"If these costs were reduced by even 1%, however, the proposed rule would reduce hospitalization costs by $38.4 million per year," the agency said. "Over 10 years, the present value of these benefits would total $233.8 million. Furthermore, if additional averted costs (e.g., physician visits, additional outpatient costs, patient time, lost productivity) were included, the savings from ADEs avoided would be substantially higher."

If adopted, the rule generally would not apply to Rxs approved more than five years before the effective date of the final rule. Since the FDA is accepting public comments until March 22, it is unlikely that the final rule will be issued before mid-year at the earliest. …

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