IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA

JUDICIAL WATCH, INC.

Plaintiff,

v. Civil Action No. 00-2973 (RCL)

FOOD AND DRUG ADMINISTRATION

Defendant.

____________________________________

PLAINTIFF’S OPPOSITION TO DEFENDANT’S

MOTION FOR A STAY OF PROCEEDINGS

Plaintiff, Judicial Watch, Inc., by counsel, respectfully submits this Opposition to Defendant’s Motion for a Stay of Proceedings. As grounds therefor, Plaintiff states as follows:

MEMORANDUM OF LAW

1. Introduction.

On September 28, 2000, Defendant Food and Drug Administration (“FDA”) announced one of the most significant and highly controversial public health decisions in decades. On that date, the FDA announced that it had approved the controversial abortion pill RU-486 for use in the United States. Clearly, the FDA’s approval of RU-486 raises far-reaching health concerns for women and their unborn children throughout the United States.

On October 13, 2000, Plaintiff sent a Freedom of Information Act (“FOIA”) request to the FDA seeking access to agency records concerning RU-486, its manufacturer, and related subjects. Although the FDA admits that it already gathered all of its documents concerning the recently approved abortion pill, it has failed to make a single document public, either to Plaintiff or to any other FOIA requestor. Instead, the FDA asks this Court to ignore FOIA’s statutorily mandated, twenty (20) day time frame for producing responsive records by allowing it until October 15, 2001, more than one year after Plaintiff made its FOIA request, to even begin producing documents about this vital public health issue.

Obviously, this extraordinary delay about an issue of such overriding public importance is completely unacceptable to Plaintiff and is in direct contravention of FOIA. Any delay, much less a year-long delay, is not supported the facts surrounding the FDA’s approval of RU-486 or the FDA’s handling of this and other FOIA requests concerning the abortion pill, especially where the FDA clearly anticipated such requests and where it admits that is has already assembled documents responsive to Plaintiffs’ request. The FDA’s motion must be denied, and the FDA must, respectfully, be ordered to begin producing responsive records forthwith.

II. Factual Background

A. Defendant’s Handling of the RU-486 Application and Approval.

The FDA received the application for approval of RU-486 on March 14, 1996. The FDA’s September 28, 2000 approval letter indicates that the application for RU-486 was approved under 21 CFR 314 Subpart H – Accelerated Approval of New Drugs for Serious or Life-threatening Illnesses. See September 28, 2000 letter from FDA to Population Council (hereinafter “FDA Approval Letter”), at 1, copy attached as Exhibit 1. This accelerated approval scheme, with its concomitant limits on manufacturer liability, is an extraordinary measure that was adopted for use in rare cases to encourage the manufacturing and importing of drugs designed to treat serious, life threatening diseases such as cancer and/or AIDS/HIV. See Press Release of Congressman Tom Coburn, M.D., “Coburn Accuses the FDA of Withholding Information About RU-486 From Congress,” (hereinafter “FDA Withholds Infromation”) at 2, copy attached as Exhibit 2. On its face, it is hard to imagine how the purposes of 21 CFR 314 Subpart H were served by the accelerated approval of RU-486, a drug which does not treat any illness, serious or otherwise, and is designed for the express purpose of terminating, not saving, a life. Instead, the expedited approval appears to be motivated by a desire to meet the political demands of the abortion lobby while protecting the manufacturer from the inevitable liability claims that will be spawned by use of this dangerous drug. It also immediately calls into question the Defendant’s credibility in conducting the approval process and in the position it has taken in this case of requesting that it be allowed to withhold information surrounding the approval process for an inordinate amount of time.

Far from treating “serious illnesses” as required by 21 CFR 314 Subpart H, RU-486 is itself the source of significant health hazards.[1] For instance, women have experienced extreme instances of nausea , vomiting, and heavy bleeding along with the passing of large blood clots. See Glasgow, Richard D., M.D., “Some Important Questions for ‘RU 486’Advocates,” URL:www.lifeissues.org/ru486/ru00-01.html (hereinafter “RU-486 Questions”), copy attached as Exhibit 4. In trials conducted in France, one death and two near-fatal cardiac arrests occurred. See “Coburn letter,” Ex. 3 at 3. In the United States’ clinical trials, five percent of the women experienced hemorrhaging and eight percent experienced incomplete chemical abortions so that emergency surgical abortions had to be performed. See id. at 1, 3; see also National Right To Life Committee Press Release, “F.D.A. Approves Sale of Abortion Pill, Likely Made in China; Abortion Industry Seeks Journalists’ Aid in Marketing Strategy,” September 28, 2000 at 2 (“Even under the carefully controlled conditions of clinical trials, the RU-486/misoprostol process puts one out of every 100 users in the hospital. Two percent of women using the method have such severe bleeding they need surgery. During U.S. trials, one woman in Iowa nearly bled to death.”) (hereinafter “F.D.A. Approves Abortion Pill”), copy attached as Exhibit 5.

