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Generic Drug Maker Liability: New Change to an Old Regime

Different rules exist for generic drug manufacturers and brand-name drug manufacturers with regard to their warning labels. The labeling process is governed by the Food and Drug Administration (FDA) rules and regulations. FDA-approved drug labels summarize the essential information needed for the safe and effective use of the drug. Importantly, these labels provide health care practitioners with essential scientific information needed to make the best prescribing decisions. These labels allow for the safe and effective use of prescription drug products and reduce the likelihood of medication errors.

Brand Name v. Generic Labeling- What’s the difference?

Actions taken by generic drug manufacturers are limited by the current regulatory framework. Both generic-drug manufacturers and brand-name drug manufacturers must obtain FDA approval. However, a generic drug is required to maintain the same labeling as its corresponding brand-name drug (with some limited exceptions). The process through which labels are changed is through the Changes Being Effected (CBE) supplement process. Only brand-name manufacturers may use the CBE process.  If the FDA approves a brand-name manufacturer’s label change, generic-drug manufacturers must make that same change to the corresponding generic drug’s label as soon as possible.

PLIVA, Inc. v. Mensing

This limitation was highlighted in a recent Supreme Court case PLIVA, Inc. v. Mensing. The Supreme Court held that because the FDA generally prohibits generic-drug manufacturers from independently altering their labels, these manufacturers cannot be liable for failing to make such changes. The Court found that it was impossible for generic manufacturers to comply with both their state-law duty to change the drug’s label to a different, safer label that adequately warned of the injuries alleged, and their federal law duty to keep the label the same. The Court therefore ruled that federal law (FDA rules) pre-empted state laws that imposed a duty to change a drug’s label on generic drug manufacturers.

 What Does This Mean for You, the Consumer?

This ruling limited product liability plaintiffs’ remedies. The Pliva decision essentially held that certain failure to warn claims against generic drug manufacturers are preempted, while those same claims against brand-name drugs are not. Therefore, many who use generic brand drugs are unable to pursue their claims against the manufacturers and have little recourse.

However, this soon may change. Recently, the FDA proposed a rule to permit generic drug manufacturers to unilaterally update their warnings labels.  In doing so, the rule creates greater accountability for generic drug manufacturers over the content of their warning.  The new rule would:

  • Permit generic-drug manufacturers to use the CBE process independent of brand-name manufacturers;
  • Open a FDA website containing the proposed label changes and background information submitted by generic-drug manufacturers;
  • Require the generic-drug manufacturers that submit CBE supplements to monitor the information posted on the website and notify the FDA if any of the information is incorrect; and
  • Impose a 30 day deadline for generic-drug manufacturers to update their labels to match those of the brand-name equivalent.

 Share Your Thoughts: What Do You Think the Rule Should be?

This rule is open for public comment until April 27, 2015. Comments may be submitted here. The FDA will also host a public meeting on March 27, 2015 from 8 am to 5 pm in Silver Spring, Maryland. The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave, Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002.