Senate Bill Seeks to Provide “Floor” for Cybersecurity Operational Standards for Internet-Connected Devices Purchased by Federal Agencies

A recent bill introduced by Sen. Mark Warner (D-Va.) is attempting to place heightened security standards on all Internet of Things (IoT) devices procured by any federal agency. Should the legislation be enacted, the expectations it sets forth regarding the security of IoT devices could be interpreted by courts as the minimal floor for any IoT product sold to the federal government and, potentially, sold commercially.

Given IoT’s increasing prevalence and importance in the life sciences field, this legislation could have significant impact on pharmaceutical and medical device manufacturers. For more information, please read our Reed Smith Client Alert, “Pending Legislation Seeks to Secure Federal Government IoT.”

FDA Guidance Offers Initial Thoughts on Technical Considerations Specific to Medical Devices Using 3D Printing

The U.S. Food and Drug Administration (FDA) announced the availability of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff,” which was published in the Federal Register. This guidance was previously circulated in May 2016 in a draft form and underwent a comment period, where FDA was able to make minor modifications to the guidance based on those from the 3D printing industry. As 3D printing of medical devices continues to alter the daily practice of medicine, this “leapfrog guidance” is meant to provide FDA’s initial thoughts on technical considerations specific to medical devices using 3D printing. This guidance outlines technical considerations associated with the 3D printing processes as well as device design, testing of products for function and durability, and quality system requirements.

In releasing the final guidance, FDA Commissioner Dr. Scott Gottlieb, issued a statement proclaiming that the FDA “is the first [agency] in the world to provide a comprehensive technical framework to advise manufacturers creating medical products on 3D printers.” According to the FDA Commissioner, the agency has reviewed more than 100 medical devices and one drug that are currently on the market, which are being manufactured by 3D printers. He goes on to say that the “FDA is now preparing for a significant wave of new technologies” and that the FDA is “working to provide a more comprehensive regulatory pathway that keeps pace with those advances, and helps facilitate efficient access to safe and effective innovations that are based on these technologies.” That regulatory framework will need to adjust how “existing laws and regulations that govern device manufacturing [apply] to non-traditional manufacturers like medical facilities and academic institutions that create 3D-printed personalized devices for specific patients they are treating.” The FDA is also researching the technology itself and has its own 3D printing labs and is providing opportunities for “innovative approaches to pharmaceutical product design or manufacturing, including additive manufacturing of pharmaceuticals.” In fact, according to the statement “[m]ore than a dozen pharmaceutical manufacturers have formally or informally been in contact with [the FDA’s Center for Drug Evaluation and Research] regarding the use of 3D printing to manufacture drugs.”

While the guidance is not meant to be an all-inclusive document to address all regulatory or technical requirements, it highlights the technical considerations and recommendations for design, manufacturing, and testing of medical devices that are manufactured using 3D printing techniques. The guidance is also meant to evolve as the technology grows over time.

As with its draft version, the guidance is split up into two categories of considerations: (1) design and manufacturing, and (2) device testing. This final guidance should help 3D printing device companies, both traditional and non-traditional, as to what to include in a premarket submission for a device that uses additive manufacturing. As the technology continues to grow, we anticipate that the FDA will become more and more involved in the process.

For more about the draft FDA guidance, please see: FDA Publishes Draft Guidance Regarding 3D Printing Of Medical Devices and for more on general legal issues involving 3D printed medical devices, please see: 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles, 3D Printing of Manufactured Goods: An Updated Analysis, and 3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers.”