In addition, the side effects associated with many age groups and many pre-existing conditions are not known because women falling into those categories were not included in the trials. See RU-486 Questions, Ex. 4 at 4-5. Inexplicably, though, as approved, the drug “will be used on women who would have been barred from the U.S. trial. For example, there will be no restrictions on age or smokers.” Id. at 5; see also Coburn letter, Ex. 3 at 3:

The U.S. clinical trials reportedly did not include smokers or women over 35 among the subjects, but neither of these conditions is listed in the label, the prescriber’s agreement, the patient agreement, or the medication guide as a contraindication. Undoubtedly, some women from both of those risk categories will be likely to receive the drug combination because neither they nor their doctors have ay way of knowing these factors pose an additional risk.”

A further serious health consequence results from the fact that RU-486 is not 100% “effective” – some of the babies actually live through the attempt to kill them. In those instances, the trials indicated that many of the babies will be born with significant birth defects. See RU-486 Questions, Ex. 4 at 8-9; see also FDA Approval Letter, Ex. 1 at 2 (acknowledging fact that some babies will survive their encounter with RU-486 by imposing notification requirements on the Population Council “in the event of an ongoing pregnancy[] which is not terminated subsequent to the conclusion of the treatment procedure”).

In addition, there are many potentially serious side effects that simply have not been studied. For example, there may be long term effects but those have not been studied. See RU-486 Questions, Ex. 4 at 8-9 (“‘Once more, as with the contraceptive pill, DES, fertility drugs and hormone replacement therapy, healthy women are used as living test-sites for an ‘exciting new drug’.’”)(Quoting Raymond, et al. RU-486 Misconceptions, Myths and Morals (Cambridge, MA: Institute on Women and Technology, 1991) at 67). Nor is there any “information about the effect of repeated use of the two powerful synthetic hormones in RU-486.” Id. (citing FDA medical officer Dr. Ridgely Bennet, U.S. Food and Drug Administration, Reproductive Health Drugs Advisory Committee, transcript of the hearing on the New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy, July 19, 1996, at 132 and comments of Dr. Janet Daling, FDA Advisory Committee member, id. at 285)(emphasis added). Finally, “there is the possibility that the powerful synthetic steroid RU-486 could damage a woman’s ova and harm her subsequent offspring years later” but, again, this serious side effect has not been assessed prior to the approval of RU-486 by Defendant. See id. at 8-9 (“‘In other words, a drug which in fact might have long-term effects on folliculogenesis, ovulation and hence future fertility is declared ‘safe and effective’, whereas, in reality, the mechanism(s) by which it might exert this action remain(s) unknown.’”)(Quoting Raymond, et al. at 75).

Further serious health hazards are created by the fact that RU-486 by itself is not sufficient to complete the abortion. In simple terms, RU-486 kills the fetus, but a second drug, Cytotec (also known as misoprostol), is required to cause the uterus to contract and expel the remains. See F.D.A. Approves Abortion Pill, Ex. 5 at 2. However, the manufacturer of Cytotec, Searle, has specifically warned that “Cytotec is not approved for the induction of labor or abortion.” See Searle’s “Important Drug Warning” issued August 23, 2000 regarding Cytotec, copy attached as Exhibit 6. Searle based this prohibition on the medical evidence which indicated that:

Serious adverse events reported following off-label use of Cytotec in pregnant women include maternal or fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.

See id. As Congressman Coburn has described the paradox, “the FDA has approved a drug which, used by itself, is not efficacious in achieving the intended purpose of a completed abortion, and which becomes effective only when used in combination with another drug whose manufacturer has warned is unsafe in that application.” Coburn Letter, Ex. 3 at 3.

