July 18, 2016

FDA Offers Draft Guidance for Generic Drug Label Updates

In July 2016, the U.S. Food and Drug Administration (FDA) published draft guidance outlining when drug companies should update a generic drug’s label after the brand name drug on which the generic is based has been withdrawn for reasons other than safety or effectiveness1.

Currently, brand name drug manufacturers can change their labels without approval if new safety evidence is discovered, but generic drug makers must wait for the FDA to instruct them to make changes. Under the newly proposed regulations, generic drug makers can submit label updates to the FDA — such as updates needed to ensure accuracy or to inform consumers of new side effects — for generic products that rely upon withdrawn reference products, before waiting for the brand name companies to do so. If the FDA decides the label change is warranted, it can request that other generic drug companies relying on the same withdrawn product make those changes.


The Hatch-Waxman Act was enacted in part to encourage the manufacture of cost-effective generic drugs by the pharmaceutical industry. Under current regulations, generic drug companies do not have to subject their products to the same rigorous clinical testing process as brand name drugs. Instead, the regulations allow for an expedited approval process for generic drugs, wherein generic manufacturers can avoid costly and lengthy clinical studies and instead establish the safety of their products through bioequivalence testing — i.e., proving that their product is scientifically equivalent to a name brand drug.

In addition to bioequivalence requirements, a generic drug’s label must contain the same “conditions of use” statement as the original brand name drug. The “sameness” requirement was enacted under the belief that virtually identical labeling across generic and brand name drugs would assure both physicians and patients that the products were truly bioequivalent.

However, this “sameness” requirement also prohibits generic drug companies from modifying labels for their generic drugs when any new testing, side effects or other relevant safety information comes to light — including when the original innovator itself has failed to update the label for the brand name drug, or when the innovator has withdrawn from the market. Consider the following example: a generic drug manufacturer learns about a new rare side effect associated with its drug, which was never discovered by the original manufacturer. Under current regulations, that generic drug manufacturer would not be able to update the label — as doing so would violate the sameness requirements.

The U.S. Supreme Court has previously upheld these regulations in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011), holding that federal law pre-empts generic drug companies from independently making changes to their product labels in order to comply with more stringent state drug labeling requirements. As a result of these decisions, an individual may bring a failure to warn action against a brand name manufacturer, but not a generic manufacturer — meaning that generic manufacturers are virtually shielded from failure to warn liability.

Consequently, many groups have pushed for changes to the FDA regulations, citing the increased use of generic drugs, which now account for an estimated 88 percent of all prescriptions that are filled in the U.S.2 They argue that generic drug manufacturers have little incentive to conduct post market surveillance, evaluation or reporting to ensure that the labels are accurate. On the other side, many generic drug companies have opposed changes to the regulations, arguing that requiring them to update and modify labels could cost them billions of dollars in legal and monitoring costs and would confuse patients with conflicting safety information for multiple generic versions of the same drug.

Proposed FDA Regulations & New Draft Guidance

To address the concerns in the wake of the Mensing case, the FDA first proposed a new draft rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, in November 2013. These regulations would have given generic drug companies the ability to unilaterally implement labeling changes before FDA approval. The regulations were immediately challenged by both generic and brand name manufacturers, resulting in an extended comment period on the rule and multiple delays for approval.

More recently, the FDA took a narrower approach. On July 8, 2016, the FDA issued draft guidance describing a new process wherein generic drug companies that wish to change or update their drug labels could submit proposed changes for FDA approval, limited to instances in which the innovator of the original brand name drug has withdrawn product from the market for reasons other than safety or effectiveness. This draft guidance recognizes that when the brand name drug has been withdrawn under these circumstances, “the labeling of those pending or marketed [generic] products may need to be updated to reflect changes that would have been necessary had the [brand name drug] not been withdrawn.”3

Generally, the changes contemplated under the draft guidance “include changes necessary to ensure that labeling adequately describes information essential for safe and effective use; that labeling is accurate and meets current standards; and that labeling is not false or misleading.”4 More specifically, labeling changes may be needed to achieve consistency with labeling of other products that have the same active ingredient, to correct outdated information or to achieve consistency with other regulations and guidelines5. Examples of updates in the draft guidance include:6

  • Updating the indication statement in the indications and usage section to reflect current disease terminology
  • Including a statement in the indications and usage section about antimicrobial resistance for systemic antibacterial drug products
  • Including an inspection statement for parenteral drug products in the dosage and administration section
  • Removing a risk from the contraindications section if the benefit outweighs the risk
  • Revising the adverse reactions section to include a new adverse reaction based on postmarketing experience
  • Adding a new clinically significant drug interaction in the drug interactions section based on postmarketing data

The draft guidance provides that generic drug companies “have the ability to submit any of the labeling updates contemplated by this guidance.”7 If the FDA then decides “that a change proposed in this manner is appropriate and approves the supplement, the Agency may request that other [generic drug] holders and any [generic drug] applicants relying on the same withdrawn [brand name drug] 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 [brand name drug].”8 The draft guidance makes clear that any proposed changes must be submitted to the FDA first and may not be implemented before they have been approved.

Notably, the draft guidance does not address the status of the overall proposed generic labeling rule originally proposed in November 2013. In May, the FDA pushed back its finalization of that rule to April 2017.

Comments on the draft guidance can be submitted until September 9, 2016.

1 Notice — Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn; Draft Guidance for Industry, 81 Fed. Reg. 132 (July 11, 2016), available at FDA.gov (Draft Guidance).

2 U.S. Food & Drug Admin, Office of Generic Drugs Annual Report (2015), available at FDA.gov

3 Draft Guidance at 1.

4 Id. at 5.

5 Id.

6 Id. at 5-7.

7 Id. at 7.

8 Id.

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