Health Journalism 2008: Under pressure – FDA oversight, funding, effectiveness

By Jill Wechsler
Pharmaceutical Executive

The main topic raised at the conference session on "FDA oversight, funding and effectiveness" was why it takes two or three years to receive any response to FOIA (freedom of information) requests. Reporters attending the session seized the opportunity to query Susan Winckler, chief of staff at the Food and Drug Administration, about why no one returns phone calls and how difficult it can be to get answers to specific questions from FDA scientists.

Winckler cited FDA's ever-growing responsibilities and heavy demands for information from Congress and other parties in explaining why press queries can get lost. Other panelists agreed that FDA lacks sufficient resources to carry out its responsibilities. Gail Cassell of Eli Lilly, lead author of the widely read report on the "FDA Science and Mission at Risk," described the agency's obsolete information systems, while former FDA official Michael Taylor noted that FDA's food safety program operates under obsolete statues and is lost in the federal beauracracy.

FDA's relation with the press was discussed at two other conference sessions. The Saturday panel on "Tapping the best of Washington from outside the Beltway," provided Julie Zawisza, head of public affairs at FDA, an opportunity to explain how the agency seeks to be more transparent and to better communicate about drug safety issues. She reported that FDA receives 12,000 FOIA requests a year and has a backlog of some 14,000 requests. Even though the media accounts for only 3 percent of FOIA filings, she noted that the law requires FDA to follow a first-in, first-out policy in handling these requests.

AHCJ has been examining the FDA's FOIA process through its Right to Know project. At the annual membership meeting during the conference, students at the Medill School of Journalism provided preliminary data from a survey of journalists on their experiences obtaining information from FDA. The survey indicates that long delays in obtaining responses often forces reporters to kill stories, that much of the information eventually provided is too old to be useful, and that the agency's FOIA system is virtually useless. This assessment of FDA is part of a larger AHCJ project to examine information access at federal agencies.

The researchers noted that the recently enacted Open Government Act of 2007 amended the Freedom of Information Act to make it more responsive and useful. The measure aims to tighten deadlines for federal agencies to meet FOIA requests and to improve tracking of requests. The policy goes into effect in January 2009, but it's not clear if federal agencies will receive any additional funding to meet the new requirements.

Zawisza of FDA offered to schedule a briefing for AHCJ members with the head of FDA's FOIA office to explore ways to expedite the FOIA process. It's possible that very simple information requests may qualify for "expedited" processing, but this has not been used much in the past.