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Summary of FDA Advertising and Promotion Enforcement Activities – September 2, 2014

This is part of a series of monthly e-alerts summarizing publicly-available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.

In July 2014, FDA’s Office of Prescription Drug Promotion (OPDP) posted the following letter on FDA’s website:

  • Untitled Letter to Concordia Pharmaceuticals, Inc. re: NDA 022331 KAPVAY (clonidine hydrochloride) extended-release tablets MA #133 (July 7, 2014) (“Concordia Untitled Letter”)

The Office of Compliance and Biologics Quality (OCBQ) in FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Compliance (OC) in FDA’s Center for Devices and Radiological Health (CDRH) did not post any enforcement letters relating to advertising and promotion on FDA’s website.

This alert merely summarizes the allegations contained in FDA’s letters. It does not contain any analysis, opinions, characterizations, or conclusions by or of Covington & Burling LLP. As a result, the information presented herein does not necessarily reflect the views of Covington & Burling LLP or any of its clients.

Letters Issued By Office of Prescription Drug Promotion (OPDP)

Concordia Untitled Letter

OPDP alleged that a professional telephone script for Kapvay (clonidine hydrochloride) extended-release tablets was “false or misleading” because it omitted risk information and omitted material facts.

Omission of Risk Information: OPDP contended that the telephone script was misleading because it included efficacy claims for Kapvay but failed to disclose Kapvay’s “contraindication, all of the warnings and precautions, and common adverse reactions associated with” the product’s use. OPDP noted that the script contained a “general statement about adverse events in the Add-On trial.”

OPDP also recognized that the script included the following: “I can email the full prescribing for Kapvay or you can also access it at the Kapvay website Which do you prefer?” However, OPDP concluded that those statements failed to “mitigate” the omission of risk information.

Omission of Material Facts: OPDP also claimed that the script was misleading because it omitted material information about the FDA-approved indication for Kapvay. Kapvay is FDA-approved for the treatment of attention deficit hyperactivity disorder (“ADHD”) as monotherapy and as adjunctive therapy to stimulant medications. The Indications and Usage section of Kapvay’s PI also includes “information regarding long term use, special diagnostic considerations and the need for comprehensive treatment.” OPDP stated that although the script included claims such as “KAPVAY, a treatment for ADHD,” it omitted information about the need for comprehensive treatment, which “may include other measures (psychological, educational, and social) for patients with this syndrome.” OPDP also contended that the script’s statement that “[d]oses should be taken twice a day, with either an equal or higher split dosage being given at bedtime” was misleading in light of the fact that the script was intended for healthcare professionals. OPDP stated that the script omitted information from the prescribing information regarding the initial dosage of Kapvay and the “increment[al]” increase of dosages.

Inadequate Presentation of Established Name: OPDP claimed that the script omitted the established name in “direct conjunction with the proprietary name.”

© 2023 Covington & Burling LLPNational Law Review, Volume IV, Number 245

About this Author

Michael Labson, Life sciences lawyer, Covington

Michael Labson provides strategic advice to pharmaceutical and biotechnology clients in dealing with the FDA and other agencies. He has litigated a variety of cases in the life sciences area, and works actively on corporate transactions and government investigations.

Mr. Labson’s recent work has involved issues such as clinical trial misconduct; FDA dispute resolution; orphan drug, pediatric and Hatch-Waxman market exclusivities; biosimilars; product promotion and scientific exchange; REMS; pharmacovigilance; Rx/OTC switches; and DEA regulation of controlled...

Scott Cunningham, Food and drug attorney, Covington Burling

Scott Cunningham is a member of the firm’s Food and Drug practice group.  He represents pharmaceutical, biotechnology, and medical device companies as well as trade associations in matters before the FDA, Congress, state and federal courts, and other regulatory and enforcement agencies.  Mr. Cunningham has significant experience in areas including new product development and clinical trials; IRBs; new product approvals; Hatch-Waxman exclusivities and product life-cycle management; advertising and promotion; False Claims Act and Anti-Kickback compliance issues and...

Scott Danzis, Food and drug attorney, Covington Burling

Scott Danzis is a partner in the firm’s Food & Drug and Health Care practice groups. His practice focuses on the regulation of medical devices and diagnostics. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarket review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, quality system and manufacturing requirements...

Stefanie Doebler, Food and drug attorney, Covington Burling
Of Counsel

Stefanie Doebler is of counsel in the firm's health care and food and drug practice groups.  Her practice focuses on health care compliance matters for pharmaceutical and medical device clients.  She provides advice related to advertising and promotion, fraud and abuse, state law compliance and reporting regulations, interactions with health care professionals, clinical trial conduct and results disclosure, supply chain management, Medicaid price reporting, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices.

Meghan Monaghan, Covington, Patent Lawyer

Meghan Monaghan is a litigator who focuses on patent litigation. She represents a variety of clients in patent litigation matters, with a concentration on the pharmaceuticals industry.

Representative Matters

  • Representation of a pioneer pharmaceutical company in multiple patent litigation suits brought in the District of South Carolina involving a statin drug product.
  • Representation of a major pharmaceutical company in Hatch-Waxman litigation against several generic drug manufacturers...