Hot Topics & Technologies in Life Sciences

Medmarc Loss Control

When asked to come up with a list of what’s hot in life sciences right now, Medmarc’s Risk Management team put our heads together and came up with the following list.

  1. Off-label Promotion Revisited
  • Following the recent case involving Amarin Pharmaceuticals, FDA is reconsidering the extent to which it will permit companies to make truthful and non-misleading statements about off-label uses as they relate to clinical decision making, research, and reimbursement.
  • FDA will hold a public hearing on November 9 and 10 as part of a comprehensive review of its regulations and policies regarding off-label promotion.
  1. Unique Device Identifier (UDI) – Extended Deadline
  • Under the UDI directive, Class II devices were supposed to be in compliance with the law’s label and GUDID (pronounced “Good ID”) rules by September 24, 2016. The same provision also eliminated the use of National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers and replaced them with the UDI codes.  Suppliers and pharmacies rely on NHRIC and NDC numbers to identify products, including for reimbursement purposes, and are unprepared to eliminate the use of these numbers.  In response to industry objections, FDA has agreed not to enforce the prohibition against NHRIC and NDC numbers until September 24, 2021.
  1. New Rule on Antibacterial Soaps
  • On September 2, 2016, the FDA issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed.
  • This rule does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings.
  1. Point-of-Care Diagnostic Testing
  • Currently, the diagnostic testing model has the provider taking samples for testing and outsourcing the analysis to a diagnostic laboratory (such as Quest Diagnostics), which involves a several day wait for test results. However, in line with the push toward preventive and personalized medicine, medical device firms are seeking to improve upon this model by offering equipment for in-office and portable diagnostic testing.
  • Alere and Roche are the current market leaders, offering point-of-care diagnostic testing for cardiometabolics (e.g., blood gases), infectious disease, toxicology, oncology, women’s health, anticoagulation therapy, and urinalysis.
  • The point-of-care model raises questions about software validation and maintenance as well as the inherent cybersecurity challenges.
  1. The Fall of Theranos
  • Known as the blood-testing start-up founded by Elizabeth Holmes as a 19-year-old Stanford dropout, Theranos was once valued at some $9 billion when a damning report published in The Wall Street Journal alleged that the company was, in effect, a sham—that its core technology was actually faulty and that Theranos administered almost all of its blood tests using competitors’ equipment.
  • The FDA investigated two Theranos sites and issued two 483s, finding that Theranos kept poor records, mishandled complaints, failed to conduct quality audits, and was “unable to produce documented supplier qualifications,” among other observations.
  • CMS imposed sanctions on the company in July 2016, prohibiting it from receiving Medicare and Medicaid payment for lab services and imposing a civil monetary penalty, among other sanctions.
  • The company is also under investigation by the SEC and FBI.
  1. Zika Lab Tests
  • Zika testing is used to detect infection in a person without signs and symptoms or to determine whether a person with signs and symptoms of Zika has been infected after exposure in a region with Zika virus. It may also be used to test people who have had sexual contact with a recent traveler to a region with Zika.
  • Zika infection may be difficult to diagnose without laboratory tests because symptoms may resemble those of other diseases, such as dengue fever or chikungunya infection.
  • FDA has been allowing the emergency use of some yet-unapproved Zika tests. To do so, FDA uses the Emergency Use Authorization (EUA) procedure (under the Food, Drug & Cosmetic Act), which allows use of the unapproved product for a specified duration of time. The FDA website lists ten Zika-related products currently approved on this basis.
  1. Cool New Technology Alert – Augmented Reality
  • Augmented reality—a blend of virtual reality and one’s real-world surroundings—looks like it may have some real beneficial uses in medicine. In 2014, the FDA cleared an augmented reality device for surgeons to use in preparation for surgery, and other devices may appear in surgical suites before long. Using these devices, surgeons can visualize the patient’s anatomy from outside of the body, by constructing a holographic overlay created from CT scan data.
  1. “Dirty” Endoscopes
  • Endoscopes, and particularly duodenoscopes, have long been recognized as high-hazard devices due to their design (i.e., the flexible neck of the scopes allows for bacteria to become trapped, potentially eluding cleaning). Olympus, a major scope manufacturer, was forced to recall thousands of its scopes following the discovery that its devices harbor bacteria that could not be eliminated even when the company’s own instructions for disinfection were followed. As a result, there were several deaths and more than 200 infections of CRE (carbapenem-resistant enterobacteriaceae), which has a significant mortality rate─some reports cite rates as high as nearly 50%.
  • This incident refocused industry attention on scopes. A German company has developed a robotically-assisted, sterile, single-use colonoscope. Because the device is single-use, it eliminates the risk of bacteria transmission between patients – assuming hospitals follow the instructions not to reuse the device, which has been an issue in areas with scarce resources.
  1. Software & Predictive Analytics
  • Several recent studies reveal that certain software and predictive analytics tools can better identify and predict the presence and path of health conditions among patients than trained doctors and pathologists.
  • The capability of the software raises questions about how the FDA will regulate them and to what extent they should be used—merely as clinical support for decision-making, or as independent diagnostic tools.
  • In its mobile medical apps guidance, the FDA specifically declined to address software “that performs patient-specific analysis to aid or support clinical decision-making.” Thus, the Agency has not interpreted such as being medical devices so far. However, if used independently to diagnose conditions, these software programs would likely come under the FDA’s scrutiny as medical devices.
  1. Cybersecurity & Device Breaches
  • Insulin pumps, heart monitors, x-ray communications systems and other medical devices have been shown to be vulnerable to cyberattack. Accordingly, there is much concern about the security of patient information entered or stored in medical devices or the cloud in the “internet of things” in which multiple devices communicate with one another.
  • In light of such concerns, and news of breaches in hospitals and insurance networks, the FDA has published cybersecurity guidance for medical-device makers to ensure the security of patient information the devices gather.

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