Listening to Industry: Ombudsman Les Weinstein Comments on His Role in CDRH

Originally Published MDDI May 2001

FIRST PERSON

CDRH Ombudsman Weinstein details the responsibilities and initiatives of his position, and shares industry dispute and complaint statistics for the year 2000.

One year ago, I was appointed the first ombudsman in FDA's Center for Devices and Radiological Health (CDRH). An ombudsman, derived from a Scandinavian term, is someone appointed to receive and investigate complaints about a government agency and to mediate or otherwise resolve disputes between that agency and the public. Ombudsmen who work in government agencies are supposed to be neutral and impartial. Their goal is to work toward the resolution of disputes without taking sides.

An ombudsman will generally grant a complainant a pledge of confidentiality if requested. This arises when a party to a dispute prefers not to reveal its identity and asks an ombudsman to keep its name or even the nature of its complaint confidential. Naturally, a confidentiality pledge may hinder an ombudsman from facilitating a resolution to a specific problem. In that case, he or she will explain this and will not investigate a complaint further if doing so might violate the confidentiality pledge. In a few matters, however, confidentiality cannot be preserved, such as allegations of criminal activity, which must be reported to FDA's Office of Internal Affairs or Office of Criminal Investigations. Even in these special cases, however, the identity of a confidential source can often be protected.

In the wake of the FDA Modernization Act of 1997 (FDAMA), CDRH created the ombudsman position to supplement existing dispute resolution mechanisms available to the medical device industry, such as petitions and hearings. Generally, these mechanisms can be used only after FDA has made a formal decision or taken an action on a particular matter, and someone wants to challenge or appeal it. The ombudsman, by contrast, can be very flexible and become involved at any stage of the agency's decision-making processes, although I personally encourage those with complaints to first appeal up the supervisory chain of command pursuant to 21 CFR 10.75 (internal agency review). Since 1993, 41% of decisions appealed up the chain were reversed in whole or in part.

One of the first things I did in this new position was meet with each ombudsman in FDA to learn how their offices are organized and what some of their most-effective practices are for handling complaints and disputes. (The Office of the Commissioner and each center in FDA has an ombudsman, except for the Center for Food Safety and Applied Nutrition.) Although I have indeed used some of their ideas, I am always mindful of the fact that each center in FDA is differ- ent, as is each of the industries they regulate. Therefore, my office reflects the way CDRH operates, and I try to meet the needs of CDRH and the medical device industry.

The ombudsman's goal is to be accessible to industry, easing the way for sponsors, applicants, manufacturers, and their consultants to be heard by CDRH. As ombudsman, I look into industry's complaints, respond to its questions, and listen to its issues and concerns. I provide information and create strategies with industry regarding available options for challenging or appealing an FDA decision. As an active, problem-solving ombudsman, I often conduct shuttle diplomacy between a complainant and the appropriate CDRH office, informally mediate disputes, or otherwise facilitate an equitable resolution of a dispute.

INITIATIVES

Outreach to Industry. My initiatives thus far have included speaking at trade association meetings, including MD&M West in January and MD&M East, scheduled for this June. I have met with small groups of industry representatives and have visited device firms to explain my role and listen to their issues and concerns. I am a member of the Medical Device Industry Initiatives (MDII) Grassroots Task Force, a joint industry/FDA group working together for mutual benefit. The emphasis of this group has recently shifted from field issues to CDRH-specific ones.

Serving CDRH Staff. In my first few months on the job, I made about 25 presentations to various offices, divisions, and branches throughout the Center. My objective was for CDRH personnel to become familiar with me, be aware of my role, and know when it would be appropriate to suggest that someone contact me.

MEDICAL DEVICES DISPUTE RESOLUTION PANEL

Another of my responsibilities as ombudsman has been to institute a new Medical Devices Dispute Resolution Panel. One of the provisions of FDAMA—section 404 on dispute resolution (section 562 of the Federal Food, Drug, and Cosmetic Act)—is designed to ensure that FDA has effective processes to resolve scientific disputes that arise between the agency and sponsors, applicants, and manufacturers. Fundamentally, the 1997 law directs FDA to use the expertise of clinicians and scientists from outside FDA to advise the agency on areas of disagreement with industry. Independent expertise will help ensure that CDRH conducts its business as fairly and objectively as possible.