The FDA has attempted to minimize this extraordinary departure from accepted practices. It has acknowledged that Cytotec is only approved for treatment of gastric ulcers and not approved for use in abortions. See January 16, 2001 letter from Melinda K. Plaisier, Associate Commissioner for Legislation, Food and Drug Administration, to Congressman Tom A. Coburn, M.D. (hereinafter “Plaisier letter”) at 1, copy attached as Exhibit 7. Nevertheless, it attempts to justify its unprecedented de facto approval of this off-label, contraindicated, untested use by rationalizing the “adverse events reported concerning Cytotec” as merely “case reports,” “anecdotal reports” or “adverse events ... reported by consumers.” See id. at 2-3 (emphasis added). This clear bent on approving RU-486 at any cost, even the health of the “consumers” it is charged with protecting, undermines any credibility for the FDA’s position in this proceeding that it should be allowed to continue to hide the facts surrounding RU-486 for another 13 months.

There are also severe psychological and emotional injuries that result from the use of RU-486 which are being ignored by the Defendant and hidden from the American public. For instance, women who use RU-486 have to face their unborn child being passed out of their bodies and disposed of in a bag, trash can, or simply left to fall in the toilet and flushed down the sewer. See “Ru 486 Not as Easy as Promised, Say Women and Abortionists,” URL:www.lifeissues.org/ru486/ru00-11.html (hereinafter “RU-486 Not Easy”), copy attached as Exhibit 8. Some of these effects have been described by women who have used the drug:

“I aborted at 6:30 on Friday night. I heard it fall into the toilet. It looked like a blood clot. I cried when I knew it had passed - partly from relief, partly from sadness. I knew it was over.” [quoting Patient #001]

*****

“I remember finally dispelling the fetus, which looked like a sort of white kidney. The nurse told me it was ‘beautifully formed.’ Another pregnant woman expelled her fetus at home and had to bring it in a jam jar.

“You have to be very confident to choose this method. It may be physically more natural, but psychologically it hits you much harder. You preside over the killing of a baby, completely unblinkingly. For women who are confused or vulnerable, and of course, so many are in this position, it is really terrible.” [quoting “Fiona”]

Id. at 1, 3.

As Edouard Sakiz, who was then the chairman and CEO of Roussel Uclaf, the original manufacturer of RU-486, described this aspect:

As abortifacient procedures go, RU 486 is not at all easy to use. In fact, it is much more complex to use than the technique of vacuum extraction. True, no anesthetic is required. But a woman who wants to end her pregnancy has to “live” with her abortion for at least a week using this technique. It’s an appalling psychological ordeal.

Quoted in Id. at 5 (referring to the fact that it may take up to a week to complete the process of killing and expelling the fetus).

These psychological and emotional injuries are exacerbated by the fact that the Defendant and the distributor of the RU-486 are attempting to hide them from the women who will be taking RU-486 through a marketing campaign that is designed to create the impression that this procedure is the equivalent of taking any other pill, simple and painless. See, generally, F.D.A. Approves Abortion Pill, Ex. 5.

Finally, there are a host of problems and concerns surrounding the manufacturer of RU-486. Despite the Defendant’s unprecedented attempt to conceal the identity of the manufacturer of RU-486, it is now generally known that it will be manufactured by a firm in Communist China which has manufactured RU-486 for use in the communist government’s forced abortion program. See FDA Withholds Information, Ex. 2. This company, Shanghai Hua Lian Pharmaceutical Co. Ltd., has an extensive history of making shipments of contaminated and counterfeit drugs, including RU-486 to the United States. See Zitner, “RU-486 Firm Linked to Drug Impurities,” Los Angeles Times, October 20, 2000, copy attached as Exhibit 9; November 1, 2000 letter of Congressman Tom Bliley, Chairman, Commerce Committee, to Jane Henney, M.D., Commissioner, Food and Drug Administration (hereinafter “Bliley letter”), copy attached as Exhibit 10. The numerous past violations by Shanghai Hua Lian, the FDA’s inadequate response to these obvious problems (as detailed in Congressman Bliley’s letter and Mr. Zitner’s article), and the FDA’s apparent approval of this company to manufacture RU-486, demonstrate conclusively that the Defendant is not acting in good faith either in its handling of the RU-486 approval process or in the position it is taking in this case.

