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Other Areas of Public Comment

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Advisory Committee Meetings 

Several comments from both industry and consumer groups requested that FDA explain the role of an advisory committee recommendation when FDA is making a decision about whether to approve a product application. These comments noted that this explanation is particularly important when FDA does not follow the advisory committee’s advice. A consumer group noted that “such transparency will facilitate acceptance and understanding of consumers.”

Comments also suggested substantive changes to FDA’s advisory committee process, including: the selection of the advisory committee members, the conflict of interest policy and training of advisory committee members.

FDA’s advisory committees provide independent expert advice to the Agency on a range of complex scientific, technical, and policy issues. An advisory committee meeting also provides a forum for a public airing of important matters concerning FDA policies and FDA-regulated medical products. Although advisory committees provide recommendations to FDA, FDA makes the final decision. After seeking the views of an advisory committee, FDA does not now always explain how the advisory committee’s advice was considered in the Agency’s final determination.

The procedures governing advisory committees are set forth in general terms in FDA regulations. FDA has published several guidance documents about the advisory committee process.

It is FDA’s practice to request the curricula vitae of all individuals serving on advisory committees and post them on FDA’s Web site where allowed by law. All advisory committee members are trained on the advisory committee process and applicable laws and regulations before participating in their first advisory committee meeting. Information that will be considered by the advisory committee (i.e., the briefing package) is posted online prior to the meeting, with appropriate redaction of non-public information.

The Task Force believes that the basis for FDA’s action to approve or not approve a product application should be understood by the public. Explaining how the advice of the advisory committee was relevant to the decision, especially where FDA does not follow that advice, will help the public better understand FDA’s decision about whether an application should be approved. Disclosing this information leads to a better understanding of the basis for FDA’s decision, increasing Agency accountability and credibility in FDA’s decision-making, and furthering the goals of the Administration for a more transparent and accountable government.

FDA will explain the Agency’s reasons for not following the recommendation of an advisory committee in review documents, and those reasons will be disclosed when those documents are disclosed. In addition, FDA will provide basic explanations to the public about the advisory committee process through the web-based resource, FDA Basics.

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Citizen Petition Process 

Comments stated that FDA should disclose the materials reviewed by FDA to respond to a citizen’s petition. Comments stated that disclosure of this information would explain to the public why certain citizen petitions were denied or granted, especially when those determinations “appear to be counter to consumers’ interests.”

When FDA receives a citizen petition, the Division of Dockets Management assigns the petition a docket number and establishes a docket for the citizen petition. Interested parties can submit information relating to the petition to the public docket and these submissions are accessible to the public. The public can submit comments about any pending citizen petition. That information is also added to the docket for that petition and made available to the public.

The information and materials that serve as the basis for FDA’s decision on the citizen petition are explained in the response to the citizen petition. FDA’s response to a petition usually involves an in-depth analysis of the issues raised in the petition and an extensive explanation of the Agency’s rationale for its determination. At the time the response is issued, FDA places in the public docket any published literature that is referenced in the response but has not been placed in the public docket by the petitioner or by commenters.

The Task Force concluded that FDA’s current practice sufficiently explains to the public the reason for its decision on any particular citizen petition. FDA provides the public with a detailed rationale in the response to the citizen petition and provides the public with access to the documents that serve as the basis for FDA’s determination. To the extent a member of the public disagrees with FDA’s decisions, there is a procedure for requesting that FDA reconsider its decision. The Task Force is not recommending changes to current practice.

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Communicating About Safety Concerns and Emerging Safety Issues 

Consumers and industry acknowledged the challenges inherent in risk communication about emerging safety issues with FDA-regulated products. Some comments noted that when the health or safety of the public is at risk, FDA should notify the public about the safety issue. Other comments stated that when FDA does not have usable information to communicate to the public about the safety issue, i.e., “news you can use,” FDA should not issue an official communication to the public. Some industry comments also stated that FDA should make every effort to communicate and coordinate with affected manufacturer(s) before notifying the public about a safety issue with a FDA-regulated product.

