12 October 1994 Rev. 30 March 2000
600 words
I fight their denials and win. The best way to fight is to ask your congressperson--or anyway, my congressperson, Jerrold Nadler (D-NY).
For example, the FDA has an excellent database of accidents involving medical devices. I requested all the reports on medical lasers.
Under the Act, the agency must "respond" to an FOI request within 10 days. And they do--with a form letter saying, "Dear Requester: Your request (copy enclosed) for records has been received by the Food and Drug Administration, Freedom of Information Staff, and we will respond as soon as possible."
Three months later, I got my laser accident reports--in microfiche so fuzzy that I couldn't make legible printouts. I asked the FDA FOI director for a paper printout, or (ideally) a floppy disk. Nope, he said arrogantly, microfiche is "more cost-efficient for the agency." If I can't read it, too bad.
I complained to my congressman, Ted Weiss. Next day, the FOI director called and humbly took down my order. Next day, I got my printout. It revealed that one particular endotracheal tube had repeatedly caught fire in the operating room, and it made a great story.
Weiss probably had more writers (and more NASW members) in his district on the Upper West Side of Manhattan than any other congressman. So Weiss made a specialty of helping writers with FOI disclosures. After Weiss died, Nadler replaced him and continued this constituent service.
So last year NIDA rejected my FOI request for a report evaluating employee drug tests. I appealed, and cc'd Nadler's staffer, Ellen Wallach. On Congressional letterhead, Nadler asked NIDA to explain in detail why they were rejecting his constituent's request. Wallach also reminded NIDA of some Clinton Administration changes encouraging disclosure.
Sure enough, after a few short months, NIDA finally coughed up my drug testing report. It revealed that the labs sometimes mixed up samples and falsely accused innocent employees, and it made a great story.
I thought these delays were just my problem, because, as an FDA PR officer reminded me, freelance science writers aren't "major media." But according to attorney Eric J. Sinrod, the 10-day limit is widely flouted ("It's High Time We Had a FOIA That Works," National Law Journal, Sept. 5, 1994). The response time was 85 days for the Immigration and Naturalization Service, 243 to 483 days for the State Department, and 340 days for the FBI, he wrote. The Justice Department has some requests pending for 15 years.
Sometimes, even a lawyer can't help. After a public interest group sued to enforce the 10-day limit, the D.C. Circuit Court simply ruled that because of the backlog, agencies can ignore the limit (Open America v. Watergate Special Prosecution Force, 547 F.2d 605).
The root problem is that agencies don't have any additional money to pay for the costs of filling requests, and FOI fees (waived for journalists) go to general revenue, rather than reimbursing agencies for the cost of filling requests. Sen. Patrick Leahy (D-VT) has introduced the Electronic Freedom of Information Improvement Act, which would allow agencies to recover half their FOI fees directly--and also encourage agencies to fill requests in computer-readable formats.
So if you have trouble with a FOI request (and you will), your congressperson can move your request ahead of everyone else's. But it's also in your professional interest to ask them to support reforms like the Leahy bill.
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[More information: The Freedom of Information Center at the U. Missouri has more templates for FOI requests, annotated with a discussion of the FOI laws. The National Freedom of Information Coalition's State & National FOI Resources is another good source.]
Actual Freedom of Information Requests
(Cut and paste!)
Norman Bauman 411 W. 54 St. Apt. 2D New York NY 10019
(212) 977-3223 28 December 1987 |
Office of Freedom of Information
HFI-35
Food and Drug Administration
5600 Fishers Lane
Rockville MD 20857
Freedom of Information Request
Dear sirs:
I am writing a story for Laser Medicine & Surgery News, which is published by Mary Ann Liebert, Inc. My readers include hospital administrators who manage laser programs, and physicians or surgeons who use lasers.
I would like information about problems that may occur with medical lasers. I need this information in enough detail to be able to tell my readers how adverse incidents are likely to occur, and how they might be prevented.
I understand that the Medical Device Reporting (MDR) data base and the Problem Reporting Program (PRP) data base contains reports of problems or adverse events involving medical lasers.
I would like a printout of all Freedom of Information-releasable information in the MDR and PRP data bases involving medical lasers.
I have discussed this with Al Van De Griek ((301) 427-8100), who said that as of 22 December 1987 there were 65 reports in the MDR data base, and 49 in the PRP data base, involving medical lasers. I would like those reports.
I have also discussed this request with Dave Duarte of the FDA press office, and Fred Sadler of the FOI office.
Please waive fees, since I am a journalist, and I am writing for publication. I believe that you should waive fees because (1) this story will help the FDA in its mission to reduce injuries to the public from medical devices and (2) this story will help reduce injuries to patients, and thus benefit the general public, rather than just my readers and my publication.
