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Judicial Watch • 10-13-2000 – FDA FOIA

10-13-2000 – FDA FOIA

10-13-2000 – FDA FOIA

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Judicial Watch 

Because one above the law. 
October 13, 2000 
VIA CERTIFIED MAIL AND FAX 
Food and Drug Administration Freedom Information Staff (HFI-35) 5600 Fishers Lane 
Rockville, 20857 
Re: Freedom ofin.formation Act 
Dear Sir/Madam: 
Pursuant the Freedom Information Act ("FOIA"), U.S.C. 552, and its regulations, hereby request from the Food and Drug Administration (FDA), all correspondence, 
memoranda, documents, reports, records, statements, audits, lists names, applications, 
diskettes, letters, expense logs and receipts, calendar diary logs, facsimile logs, telephone 
records, call sheets, tape recordings, video recordings, notes, examinations, opinions, folders, 
files, books, manuals, pamphlets, forms, drawings, charts, photographs, electronic mail, and 
other documents and things, that refer relate the following any way: 	
The production ofRU-486 (Mifeprex mifepristone) Hua Lian Pharmaceutical, and its parent corporation, Shang,.11.ai Pharmaceutical Group. 	
All reports FDA inspectors Hua Lian Phannaceutical factory, include the July 2000 inspection. 

so1 School Street, Suite 725 

Washinton. 20024 Tel: (202) 646-5172 Fax: (202) 646-5199 FDA requirements that the Hua Lian must satisfy and/or attain order produce 
RU-486 pill form. 	
Hua Lians Pharmaceutical's failure meet certification requirements produce RU-486 pill form. 	
Any and all documents regarding Danco Laboratories, Neogen Pharmaceuticals, Neogen Industries, Advances/Neogen Group, and/or Exelgyn relation RU486; including, but not limited the manufacturing, production, and distribution ofRU-486. 	
The application and documentation submitted the Population Council relation the FDA's approval ofRU-486. 	
All documents regarding the Population Council relation RU-486, including the patent transfer RU-486 the Population Council. 	
All documentation regarding the Rockefeller Foundation, Concept Foundation, World Health Organization, and the World Bank relation RU-486. 	
The FDA decision not disclose the name location the manufacturer ofRU

486. 
Thank you for your expected cooperation responding timely our request, which should within working days required under the Act, because time the essence. 
Pursuant the FOIA, any portions the requested documents are claimed privileged, those portions which are not claimed privileged should provided the undersigned. This should done prior the conclusion the statutory 20-day period for 

response. addition, under the FOIA there absolute requirement produce those 

segregable portions documents which are not claimed privileged, well list ("Vaughn Index") that indicates date, author, general subject matter, and claims privilege(s) those documents, portions thereof, which have been withheld not provided. 
Rosen, 484 F.2d 820 (D.C. Cir 1973), cert. denied, 415 U.S. 977 (1974); Central 
525 Supp. 547 (D.C. 1981); see LaRocca State Farm Mut. 
Auto. Ins. Co., F.R.D. 278 (W.D. Pa. 1985). note that President Clinton instructed agencies October, 1993, ensure 
compliance with both the spirit well the letter the Act. See President Clinton's FOIA 
Memorandum, U.S. Department Justice, FOIA Summer/Fall 1993, addition, 
Attorney General Reno issued FOIA Memorandum October, 1993, which inter alia states strongly encourage your FOIA officers make 'discretionary disclosures' whenever possible 
under the Act," and orders presumption disclosure." See Attorney General Reno's FOIA 
Memorandum U.S. Department Justice, FOIA Spring 1994, 1-2. 
Judicial Watch entitled public interest fee waiver for this request. U.S.C.  552 (a)(4)(A)(iii), the FOIA sets forth two prong test determine whether fee waiver appropriate. First, the disclosure must the public interest contributing significantly the public's understanding the operations the government. Schrecker Department Justice, 970 Supp. 49, (D.D.C. 1997); Fitzgibbon Agency for International Development, 724 Supp. 1048, 1050 (D.D.C. 1989); Larson Central Intelligence Agency, 843 F.2d 1481, 
1483 (D.C. Cir. 1988). Second, the disclosure must not primarily the commercial interest the requester. Schrecker, 970 Supp. 50; Fitzgibbon, 724 F.2d 1050; Larson, 843 F.2d 483. 
Judicial Watch 501 (c)(3) not-for-profit public interest organization. One its purposes provide the public with information which exposes government activities that are contrary the law. Judicial Watch is, effect, educational foundation, well law firm, 

which uses several mechanisms for the dissemination the information acquires, and operates ensure that this information will made available the public daily basis: 
 	Judicial Watch, press entity itself, produces several press releases each week. 
 