Many comments encouraged FDA to establish principles and criteria for communicating about emerging food safety issues; others noted favorably FDA’s development of the Strategic Plan for Risk Communication and urged FDA to implement the principles set forth in that document.

FDA determines whether, when, and how to communicate safety information to the public, but FDA does not currently disclose the rationale for its conclusions that a safety issue does or does not merit disclosure. Although some individual Centers have procedures for communicating about safety issues, FDA does not have an Agency-wide set of principles about when and how to communicate this information.

The Task Force believes that it is important to provide the public with a better understanding of FDA’s basis for issuing communications about safety concerns with FDA-regulated products. And to the extent possible, the Task Force believes that FDA should communicate risk information to the public in a consistent way. Disclosing the criteria FDA uses to determine whether to communicate about a potential safety problem with a FDA-regulated product will enhance FDA’s process for communicating important information to the public that can be used to make healthcare decisions, and further the Administration’s goal for more transparency in government operations.

Last fall, FDA announced the Strategic Plan for Risk Communication (Strategic Plan), which describes FDA’s strategy for improving how it communicates about FDA-regulated products. As part of FDA’s Strategic Plan, FDA has committed to identifying consistent criteria for when and how to communicate emerging risk information.

The Task Force concluded that FDA should tell the public the criteria FDA uses to decide whether to communicate about a potential safety problem with an FDA-regulated product, when to communicate that information, and how to effectively communicate that information to target audiences. FDA’s implementation of the Strategic Plan for Risk Communication will address these issues.

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Freedom of Information Act 

In general, comments stated that FDA should improve the efficiency of the process for requesting and receiving documents via a Freedom of Information (FOIA) request. Many of these comments stated that it took too long to receive a response and some of these comments stated that FDA should implement a fast track process. Some comments stated that FDA should make better use of technology to accept and respond to FOIA requests. A comment stated that FDA should implement a process to ensure that responsive documents were redacted in a consistent manner.

While the Transparency Initiative was not intended to be a review of the FOIA process, the draft proposals for public comment in this report have direct implications on the process FDA uses to implement FOIA. As outlined in Section V, the Task Force believes that the public interest weighs in favor of allowing the public ready access to certain important information and proposes that FDA proactively provide this information to the public. The implementation of any of these draft proposals for public comment will make that information available to the public without the need to submit a FOIA request for the information.

HHS has made reform of the FOIA process a key component of the Department’s efforts in support of the Administration’s Open Government Directive. The Department is taking steps to improve the FOIA process, including creating a new staff position within the Office of the Assistant Secretary of Public Affairs dedicated to FOIA reform. This person will identify, develop and help implement key FOIA reforms across the Department. FDA is participating in the Department-wide process. FDA also plans to track and disclose measures of performance related to FOIA on a monthly basis. The public will be able to follow FDA’s progress on key FOIA-related performance measures online.

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Inspection Results from Food Facilities 

Several comments requested that FDA make inspection results available to the public online, in a timely fashion. Many of these comments identified inspection results from food facilities in particular.

Disclosing observations regarding significant violations found during an inspection of a food establishment, or the knowledge that these may be disclosed, may encourage FDA-regulated food facilities to comply with the law. Further, individuals and companies that purchase products from these entities have an interest in knowing what FDA observed during an inspection of an establishment. Disclosure of the inspectional observations provides companies, federal agencies, and others who may want to contract with, or purchase food products from, these entities with information they can use to make informed decisions.

The Task Force believes that inspection reports contain information that if disclosed, would be helpful in protecting the food supply. But not all of the information in inspection reports is needed to promote the public health. The Task Force believes that some information should be withheld from public disclosure and must be redacted, for example, information about a firm’s manufacturing processes. This type of information is usually found in inspection reports.