B. Defendant’s Handling of Information Requests Including Plaintiff’s FOIA Request.

In addition to the many extraordinary circumstances surrounding the FDA’s approval of RU-486 (e.g., its improper approval on an expedited basis under a limited program created specifically for drugs to treat serious illnesses, its approval in spite of the serious side effects it produces, its approval for use even though it is not effective without also taking Cytotec for a contraindicated and off-label purpose, and the approval of the manufacturer despite the manufacturer’s extensive record of supplying contaminated and counterfeit products), it has also been surrounded by a shroud of secrecy and a marketing campaign based on deception. See FDA Withholds Information, Ex. 2; F.D.A. Approves Abortion Pill, Ex. 5; RU-486 Not Easy, Ex. 8; RU-486 Firm Linked to Drug Impurities, Ex. 9; Bliley Letter, Ex. 10; October 4, 2000 letter of Senator Tim Hutchinson to Jane Henney, M.D., Commissioner, Food and Drug Administration (hereinafter “Hutchinson Letter”), copy attached as Exhibit 11 (making numerous requests for basic information about RU-486 which had not been provided by Defendant prior to the approval of RU-486).

For example, the FDA initially proposed detailed regulations governing the use of RU-486 in a letter to the manufacturer. Without any explanation, these regulations, which were designed to protect women, were dropped when the drug was finally approved. See Hutchinson Letter, Ex. 11 at 2. Because these regulations were clearly based on legitimate concerns for women’s health, see Coburn Letter, Ex. 3 (discussing in detail the medical bases for these regulations), and because no medical reason would justify their elimination, the only conclusion that can be reached is that the secret elimination of these restrictions was politically motivated. See FDA Approves Abortion Pill, Ex. 5 at 1 (“Now, four months later, the FDA has dropped most of these protections for women’s health. What has changed, other than a four-month campaign of political pressure by the abortion industry and its allies? The FDA opted for the convenience of abortionists over the safety of women”); Press Release of Congressman David Vitter, “Hutchinson, Vitter Introduce RU-486 Patient Health and Safety Act,” copy attached as Exhibit 12 (“The ‘RU-486 Patient Health and Safety Act’ would pass into law many of the health and safety guidelines the FDA originally proposed for RU-486 but dropped after pro-abortion activists launched an aggressive lobbying campaign to kill the provisions”).

In other areas, the Defendant has been more candid about the fact that it has deliberately kept facts regarding RU-486 from the American people. For example, Jane Henney, the Commissioner of the FDA has admitted that “the agency for the first time did not publish the names of the experts who reviewed RU-486 for the agency. In addition, it broke precedent by not publishing the name or location of the company that will manufacture the drug.” Clearly, this drug has received unprecedented treatment by the FDA. Unfortunately, the special treatment has been aimed at hiding the facts from the American people and protecting the drug’s manufacturer, rather than protecting the citizens of the United States.

It is against this background of politically motivated decisions and secrecy that Defendant’s handling of Plaintiff’s FOIA request must be viewed.

On October 13, 2000, Plaintiff requested documents under the Freedom of Information Act, 5 U.S.C. § 552 (“FOIA”), from Defendant, the Food and Drug Administration (“FDA”), regarding the consideration of the application for approval for RU-486 and consideration and approval of the manufacturer and distributor for this drug.

Defendant sent a letter to Plaintiff acknowledging the request, but produced no documents. Believing that time is of the essence since these documents contain information critical to the physical, psychological and emotional health of the citizens who may be considering taking RU-486, and to their unborn children, Plaintiff filed suit seeking the disclosure of documents to which the American people are entitled by law.

Defendant did not respond to Plaintiff’s lawsuit by producing the documents. To the contrary, Defendant now requests an unwarranted delay of almost thirteen (13) months to respond to Plaintiff’s request, or until October 15, 2001. By that time, literally thousands of Americans, born and unborn, will have been exposed to this drug without first knowing all the facts about the health risks involved.

During the almost five (5) years that passed from the time the Defendant received the application until RU-486 was approved on September 28, 2000, the FDA allegedly generated nearly 250,000 documents regarding its consideration and approval of the application. See Memorandum of Points and Authorities in Support of Defendant Food and Drug Administration’s Motion for a Stay (hereinafter “Defendant’s Memorandum”) at 5-6. While this number is large, it is not extraordinary. These are the documents which were relied upon by the agency employees as they considered and eventually approved the drug for distribution in the United States. It follows that the agency implemented procedures for organizing, storing and handling this volume of documents in the ordinary course of business so that they were available for use and analysis to the agency employees who were working on the application. If the FDA was able to organize this volume of documents in such a way as to make them available to the people approving the drug for ingestion, it can certainly make them available to the people who will actually be consuming the product. The fact that Defendant seeks to hide the information it used to approve the drug from those who will be using it is simply intolerable.