Please send the information to me at the following address:
If you have any questions, you may call me at (212) 977-3223.
Sincerely,
Norman Bauman
(212) 977-3223
3 August 1990
Office of Freedom of Information
HFI-35
Food and Drug Administration
5600 Fishers Lane
Rockville MD 20857
Freedom of Information Request
Dear sirs:
I am a journalist writing for the Journal of Clinical Laser Medicine & Surgery, and other medical publications. My readers include physicians, nurses, and laser safety officers.
I would like all releasable information regarding endotracheal tube fires associated with laser surgery.
I would like all releasable information in the Device Experience Network, including all reports under the Medical Device Reporting (MDR) Regulation, all reports in the Device Experience Network, and all reports in the Product Problem Reporting Program, regarding endotracheal tube fires associated with laser surgery.
I would like the computer printouts, the original reports from the manufacturer, copies of any correspondence relating to the reports, and field investigation reports.
In particular, I would like copies of all reports, in computer printout, hard copy, or other form, on the following incidents:
M119656 86 Xomed
M124941 20 Jun 86 Xomed Xomed
M130172 9 Oct 86 Endotracheal tube Cooper
M128848 15 Oct 86 Xomed Xomed
M128851 17 Oct 86 Endotracheal tube Cooper
M143739 23 Sep 87 Endotracheal tube Cooper
M148563 21 Dec 87 Xomed Xomed
M162558 23 Dec 88 PVC Laserscope
M168146 89 Xomed
M189851 1 Jun 90 Mallinckrodt Mallinckrodt
I would also like any other reports, not included in the above list, mentioning endotracheal tube or anesthesia fires involving lasers.
I would like to know whether these reports refer to separate incidents, or whether there are any duplicate reports referring to the same incidents.
I especially want to know the dates above incidents occurred (rather than just the date that the incident was reported), since that is a way of eliminating or suggesting the possibility that two or more reports may refer to the same incident.
If there is anything incorporated in these documents that discloses information that cannot be released under the Freedom of Information Act, I would like you to send me a copy of the documents with that information deleted.
Please waive fees, since I am a journalist, and I am writing for publication. I believe that you should waive fees because (1) this story will help the FDA in its mission to reduce injuries to the public from medical devices and (2) this story will help reduce injuries to patients, and thus benefit the general public, rather than just my readers and my publication.
If you have any questions, you may call me at (212) 977-3223.
Sincerely,
Norman Bauman
(212) 977-3223
9 December 1993
James Helsing, FOI Officer
Office of Freedom of Information
Substance Abuse and Mental Health Services Administration
Public Health Service
Department of Health and Human Services
5600 Fisher's La. RM 13C-05
Rockville MD 20857
Freedom of Information Request
Dear Mr. Helsing:
As I told you today, I am a journalist writing for the New Scientist, Medical Tribune and other medical, scientific and business publications. My readers include physicians, scientists, managers, and criminal defense and prosecution attorneys.
"A Survey of On-Site Testing Facilities of Drugs in the Workplace," Douglas Rollins, MD, PhD, et al., NIDA, Office of Workplace Initiatives (1992)
This report was cited, as an unpublished report, on p. 180-181 of "Under the Influence? Drugs and the American Work Force," Jacques Normand, Richard O. Lempert, Charles P. O'Brien, editors, National Academy of Sciences (1994).
I would like to know what these data are, where they are located and what they consist of.
You told me today that the NIDA certification program was transferred to Centers for Disease Prevention, and that inspections are done under contract by the Research Triangle Institute, North Carolina, and that documents or reports on individual certifications are maintained by the contractor, not the government.
You said that those reports are not available under FOI request, because it has been determined that to disclose those reports would be harmful to the certification process.
If so, I would like to know who in your agency has determined that disclosures would be harmful, and the reason for that determination.
If the courts have determined that any of this material cannot be released, then I would like to have the citations of those court decisions, with the names, addresses and telephone numbers of the parties requesting the information in those cases.
If there is anything incorporated in this material that discloses information that cannot be released under the FOI Act, I would like you to send me a copy of the documents with that information deleted.
Are there summary reports that summarize the results of individual inspections, or management reports summarizing, describing or evaluating those inspections? If so, I would like copies of those summaries or reports.
Please waive fees, since I am a journalist, and I am writing for publication. I believe that you should waive fees because I am writing stories which will help SAMHA in its mission to alleviate the problem of substance abuse in the workplace.
If you have any questions, you may call me at (212) 977-3223.
Sincerely,
Norman Bauman