Tag Archives: Off-label Promotion

FDA to hold Public Hearing on Communicating Information about Off-Label Conditions of Use

Yesterday, FDA issued a Notice announced that it will be holding a 2-day public hearing on November 9-10, 2016 on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” In the Notice, the agency explained that “FDA is engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved … Continue Reading

Upcoming Webinar: “Advertising Drugs and Health Care Products via Social Media: FDA Regulation”

On Wednesday, May 7, Covington attorneys Stefanie Doebler and Saurabh Anand will be participating in a webinar that might be of interest to many of the readers of this blog.  The presentation, entitled “Advertising Drugs and Health Care Products via Social Media,” will provide attendees with an overview of a recent FDA draft guidance addressing … Continue Reading

FDA Issues Revised Draft Guidance on Distributing Reprints

On March 3, 2014, FDA announced the availability of a revised draft guidance document entitled “Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices.”  This draft guidance revises the final guidance, “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and … Continue Reading

FDA Issues Untitled Letter Focused On Promotional Claims On Facebook

On March 12, FDA’s Office of Prescription Drug Promotion (OPDP) posted an untitled letter on its webpage alleging that Institut Biochimique SA’s (IBSA) Facebook page for the drug Tirosint® misbranded the drug.  Though the enforcement letter discusses a drug, the principles discussed in the letter are instructive for medical device promotion activities.  The untitled letter … Continue Reading

Summary of FDA Advertising and Promotion Enforcement Activities in July and August 2013

On July 31, the Office of Compliance (OC) in FDA’s Center for Devices and Radiological Health (CDRH) issued a warning letter to Wonjin Mulsan Co., Ltd. regarding its POWER-Q1000 Compressible Limb Therapy System (“POWER-Q1000”). Based on an inspection of the Wonjin Mulsan Co., Ltd.’s facility in South Korea, the letter included several allegations related to … Continue Reading

FDA Issues Draft Guidance on Molecular Diagnostic Instruments with “Combined Functions” That Reflects Regulatory Creep

On April 9, 2013, FDA published a Federal Register notice announcing a new draft guidance on molecular diagnostic instruments with “combined functions” — i.e., combining functions subject to FDA approval or clearance as well as functions not subject to FDA approval or clearance (such as research use only (RUO)).  The draft guidance has significant implications … Continue Reading

Summary of 2012 FDA Promotional Enforcement Activity

In 2012, the Office of Compliance at CDRH issued 15 warning letters relating to the promotion of approved or cleared medical devices, a significant increase from both 2011 and 2010.  CDRH’s letters cited a variety of promotional materials, including Twitter posts and billboards, but websites were by far the most prominently featured promotional piece in … Continue Reading

Par Pharmaceutical Pleads Guilty and Agrees to Pay $45 Million to Resolve Off-Label Promotion Claims

On March 5, 2013, DOJ announced that manufacturer Par Pharmaceutical pleaded guilty to a criminal misdemeanor charge for misbranding with respect to its product Megace ES (megestrol acetate).  Par agreed to pay $45 million and entered into a five-year corporate integrity agreement.  The settlement also resolves the suit Par filed against FDA in 2011 concerning … Continue Reading

Harkonen Fails to Shed Light on Commercial Speech Issues

On March 4, 2013, the Ninth Circuit affirmed the conviction of former InterMune President and CEO W. Scott Harkonen for wire fraud.  As we have previously noted, this pharmaceutical promotion case could have clarified commercial speech issues, such as the scope of First Amendment rights for scientific speech.  These issues are relevant not only to drug promotion but also … Continue Reading

Caplinger v. Medtronic: Medical device preemption and allegations off-label promotion

Supreme Court preemption doctrine leaves only a narrow sliver of claims available to plaintiffs who claim to have been injured by a Class III medical device.  (For a more detailed discussion of the application and intersection of express preemption and implied preemption in the medical device context, see our earlier post.)  As a result, plaintiffs … Continue Reading

Caronia Update: Government Does Not Appeal Significant Second Circuit Decision

The federal government will not appeal the decision of a Second Circuit panel in United States v. Caronia.  The government did not petition for rehearing by the panel or the en banc Second Circuit before the January 16 deadline.  Further, the Wall Street Journal and others are reporting that FDA officials have confirmed that the government … Continue Reading

Summary of Four Recent FDA Warning Letters on Device Advertising/Promotion Activities Now Available

In November, the Office of Compliance (OC) in FDA’s Center for Devices and Radiological Health (CDRH) posted on its website four warning letters relating to the advertising and promotion of medical devices: Warning letter to Quanta Systems, S.p.A. re: Quanta Q-Plus (Q-Plus Series) and Light Series Laser models (October 18, 2012) Warning letter to NeuroMed Devices, Inc. … Continue Reading

Device Companies Under Increased Government Scrutiny

Scrutiny of medical device companies by federal prosecutors is expected to increase in the coming years. As reported in a recent trade publication, Susan Winkler, a lawyer in the U.S. Attorney’s Office in the District of Massachusetts and former chief of that Office’s healthcare fraud unit, has stated that device companies have received less attention … Continue Reading

U.S. v. Caronia: Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a significant opinion in United States v. Caronia, concerning the application of the First Amendment to off-label promotion.  The court held that “the government cannot prosecute pharmaceutical manufacturers and their representatives under the [Federal Food, Drug, and Cosmetic Act] for … Continue Reading