CDRH decided to implement this provision by creating a new panel under the Medical Devices Advisory Committee to consist of eight people. Five are standing members, of whom three are voting members with broad scientific and medical backgrounds, one is a nonvoting industry representative, and one is a nonvoting consumer representative. These members serve a four-year term. In addition, each time the panel hears a dispute, three temporary voting members with expertise related to the particular issue in dispute will be selected. The panel makes recommendations to the center director, who will make the final CDRH decision.

The initial standing panel members have been selected, and the first meeting was held on October 31, 2000. This inaugural session was held to introduce the members to the public and for the members to hear FDA's and industry's thoughts on the role of the panel in dispute resolution.

In addition to serving as a useful forum in which scientific disputes can be aired, the panel further supports four requirements of the Federal Food, Drug, and Cosmetic Act:

1. Section 514(b)(5), which requires the establishment of an advisory committee to take referrals of any matter concerning the establishment, amendment, or revocation of a performance standard that requires the exercise of scientific judgment.

2. Section 515(g)(2)(B), which requires the establishment of an advisory committee to receive referrals of petitions seeking a review of a denial or withdrawal of a premarket approval (PMA), the revocation of an approved product development protocol (PDP), a declaration that an approved PDP has not been completed, or a revocation of an approved notice of completion that permitted marketing of a device developed under a PDP.

3. Section 522(b), which requires a set process to resolve any disputes concerning FDA's ordering a manufacturer to conduct postmarket surveillance beyond 36 months.

4. Section 562, which requires FDA to provide a procedure for the review of all scientific disputes regarding the regulation of medical devices, including review by an appropriate scientific advisory panel, but only to the extent that other provisions of the act or of applicable FDA regulations do not already provide a right of review.

FDA believes its current procedures already provide methods to obtain review of most, if not all, scientific disputes. The Dispute Resolution Panel serves as an additional, more focused, body for the timely review of scientific disputes.

As CDRH ombudsman, I am also responsible for revising the Draft Guidance on Resolving Scientific Disputes Concerning the Regulation of Medical Devices, which was issued on April 27, 1999, for public comment. This document describes the role of the dispute resolution panel, the types of controversies eligible for review by the panel, and instructions for submitting a request for review. CDRH has received several comments from industry, which I am taking into consideration while drafting the final version, which I hope will be issued soon.

INITIAL STATISTICS

In my ombudsman role, I have created a system that instantly shows me the status of a particular complaint or dispute. It also provides me with meaningful statistics about the kinds of complaints and disputes the Center is receiving, so that I can pinpoint problem areas and recommend how to fix them.

My statistics for 2000 (from April 6, the day I came on board, through December 31) indicate that I received 24 complaints and was asked to resolve 11 disputes. Of these 35 total complaints and disputes, 51% have since been satisfied or resolved (83% in industry's favor and 17% in FDA's favor), 37% are pending, and 11% were referred elsewhere. A total of 61% of the complaints/disputes involved the Office of Device Evaluation, 18% the Office of Compliance, and 24% other offices (some involved more than one office). A little more than half (51%) concerned 510(k)s, and 6% concerned PMA applications. The following is a breakdown of the issues involved:

CONCLUSION

My full title is ombudsman and quality assurance (QA) manager. These two roles are interrelated. As QA manager, I am interested in the quality and consistency of the decisions CDRH makes. (I'd like to think that if I do a really good job in this role, I won't have much to do as ombudsman!) The complaints I receive help me identify areas in the CDRH decision-making process that may need to be improved. I am very interested in hearing from industry about the perceived effectiveness of CDRH programs and about problems that may be getting in the way of the Center's carrying out its regulatory responsibilities.

To this end, I sometimes sit in on randomly selected CDRH meetings with sponsors; I then call the sponsors afterward to hear their thoughts about the meetings. In addition, I conduct surveys to measure industry's satisfaction with FDA practices. This input helps CDRH to continually assess the work that it does and improve its operations. I provide this feedback to David Feigal, MD, the Center director, to whom I report. Formerly the ombudsman in FDA's Center for Biologics Evaluation and Research, he has been most supportive of my current position at CDRH.

The mission of the United States Ombudsman Association is to promote and support fairness, accountability, and equity in government. As the CDRH Ombudsman, my mission is to promote and support fairness, accountability, and equity at CDRH.

Les Weinstein, Esq., is CDRH ombudsman and QA manager. Prior to holding his current position, he worked in the Office of the Associate Commissioner for Public Affairs as the deputy director of the FOIA office and as FDA's denials and appeals officer.

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