FDA will post advisory committee briefing materials on its Web site at least two business days in advance of meetings, doubling the current lead time in an effort to enhance transparency, according to a ¹ draft guidance released last week.

The Feb. 28 draft, entitled Advisory Committee Meetings - Preparation and Public Availability of Information Given to Advisory Committee Members, was produced to help ensure the agency's compliance with the Federal Advisory Committee Act (FACA) and the Freedom of Information Act (FOIA).

It provides guidelines for the device, drug and biotechnology industry in developing and submitting publicly releasable data and product information that will be presented to an advisory panel alongside FDA analysis of the data. The agency encourages companies to submit documents that do not contain proprietary information requiring redaction, citing improved efficiency both for the agency and sponsors.

The draft guidance, which replaces three previously issued drafts - separately addressing disclosure for drug, biologic and device meetings - is part of a five-point plan announced last year to strengthen transparency in its advisory panel processes (² Also see "Advisory Panel Conflict Waivers To Stay; FDA Will Provide Clarity On Process" - Medtech Insight, 7 August, 2006., p. 14).

Also part of the new agency agenda are two yet-to-be-released draft guidances - one outlining procedures for granting conflict-of-interest waivers and one addressing when those waivers will be available to the public. Further, the agency plans to improve electronic notifications of committee meeting schedules and to create a more streamlined system to appoint members to pharmaceutical-related advisory panels.

FDA also recently started to more frequently identify product brand names and manufacturer names in Federal Register notices announcing newly scheduled advisory panel meetings (³ Also see "FDA Neuro Panel Will Review Cyberonics, Confluent Postmarket Data" - Medtech Insight, 1 January, 2007., p. 4)

Critic Applauds Earlier Public Release

FDA has been under pressure from Congress and public advocacy groups about improving its advisory committee procedures for years.

In 1999, the advocacy group Public Citizen sued the agency under FOIA and FACA to increase transparency in the process. FDA settled the case, agreeing to make materials that are provided to committee members available for public inspection and copying (⁴ Also see "Anti-Silicone Implant Media Campaign, Rally Planned By Consumer Groups" - Medtech Insight, 6 October, 2003., p. 14).

In 2001, FDA issued a ⁵ draft guidance, named the Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings, specifying that the agency will make briefing materials available one business day before meetings "whenever practicable."

"Simply making [the briefing materials] available at all before the meeting has [caused] an enormous change in a number of instances that we have been able to make statements that at least became part of the reason why FDA didn't approve a particular product," Sidney Wolfe, director of Public Citizen's Health Research Group, told "The Gray Sheet."

Nonetheless, Wolfe said, "we were unhappy about the fact that it was only 24 hours" before the meeting.

The newly released draft guidance extends the pre-panel public review time to two business days. And the agency notes that "we will probably make the briefing materials available on our Web site more than two full business days" before meetings for which the materials do not contain information considered exempt from public disclosure under FOIA.

Public Citizen welcomes the agency's push for more transparency. "It would have been nice if it was three or four business days, but it's a big improvement and we applaud it," Wolfe said.

FDA To Notify Firms Sooner About Upcoming Meetings

The agency also will alter the timing of its communication with industry for meetings involving briefing materials including information that might be exempt under FOIA. FDA will notify sponsors about relevant meetings approximately 11 weeks before meetings are scheduled. This change increases the timeline for notification by three weeks compared with the 2001 draft guidance.

Under the new schedule, the sponsor needs to submit two versions of the briefing materials - one complete (for review by the panel) and one with the sensitive information redacted - about nine weeks prior to a panel meeting.

About six weeks before the meeting, FDA says it will inform the sponsor what it will keep redacted when the information is released to the public. The sponsor has the option of removing information from its materials that FDA decides does not legally need to be hidden from public view.

The new draft cites "summaries" of clinical safety and effectiveness data, "a general description of physical characteristics and performance parameters," and clinical or preclinical protocols among examples of information that would generally be discloseable under FOIA.

On the other hand, manufacturing process information, proprietary physical characteristics and performance parameter and clinical "raw data" are examples of information that likely would be exempt from disclosure.

The agency stresses that industry has responsibility to identify exempt information. "Sponsors should not expect us to identify trade secrets or confidential commercial information" for them, FDA writes, although the agency will seek out and redact information that invades personal privacy.

Ultimately, FDA recommends that companies submit documents with nothing to hide.

"We strongly encourage sponsors to submit briefing materials that may be released to the public in their entirety without redaction." With this approach, the agency will accept briefing materials up until 22 days prior to a panel meeting.

Wolfe had some concern that the guidance provides a loophole for industry because it specifies that information not submitted at the appropriate time will not be made available to the committee members.

Theoretically, companies could "spring new information on everybody" at the meeting, Wolfe explained, which would violate the purpose of making the documents publicly available in the first place.

After speaking with FDA, though, he is assured that if this does happen, "the guidance can be changed to sort of tighten it up," Wolfe said.

- Morgan Weiland (m.weiland@elsevier.com)

FDA Aims To Up Transparency By Making Panel Materials Public Sooner

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