Additionally, the FDA has admitted that it “anticipated receiving multiple FOI requests for documents concerning the drug” and that it “was concerned that the collection and review of the large number of documents anticipated to be involved ... required advance planning and coordination.” See Defendant’s Memorandum at 5-6. But in spite of this, the Defendant chose to wait until “shortly after the drug was approved on September 28, 2000” to form an internal committee (the “Mifepristone Group”) “to coordinate the collection, review, indexing, redaction, and dissemination of documents concerning mifepristone.” See id. at 6. Clearly the Defendant knew that it would be dealing with a large volume of documents, that they would be the subject of multiple FOIA requests and that it would be required by law to respond to the FOIA requests within twenty (20) days pursuant to 5 U.S.C. §552(a)(6)(A)(i). The fact that it chose to wait until after the drug had been approved to start planning for responding to the requests, rather than making provisions for responding to the inevitable FOIA requests as it handled, analyzed, gathered, stored and retrieved the documents during the preceding 4-plus years should not now be used to delay production of these documents to the American public. It is simply outrageous that the FDA would handle the approval of the drug on the “fast track,” expedited basis, but then seek to handle informing the American people on the “slow track.”

From all indications, the FDA’s approval of RU-486 was nothing more then a political maneuver by the Clinton-Gore administration to satisfy a constituency of those who believe abortion should be granted and performed on demand, regardless or the health of safety of the woman or unborn child. The information pertaining to RU-486 may be voluminous, but it was available to the FDA when it ram-rodded approval for political reasons. It must now be made available to people who are about to become the victims of this political maneuver, the American citizens who are about to start ingesting it.

III. Discussion.

A. FOIA Requires Timely Production.

The U.S. Supreme Court has declared that “[t]he basic purpose of FOIA is to ensure an informed citizenry, vital to the functioning of a democratic society, needed to check against corruption and to hold the governors accountable to the governed.” NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242 (1978). The Supreme Court has further noted that FOIA prevents the tyranny that inevitably results from excessive government secrecy. Department of Justice v. Reporters Committee, 489 U.S. 749, 772-75 (1989). Indeed, our democratic government is completely dependent on our citizens being informed about the activities of the government. When citizens are not informed, democracy cannot function. FOIA was thus enacted to protect and guarantee the openness essential to the operation of our government.

Underlying the FOIA is a strong presumption in favor of full and complete disclosure of agency records, with the burden placed squarely on the government to justify any action tending to frustrate the Act’s purpose of openness in government operations. “Unlike the review of other agency action that must be upheld if supported by substantial evidence and not arbitrary or capricious, the FOIA expressly places the burden ‘on the agency to sustain its action’ and directs the district courts to ‘determine the matter de novo.’” Reporters Committee, 489 U.S. at 755, quoting, 5 U.S.C. § 552(a)(4)(B).

Equally important to effectuating the purpose of FOIA is ensuring that agency records be disclosed in a timely manner. As the legislative history of FOIA makes clear, Congress recognized that delay in releasing information can be “tantamount to denial.” See H. Rep. No. 876, 93rd Cong., 2d Sess., reprinted in 1974 U.S. Code Cong. & Admin. News, 6267, 6271. Accordingly, FOIA contains strict deadlines requiring that documents be produced within 20 days of the receipt of the request. 5 U.S.C. § 552 (a)(6)(A)(i).

This important policy of complete and timely disclosure can only be overcome, and the deadline potentially extended, if the agency makes a showing that it is facing “exceptional circumstances” and that it is “exercising due diligence in responding to the request.” See 5 U.S.C. § 552 (a)(6)(C). This “safety valve” provision was “carefully crafted to put a substantial burden on the government to justify to the courts any noncompliance with FOIA time limits.” Open America v. Watergate Special Prosecution Force, 547 F.2d 605, 617 (D.C. Cir. 1976) (Leventhal, J., concurring). In Open America, the D.C. Circuit found that exceptional circumstances exist only when an agency meet the following, rigorous three-part test: (1) when the agency is deluged with a volume of request for information vastly in excess of that anticipated by Congress; (2) when the existing resources are inadequate to deal with the volume of such requests within the time limits set forth by FOIA; and (3) when the agency can show that it is exercising due diligence in processing the request. Open America, 547 F.2d at 616; see also Gilmore v. U.S. Department of Energy, 4 F. Supp.2d 912, 925 (N.D. Cal. 1998).

In 1998, however, Congress passed the Electronic Freedom of Information Act Amendments of 1996, Pub.L.No. 104-231, 110 Stat. 3048 (1996) (“EFOIAA”), to address, in part, agency delays in responding to FOIA requests. In addressing Open America in particular, Congress declared:

Relying upon overly broad dictum in this case, agencies have employed the exceptional circumstances-due diligence exception to obtain judicial approval for lengthy delays whenever they have a backlog. Backlogs of requests for records under the FOIA should not give agencies an automatic excuse to ignore the time limits.

