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 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. ProAssurance Investor Update March 6, 2017 3

New Paradigms for Clinical Research: What are the implications for patient safety? Sara E. Dyson, Esq.

“Slow and Burdensome” President Trump Met With Pharma Execs on January 31, 2017 Picture from “Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated,” RAPS, January 31, 2017. February 28, 2017 Carolyn Johnson ProAssurance Investor Update March 6, 2017 5

ProAssurance Investor Update March 6, 2017 6

FDA’s View: A Broken System ProAssurance Investor Update March 6, 2017 7

What are the New Ways to Collect and Use Data? Dr. Scott Gottlieb, FDA Commissioner (photo from www.fd.gov) ProAssurance Investor Update March 6, 2017 8

Call to Improve Medical Device Studies JAMA stands for Journal of the American Medical Association ProAssurance Investor Update March 6, 2017 9

Call to Improve Drug Studies JAMA stands for Journal of the American Medical Association ProAssurance Investor Update March 6, 2017 10

Editorial by Robert M. Califf, MD August 15, 2017 “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.” ProAssurance Investor Update March 6, 2017 11

The Media’s Response ProAssurance Investor Update March 6, 2017 12

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 or best practices in the conduct of the research. “You would not be able to invent the A member of the investment group, Bartley Madden, claims polio vaccine today [because of that this trial is a “test case” to determine whether government regulations].” unregulated, off-shore trials are a viable alternative route to bringing products Breland , Ali. “Peter Thiel Funding Herpes Vaccine Test Outside of US to market. Safety Rules,” The Hill , August 28, 2017. Taylor , Marisa. “Peter Thiel Funds ‘Unethical’ Offshore Herpes Vaccine Trial,” The Daily Beast , August 27, 2017. ProAssurance Investor Update March 6, 2017 13

ProAssurance Investor Update March 6, 2017 14

Takeaways

How Could Clinical Research Be Impacted? Expect changes to the clinical research process – likely in form of “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? ProAssurance Investor Update March 6, 2017 16

How Could Clinical Research Be Impacted? (cont.) Consider the products liability Products Challenged In implications. Products Liability  Compliance and methodology as Litigation relates to the clinical research process can become an issue Was The Clinical Research during products liability litigation. Process Flawed?  There have been no discussions Testosterone replacement about liability shields for manufacturers in connection with Transvaginal mesh new programs, legislation, public Anti-coagulant drugs policies, etc. IVC filters By comparison, the PREP Act • Anti-psychotic drugs provides a liability shield when an unapproved product is used in an emergency and certain conditions (This list is not exhaustive and applies to the last within the law are fulfilled. year, roughly.) ProAssurance Investor Update March 6, 2017 17

FDA’s Pilot Programs and Changing Vision: Can quality be increased while industry burden is decreased? Kathryn T. Klaus, Esq.

FDA Inspections: What’s New?

ProAssurance Investor Update March 6, 2017 20

ProAssurance Investor Update March 6, 2017 21

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 • ProAssurance Investor Update March 6, 2017 22

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 ProAssurance Investor Update March 6, 2017 23

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 ProAssurance Investor Update March 6, 2017 26

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 ProAssurance Investor Update March 6, 2017 27

Products Liability Implications

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? ProAssurance Investor Update March 6, 2017 29

Cybersecurity: How are medical device companies faring and what is FDA’s oversight approach? Courtney S. Young, Esq.

Devices are Vulnerable ProAssurance Investor Update March 6, 2017 31

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 occurred. ProAssurance Investor Update March 6, 2017 32

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 ProAssurance Investor Update March 6, 2017 33

Hacking ProAssurance Investor Update March 6, 2017 34

Infection ProAssurance Investor Update March 6, 2017 35

Device Makers Will Face Liability ProAssurance Investor Update March 6, 2017 36

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 ProAssurance Investor Update March 6, 2017 37

FDA’s Approach

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 ProAssurance Investor Update March 6, 2017 39