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  1. CDER Ombudsman

CDER Ombudsman 2016 Annual Report

FDA, Center for Drug Evaluation and Research

Virginia L. Behr, CDER Ombudsman, and Kristina J. Lauritsen, PhD, Assistant Ombudsman, fulfill ombudsman duties in FDA’s Center for Drug Evaluation and Research (CDER). Ms. Behr and Dr. Lauritsen report to the Director of the Office of Executive Programs who reports to the CDER Director.

This annual report details the number and variety of interactions with Ombudsman Behr and Assistant Ombudsman Lauritsen (referred to as Ombudsmen) for calendar year 2016.

I. Ombudsman’s Role

The United States Ombudsman’s Association (USOA) defines a governmental ombudsman as “an independent, impartial public official with authority and responsibility to receive, investigate or informally address complaints about governmental actions, and, when appropriate, make findings and recommendations, and publish reports.” 

Simply put, the Ombudsmen receive inquiries and investigate complaints in an informal, unbiased manner. The complaints and inquiries come from the regulated pharmaceutical industry, law firms or consultants representing industry, advocacy groups, public and private research institutions, health care practitioners, and consumers.  The complaints or questions can be of a regulatory, scientific, or administrative nature. The Ombudsmen informally resolve disputes and disseminate information about established appeals processes and other formal mechanisms for dispute resolution, both for disputes between regulated industry and CDER and for resolving differences of opinion amongst FDA staff. In addition, the Ombudsmen provide general information on product development and regulation.  They receive feedback about CDER programs and advise management about program issues. Although the Ombudsmen make recommendations for Center improvement to the Center Director and senior managers, they cannot require action because ombudsmen do not have disciplinary or enforcement powers.  

The Ombudsmen follow a code of ethics and operating principles drawn from those established by the Coalition of Federal Ombudsmen (CoFO), USOA, the International Ombudsman Association (IOA), and the Administrative Conference of the United States (ACUS) report “Recommendation 2016-5: The Use of Ombuds in Federal Agencies[1].” These include standards for ensuring confidentiality, impartiality/neutrality, and informality and are described on the CDER Ombudsman’s Office website. 

 

II. Contact Methods, Demographics, and Most Common Topics

The Ombudsmen receive inquiries and complaints by fax, phone, postal mail, email, and in person. In 2016, the Ombudsmen received 289 communications, mostly via email and phone. In many instances, several emails or phone calls were exchanged per case; those follow-up correspondences were not counted for this report unless substantially different issues were raised. Below are a list and graphic depiction of the number of contacts with the corresponding demographics, and a list of the most common contact topics. Demographics (Number of Contacts)
  • External parties (215)
    • Industry: commercial sponsors, pharmaceutical industry (88)
    •  
    • Law firms (37)
    • Whistleblowers (21)
    • Consumers (19)
    • Investors[2] (16)
    • Consultants (13)
    • Other[3] (12)
    • Research sponsors (4)
    • Health care professionals (3)
    • Advocacy groups (1)
    • Press (1)

  • Internal parties, i.e. FDA employees, including other FDA Centers (74)

Internal parties, i.e. FDA employees, including other FDA Centers

As shown by the chart above, 74 percent of the communications came from the external parties, including regulated industry or those representing them, whistleblowers (usually those working in the industry in some capacity), research sponsors, advocacy groups, health care professionals, investors, and consumers.

