FOIA & the FDA: Legislation

Table of Contents


Under pressure - FDA oversight, funding, effectiveness: A webcast of this panel at Health Journalism 2008 is available.

Working your way through the FDA: Julie Zawisza, assistant commissioner for public affairs at the FDA gave this presentation at Health Journalism 2008.

FDA's FOIA contacts

FDA public affairs list of who to contact about specific topics (PDF)

Handbook for requesting information and records from FDA

FDA newsroom

FDA Press Office contacts

FDA's regional public affairs specialists

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FDA's Freedom of Information Annual Report - FY 2007

Congress has considered several bills in the past year to strengthen existing FOIA laws. Descriptions of each are below.


H.R. 1309 (Related to H.R. 1326, S. 849)
Rep. Wm. Lacy Clay (Mo.)
Introduced: 3/5/07
Latest Action: Passed House on 3/14/07; referred to Senate Committee on Homeland Security and Governmental Affairs on 3/15/07
Summary: This bill would strengthen a journalist's right to be charged the standard processing fees for media for FOIA requests, even if the journalist is not associated with a particular publication, effectively strengthening freelancers' rights. Access to fee reimbursement for attorneys would also be improved. The Attorney General and would have more oversight over denial of FOIA requests, and more reporting of agency FOIA activity to Congress would be required. Agencies would need to establish better systems for tracking FOIA requests. The 20-day compliance period for requests would have to begin on the day that the agency receives a FOIA request, and agencies would need to reimburse any fees paid if a request is denied. Finally, the bill establishes an Office of Government Information Services in the National Archives to help FOIA filers with questions and report to Congress and the President on any necessary FOIA improvements.

H.R. 1326 (Related to H.R. 1309, S. 849)
Rep. Lamar Smith (Texas)
Introduced: 3/5/07
Latest Action: Referred to House Subcommittee on Information Policy, Census and National Archives on 3/27/07
Summary: The bill is quite similar to H.R. 1309, and has been sitting in subcommittee since March, while H.R. 1309 passed the House and went on to the Senate. Provisions in the bill include the right for freelance journalists to pay news media processing fees regardless of any affiliation with a publication, easier reimbursement of fees for attorneys making FOIA requests, better FOIA tracking systems for agencies and increased reporting of agency FOIA activity to Congress and the President.

H.R. 541
Rep. Brad Sherman (Calif.)
Introduced: 1/17/07
Latest Action: Referred to the House Subcommittee on Information Policy, Census and National Archives on 3/19/07
Summary: This bill would establish a 16-member commission to discuss ways to expedite agency processing of FOIA requests.


S. 849 (Related to H.R. 1309, H.R. 1326)
Sen. Patrick J. Leahy (Vt.)
Introduced: 3/13/07
Latest Action: Passed Senate with unanimous consent 8/3/07; Sent to the House and held at the desk as of 9/4/07.
Summary: This bill is similar to both H.R. 1309 and H.R. 1326, and has been approved by the Senate and sent back to the House. The bill provides definitions of "representatives of the news media" and "news," and states that a freelance journalist should be treated as a member of the media when filing a FOIA request if the journalist can demonstrate a reasonable expectation of publication of their work. The bill also expands reimbursement rights for attorneys who file FOIA requests and accrue filing fees. Agencies must begin the 20-day compliance period for filling a FOIA request on the day that the request is received, with a few exceptions, and search fees are also waived if the agency doesn't meet the time limits for filling the request. Better tracking systems and increased record access for agency FOIA requests will be implemented, and agencies will need to fully explain any FOIA denials. The Attorney General will have more oversight over agency FOIA activity, and Congress will receive more information on FOIA activity. Each federal agency will be required to establish a chief FOIA officer. Finally, an Office of Government Information Services will be established to help FOIA filers with questions and report to Congress and the President on any necessary FOIA improvements.

OPEN Government Act of 2007

Under this act, which was signed by President Bush in December, the FOIA process is due to become more open and accountable.

The act, according to senate documents, sets out the "intent of Congress" that public records should be disclosed unless there is a compelling reason to withhold them, tightens deadlines for responding to FOIA requests and lays out penalties for failing to disclose.

Specifically the act, when it takes effect Dec. 31, 2008 - a full year after it's signing - says that failure to respond to a FOIA request within 20 days prevents an agency from assessing search and duplication fees for those requests; requires government agencies to pay court costs of a FOIA lawsuit if overturned in court or when the lawsuit itself caused the agency to reverse itself; calls for disciplinary action against federal employees who "arbitrarily or capriciously" withhold documents; and clarifies that independent journalists are eligible for fee waivers even if they aren't directly affiliated with a recognized news organization. It also sets out that government records kept by private contractors performing recordkeeping functions are subject to FOIA requirements "just as if those records were maintained by the relevant government agency."

It also sets out a number of provisions to make it easier for FOIA applicants and Congress to keep of FOIA inquiries and complaints by requiring agencies to assign a tracking number to each FOIA request and set up a telephone or Internet system to check on the request's status and requiring agencies to report the average and range of response times to FOIA requests and reports on fee-waiver statistics, including numbers of requests granted and denied as well as the average response time on deciding a fee-waiver request.

To enforce these provisions the act also establishes an "Office of Government Information Services" within the National Archives and Records Administration. That office would include an FOIA ombudsman to review agency policies, audit performance, recommend policy changes and even mediate disputes between agencies and those filing FOIA requests - though FOIA applicants would still be able to sue for disclosure if the mediation was unsuccessful.

However, the FOIA ombudsman position has come under attack by the Bush Administration. With a few lines buried in the president's budget request for the Commerce and Justice Departments, the administration eliminated the position within the National Archives and shifts the duties to the Justice Department - the same department required to defend federal agencies in lawsuits stemming from FOIA denials.

That move has drawn stern condemnation from open government advocates, including one of the OPEN Government Act's cosponsors, Sen. Patrick Leahy, D-Vt., who said the move was "an outrageous disregard of the law."

Leahy was particularly incensed that the move was "done in the dark of night."

"It's a slap at the free press, it's a slap at the public and it's been roundly criticized by both Republicans and Democrats," Leahy said in an interview.

The Sunshine in Government Initiative also objected to the move in a letter to Congress.

"Asking the Justice Department to perform the responsibilities creates an inherent conflict of interest," SGI wrote. "The money should follow the law."

Leahy and his ally in open government legislation, Sen. John Cornyn, R-Texas, have also introduced legislation in March to require Congress to be more open about legislative changes that provide more exemptions to the FOIA law. Such exemptions are "typically buried in complex and lengthy legislative proposals," according to a joint announcement of the proposal.