Magazine article Drug Topics

FDA Reopens Comment Period on Proposed Changes to Generic Labeling

Magazine article Drug Topics

FDA Reopens Comment Period on Proposed Changes to Generic Labeling

Article excerpt

Should makers of generic drugs be required to update the safety concerns section in their drug labels before FDA reviews the change? Should this be done even if the information differs temporarily from that listed in brand-name drug labels?

Looking for more comments from stakeholders on its proposed rule introduced in November 2013, FDA held a listening session on March 27. The comment period regarding proposed alternatives to FDA's proposal ended April 27.

Under current law only brandname drug sponsors can add such information without an FDA decision. But generic drugs now make up 86% of the market for outpatient drugs, said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, addressing participants at the March 27 session.

"Currently, if a generic drug manufacturer believes that newly acquired safety information should be added to product labeling, they must notify the FDA and wait for the FDA to determine whether the label for both the brand and the generic should be revised, which may result in a delay," Woodcock said.

FDA's proposal would include the creation of a web page by the agency for information on label changes.

Liability issues

Overshadowing the discussion is the issue of companies' liability for failure to warn patients about safety issues.

Supreme Court decisions in 2011 and 2013 held that generic drug makers can't be sued for making a drug or for not warning about possible risks because the companies legally may not have warnings that differ from the brand product.

The day-long session saw a number of emotional moments during testimony from people who had suffered horrific injury or had lost babies as a result of adverse events triggered by generic drugs.

Stakeholder opposition

However, the American Society of Health-System Pharmacists (ASHP), the Academy of Managed Care Pharmacy, the American Pharmacists Association, and others have submitted testimony opposing the rule, saying it might lead to confusion and would raise costs.

ASHP said it is concerned about whether the agency can implement the rule effectively to ensure that everyone has access to complete information, regardless of the labeling source. According to ASHP, "FDA has historically faced challenges with maintaining consistent and current prescription drug labels. …

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