In no particular order, below is a list of the most common complaint topics received by the Ombudsmen in 2016. Most Common Contact Topics from External Parties
  • Dispute resolution assistance
  •  Disputing a CDER action or decision, usually a pharmaceutical firm (or a law firm or regulatory consultant representing them)
  • Requesting advice on how best to resolve a problem, whether seeking informal enquiry by the Ombudsmen or exploring formal appeals processes
  • General enquiries such as questions about CDER programs, policies, and regulatory requirements
  • Decision delays or response delays
    • Generic drug companies complaining of abbreviated new drug application (ANDA) decision delay, especially for generic opioid applications
    • Policy discussions holding up regulatory actions
  • Communication problems, including lack of response or miscommunication, primarily with the Office of Generic Drugs, Office of New Drugs, and Office of Compliance
  • Complaints that CDER wasn’t following regulations or proper procedures
  • Complaints about a CDER decision or action
    • Refusal to receive an ANDA
    • Detained product or import issue
    • Therapeutic equivalence rating for a generic drug
    • Monies owed to the government under various user fee programs
      • Initial assessment decisions
      • Delay in waiver and refund request decisions
      • Decisions on appeals of assessments
  • Industry whistleblower
    • Current Good Manufacturing Practices violations
    • Fraudulent data in a New Drug Application (NDA)

Most Common Contact Topics from Internal Parties

In most cases, FDA employees asked for the Ombudsmen’s advice about a difficult situation, albeit an issue internal to FDA or with an external constituent.  Examples include:  managing contacts from external whistleblowers, assessing responses to complaints, how to improve interactions with sponsors, addressing communication or policy issues, and improving cross-Center collaboration. Additionally, the Ombudsmen discussed dispute resolution options for scientific or regulatory disputes internal to FDA, and provided guidance to FDA employees for multiple, high priority internal disputes.

Nine employees sought assistance with workplace conflict; in most cases the Ombudsmen referred the employee to FDA’s Conflict Prevention and Resolution Staff or FDA’s Employee Assistance Program.

III. Trends

This section will briefly discuss notable differences in demographics and issues brought to the Ombudsmen in 2016 as compared to the previous year. The most notable change was an increase in the number of complaints from commercial sponsors and law firms, a 19 percent and 32 percent rise, respectively. Slightly more consumers contacted the ombudsmen this year with a smattering of concerns across topic areas such as:  drug access, drug packaging problems, potentially illegal online drug sales, and unlawful drug advertising. Continuing a trend from 2015, complaints were received about CDER Compliance’s conclusions or actions, including import alerts and detentions. However, the complaints in 2016 tended to be more about perceived delays in CDER Compliance’s final decisions on appeals (arguing against the initial FDA decision) submitted by the industry. IV. Other Ombudsmen Activities In 2016, the Ombudsmen took part in the ACUS study “The Use of Ombuds in Federal Agencies[4]” and continued to advise and mentor other federal ombudsmen about a variety of issues unique to the profession. The Ombudsmen collaborated with other FDA personnel, including ombudsmen in other Centers, in order to share best practices and develop and refine dispute resolution policies and procedures. Ms. Behr continues to serve as collateral duty mediator for the FDA’s alternative dispute resolution program in FDA’s Office of Equal Employment Opportunity. She also mediates cases for the federal government-wide Sharing Neutrals program. In addition, the Ombudsmen reviewed dispute resolution trends with CDER’s Formal Dispute Resolution Project Manager, Division of Drug Information, and Small Business Assistance.

V. Outreach Efforts

The Ombudsmen presented the ombudsman’s role and dispute resolution procedures in multiple forums, including CDER’s Office of Pharmaceutical Quality (OPQ) Leadership meeting, OPQ All Hands meeting, New Reviewers Blended Learning Program, New Employee Orientation, and Office of New Drugs (OND) Team Leaders Forum.

In order to improve communications with industry, Ms. Behr:

  • Teamed up with CDER’s Formal Dispute Resolution project manager for an in-depth discussion with industry representatives who comprise the Washington Regulatory Liaisons Group.
  • Served as a panel member for OND’s Communications Best Practices training; the training was part of a PDUFA V commitment.

 

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[1] https://www.acus.gov/recommendation/recommendation-2016-5-use-ombuds-federal-agencies
[2] This group is comprised of contacts self-identifying as investors in a publicly traded pharmaceutical company.
[3] This category included federal ombudsmen, foreign regulators, trade groups, other federal and state agencies, and citizens interested in the ombudsman profession (including students).
[4] https://www.acus.gov/research-projects/use-ombuds-federal-agencies

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