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More Information on the Drug Approval Process

Comments on FDA Proposed Changes to Disclosure of Information from FDA Advisory Committee Meetings

March 26, 2001

Public Citizen's Health Research Group's Comments On
Public Hearing Before a Public Advisory Committee; Examination of Administrative Record and Other Advisory Committee Records. Direct Final Rule

Docket No. 00N-1634

Public Citizen strenuously opposes this proposal by the Food and Drug Administration (FDA) to amend its regulations regarding the public disclosure of written information distributed to FDA advisory committee members for their review and consideration prior to an advisory committee meeting. The FDA's proposal would unnecessarily delay public access to important summary safety and efficacy information that is not exempt from disclosure about new drugs.

In the case of drugs, the written information distributed to advisory committee members prior to meetings most often consists of briefing materials prepared by manufacturers and the reviews by FDA scientists of data submitted by manufacturers to support the approval of a new drug. The industry's strategic manipulation of information about new drugs leaves the FDA reviews as the only reliable source of objective information about the safety and efficacy of new drugs. Without timely access to the agency's reviews it is virtually impossible for health professionals and the public to form an independent opinion of the therapeutic value of new drugs and to meaningfully participate in subsequent FDA advisory committee meetings.

The regulation currently in effect, which Public Citizen believes should remain in place, was written in 1979 and has, to the best of our knowledge, never been adhered to by the agency. This regulation requires that unless the written information provided to the advisory committee members for review and consideration at the committee meeting is otherwise exempt from disclosure under the Freedom of Information Act (FOIA), the information must be available for public disclosure at the same time it is made available to the advisory committee members. The current regulation as written reads:

(a) The administrative record and other committee records are available , at the following times:
        (1) The written information for consideration by the committee at any meeting: at the same time it is made available to the committee.[1]

The FDA is proposing the following change in the regulation:

...that the written information for consideration by an advisory committee at any meeting is available for public disclosure whenever practicable, before or at the time of the meeting.[2]

Public Citizen's concern is that the FDA's definition of "public disclosure whenever practicable" will, based on its past performance, become a scant 24 hours prior to the advisory committee meeting or at the time of the meeting, even though the advisory committee information must be ready for posting on the agency's web site by the close-of-business seven business days prior to the advisory committee meeting. Both the FDA's December 1999 Draft Guidance[3] for Industry for the Center for Drug Evaluation and Research's (CDER) disclosure of information provided to advisory committees and a similar Draft Guidance[4] from the Center for Biologics Evaluation and Research (CBER) issued in February 2001 reflect the no sooner than 24 hours before the meeting "rule."

The FDA's rationale for withholding advisory committee information from the public until 24 hours prior to a meeting is that it is crucial that the advisory committee members receive the background information as soon as practicable after the materials are produced so that members can adequately prepare for the meeting. Because, in the agency's view, the advisory committee materials often need to be redacted before being made publicly available, complying with the regulation as it now reads, would require the agency to wait until the materials are redacted before sending the information to the advisory committee members. This, again in FDA's view, would result in less time for the committee members to review the materials prior to the committee meeting. According to the agency such a delay would be detrimental to the advisory committee process because it would limit the time advisory committee members would have to study complex scientific information in preparation for an advisory committee meeting. The FDA also states that the simultaneous availability of briefing materials to the advisory committee and to the public is not required under the Federal Advisory Committee Act.

The FDA has always encouraged public participation in advisory committee meetings. Interested persons could present data, information, or views, orally or in writing, on issues pending before the committee. The current agency regulation recognizes that for meaningful public participation in advisory committee meetings the public must have access to the material that will be discussed prior to the committee meeting. Interpretation of complex scientific information is no less difficult for the general public than it is for advisory committee members and therefore the public should have an equal amount of time to study the materials that will be discussed as do the advisory committee members.

The information that Public Citizen is primarily interested in seeing in the public domain at the earliest opportunity are the FDA reviews of safety and efficacy for the drug under consideration by an advisory committee. As was mentioned above, these reviews may give the only objective view of the therapeutic value and safety of a drug. Public Citizen would like to suggest that it would be in the best interest of the public if the agency reviews were disclosed at least 14 days prior to an advisory committee meeting, or at the same time they are distributed to the advisory committee members. It is extremely unlikely that agency reviews will contain Freedom of Information Act (FOIA) exempt material. We feel that this is a reasonable request and one that does not violate any provision of FOIA for the following reasons:

1.     Summary safety and efficacy information about a drug are not exempt from disclosure under FOIA and thus there is no need to even consider the redaction of this type of information.

For example, the FDA recognized in its proposed rule regarding the public disclosure of information related to gene therapy or xenotransplantation that summary safety and efficacy data about products in development are available through publicly accessible filings to the Securities and Exchange Commission (SEC).[5]

2.    FDA Medical Officers and other scientific reviewers could be asked to segregate their comments about product formulation and other chemistry, manufacturing, and controls information. This type of information is exempt from disclosure under FOIA and simply would not be posted to the agency's web site.

In a presentation before the FDA Consumer Roundtable held December 13, 2000 in Washington DC, the FDA's Chief Counsel, in prepared remarks, stated the importance to consumers of openness and transparency within the agency.[6] Among other remarks the Chief Counsel said:

1.    FDA openness and transparency empowers consumers to make informed choices about their health. It helps assure consumer confidence in the credibility of FDA's process.

2.    FDA continues to be one of the world's leading agencies in its emphasis on openness and transparency.

3.    ...consumers expect and need better and more timely information about the products FDA regulates.

These statements made by one of the highest ranking officials within the FDA appear in direct conflict with statements such as " the simultaneous availability of briefing materials to the advisory committee and to the public is not required under the Federal Advisory Committee Act" that appear in the agency's proposed rule amending the current regulations. The FDA must realize that the reviews of drugs prepared by agency scientists may be the only remaining objective source of information regarding the safety and efficacy of drugs and as such these reviews should be available to the public at the earliest opportunity.

We strongly urge that the FDA reconsider amending the current regulation and take the steps we suggested above to provide the agency's reviews to the public at least 14 days prior to an advisory committee meeting.

Thank you for the opportunity to comment on this important issue.

Sincerely,

Larry D. Sasich, Pharm.D., M.P.H.
Public Citizen Health Research Group

Sidney M. Wolfe, M.D.
Director,
Public Citizen Health Research Group

 


 

REFERENCES

[1] 21 CFR part 14 Section 14.75(a)(1)

[2] Department of Health and Human Services, Food and Drug Administration. Public Hearing Before a Public Advisory Committee; Examination of Administrative Record and Other Advisory Committee Records. Federal Register Vol.66, No.5, January 8, 2001, pages 1257 to 1259.

[3] Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry ­ Disclosing Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by the Center or Drug Evaluation and Research, Beginning on January 1, 2000. December 1999.

[4] Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. Guidance for Industry ­ Disclosing Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Related to the Testing for Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research, February 2001.

[5] Department of Health and Human Services, Food and Drug Administration. Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation. Federal Register Vol.66, No.12, January 18, 2001, pages 4688 to 4706.

[6] Remarks by: Margaret Porter, Chief Counsel and Sharon Holston, Deputy Commissioner for International and Constituent Relations, U.S. Food and Drug Administration. Openness and Transparency ­ FDA Consumer Roundtable, Washington, D.C., December 13, 2000.

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