Executive Summary: FDA Transparency Initiative, Improving Transparency to Regulated Industry
Regulated industry provides the public with food, drugs, medical devices, cosmetics, and other widely used and important consumer products. FDA’s mission is to protect and promote the public health through oversight of these products.
In order to succeed, FDA must clearly communicate standards and expectations to industry. Communicating requirements and expectations to industry in a more accessible manner promotes understanding of, and compliance with, rules set up to protect the supply of food and medical products.
In response to a request for input from FDA, regulated companies requested additional transparency about the standards to which their products are held, the process for soliciting guidance from the agency, and the progress of regulatory efforts at the agency. In this report, FDA outlines 19 action items and five draft proposals to improve transparency to regulated industry.
Better communication. A critical part of FDA’s mission is to disseminate information about FDA policies and procedures in a manner that can be accessed by all interested members of industry. Six action items commit the agency to improving communication to industry about agency procedures:
- FDA will develop a web-based resource called FDA Basics for Industry that will provide basic information online about the regulatory process governing FDA-regulated products, and include information that is frequently requested by industry.
- FDA will update the agency organizational charts and senior leadership personnel changes on the FDA Web site on at least a quarterly basis and ensure that the level of detail provided on the organizational charts is consistent across the agency.
- FDA will provide links to the processes available for industry to submit general regulatory questions to each Center.
- FDA will also aim to respond to general questions about an existing policy, regulation, or the regulatory process that are submitted via email, whenever practicable, within 5 business days or acknowledge receipt of the inquiry and provide an estimated time for response.
- FDA will issue a final version of the “Strategic Priorities FY 2011-2015” by March 2011.
- FDA will post on the FDA Web site slide presentations that are delivered by FDA employees to external audiences at events sponsored by, or co-sponsored by, the agency.
- FDA will compile all FDA Center guidance and standard operating procedures on FDA employees meeting with sponsors about product applications on the web-based resource, FDA Basics for Industry.
- FDA will describe the types of notifications the agency provides to industry with respect to the product application review process. FDA will provide an overview of the processes used to strive for consistency of product application review.
- FDA will also communicate general expectations about the circumstances, if any, under which it is appropriate to use secure email between FDA and a manufacturer when there is a question involving the manufacturer’s product.
- FDA will explain how a sponsor is informed about whether the review of its product application is on track to meet the target date for FDA action on the application. FDA is also willing to hold further discussions with industry about application tracking systems, and explore the feasibility of implementing such a system at FDA.
Guidance and Regulations. Timely, relevant guidance supports efforts by industry to comply with the law and develop novel products that may benefit the public health. Two action items focus on greater transparency around the guidance development process and two action items focus on transparency of the regulations development process:
- Commissioner Hamburg has formed a cross-agency workgroup to identify the best practices for improving the agency’s work on guidance.
- FDA will describe the ways in which interested individuals can provide input to the agency about guidance development. Links that provide industry with a list of guidance documents that have been withdrawn during the past year as well as possible topics for future guidance development or revision also will be made accessible in one location on the FDA Web site.
- After FDA issues a final rule, FDA will conduct outreach to the affected stakeholders as part of implementing the final rule if the rule imposes substantial new obligations.
- FDA will also work with the Department of Health and Human Services (HHS) and the Office of Management and Budget (OMB) to improve the accuracy of the timetables included in the agency’s regulatory agenda published as part of the Unified Agenda.
- FDA will provide contact information for points of contact within each District to whom to direct questions about the import regulatory process.
- FDA will allow interested members of the public to receive email notifications when an Import Alert is posted on the FDA Web site, or an existing Import Alert is updated.
- As part of the agency’s efforts to implement the forthcoming Strategic Import Plan, FDA will develop and execute a project to promote more uniform processes and procedures across districts, when appropriate. This project will be tracked on FDA-TRACK, the FDA’s agency-wide performance management system.
- FDA will aim to respond to general questions about the import process, if practicable, within 5 business days or acknowledge receipt of the inquiry and provide an estimated time for response. The Division of Import Operations and Policy (DIOP) in the Office of Regulatory Affairs (ORA) will compile a list of answers to questions frequently asked by industry and post this information on the FDA Web site.
- FDA will work with U.S. Customs and Border Protection (CBP) to explore developing a process by which brokers and filers can correct inadvertent data errors submitted about imported products and FDA should post that process online.
In addition to the above steps, FDA is requesting comments on five draft proposals to improve transparency to regulated industry. These draft proposals for public comment include: (1) disclosing, for certain high priority guidance documents in development, a timeline from the start of the agency’s work on the draft guidance to publication of the final guidance, (2) posting on the FDA Web site a list of presentations given by FDA employees to external audiences, (3) informing submitters if an appeal request will be reviewed by the FDA Commissioner and when a decision may be expected, (4) reviewing existing procedures to evaluate importers, or third parties working on behalf of importers, who file information electronically about products offered for import, and (5) initiating a planning process to develop a web-based system that provides information about importing requirements.