The Task Force concluded that FDA should explore the feasibility of making inspectional observations from food facilities available to the public quickly. Additional information is needed to determine whether useful information about inspection results can be provided to the public in a manner that does not unduly hamper the ability of investigators to conduct inspections of facilities in a timely manner. The Office of Foods will convene a workgroup to explore the feasibility of making information about inspectional observations of food facilities more available to the public in a timely fashion, including by re-designing inspection reports to provide a separate summary page of significant inspection results. The Task Force was informed that other jurisdictions have figured out a way to make useful information about inspection results from food facilities available to the public quickly and the workgroup can look to some of those experiences as possible models.

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Media Policy 

Comments from some members of the media stated that FDA’s current procedures for dealing with the media restricted the flow of information between the public and FDA personnel. These comments stated that public affairs officials can play an important role answering questions and facilitating interviews, “[b]ut when they forbid, delay or monitor contact between reporters and employees, they interfere with the public’s right to know and can delay access to timely information necessary to protect and advance public health.” Comments stated that prior administrations allowed more communication between FDA employees and the media and that FDA’s practice is not universal among federal agencies.

A conference call was held on April 12, 2010 with representatives from the Association of Health Care Journalists and the Society of Environmental Journalists to follow-up on the comments they submitted to the Task Force. During the call, representatives provided suggestions on ways FDA can facilitate contacts with the press, including holding regular conference calls about activities at the agency, providing the press with a list of agency experts by topic area, and committing to return calls from the press within two hours. Participants stated that FDA would benefit from a written media policy. One participant noted that implementing a media policy is “harder at regulatory agencies,” such as FDA.

Given FDA’s regulatory authority and responsibility, it is very important that FDA provide information to the news media as promptly and accurately as possible. Like many other public agencies, FDA has a public affairs office to facilitate and coordinate requests from the media. On average, the public affairs office fields between 50 and 100 inquiries from journalists every day. FDA personnel may establish a record of what is discussed to improve their own understanding of issues and to identify additional information of relevance that can be shared with the journalists.

FDA plans to track and disclose measures of performance related to its interactions with the media and will start by tracking the number of press inquiries received each month. FDA will also draft a policy outlining FDA’s media process and post this policy on its Web site. FDA will continue to explore additional ways to make the Agency’s system as effective as possible.

In addition, the Department of Health and Human Services, as part of the President’s Open Government Initiative, is reviewing the media policies of various HHS agencies. FDA will participate in this process.

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Meetings with Stakeholders 

Comments stated that FDA should post a calendar that lists meetings with certain members of the public. One comment stated that “any important official meetings” between FDA and industry representatives should be disclosed while other comments stated that FDA should disclose meetings with external stakeholders as well as industry. One comment stated that the name and affiliation of attendees as well as the date, time, location, and subject of the meeting should be disclosed.

FDA staff interact with the public frequently, from scheduled in-person meetings, to unscheduled phone calls and emails about the status of a matter. Many meetings with industry are about product applications under review, thus proprietary information is discussed at such meetings and may be apparent if FDA discloses details about the subject of the meeting. Meetings with patients and patient groups may concern specific FDA-regulated products for certain diseases, thus personal information may be discussed at the meeting, in which case it would not be appropriate to disclose both the subject of the meeting and the names of the patients participating. Capturing an increased level of detailed information regarding all those interactions would consume significant Agency resources but provide little insight about the functioning of the Agency.

Under FDA’s current regulations significant meetings with persons outside the executive branch involving FDA leadership are disclosed. On a weekly basis, FDA posts to a public calendar significant meetings, conferences, seminars, speeches, and social events sponsored by regulated industry that are attended by the FDA Commissioner, Principal Deputy Commissioner, the Deputy Commissioners, the Associate Commissioner for Regulatory Affairs, Center Directors, or the Chief Counsel. The calendar provides the date and subject matter of the meeting.

The Task Force concluded that listing all meetings held by all Agency personnel would not provide the public with a corresponding level of understanding about FDA and how it does its work. Information about significant meetings held by the key policy makers at FDA, however, is publicly available and easily accessible on the FDA Web site. The Task Force recommends that FDA continue its current practice.

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