# Presentation: 943735

## FDLI Annual ConferenceApril 16, 2004

**Les Weinstein, Esq.**
**CDRH Ombudsman**

## Ombudsman

- Person appointed to receive and investigate complaints about a government agency and to mediate or otherwise resolve disputes between that agency and the public
- Resolve disagreements at an early stage before they escalate
- Alternative Dispute Resolution (ADR)
- Conciliation, mediation, arbitration, and negotiation

## Provide focus to existing agency appeal dispute resolution mechanisms
some informal and others more formal
Get involved in any stage of the Center’s decision making processes
Accessible to industry, easing the way to be heard 
Look into complaints 
Listen to industry’s issues and concerns

- some informal and others more formal
- Get involved in any stage of the Center’s decision making processes
- Accessible to industry, easing the way to be heard
- Look into complaints
- Listen to industry’s issues and concerns

**Ombudsman ****(continued)**

## Strategize options available to challenge or appeal
Shuttle diplomacy
Informally mediate disputes
Facilitate equitable resolution
Promote and support fairness, accountability and equity

- Shuttle diplomacy
- Informally mediate disputes
- Facilitate equitable resolution
- Promote and support fairness, accountability and equity

**Ombudsman ****(continued)**

## Are laws and regulations being applied consistently?
Are policies and procedures in conformance with the law?
Catalyst to get Center staff to take a second look
Neutral and impartial
Pledge of confidentiality

- Are policies and procedures in conformance with the law?
- Catalyst to get Center staff to take a second look
- Neutral and impartial
- Pledge of confidentiality

**Ombudsman ****(continued)**

## Complaints and Disputes - 2003

- Number received:

## Complaints and Disputes - 2003

**	****	**

- Office involved:

## Complaints and Disputes - 2003

|  |  |
| --- | --- |
| 510(k)’s | 25% |
| PMA’s | 9% |
| Imports | 6% |
| Competitors/Trade Complaints | 6% |
| IDE’s | 4% |
| 513g’s | 4% |
| Adverse Events/MDR | 4% |

- Most common subjects:

## Complaints and Disputes - 2003

|                                          |  |
| --- | --- |
| 1.  Miscommunication or lack of communication | 22%   |
| 2.  Lack of timeliness (of approval/clearance; setting up      meetings; returning phone calls; etc.) | 18%   |
| 3.  Data, testing requirements to support a premarket  submission; “least burdensome” | 16%   |
| 4.  Various policies and procedures | 13%   |
| 5.  Level playing field (claims of unequal treatment) | 9%   |
| 6.  Difficult or unhelpful employees | 9%   |
| 7.  Safety concerns/issues  | 4% |
| 8.  Freedom of Information Act (FOIA) | 3%   |
| 9.  Combination products | 2%   |
| 10. Claims of conflict of interest, bias, or retaliation | 2% |

- Most common reasons by rank:

## Complaints and Disputes - 2003

- Status:

## Complaints and Disputes - 2003

- Status excluding those referred outside CDRH, withdrawn or had no follow-up by complainant:

## Medical Devices Dispute Resolution Panel

- FDAMA – Section 404
- Additional, more focused procedure for timely review of scientific disputes between FDA and sponsor, applicant or  manufacturer
- Independent expertise of outside clinicians/scientists
- Congressional intent:  fair, impartial and timely hearing

## Dispute Resolution Panel

- FDA amended 21 CFR 10.75
- Guidance on Resolving Scientific Disputes:  A Guide to Use of Dispute Resolution Panel
- Issued 7/2/01
- Revised Draft Guidance based on public comments re:
- Independence of the process:  Ombudsman grants requests for Panel review without approval of Center Director or Deputy Director

## Threshold for Panel review:  some early disputes, before a Center decision or action, may be appropriate for review
Timelines:  process streamlined and timeframes tightened

- Timelines:  process streamlined and timeframes tightened

**Dispute Resolution Panel**

## Eight members:
Five standing members
3 voting members with broad scientific/medical backgrounds
1 non-voting industry representative
1 non-voting consumer representative
Three voting temporary members chosen to hear a particular dispute
Makes recommendation to Center Director
Who can concur, concur with exception(s), or not concur

- Five standing members
- 3 voting members with broad scientific/medical backgrounds
- 1 non-voting industry representative
- 1 non-voting consumer representative
- Three voting temporary members chosen to hear a particular dispute
- Makes recommendation to Center Director
- Who can concur, concur with exception(s), or not concur

**Dispute Resolution Panel**

## In addition to review of scientific disputes for which no other path exists, Panel implements three other requirements of Federal Food, Drug and Cosmetic Act:
Section 514(b)(5) re:  performance standards
Section 515(g)(2)(B) re:  appeals of PMA and PDP decisions
Section 522(b) re:  an order for postmarket surveillance for more than 36 months 

- Section 514(b)(5) re:  performance standards
- Section 515(g)(2)(B) re:  appeals of PMA and PDP decisions
- Section 522(b) re:  an order for postmarket surveillance for more than 36 months

**Dispute Resolution Panel**

## Only Meeting
September 6, 2001
Lifecore Biomedical appeal of  not-approvable letter for Intergel PMA

- September 6, 2001
- Lifecore Biomedical appeal of  not-approvable letter for Intergel PMA

**Dispute Resolution Panel**

## Pre-Panel Process for Lifecore Meeting
Ombudsman’s Summary of Scientific Issues in Dispute
Three temporary voting members selected:  two gynecologists and one statistician 
Panel packages to Panel and parties two weeks before meeting
Ombudsman’s role:  in the middle!

- Ombudsman’s Summary of Scientific Issues in Dispute
- Three temporary voting members selected:  two gynecologists and one statistician
- Panel packages to Panel and parties two weeks before meeting
- Ombudsman’s role:  in the middle!

**Dispute Resolution Panel**

## Panel Meeting
Presentations by Lifecore, CDRH and public
Chair’s role
Unanimous vote
Recommended approval of PMA
Center Director concurred and PMA was approved
Next Panel Meeting?

- Presentations by Lifecore, CDRH and public
- Chair’s role
- Unanimous vote
- Recommended approval of PMA
- Center Director concurred and PMA was approved
- Next Panel Meeting?

**Dispute Resolution Panel**

## How to Contact the Ombudsman

- Les Weinstein
- Center for Devices and Radiological Health
- U.S. Food and Drug Administration
- 9200 Corporate Blvd. (HFZ-5)
- Rockville MD 20850
- Phone: 301-827-7991
- Fax: 301-827-2565
- email: ombudsman@cdrh.fda.gov
- website: www.fda.gov/cdrh