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Risk Management Webinar Series
RIPPED FROM THE HEADLINES:
LESSONS LEARNED FROM LIFE SCIENCES IN THE NEWS
SARA E. DYSON, ESQ. KATHRYN T. KLAUS, ESQ. COURTNEY S. YOUNG, ESQ.
October 23, 2017
Risk Management Webinar Series S ARA E. D YSON , E SQ . K ATHRYN T. - - PowerPoint PPT Presentation
Risk Management Webinar Series S ARA E. D YSON , E SQ . K ATHRYN T. - - PowerPoint PPT Presentation
Risk Management Webinar Series S ARA E. D YSON , E SQ . K ATHRYN T. K LAUS , E SQ . C OURTNEY S. Y OUNG , E SQ . October 23, 2017 R IPPED FROM THE H EADLINES : L ESSONS L EARNED FROM L IFE S CIENCES IN THE N EWS A GENDA New Paradigms for
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AGENDA
New Paradigms for Clinical Research: What are the implications for products liability? FDA’s Pilot Programs and Changing Vision: Can quality be increased while industry burden is decreased? Cybersecurity: How are medical device companies faring and what is FDA’s oversight approach? And a few other items of interest.
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New Paradigms for Clinical Research: What are the implications for patient safety?
Sara E. Dyson, Esq.
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“Slow and Burdensome”
Picture from “Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated,” RAPS, January 31, 2017.
President Trump Met With Pharma Execs on January 31, 2017
February 28, 2017 Carolyn Johnson
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FDA’s View: A Broken System
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- Dr. Scott Gottlieb, FDA Commissioner
(photo from www.fd.gov)
What are the New Ways to Collect and Use Data?
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Call to Improve Medical Device Studies
JAMA stands for Journal of the American Medical Association
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Call to Improve Drug Studies
JAMA stands for Journal of the American Medical Association
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Editorial by Robert M. Califf, MD “These articles, which were authored by groups that include prominent safety advocates, provide empirical evidence that the current regulatory system does not always impose the most rigorous standard of clinical evidence.”
August 15, 2017
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The Media’s Response
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A Peculiar Case Study in “Self-Deregulation”
Between April and August of 2016, Rational Vaccines conducted a clinical trial of a herpes vaccine. This clinical trial is significant because Rational Vaccines did not comply with regulatory requirements
- r best practices in the
conduct of the research. A member of the investment group, Bartley Madden, claims that this trial is a “test case” to determine whether unregulated, off-shore trials are a viable alternative route to bringing products to market.
Taylor, Marisa. “Peter Thiel Funds ‘Unethical’ Offshore Herpes Vaccine Trial,” The Daily Beast, August 27, 2017.
“You would not be able to invent the polio vaccine today [because of government regulations].”
Breland, Ali. “Peter Thiel Funding Herpes Vaccine Test Outside of US Safety Rules,” The Hill, August 28, 2017.
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Takeaways
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How Could Clinical Research Be Impacted?
Expect changes to the clinical research process – likely in form
- f “options” to the traditional clinical research process and route
to market or by way of “fast-tracking” programs.
Right-to-try programs Use of real-world data Computer simulation and modeling
FDA will not likely “deregulate” the entire process, and international laws will remain applicable.
What’s going to happen to the herpes vaccine?
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How Could Clinical Research Be Impacted? (cont.)
Consider the products liability implications.
Compliance and methodology as relates to the clinical research process can become an issue during products liability litigation. There have been no discussions about liability shields for manufacturers in connection with new programs, legislation, public policies, etc.
- By comparison, the PREP Act
provides a liability shield when an unapproved product is used in an emergency and certain conditions within the law are fulfilled.
Products Challenged In Products Liability Litigation Was The Clinical Research Process Flawed?
Testosterone replacement Transvaginal mesh Anti-coagulant drugs IVC filters Anti-psychotic drugs
(This list is not exhaustive and applies to the last year, roughly.)
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FDA’s Pilot Programs and Changing Vision: Can quality be increased while industry burden is decreased?
Kathryn T. Klaus, Esq.
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FDA Inspections: What’s New?
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FDA’s Changing Device Inspection Model
Program Alignment
Modernization plan responding to the rapid pace of innovation and specialization ORA shift from geographic model to area of specialization
Calendar Risk
Requirement set in FDARA (2017) Brings device inspections into alignment with drug inspections, which have followed risk- based model since 2015 Risk Factors:
- Compliance history
- Recalls
- Inherent risk of device
- Inspection frequency
- Foreign inspections
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MDSAP: Medical Device Single Audit Program
WHO: U.S., Canada, Australia, Brazil, and Japan WHAT: Allows for any MDSAP country to conduct a single regulatory inspection that meets the requirements of ALL regulatory agencies in the participating countries WHY: Improve oversight through efficient deployment of shared resources, while minimizing the regulatory burden on industry HOW: U.S. will use MDSAP audit reports just as it uses FDA audit reports, with same OAI/VAI/NAI classification WHEN: Voluntary in all jurisdictions EXCEPT Canada, which is requiring an MDSAP audit with certification by January 2019
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FDA: What’s ahead?
