2011-24583. Statement of Organizations, Functions, and Delegations of Authority

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that it has reorganized the Center for Drug Evaluation and Research (CDER) by establishing two offices and their substructures under the Office of Medical Policy: Office of Prescription Drug Promotion (OPDP) and Office of Medical Policy Initiatives (OMPI). OPDP will consist of the Division of Direct-to-Consumer Promotion and the Division of Professional Promotion. OMPI will consist of the Division of Medical Policy Development and Division of Medical Policy Programs.

FOR FURTHER INFORMATION CONTACT:

Karen Koenick, Center for Drug Evaluation and Research (HFD-063), Food and Drug Administration, 11919 Rockville Pike, rm. 324, Rockville, MD 20852, 301-796-4422.

SUPPLEMENTARY INFORMATION:

I. Introduction

The Statement of Organization, Functions, and Delegations of Authority for CDER (35 FR 3685, February 25, 1970; 60 FR 56605, November 9, 1995; 64 FR 36361, July 6, 1999; 72 FR 50112, August 30, 2007; 76 FR 19376, April 7, 2011; and 76 FR 51039, August 17, 2011) is amended to reflect the restructuring of CDER that was approved by the Secretary of Health and Human Services on May 25, 2011, as follows:

II. Organization

CDER is headed by the Director and includes the following organizational units:

Office of Medical Policy

1. Provides Center oversight and leadership in the development of medical policy procedures and policy initiatives pertaining to drug development, drug approval, bioresearch monitoring, human subject protection, and postmarket surveillance.

2. Provides scientific and regulatory leadership in ensuring accurate and effective communication of medical information to health care professionals and patients and compliance with applicable regulations.

3. Fosters an interdisciplinary approach to medical policy development, implementation, and coordination through collaboration with other disciplines, program areas, and FDA Centers in a manner that enhances integration of evolving science and policy into drug development, regulatory review, and postmarket surveillance processes.

Office of Prescription Drug Promotion

1. Formulates and establishes policy for the regulation of prescription drug promotion, including advertisements and promotion labeling, and other promotional activities.

2. Plans and supervises research studies to evaluate the impact of health communication and prescription drug promotion directed to health care professionals and consumers.

Division of Direct-To-Consumer Promotion

1. Reviews draft Direct-to-Consumer Promotion (DTCP) promotional materials and provides detailed written advisory comments to industry sponsors. Examples of draft materials include television ads, magazine ads, Internet Web sites, and patient brochures.

2. Develops and issues enforcement actions against false and misleading DTCP materials and activities for prescription drugs.

3. Reviews draft patient labeling for inappropriate promotional content.

Division of Professional Promotion

1. Reviews draft promotional materials directed to health care professionals and provides detailed written advisory comments to industry sponsors. Examples of draft materials include journal ads, Internet Web sites, commercial exhibit hall materials, sales aids, and broadcast advertisements.

2. Develops and issues enforcement actions against false and misleading prescription drug promotional materials and activities directed to health care professionals.

3. Reviews draft professional labeling for inappropriate promotional content.

Office of Medical Policy Initiatives

1. Provides oversight and direction for development of medical policies and procedures pertaining to drug development and drug approval and postmarket surveillance processes.

2. Provides oversight and direction for new and ongoing policy initiatives in broad-based medical and clinical policy areas, including initiatives to develop active safety monitoring of marketed products, improve the science and efficiency of clinical trials, regulate biosimilars (or follow-on biologics), and enhance consumer-directed drug information.

Division of Medical Policy Development

1. Responsible for the development of medical policy pertaining to drug development, drug approval, bioresearch monitoring, human subject protection, and postmarket surveillance processes in collaboration with appropriate program areas and coordinating committees. Develops issue papers, guidances, regulations, and operating procedures.

2. Provides advice and assistance to FDA staff and external constituents concerning implementation or application of new and existing medical policies and procedures.

3. Collaborates with the Office of Regulatory Policy to ensure timely and efficient clearance and dissemination of new and revised policy documents.

Division of Medical Policy Programs

1. Implements the Sentinel Initiative, an innovative safety monitoring program for marketed medical products that employs active surveillance of automated health care databases.

2. Coordinates with FDA Centers, external partners, and stakeholders to ensure efficient implementation of quality science and technology, and effective privacy and security strategies.

3. Manages and coordinates policy development related to biosimilars legislation and resulting programs.

4. Manages and coordinates clinical trial modernization policy and programs, including coordinating public-private partnerships dedicated to removing barriers to clinical trials participation, enhancing evidence derived from clinical trials, and optimizing the use of clinical trial resources.

5. Manages and coordinates policy and program initiatives to improve quality and utility, and broaden dissemination, of consumer-directed medical information.

6. Manages and coordinates efforts to ensure that professional labeling is compliant with applicable regulations and is optimized as a tool for communicating about the safety and efficacy of drugs.

7. Coordinates and collaborates with relevant program areas to ensure optimal FDA scientific and technical input for ongoing policy initiatives.

8. Develops and manages new science and technology policy initiatives pertaining to drug development, drug approval, and postmarket surveillance processes.

III. Delegation of Authority

Pending further delegation, directives or orders by the Commissioner of Food and Drugs, all delegations and redelegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further redelegations, provided they are consistent with this reorganization.

Dated: September 20, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.