Blog Tag: Off-label Use

FDA Will Hold Hearing on Communications Regarding Unapproved Uses

The Food and Drug Administration has issued a notice announcing a public hearing on November 9 & 10, 2016 to gather input relating to companies’ communications about their medical products, with a particular focus on communications regarding off-label uses of approved drugs and medical devices.

Currently, the FDA regulates how pharmaceutical and medical device companies can communicate uses of their products through approved labels, but many of those companies believe that greater sharing of information could significantly enhance patient treatments and outcomes.  The press release explains that the FDA is aware of technological and business changes that are increasingly affecting medical decision making and prescribing.  Such awareness prompted the FDA to review its regulations and policies governing companies’ communications regarding unapproved uses of approved medical products.  The Agency anticipates that feedback from the meeting will help inform policy development in this area.

In the press release, specific attention is drawn to the FDA’s heightened interested in comprehensively understanding: how increased communications from companies regarding unapproved uses could impact the public health; how changes in the health care system that give payers and formulary committees more power in prescribing practices incentivize firms to provide more safety and effectiveness data; the impact of increased accessibility of information relating to medical products on companies’ incentives to communicate information about off-label uses; the standards that should apply to off-label communications to minimize the potential of harm; and what factors should be considered when evaluating whether communications regarding unapproved uses are misleading, including what information must be disclosed to ensure consumers are not misled.

In August, 2016, the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO) released guidelines intended to improve communication between biopharmaceutical companies and other health care professionals.  Following the FDA’s announcement of the November meeting, Jeff Francer, Vice President and Senior Counsel of PhRMA, issued a statement praising the FDA on its efforts to modernize its regulations surrounding information sharing:

Given our increasingly data-driven, value-based health care system, we hope that FDA will act quickly to define new and clearer regulatory standards to permit responsible sharing of information and data about medicines with other parties in the health care system.

Comments will be accepted after the hearing, until January 9, 2017.

Vascular Solutions Indicted

Vascular Solutions Indicted

The Star Tribune reports that a federal grand jury indicted Howard Root, CEO of Vascular Solutions, Inc. (VSI), on one felony count of conspiracy and eight misdemeanor charges of selling unapproved and adulterated medical devices.  The same charges were also brought against VSI.  According to its website, Minneapolis MN-based VSI makes medical devices for diagnostic and interventional vascular procedures.

According to the United States Department of Justice, the indictment alleges that VSI and Root ran an off-label promotion scheme to market VSI’s Vari-Lase product for the ablation of perforator veins, which connect superficial veins to deep veins. According to its 510(K) summary, the FDA cleared the Vari-Lase for treatment of superficial veins.  As the Department of Justice notes, the FDA did not approve the Vari-Lase for treating perforator veins due to higher risks associated with perforator veins’ contact with deep veins. Yet, as stated by the indictment, VSI and Root continued to promote and sell Vari-Lase for treating perforator veins even after failing to obtain FDA approval.

The Department of Justice reports that VSI and Root continued off-label promotion of the Vari-Lase even after a whistleblower complained to Root in 2009 and the government told VSI about its investigation in 2011, and VSI and Root continued to deceive the FDA by using code words and misleading investigators. The Star Tribune states that Vari-Lase was eventually voluntarily pulled from the market in July 2014 when VSI agreed to pay $520,000 to resolve civil allegations related to the same alleged off-label promotion.

Following the indictment, VSI issued a press release stating that “[t]he indictment is the profoundly flawed product of government attorneys who have conducted a misguided and abusive investigation.”  The case is now pending in the U.S. District Court for the Western District of Texas.