Recently FDA has confirmed announcement of a major and final rule of labeling coming in July 2016 that will entail new guidelines for updating labels of generic drugs in terms of safety information. Announcing this final rule, FDA intends to make the process of label update easier for generic drug companies.

Influence of Present Rule

As per the current regulations for updating drug label, the guidelines are different for branded drug manufacturer and generic drug manufacturer that creates a timeline difference (which is generally more for generic drug manufacturers) for both manufacturers to update and implement any safety related information on the packaging. Such a delay may cause health complications for a patient who is buying a generic drug whose safety information has not been updated on the package.

Corresponding to present guidelines, generic drug manufacturing companies cannot update product labels independently for any new safety information associated with new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs). This situation poses threat to patient health as companies cannot warn users about any safety issue identified which is yet to be specified on the reference product’s label.

What Would The New Rule Entail?

After final considerations, if this rule comes into force, generic drug manufacturers will be able to issue a labeling update related to any safety information change in short timelines. It will entail a process that would allow the discrepancies to exist on temporary basis among the brand name reference products, generic drugs and approved generic drugs. When companies are filing applications to FDA for labeling change, they need to provide relevant information that describes the basis for label change along with:

  • New data to be implemented after change
  • Published literature
  • Adverse event data
  • Epidemiologic studies

FDA said:

“The rule may encourage generic drug companies to participate more actively with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling in accordance with current regulatory requirements,”

Whenever a new rule is proposed by FDA, apart from elaborated internal discussions, the agency also considers suggestions from public docket to create the final guideline. For this particular guideline associated with safety label updating process, FDA received approximately 2300 comments which will be taken into consideration together with the final financial implications and benefits.

Disagreements Witnessed For the Rule

A lot of disagreements were unveiled in generic industry against the proposed rule as some sponsors believed that new legal liabilities and delay in announcing the final rule would bring financial instability and lead to loss of billions of dollars to generic companies. They proposed that FDA should be quick in making final decisions intended for this rule and ensure that updated safety information is accessible by patients on time.

In Conclusion: A Challenge Ahead For GDMs

As generic drug industry awaits for the new rule to be released by FDA, manufacturers should get ready to have a quick response time in case of any change in safety information. This will be a challenging undertaking as presently the complete information about final guideline is not known to generic drug manufacturers


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