Lollipop device helps the blind see with the tongue

The FDA has cleared for marketing the BrainPort V100, an investigational medical device that people who are blind may use with a white cane or guide dog to perceive the location, position, size, and shape of objects, and to determine whether objects are moving or stationary. The  BrainPort V100 was reviewed by the FDA through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally-marketed device.

The battery-operated non-surgical device, manufactured by Wicab, Inc., of Middleton, Wisconsin, includes a video camera mounted on a pair of sunglasses that is connected to a small, flat lollipop-like device containing 400 electrodes that the user holds against the tongue. Software converts the image captured by the video camera into electrical signals that are sent to the lollipop device and felt as vibrations on the user’s tongue.

According to Wicab, the video camera works in a variety of lighting conditions and has an adjustable field of view. White pixels from the camera are felt on the tongue as strong stimulation, black pixels as no stimulation, and gray levels as medium levels of stimulation. Users of the device report the sensation as pictures that are painted on the tongue. A small hand-held unit about the size of a cell phone provides user controls and contains a rechargeable battery. With a minimum of 10 hours of supervised one-on-one training and experience, the user learns to interpret the signals to determine the location, position, size, and shape of objects, and to determine if objects are moving or stationary.

According to the FDA, the safety and effectiveness assessment of the BrainPort V100 included object recognition and word identification, as well as oral health exams to determine risks associated with holding the intra-oral device in the mouth. Clinical studies showed that 51 of the 74 subjects who completed one year of training were successful at the object recognition test. Some subjects reported burning, stinging or metallic taste associated with the intra-oral device. There were, however, no serious device-related adverse events reported.

Robert Beckman, CEO of Wicab, recently told Mobile World Live that he “is looking to mobile and wireless technologies to improve the company’s first-generation BrainPort V100 device.” Right now the device is not connected to the internet, explained Beckman. “[Through the use of wireless connections] we can eliminate the handheld controller and all the controls will be on the frame of the glasses, and we will wirelessly connect the device to mobile technology which will greatly expand the capabilities of the device.”

 

Criminal device marketing, or something in that vein

The marketing of medical devices is receiving greater scrutiny.  Manufacturers of medical devices are increasingly being exposed to a combination of civil and criminal exposure for off-label device promotion that stretches beyond the marketing permitted by limited FDA device approvals. One company—Minnesota-based Vascular Solutions Inc.—has experienced the recent crackdown first hand, after the company’s promotion of a varicose-vein devices led first to a whistleblower lawsuit and then to criminal charges from the Department of Justice (DOJ).

Vascular Solutions

In 2012, the Twin Cities Pioneer Press reported that the government intervened in a whistleblower lawsuit against Vascular Solutions, which alleged that the off-label promotion of the company’s varicose-vein devices resulted in $20 million in damages to the federal government. In 2014, the fraud became a criminal issue when Vascular Solutions’ CEO was indicted for conspiring to sell devices for unapproved purposes.  The criminal investigation was ongoing when the company settled the whistleblower lawsuit for $520,000.

DOJ

According to reporting by the StarTribune, John Lundquist—attorney for the indicted CEO, Howard Root—said that the DOJ is trying to do is get the attention of medical device companies.  Lundquist added, in an address to medical device company executives at a legal-compliance forum, “the Justice Department is making it known that they are going to prosecute individuals whenever they can, and it is probably folks like you in this room.”

Cost

Although Lundquist, Vascular Solutions, and Root contend that the allegations are baseless, Mark DuVal, a device and biotech lawyer in Minneapolis, told the StarTribune that the indictment and civil lawsuits are costly either way. Duval estimated that it would cost Root and Vascular Solutions about $20 million to go all the way to trial and defend against the charges.

FDA approval

Any impropriety in the promotional tactics of Vascular Solutions comes down to whether it violated FDA regulations by promoting an FDA-approved medical device for something other than its approved indication or use. Such a sale, if outside the scope of FDA approval, can render a device mislabeled or adulterated. As made clear by the indictment, the sale of mislabeled or adulterated devices can be a criminal manner. Although the DOJ typically focuses its scrutiny of off-label promotion for drug manufacturers, according to the StarTribune, the DOJ has secured billions in settlements over such unapproved marketing.

Marketing

At least for Vascular Solutions, there is still an open question about whether the company was promoting an approved or unapproved use. However, approved or unapproved, the DOJ is sending a message that for all medical device companies, marketing techniques are under a watchful eye. The shift has taken place on a DOJ policy level. According to the StarTribune, assistant attorney general for the Justice Department’s criminal division announced in 2014 that the DOJ changed its policies so that all qui tam lawsuits are automatically shared with criminal prosecutors.

Pressure mounts on FDA to loosen drug and device regulations

The 21st Century Cures Act, which passed the House Energy and Commerce Committee unanimously last week, is intended to boost medical research in the U.S. and revise rules over drug and medical device safety (click here for yesterday’s post on the implications the Act could have on physician reporting requirements). The legislation will likely head to a full vote in the House in June with the Senate taking it up by year’s end.

