FDA: Major Rule on Generic Drug Labeling Changes to Come in Summer 2016


In November 2013, the FDA introduced a proposed rule entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.” Last month, the Agency announced the delay of the final regulation, saying the rule on generic drug labeling changes will come in July 2016.

Public Citizen Petition

In 2011, Public Citizen submitted a petition to the FDA asking the Agency to “amend 21 C.F.R. § 314.70(a) to specify that 21 C.F.R. § 314.70(b) and (c) apply to abbreviated new drug application (ANDA) holders.” In the petition Public Citizen stated that the amendment should do the following:

  • “Authorize an ANDA holder to change that drug’s approved label by filing a supplement through the CBE and PAS procedures.”
  • “Make exceptions to reflect situations in which the agency believes that particular ANDA holders lack an adequate basis to make labeling changes, such as, perhaps, during the first few months after the first ANDA holder enters the market or for an ANDA holder that sells very few prescriptions of a drug.”

Public Citizen also asked the FDA to amend 21 C.F.R. § 314.150(b)(10), which allows “ANDA approval to be withdrawn if a generic drug’s approved labeling differs from that of the reference listed drug (RLD).” The organization stated that FDA should “specify that this regulation does not apply to ANDA holders permitted to supplement labeling through CBE or PAS procedures.” The final request made by Public Citizen was that “the FDA clarify that all ANDA holders are required to report safety concerns to the FDA as soon as they become aware of a clinically significant hazard.”

FDA Response to Public Citizen

In response to this petition, the FDA released a proposed rule regarding generic drug labeling changes on November 13, 2013. If finalized, this rule will allow new safety information to be independently added to the labels of generic drugs, an activity which has been done to the labels of the reference products for nearly 30 years.

Currently, companies that market generic drugs cannot update the product’s label to add new safety information as it is acquired. Instead, companies must wait until the label of the branded drug is changed. As such, if the drug company learns of a safety issue that has yet to be acknowledged by the manufacturer of the branded drug, they cannot take measures to notify the public of the impending concern by making generic drug labeling changes.

If the rule is finalized, this is all going to change. Under the proposed rule, generic drug sponsors will be able to immediately modify the drug’s label to reflect any safety-related changes. This means we could potentially begin to see temporary differences between the labels of brand-name and generic drugs.

Industry’s Response to FDA

Since 2013, the FDA has received more than 23,000 comments regarding the proposed rule which would allow generic drug labeling changes. Although the content of these comments have varied, the Agency has received some feedback from companies expressing their opposition to the potential regulation. According to RAPS, the companies in disagreement, generally generic drug makers, claim that the impending regulation will “expose them to billions of dollars in new legal liabilities.” RAPS also stated that the companies’ response to the rule on generic drug labeling changes and the FDA’s delay have left many patient advocacy groups enraged.

Due to the controversial nature of the proposed rule, the FDA has been “deliberating, holding meetings, and re-opening the federal docket for more comments” over the past two years. Despite pressure from some who have been urging the rule to be finalized quickly, the Agency has taken its time. The FDA has recently said that that it is “considering several alternatives,” and wants to ensure that all financial implications as well as the benefits associated with the final rule have been taken into account.

It will be very interesting to watch how the FDA responds to this controversial topic, and we are intrigued to see what is released in seven months.

Do you have a generic product on its way to approval? Is your product already approved by an ANDA and subject to the potential new rule? We can help you obtain approval for your product and prepare for the possible regulation. Using our novel approach, which combines scientific knowledge with extensive regulatory expertise, we have a proven track record of helping our clients achieve successful interactions with FDA. To learn more about our services, please contact us.