See H. Rep. No. 795, 104th Cong., 2d Sess., reprinted in 1996 U.S. Code Cong. & Admin. News, 3448, 3456-57. Moreover, the EFOIAA specifically states that it is intended to “address[] the single most frequent complaint about the operation of the FOIA: agency delays in responding to FOIA requests.” Id. at 3466. To help Federal agencies in reducing their backlog of FOIA requests,” the EFOIAA “would double the time limit for an agency to respond to FOIA requests from ten days to twenty.” Id. at 3469. Having thus reaffirmed the importance of timely responses by agencies to FOIA requests, and having doubled the time allowed to agencies to provide responses, the EFOIAA expressly limited those circumstance previously considered exceptional:

For purposes of this subparagraph, the term “exceptional circumstances” does not include a delay that results from a predictable agency workload of requests under this section, unless the agency demonstrates reasonable progress in reducing its backlog of pending requests.

5 U.S.C. § 552(a)(6)(C)(ii). Consequently, Congress has significantly modified, if not overturned, the D.C. Circuit’s holding in Open America. Nonetheless, the FDA still relies on Open America as the basis for its extraordinary request for a year-long delay in producing responsive documents to Plaintiff.

B. The FDA Has Failed to Demonstrate the Existence of “Exceptional Circumstances”.

It is not “exceptional circumstances” when an inevitable, predictable FOIA request comes in during the normal course of agency business, such as here. “Where a pattern and practice of late responses is alleged . . . a normal, predictable workload cannot constitute ‘exceptional circumstances.’” Gilmore v. United States Department of Energy, 4 F.Supp. 2d 912, 925 (N.D. Cal. 1998); see also, Electronic Privacy Information Center v. FBI, 865 F. Supp. 1 (D.D.C. 1994) (rejecting FBI’s motion for stay based on backlog claim, finding Open America “inapposite” where contested records were previously reviewed for release of summary); Rosenfeld v. United States Department of Justice, No. C-90-3576, slip op. At 8-13 (N.D. Cal. February 18, 1992) (“exceptional circumstances” not present when, despite substantial backlog, FBI made no significant effort to increase resources to satisfy FOIA obligations). Further, a mere lack of resources or a showing of “an inadequate staff insufficient funding, or great number of requests,” does not amount to “exceptional circumstances” justifying a stay under FOIA. See Hamlin v. Kelley, 433 F.Supp. 180, 182 (N.D. Ill. 1977). As the Hamlin court, relying on the legislative history, observed in rejecting the government’s claim that it could be the “fox guarding the hen house:”

the Senate Report indicates that Congress deliberately removed from the agencies the authority to delay FOIA requests for the reasons now raised by defendants because the agencies could not be trusted to keep their affairs regular with respect to these reports. ‘Frequent instances of agencies’ failing to follow their own regulations militate against allowing them to govern their own performance [under the Act].’

433 F.Supp. at 182, citing S.Rep. No. 93-854, May 16, 1974 at 27.

The FDA has failed to demonstrate exceptional circumstances. First, the mere fact that a large number of documents is involved does not make the request or response exceptional. These are the documents that the agency worked with on a day-to-day basis as it processed the application for approval. The fact that Defendant was able to approve RU-486 on an expedited basis demonstrates conclusively that it has an ability to effectively and efficiently handle, store and retrieve this volume of documents in the ordinary course of business. Nor was Plaintiff’s FOIA request for documents unpredictable. To the contrary, “[w]hen mifepristone was approved, FDA anticipated receiving multiple FOI requests for documents concerning the drug.” Defendant’s Memorandum at 5.

