Life-Science Panorama

A Journal for Industry Executives

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February 28th, 2012

What Industry Trends Keep You up at Night?

By Daniel R. Matlis

Last year, I had breakfast with Dave Johnson, CEO of ConvaTec Inc. at “CEO Unplugged,” During the session; Mr. Johnson discussed the business and regulatory challenges the Medical Technology industry is facing today.  In this environment, “I sleep like a baby - I wake up every 2 hours and cry,” he said.

Over the last year, I have had the opportunity to ask Medical Device industry executives, outsourcers and regulators what keeps them up at night?

The answer boils down this: “The increasing pace of globalization and outsourcing in the Medical Device industry has created demanding challenges for brand owners, their partners, and regulators alike.”

To identify key pain-points and innovative strategies that brand owners, their partners, and regulators are undertaking to cope in this new environment, Axendia is launching a research study.

This research will evaluate the impact of globalization and outsourcing across the entire Medical Device life cycle (from R&D design, supply chain, manufacturing and distribution). The study will provide insights into how industry leaders and regulators are utilizing innovative strategies and systems to improve visibility, control, and collaboration.  It will also provide a roadmap to enable organization to mitigate risk and increase business success.

To support this project, the research team is seeking input from industry practitioners representing the broad spectrum of companies in the Medical Device sector - including organizations of all sizes and every geographic region across the broad spectrum of Medical Device products.

To provide your input for this important industry research and share your perspectives on Medical Device issues and trends, please complete the survey by clicking on this link:

The results of this study will be published in a comprehensive research report and presented at the MedicalDeviceSummit conference scheduled for May 9th and 10th in Chicago, IL.

Industry practitioners who complete the survey will be eligible to receive a copy of the Research Report once it is completed.  Individual responses will remain confidential; responses will be aggregated to formulate the report findings.

We look forward to your contribution on this important research.  Please complete the survey by clicking on this link:

February 8th, 2012

The Most Important Proposed FDA Rule No One Is Talking About

By James McCormack PhD

On February 19, 2010, FDA published a proposed rule [75 FR 7412] that, when finalized, will have a profound effect on sponsors and the relationship between sponsors and persons they hire to plan, design, perform, review, or report biomedical research.  The proposed rule titled, “Reporting Information Regarding Falsification of Data”, will require sponsors to report to FDA, information indicating that any person has, or may have, engaged in the falsification of data in the course of performing their duties. 

Why does FDA believe this regulation is necessary?  The answer to that question can be principally found in the disqualification of a clinical investigator, Dr. Robert A. Fiddes, in June 1999 (See FDA’s Debarment Order, Clinical Investigator Disqualification List, and the Notice of Opportunity for Hearing). Among the many acts of falsification, he created false case reports for subjects that were never enrolled or did not exist, forged signatures on informed consent forms for the respective subjects, falsified records of medical procedures that were never performed, substituted test results from subjects who met the study’s inclusion criteria and improperly substituted for other subjects who did not meet the inclusion criteria, and paid Individuals, who were not study subjects, to give specimens in place of false study subjects.  Although Dr. Fiddes conducted studies for 47 sponsors affecting over 90 applications his actions were not reported to FDA.  Out of concern for the integrity of the preclearance review process and the rights and welfare of research subjects, FDA investigated why such widespread falsification could have gone unreported.  The agency determined that there was some ambiguity in the regulatory requirements regarding what information and when sponsors were to report information on possible incidences of falsification.  Therefore, the agency has proposed this rule to clarify a sponsor’s reporting requirements for studies conducted by, or on their behalf, or a study on which a sponsor relies to support a product approval.

            What research is covered by the proposed rule?  The reporting requirements will apply to information related to studies including, clinical investigations, nonclinical laboratory studies, and clinical studies in animals.

            What products are covered?  All FDA regulated products; food, drugs (human and veterinary), biologics, and medical devices.

            What do sponsors have to report?  The proposed rule does not require sponsors to make a definitive determination of falsification or establish the intent of the person who may have committed data falsification.  A sponsor is responsible for submitting information that they are aware of that a person has, or may have, falsified data.  The agency intentionally did not propose a specific threshold of information or the form, quantity, or reliability of the evidence that a person may have falsified data.  It seems apparent that the agency intends the reporting requirement to be an intelligence gathering activity that will be subject to further investigation and evaluation before serving as the basis of administrative or enforcement actions.         

When do sponsors have to report?  Under the proposed rule sponsors are required to report information they have regarding falsification, or possible falsification, to the appropriate FDA Center, no later than 45 calendar days after becoming aware of the information.

How do sponsors distinguish falsification from unintentional errors?  This is perhaps the most intriguing question raised by the proposed rule.  The agency addressed the distinction by defining “falsification” as creating, altering, recording, or omitting data in such a way that the data do not represent what actually occurred.  The proposed rule provides examples of unintentional errors, e.g., typographical errors and transposed numbers or characters, and states that such events should not be reported under the proposed rule. 

The public comment period ended in May 2010.  It is likely that the rule be finalized soon and the biomedical research environment will change accordingly.  Sponsors will need to develop robust controls to assure that possible incidences of falsification are detected, evaluated, and reported and persons performing services for sponsors should consider implementing their own controls as sponsor scrutiny will certainly increase.    

Dr. James McCormack presently serves as the Vice President of Life Sciences Compliance, at IBM.  He previously served as the Corporate Vice President of Regulatory Affairs and Compliance at Charles River Laboratories following an 18-year career in FDA as a preclearance review scientist and as FDA’s Bioresearch Monitoring Program Coordinator. 

The views expressed in this article are those of the author and do not necessarily represent those of his employer, Life-Science Panorama, its editor or Axendia, Inc.