Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The US Food and Drug Administration (FDA) on Friday released draft guidance describing the process for drug companies when they have to update a generic’s label after the reference product (for which the generic is based) is withdrawn for reasons other than safety or effectiveness.
The guidance focuses on a problem that has long plagued the generic industry, as generic labels are required by law to mirror their reference product counterparts at the time of approval but sometimes rely on drugs that have been withdrawn for economic reasons.
Most recently, FDA pushed back its finalization of a rule (to April 2017) that would require generic drugmakers to update labels when safety events become known and ahead of FDA’s acceptance of such label changes, as brand name companies have done for three decades. Congress, however, has been looking to force FDA to re-write the rule.
But as FDA notes in Friday’s draft guidance, the agency seems intent on ensuring that both new drug application (NDA) and abbreviated new drug application (ANDA) holders update labels as quickly as possible when new safety events become known.
“As a general matter, all holders of marketing applications for drug products (both NDAs and ANDAs) have an ongoing obligation to ensure their product labeling is accurate, and not false or misleading. When new information becomes available that causes the labeling to become inaccurate, false or misleading, the application holder must take steps to update its labeling,” FDA says.
And unlike the proposed rule, this latest 12-page draft guidance offers more information for generic companies that can no longer rely on their reference listed drug’s (RLD) label.
“Where approval of an NDA RLD has been withdrawn, the NDA holder can no longer update labeling for the withdrawn RLD. The labeling of ANDAs that rely on the withdrawn RLD might eventually become inaccurate and outdated, resulting in labeling that is false and/or misleading, for example,” FDA explains.
Similarly, new original ANDAs that rely on the withdrawn RLDs might include proposed labeling based on the last approved RLD label and include outdated information, FDA warns.
This draft guidance “clarifies that consistent with the statute, where the RLD is withdrawn, certain labeling changes may continue to be made for
ANDA holders are responsible for reviewing postmarketing data and published literature to satisfy applicable reporting requirements FDA says, though the agency also notes that it, as well as ANDA holders and applicants, “may be aware of data relevant to labeling updates in a variety of situations. For example, relevant data may already be reflected in the updated labeling of other drugs in the same pharmacologic or therapeutic class (e.g., class labeling); in non-product specific literature; or in postmarketing information.”
However, FDA makes clear that the “updates contemplated by this guidance generally would not involve reliance on product-specific, proprietary information about another drug. Any changes proposed under this guidance must be consistent with the requirement that an ANDA include sufficient information to show that the conditions of use have been previously approved for the RLD.”
Examples of when labeling changes under this guidance may be needed, include:
FDA adds that examples of updates “contemplated by this guidance” might also include (the list is not intended to be exhaustive):
ANDA holders can submit any labeling updates contemplated by this guidance through the submission of a prior approval supplement (PAS), FDA says.
“If FDA determines that a change proposed in this manner is appropriate and approves the supplement, the Agency may request that other ANDA holders and any ANDA applicants relying on the same withdrawn RLD make the same updates, where appropriate. This latter step is intended to ensure that labeling remains uniform across generic drugs that rely on the same RLD,” the draft says.
Comments on the draft can be submitted over the next two months.
Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn: FDA Draft Guidance for Industry
Tags: generic drug labels, ANDA, withdrawn reference product