The US FDA’s Proposed Generic Labeling Rule: Still Steering Troubled Waters

Gaurav Kukade

Earlier this year significant buzz and promise was created when the US FDA announced that a new generic labeling guidance would be released in July 2016 that would require generic manufacturers to update their own labels in light of the drug safety information received. However many experts debated the rule and felt that it would create significant challenges for the industry. This voice gained more validity when the US FDA announced recently that the release of this regulation has been postponed to April 2017, the third time the enforcement of the rule has been postponed. In fact a few of the consumer groups and organizations now believe this rule will never see the light of the day .
Generic drug manufacturers are taking a staunch position with very relevant and real implications as noted below.

Cost Implications to Implement Safety Tracking System

Some estimate that the rule will cost the healthcare system around $ 4 billion annually. Since the ruling will mandate that generic companies implement drug safety surveillance and signal detection in pharmacovigilance (a burden that only innovator manufacturers hold today), additional costs will be indirectly imposed on the patients. The market share of generic drugs is vast. It is reported that more than 86% of all prescriptions dispensed in the US are filled by generic medicines but these account for only 27% of the expenditures on prescription drugs. The additional costs to implement drug safety systems at generic manufacturers are of real concern not only to generic manufactures but also the healthcare industry at large.

Increased Risk of Litigations Due to Failure to Warn

It has been widely anticipated that the proposed rule will bring generic manufacturers under a continuous threat of litigation for failure to warn, thus inviting cost implications and timeline delays. The new rule would make generic companies liable under failure to warn cases, so manufacturers will need to ensure their labels are updated with the most up-to-date safety information as close to real-time as possible. With pharmaceutical product labeling updates being such a complex process especially with global distributions, manufacturers will be at risk if they have different content in the labels for the same product. There is a strong possibility that these varying labels will get challenged in the court of law with the generic manufacturers being caught between ensuring pharmaceutical regulatory compliance and risk of litigation.

Accuracy of Safety Label Updates May Suffer Due to Dispersed and Incomplete Safety Data

The FDA specifically requires that the product information be changed only when there is a causality established between the reported adverse event and the drug. For these decisions to be made one would need to have a complete overview of all safety issues for the innovator and the generic versions of the drug. This becomes even more complicated when multiple generic manufacturers enter the market i.e. when the exclusivity granted to the ‘first to file’ generic manufacturer ends . In this situation when each generic manufacturers creates, evaluates and actions upon their own drug safety information via CBE 0 the innovator and other generics companies will find it increasingly difficult to evaluate safety information since no one will have access to all the data. The current system, where the label updates are driven either by the FDA who has access to all the data or the innovator, makes more sense.

Increased Confusion for Patients and HCPs

The risk of multiple versions of the label causing confusion for patients and healthcare professionals is real. Furthermore public confidence in the prescribing of generics may be impacted in a situation when the generic label includes different information than the branded product, though by definition the two labels are supposed to be the same. This confusion is expected to carry over to insurance providers and approving agencies.

In summary, given the impact and strong case against the new generic labeling rule, it is not surprising that the FDA is taking its time to ensure due diligence and explore if there is a more scientific, robust and efficient way of ensuring risk management and patient safety, possibly eliminating the issues discussed above.

For more information:

  1. Supplemental Comments of the Generic Pharmaceutical Association regarding Docket FDA-2013-N-0500
  2. Generic Labeling Allies Letter