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FDA’s Focus on the Future
TPLC “Super Office” Case for Quality Digital Health Software Precertification Premarket Approval: Critical to Quality MDR Summary Reporting
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FDA’s Focus on the Future
CDRH Director, Dr. Jeffrey Shuren, discussed FDA’s approach going forward:
Introducing flexible regulatory paradigms – a “Least Burdensome” approach Evaluate benefit/risk vs. risk/benefit – shifting the uncertainty Real World Evidence CDRH investment in its employees, building a collaborative culture, enhancing customer service relationship over policing role
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Products Liability Implications
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Regulatory vs. Products Liability
Visibility
FDA obligations are the floor, NOT the ceiling Plaintiffs’ bar is an avid watcher of FDA enforcement actions
- Failure to prepare is preparation to fail – and plaintiffs will be watching
Changing standards for MDR reporting and the duty to warn
Could summary reporting inhibit companies’ ability to gather information about similar products’ failures? Could necessary recalls be delayed?
Global harmonization of inspection standards – could it lead to a more litigious environment abroad?
While the U.S. system has long been litigation-centric, the same has not been true overseas. Could this change?
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Cybersecurity: How are medical device companies faring and what is FDA’s oversight approach?
Courtney S. Young, Esq.
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Devices are Vulnerable
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Medical Devices Have Changed
Medical devices have changed from the once non- networked, isolated equipment, to devices with one-way vendor monitoring, to fully networked equipment with multi-directional communications, remote access, wireless connectivity, and software. The transition to software as a medical device has
- ccurred.
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The Landscape and Environment Have Changed
Increased number and complexity of devices and advances in connectivity and interoperability has meant greater security risk.
Risk accelerated by Internet of Things (IoT)
While increased connectivity and wireless technologies continue to create new opportunities for service delivery, remote monitoring, and diagnostics, it also creates more opportunities for attack and enlarges the potential devastation of such an attack
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Hacking
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Infection
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Device Makers Will Face Liability
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Sources of Liability
Products Liability
Device causes property damage or bodily injury
Privacy/Data Breach
PHI is exposed (e.g.)
Contractual Liability
E.g., from financial harm to other party
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FDA’s Approach
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FDA’s Approach to Cybersecurity FDA understands cybersecurity as a patient- safety issue Encourage (require) companies to undertake a proactive, comprehensive risk management program, applying NIST framework and adhering to FDA guidance documents Emphasize community approach of communication, information sharing, and collaboration
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Premarket Guidance – Key Principles
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Draft issued June 2013; Final issued October 2014. Shared responsibility among stakeholders, including healthcare facilities, patients, providers, and manufacturers of medical devices Address cybersecurity during design and development of the device Establish design inputs of device-related to cybersecurity vulnerability and management approach as part of the software validation and risk analysis that is required by 21 CFR 820.30(g)
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Postmarket Guidance – Key Principles
Postmarket Management of Cybersecurity in Medical Devices. Draft issued January 2016; Final issued December 2016. Use a risk-based framework to assure risks to public health are addressed in a continual and timely fashion Articulate manufacturer responsibilities by leveraging existing QSR and postmarket authorities Foster a collaborative and coordinated approach to information sharing and risk assessment Align with Presidential EOs and NIST Framework Incentivize the “right” behavior
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Other Documents
NIST: Framework for Improving Critical Infrastructure Cybersecurity
Identify – identify the risks associated with the device Protect – provide the appropriate level of security for the risk and provide justification for the chosen security functions Detect – implement device features that allow security compromises to be detected Respond – provide a response plan to end users regarding actions to take following detection of a cybersecurity breach Recover – provide a method for retention and recovery of device configurations
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Common Regulatory Misconceptions
FDA Fact Sheet: FDA’s Role in Medical Device CybersecurityMedical device makers can (almost) always update devices for cybersecurity. The Agency generally does not need to review changes made solely to update cybersecurity The FDA does not conduct premarket testing for medical products. Testing is the responsibility of the manufacturer. Medical device manufactures using OTS software are responsible for ensuring its safe and effective performance in the medical device (not the OTS software manufacturer).
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Takeaways
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Importance of Culture of Cybersecurity
Increasingly, companies may face liability and/or regulatory enforcement actions not just when something goes wrong, but when something could go wrong, and their actions or inactions have augmented cyber vulnerabilities.
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Comply With FDA Regulations
Make compliance a priority and follow the FDA’s regulations (and Guidance policies) applicable to your device and software. Follow “voluntary” industry-developed standards applicable to your device and software.
Medmarc’s Defense Panel Poll
59% of our attorneys indicated that in at least half
- f their cases, plaintiffs (or plaintiffs’ attorneys)
became aware of the potential cause of action because of an FDA enforcement action, like a recall, 483, or Warning Letter.
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Design solutions – not “warning out” risks – are required. Restatement of Torts – 3rd: “…when a safer design can reasonably be implemented and risks can reasonably be designed out of a product, adoption
- f the safer design is required over a
warning that leaves a significant residuum of such risks.” Example: warning the user to avoid certain
- perations that may result in infection
from viruses vs. preventing the user from performing those operations or otherwise preventing the infection.
Design Out Risk
Just IFU it!
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Focus On Your Legacy Products
From a blog dedicated to cyber security issues found at: http://securityaffairs.co/wordpress/30.1% of members of medical device industry indicated that identifying and mitigating risks of fielded and legacy devices is the biggest challenge facing the medical device industry with regards to cybersecurity.
(Deloitte, 2016)
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Speed Round: A quick look at some of the year’s most compelling news items
Sara E. Dyson, Esq. Kathryn T. Klaus, Esq. Courtney S. Young, Esq.
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Speaker Contact Information
Sara Dyson sdyson@medmarc.com 703-652-1367 Kate Klaus kklaus@medmarc.com 703-652-1330 Courtney Young csyoung@medmarc.com 703-652-1385