Further, the Defendant’s Memorandum and attached declarations do not indicate that there has been any extraordinary or unpredictable workload at the FDA in general. Instead, the Memorandum indicates that the Defendant has been experiencing a predictably heavy volume of FOIA requests for over eighteen months which has resulted in a backlog of 4,000 requests. See Defendant’s Memorandum at 12. Thus the “delay [has] result[ed] from a predictable agency workload of requests under” FOIA which would not be included in the definition of “exceptional circumstances” under the Electronic Freedom of Information Act Amendments of 1996 “unless the [Defendant] demonstrates reasonable progress in reducing its backlog of pending requests,” 5 U.S.C. § 552(a)(6)(C)(ii) (emphasis added). Defendant attempts to meet this criterion by arguing that it “has taken steps to address its backlog of requests.” Defendant’s Memorandum at 13. This argument does not satisfy Congress’ requirement that the Defendant demonstrate “reasonable progress in reducing its backlog,” not just that it is taking steps that may one day lead to a reduction. In fact, a careful reading of Defendant’s Memorandum shows that it has failed to demonstrate any progress in reducing the backlog. See id. at 12-16. Accordingly, Defendant has utterly failed to make a carry its burden of demonstrating “exceptional circumstances” which would justify a stay under the Electronic Freedom of Information Act Amendments of 1996 and the Motion should be denied.

Finally, Defendant’s reliance on Open America v. Watergate Special Prosecution Task Force, 547 F.2d 605 (D.C. Cir. 1976), which predated the Electronic Freedom of Information Act Amendments of 1996, is misplaced. In that case, the agency had experienced a “virtual deluge of requests,” id. at 610, which the agency and Congress had grossly underestimated. Id. at 612. The holding was tailored to that situation: “‘exceptional circumstance exist’ when an agency ... is deluged with a volume of requests for information vastly in excess of that anticipated by Congress.” Id. at 616. By contrast, the FDA has been experiencing the same monthly volume of requests for at least the last eighteen months. See Defendant’s Memorandum at 12. Thus, there has been no showing by the Defendant of the vastly excessive and unanticipated volume of FOIA requests that constituted “exceptional circumstances” in Open America.

C. The FDA Has Not Shown “Due Diligence”.

The FDA has failed to meet its burden of showing, beyond its own conclusory allegations, that it “is exercising due diligence.” It admits that it anticipated FOIA requests for the agency documents at issue. See Defendant’s Memorandum at 5 (“FDA anticipated receiving multiple FOI requests for documents concerning the drug.”). Due diligence under these circumstances -- which involve one of the most significant, highly controversial public health decisions in decades -- would have required that the FDA begin the process for gathering, reviewing and redacting documents responsive to what it has admitted were the inevitable FOIA requests for documents pertaining to the approval of RU-486. It is also clear that Defendant recognized that responding to these “anticipated” requests would require substantial effort:

In light of the multiple FOIA requests anticipated by FDA, the nuances likely to be contained in each such request, the number of documents thought to be involved, and the complexity of the subject matter, the Mifepristone Group determined that it would be most efficient to collect all of the agency documents involved and then make them publicly available as a single CD-ROM.

See Defendant’s Memorandum at 6-7. Despite this foreknowledge, the Defendant did not begin to take steps to prepare to respond to the FOIA requests that it correctly anticipated. until after the drug had been approved. This demonstrates not only a lack of due diligence but an utter disregard of FOIA’s 20 day deadline for responding to requests.

D. Plaintiff Has an “Urgent Need” for the Documents.

The Electronic FOIA Amendments specify that expedited processing will be granted when there exists when a “compelling need is demonstrated. 5 U.S.C. § 552(a)(6)(E). “Compelling need” means either that (1) “a failure to obtain requested records on an expedited basis ... could reasonably be expected to pose an imminent threat to the life or physical safety of an individual” or (2) “with respect to a request made by a person primarily engaged in disseminating information, urgency to inform the public concerning actual or alleged Federal Government activity.” 5 U.S.C. § 552(a)(6)(E)(v)(I) and (II). Here, the failure to obtain these records on an expedited basis means that numerous individuals will begin using this drug without knowing about the predictable, severe and even fatal side effects they could suffer. Clearly, any further delay in producing these records will “pose an imminent threat to the life or physical safety of [numerous] individual[s].” Further, Plaintiff has already established that it has the capacity to disseminate the documents to a broad public audience, and that the documents are likely to contribute significantly to the public’s understanding of the operations and activities of government. Complaint at ¶ 3. This showing, when combined with the serious health concerns with RU-486, demonstrate an “urgency to inform the public concerning actual or alleged Federal Government activity.”

Further, even under the holding in Open America, this showing of “exceptional need or urgency” is sufficient to defeat the Defendant’s request for a stay. In Open America, the plaintiffs had “alleged no urgency, have alleged no exceptional need, for the information they seek.” 547 F.2d at 614. The D.C. Circuit specifically conditioned its holding that a stay was appropriate on this finding by stating that it applied to all requests “except those where exceptional need or urgency is shown.” Id. at 616. Thus, in a case such as that presented here where there clearly is “exceptional need and urgency, a stay must be denied under Open America. See also, Aguilera v. FBI, 941 F.Supp. 144, 149-52 (D.D.C. 1996) (granting expedited access to documents due to exigent circumstances), appeal dismissed, No. 98-5035 (D.C. Cir. March 18, 1998).