A Complete Victory for Multi-Office Team as the U.S. Department of Justice Dismisses Billion-Dollar False Claims Act Case

On November 8, 2017, following many years of investigation, the U.S. Department of Justice dismissed a billion-dollar False Claims Act (FCA) case against our long-standing client HCR ManorCare, the industry leader in post-acute rehabilitation care. The DOJ alleged that HCR ManorCare delivered unnecessary therapy to patients covered under Medicare Part A in its skilled nursing facilities; HCR ManorCare was determined to fight these allegations, certain they were not true. Throughout the case, our team engaged qualified experts to disprove DOJ’s experts, and also interviewed clinicians who treated sample patients, to prove that no unnecessary services were delivered. Our team also convinced the court that DOJ’s main expert witness had lied in her deposition, resulting in the expert’s report and testimony being stricken from the case. Following this, the DOJ advised the federal court in the Eastern District of Virginia of its intention to dismiss the case. Thanks to the hard work of our Reed Smith team, this case will be dismissed with prejudice, with no payment by HCR ManorCare.

For more information on this important topic, please read the full announcement here.

FDA Finalizes Policy for Sharing Patient-Specific Data from Medical Devices

FDA recently released guidance (“Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request”) finalizing its policy on medical device manufacturers sharing patient-specific information from devices with patients at the patients’ request.

In response to the more active roles patients are playing in their health care, and increased frequency with which patients are seeking information that has been recorded, processed or stored on medical devices from the device manufacturers, FDA initially sought to provide clarification on manufacturers’ responsibility with respect to such requests in a draft guidance issued June 10, 2016. In the draft guidance and the recently finalized version, FDA clarifies that a device manufacturer may provide patient-specific information to patients who request it, but that the manufacturer is not obligated to do so under the Food, Drug, and Cosmetic Act (the “Act”). Importantly however, FDA states that the device manufacturer’s responsibility to provide patient-specific information under the Act is distinct and separate from its obligation to provide patients with protected health information (“PHI”) under the Health Insurance Portability and Accountability Act (“HIPAA”), and the HIPAA Privacy Rule. Continue Reading

FDA Withdraws “Compounding Animal Drugs from Bulk Drug Substances” Draft Guidance

The U.S. Food & Drug Administration (“FDA”) announced on November 7, 2017, that it is withdrawing the draft Guidance for Industry #230, “Compounding Animal Drugs from Bulk Drug Substances.” FDA confirmed that it does not intend to finalize the current draft. Rather, it will issue a new draft in early 2018 for public comment.

For more information on this important topic, please read the full client alert here.

Upcoming Free CLE Webinar: “The Internet of Things’ Impact on the Health Care Industry: Diagnosing the Dangers with Disruptive Technology”

Reed Smith not only assists our pharmaceutical and medical device clients with their current legal challenges and opportunities, we look around corners to anticipate the next industry disruptor – and to help our clients navigate the legal issues that come with it.

For our life sciences clients, the Internet of Things is clearly a game changer. That’s why we’re pleased to be offering a free CLE webinar this Thursday, November 9 at 12 p.m. ET on “The Internet of Things’ Impact on the Health Care Industry: Diagnosing the Dangers with Disruptive Technology.”

Traditional health care delivery systems have fully integrated Internet of Things (IoT) devices into their processes, which has led to increased efficiencies but also heightened exposure to new risks. As IoT technologies continue to innovate at an accelerated pace, IoT is also on the verge of significantly disrupting the traditional processes of health care delivery and giving rise to heightened risks.

This webinar will provide those in the health care industry with an overview of the current legal exposures involved with IoT use, including: regulatory implications, security, privacy, and litigation risks; and liability insurance as an additional protective measure. It will also address the expected concerns with near future applications.

The webinar is presumptively approved for 1.0 general CLE credit in California, Illinois, New Jersey, Pennsylvania, Texas and West Virginia. For lawyers licensed in New York, this course is eligible for 1.0 credit under New York’s Approved Jurisdiction Policy. To register for the free webinar, please click here.

Reed Smith Partner Kevin Madagan to Speak at HDA’s Annual DSCSA Traceability Seminar

Washington D.C. Partner Kevin Madagan of Reed Smith’s Life Science Health Industry group will participate in an exert legal panel discussion at the 2017 Health Care Distribution Alliance (HDA) Traceability Seminar held November 8-10 in Washington D.C.