The legislation would increase funding for the National Institutes of Health (NIH) by $10 billion over five years. The NIH would be allowed to use some of that money for the Obama Administration’s $215 million medicine initiative, which would create a database of genomic information obtained from one million U.S. patients who volunteer to participate. Costs would be offset by changing the timing of specific government payments to Medicare Part D plans. Apart from this potential use of Medicare to partially offset increased federal spending, critics question whether the measure, as detailed, would provide the touted boosts to research or instead open the way for companies to sell drugs and devices that are not fully tested.

Pressure on the FDA to revise its drug and device approvals regulation is not limited to congressional chambers or the public sector, as industry is currently challenging regulations perceived to be onerous to off-label usage of drugs. Currently, a patient is free to mention to another patient that a drug’s clinical trial is an effective treatment for an illness or disease. The drug’s manufacturer, however, is not free to tell an individual or a doctor the same thing without facing criminal charges or civil liability. Drug manufacturers would like this to change. Earlier this month, Amarin Pharma filed a lawsuit against the Food and Drug Administration, hoping to resolve this issue in favor of the drug manufacturers.

Prior to the lawsuit, an FDA advisory panel refused to approve Vascepa (Amarin’s flagship therapy) for treatment of “mixed dyslipidenia” after the completion of a Phase III clinical study that  seemed to show that Vascepa safely reduced triglycerides levels in patients with mixed dyslipidemia. The FDA advisory panel made its recommendation because it reached the conclusion that any approval was postponed until results of a longer clinical trial of Vascepa that is focusing on whether the reduction of triglycerides levels in fact has positive cardiovascular benefits were available. In Amarin’s situation, it cannot say anything about the current clinical trial of its drug Vascepa and the effectiveness of the drug for off-label treatments.

The FDA has argued that the off-label ban is a necessary part of the agency’s drug approval process, which requires manufacturers to demonstrate efficacy for each intended use. Although the FDA investigates and the government regularly prosecutes pharmaceutical companies and their representatives that promote off-label uses of their drugs, once approved, doctors can prescribe it for any use, which the FDA recognizes as proper.

The debate continues regarding whether the FDA’s current policy hinders or protects public health. The government does have a substantial interest, but does a ban on off-label promotion of truthful statements about a drug advance said public health? In theory, drug manufacturers should always be mindful of statements made about a drug’s efficacy, whether for profit or defense, in future litigation. Certainly the FDA has a lot of work cut out for it if the 21st Century Cures Act passes or if the Amarin litigation forces it to revise its thinking on off-label usage.

Directed ‘HIT,’ the center of the precision medicine bullseye

The Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing titled “Continuing America’s Leadership: Realizing the Promise of Precision Medicine for Patients.” The hearing discussed the reality that, with innovative approaches, physicians may no longer need to make treatment recommendations based upon outcomes for an average patient. Instead, precision medicine could be utilized to account for individual differences in patients’ genes, environments, and lifestyles in order to enhance the quality and effectiveness of health care. The hearing covered ways that health information technology (HIT) could be advanced to make precision medicine the norm in order to achieve goals like those set out in President Obama’s Precision Medicine Initiative.

HIT

Dr. Karen DeSalvo the National Coordinator of the HHS Office of the National Coordinator for Health for Health Information Technology (ONC) testified before the Senate committee that “health information technology is the foundation required to bring precision medicine to operational life.” To achieve broad utilization of precision medicine, DeSalvo testified that the nation needs to continue to move forward with plans like the ONC’s interoperability roadmap. To develop the HIT infrastructure, the ONC believes three goals need to be met: (1) develop consistent use of applicable standards for application programming interfaces, health care terminology, implementation, and security; (2) foster an environment of trust and security around individual’s data; and (3) incentivize interoperability.

Testimony

Jeffrey Shuren, Director, Center for Devices and Radiological Health (CDRH) at the FDA, testified that technology will also play a key role in precision medicine through technological medical advancements like Next-Generation Sequencing (NGS). According to Shuren, “An NGS test is capable of detecting the billions of bases in the human genome, and in doing so identify the approximately 3 million genetic variants an individual may have.” As a result, a single use of an NGS test could help diagnose and even predict patient’s risks for countless conditions. Francis S. Collins, the Director of the National Institutes of Health (NIH) added that technology can increase biomedical understanding through “widespread adoption of electronic health records, the recent revolution in mobile health technologies, and the emergence of computational tools for analyzing large biomedical data sets.”

Senators

Senator Lamar Alexander (R-Tenn) criticized what he called the “failed promise” of the EHR incentive program as a barrier to the advancement of precision medicine. Alexander said that the $28 billion drive to increase EHR utilization has not been worth the effort due to complaints of disrupted workflow. Alexander did say that interoperability should remain a goal. Senator Patty Murray (D-Wash) commented that Republicans and Democrats need to work together and invest in “priorities like the President’s precision medicine initiative.” Murray added that while it is important to promote precision medicine, the protection of privacy needs to remain a top concern in light of “serious security breaches impacting families’ personal health information.”