Magazine article Drug Topics

Proposed New FDA Rule Might Allow Altered Labeling of Generic Meds

Magazine article Drug Topics

Proposed New FDA Rule Might Allow Altered Labeling of Generic Meds

Article excerpt

A new rule under FDA consideration could have a significant impact on the pharmacy industry and generic drug dispensing, yet most in the industry are not aware that change could be on the horizon.

FDA has proposed a new rule that would allow individual generic-drug application holdes to update product labeling information to temporarily reflect changes in safety information prior to FDA review.

In a recent statement presented to a U.S. House of Representatives Subcommittee on Health, Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research, said that the proposed rule would add parity among application holdes and "would speed the dissemination of new safety information about generic drugs to health professionals and patients."

However, pharmacy associations have raised concerns about whether the rule as it is written would increase confusion in the industry, undermine the public's trust in generic medication, increase liability to pharmacists, and potentially create generic drug shortages.

"From a pharmacy - a professional pharmacy - perspective, this is a huge issue for us, and we want to make sure we can turn the tide on this with the FDA," said Edith A. Rosato, RPh, IOM, chief executive officer of the Academy of Managed Care Pharmacy.

Despite the debate the proposed rule has sparked among leaders in pharmacy, a new survey released by the Generic Pharmaceutical Association (GPhA) found that 79% of the physicians, pharmacists, and physician assistants surveyed knew nothing about the proposed rule.

'This proposed ruling right now has not gotten out to the marketplace - or at least not in a way that they are paying attention to," Rich Higginson, director of corporate research for Fairleigh Dickinson's PublicMind, said during a recent webinar to announce the results. PublicMind conducted the random nationwide telephone survey of 450 physicians, physician assistants, and pharmacists.

The proposed rule

In November 2013, FDA proposed a new rule, known as the "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products," that would allow generic drug manufacturers to change their labeling to reflect newly acquired safety information before the change is reviewed by FDA, through what FDA refers to as a "changes being effected" (CBE-0) supplement.

Under this rule, the label on a generic drug could differ temporarily from the label on the reference listed drug or other generics.

"The proposed rule recognizes the obligation of all drug application holders to monitor safety information about the drugs they market and ensure that product labeling is accurate and up to date, and proposes a pathway to ensure that all drug application holders can fulfill that obligation and communicate important new safety information to prescribes and consumers," Woodcock said in her statement to the subcommittee.

As it stands currently, generic manufactures can't update product safety information until the brandname product receives approval for that purpose from FDA. However, makes of brand-name drugs are able to independently update and distribute such products' safety information before they receive FDA approval.

Under the proposed new rule, manufactures of generic drugs would be given this same power. They would need to provide a copy of the information supporting the change to the manufacturer of the branded drug as well as to FDA.

"In the current marketplace, in which approximately 80% of drugs dispensed are generic and brand-drug manufacturers may discontinue marketing after generic-chug entry, FDA believes it is time to provide generic-chug application holders with the means to update product labeling to reflect data obtained through post-marketing surveillance, even though this will result in temporary labeling differences among products," Woodcock said in her statement to the subcommittee.

During the period that FDA reviews the change, it will communicate any proposed safety-related changes to generic-drug labeling through a dedicated web page. …

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