Finally, this case is similar to other cases where “exceptional need or urgency” has been found to exist because fundamental principles of human safety or liberty were involved. In such situations, courts are rightfully reluctant to allow government officials the luxury of analyzing documents at their leisure when these important principles are at stake. See e.g., Raulerson v. Reno, No. 95-2053, slip op. At 3-5 (D.D.C. March 30, 1998) (denying stay because Plaintiff had “urgent need” for documents for criminal appeal of conviction), appeal dismissed, No. 98-5112 (D.C. Cir. May 5, 1998); Aguilera v. FBI, 941 F. Supp at 152-53 (plaintiff demonstrated he faces grave punishment), appeal dismissed, No. 98-5035 (D.C. Cir. March 18, 1998); Gilmore v. FBI, No. 93-2117, slip op. At 1, 3 (N.D. Cal. July 26, 1994) (plaintiff demonstrated “that the information he seeks will become less valuable if the FBI processes his request on a first-in, first-out basis”); Morrow v. FBI, 2 F.3d 642 (5^th Cir. 1993) (ordering FBI to demonstrate that it exercised due diligence if it did not process FOIA request within 10 days); Freeman v. Department of Justice, No. 92-557, slip op. At 6 (D.D.C. October 2, 1992) (information useful to requester’s criminal defense); Ferguson v. FBI, 722 F.Supp. 1137, 1141-44 (S.D.N.Y. 1989) (need for documents in post-conviction challenge and upcoming criminal trial); Florida Rural Legal Services v. Department of Justice, No. 87-1264, slip op. At 3-4 (S.D. Fla. February 10, 1988) (nonprofit organization showed urgent need to help undocumented persons make timely applications for naturalization); Clever v. Kelley, 427 F.Supp. 80, 81 (D.D.C. 1976) (multiple criminal charges carrying possible death penalty); Boult v. Department of Justice, No. C76-1217A, slip op. At 3-4 (N.D. Ga. October 22, 1976) (pending deportation that could endanger requester’s physical safety).

Defendant’s request for a delay until after the initial media interest in RU-486 has faded itself raises alarms. In Ettlinger v. FBI, 596 F.Supp. 867, 879 (D.Mass. 1984), the district court noted that “to the extent that the FBI takes unjustified positions in FOIA proceedings it generates its own burdens and increases delays, . . . when the agency’s position on a specific FOIA document production or fee waiver request has been determined to be unjustified . . . the resulting special impact on the particular request warrants some degree of priority attention to that request.” Id.

IV. Conclusion.

The American people are entitled to know all of the information available about this new and dangerous drug before they begin using it. They should not be forced to make decisions about the drug in a vacuum of information. The Freedom of Information Act exists to protect against such situations, and is indeed the only meaningful protection available to the people.

In this case, these important documents must be turned over immediately. In this case, justice delayed is justice denied. Defendant’s motion to delay should be denied.

Respectfully submitted,

JUDICIAL WATCH, INC.

________________________

Larry Klayman, Esq.

DC Bar No. 334581

_________________________

Paul J. Orfanedes, Esq.

CERTIFICATE OF SERVICE

I hereby certify that on February 15, 2001 a true and correct copy of the foregoing PLAINTIFF’S OPPOSITION TO DEFENDANT’S MOTION FOR A STAY OF PROCEEDINGS was served by first-class mail, postage prepaid, on the following:

Attorneys for Defendant U.S. Department of Commerce:

Edith Shine, Esq.

Assistant United States Attorney

Judiciary Center Building

555 Fourth Street, N.W.

Washington, DC 20001

__________________________

Paul J. Orfanedes

[1] For purposes of this Opposition, Plaintiff refers only to the health hazards to the woman who ingests this drug without referring to the obvious health affects on the unborn child. Nevertheless, Plaintiff notes the significant departure from the FDA’s mandate that the approval of RU-486 represents. As stated succinctly by Congressman Coburn of Oklahoma, “[i]t was a sad day when the FDA approved RU-486 – the first drug ever approved for the specific purpose of ending human life.” See October 16, 2000 letter from Congressman Tom Coburn to Ralph W. Hale, M.D. (hereinafter “Coburn letter”), copy attached as Exhibit 3.