Implementation of the Drug Supply Chain Security Act (DSCSA) continues to transform the pharmaceutical supply chain. As the industry works toward the law’s 2023 finish line, HDA’s annual traceability seminar  brings together healthcare supply chain leaders to learn more about upcoming DSCSA implementation milestones as well as innovative approaches and lessons learned as distributors, manufacturers and dispensers implement serialization and traceability technologies to further preserve the safety and security of the healthcare supply chain.

Among key DSCSA deadlines, pharmaceutical manufacturers will reach a major serialization milestone on November 27, 2017, with FDA enforcement discretion to end one year from that date. HDA, fellow supply chain colleagues, federal and state regulators, and industry traceability experts will provide details on the progress toward this milestone, as well as the status and timelines for implementation, updates on industry projects to support the 2019 deadline to process serialized, saleable returns with a Verification Router Service. The seminar also will cover exceptions handling, 3PL perspectives, challenges and a status update on unit-level serialization, as well as the key regulatory perspectives on the entire process.

This seminar is designed for distributors, pharmacies and supply chain partners responsible for the implementation of traceability strategy, systems and processes in the healthcare supply chain.

For a full list of topics, agenda, registration, and additional information please click here.

FDA Sets the Stage for Cures Act Breakthrough Devices Program in Highly Anticipated Guidance Document

On October 25, 2017, FDA released a critical draft guidance on the breakthrough medical device pathway established by the 21st Century Cures Act (the “Cures Act”). The Draft Guidance For Industry, Breakthrough Device Pathway (“Draft Guidance”) reflects FDA’s proposal regarding the process by which a sponsor may seek a designation as a breakthrough device, assigning a team of staff to review devices designated for expedited development and priority review; and information about the criteria that will be used in evaluating a request for designation (the “Breakthrough Devices Program”). This new Breakthrough Devices Program will supersede the current Expedited Access Pathway (“EAP”), which FDA launched in 2015. It will also supersede FDA’s Priority Review Program, which implemented statutory criteria for granting priority review to premarket submissions. Continue Reading

Reed Smith Partner Rachael Pontikes to speak at FDLI’s Drug Quality Security Act Conference

Chicago Partner Rachael Pontikes of Reed Smith’s Life Science Health Industry group will speak at the Food and Drug Law Institute’s (FDLI) Drug Quality Security Act Conference on November 15 in Washington D.C.

The conference will include panels of government regulatory and industry experts discovering current issues surrounding the DQSA’s Title I Compounding Quality Act (CQA) and II Drug Supply Chain Security Act (DSCSA), just four years after being implemented. The conference will also touch on industry updates including, FDA’s Significant Documents and Industry Actions/Reactions on Regulation of Compounding; FDA and Inspections: What to Consider when FDA Visits Your Facility; Licensure of wholesale distributors and 3PL’s: Where does FDA stand, where do states stand, what about VAWD, and what can you do about it?, and so much more.

For a full list of topics, agenda, registration, and additional information please click here.

Philadelphia Life Sciences CLE Day for In-House Counsel: November 2

Reed Smith’s Life Sciences Health Industry Group is proud to be hosting its third annual Life Sciences CLE Day at our Philadelphia office on Thursday, November 2. The day starts with breakfast and networking at 8:30 a.m. and sessions commence at 9 a.m. The event, which includes a working lunch, concludes at 4 p.m., with a networking reception to follow. This program is geared toward in-house counsel at pharmaceutical and medical device companies. (To see the complete agenda, please click here).

The CLE Day is presumptively approved for 7.2 CLE credits in New Jersey and 6 CLE credits in Pennsylvania. An application for Delaware credit is pending. For lawyers licensed in New York, this course is eligible for 7 credits under New York’s Approved Jurisdiction Policy.

To learn more about the event, please click here.