The Judicial Watch Newsletter has monthly circulation over 300,000 copies nationwide. 

Judicial Watch maintains website which people can view copies of, among other things, FOIA documents, press releases, responsive documents, deposition transcripts and court opinions. This website viewed over 20,000 people per day average, and few occasions, had logged 1,000,000 visitors single day. 

 	
Over 60,000 people subscribe our "Infonet" listserve for daily updates our lawsuits, FOIA requests, investigations and public education programs. 

 	
Judicial Watch's Chainnan has been invited testify before Congressional committees expert witness legal matters, including, but not limited the Privacy Act and the Freedom Information Act. 

 	
Judicial Watch's Chairman and other employees frequently appear nationally broadcast radio and television programs provide information, analysis and commentary concerning government corruption and other legal issues. 

 	
Judicial Watch has been credited Courts, the Congress and various other media outlets several occasions for uncovering information and documents concerning government corruption, illegal and/or inappropriate activities, and documented instances government attempts "stonewall" requests for information and 

accountability the public interest.1 
 	Judicial Watch involved the production and broadcast monthly one hour news and information television program, Public Disclosure, fashioned after the long running news broadcast Minutes. Public Disclosure syndicated across the country. 
 
Judicial Watch produces its own weekly radio program, The Judicial Watch Report, which airs nationwide stations and the Internet. Judicial Watch disseminates information obtains through this medium well. 
 
Judicial Watch hosts and sponsors conferences and rallies public education forums for the dissemination the information acquires. For example, Judicial Watch will host Ethics iJt Government 2000 Conference the Washington Hilton October 
20-21 2000. short, Judicial Watch's efforts expose government corruption make news almost daily basis, and functions, part, member the media. 
Clearly, information that exposes government activity that contrary the rule law will contribute significantly the public's understanding the operations and activities government. fact, according the Office Management and Budget, Freedom Information Reform Act 1986 -Uniform Freedom Information Act Fee Schedule 
Guidelines,  67(g), this one the categories activity which courts have characterized the public interest. 

This FOIA request based upon reporting several news outlets, include The 
1See attached press releases. 

Washington Posf, that appears allege inappropriate unlawful activities the FDA and/or its officers, employees, and/or agents. this case, the public's understanding the actions and activities the FDA with regard RU-486 issue that merits full and immediate disclosure. 
Congress has spoken clearly this subject amending FOIA that can "be liberally construed favor waivers for noncommercial requesters." McClellan Ecological Seepage Situation, 1284 (quoting 132 Cong. Rec. S14298 (Sept.30, 1986). The main purpose the amendment, according Senator Leahy, was prevent gamesmanship the part government agencies i.e., "remove roadblocks and technicalities which have been used various Federal agencies deny waivers reductions fees under FOIA." Id. (quoting 132 
Cong. Rec. S16496, October 15, 1986). request expeditious handling and immediate release the requested in.formation the public interest. The health and safety the public may grave risk due the questionable purity and safety Chinese pharmaceutical products, standards, 
practices. The extraordinary steps taken the FDA -the 

refusal disclose 
identifying information concerning the manufacturer pharmaceuticals intended for the citizens, that FDA officials have sworn protect -is outrageous act that calls into question exactly what public service the FDA providing. These highly irregular, secretive actions the part the FDA, relation the approval the controversial RU-486 pill, demand the immediate and full disclosure the information requested this letter for the sake the health and safety the public. other interest, issue agenda can "trump" the American public's right accountability from its "trusted servants" the FDA-who are charged with protecting the public's health and safety. Denying the American public information about 
pharmaceuticals that the FDA has approved for their use does not help protect them any way. "Chinese Make RU-486 For U.S.," Philip Pan, Washington Post Foreign Service, Thursday, October 12, 2000; PageAOl found at: http://www.washingtonpost.com/wpdyn/articles/A53938-20000ctl .html (attached). 

Release the information will promote confidence honest democratic system, and contribute furthering the integrity the American national government deterring and/or sanctioning corrupt activities. The failure will likely result the further compromise important interests the American people. 
Sincerely, 
ruDICIAL WATCH, INC. 

Christopher Farrell
firm. 
Was 
09/30/1 
But several Chinese officials and the head Bangkok-based 
A.b_o...d 

foundation that has worked closely with the company confirmed today A!Ulli 
(The,
that Hua Lian Pharmaceutical Co. will produce the drug for the United 09/29/1 States. 

For-9. 
.0.J:!J.9. FDA official Washington declined comment, citing the agency's 
Was 
position that would not disclose the location the manufacturing site. 09/29/1 
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Classifieds Print Edition Archives Site Index 
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BRlTANNICA.COM

Chinese Make RU-486  T.S. (wash.ingtonpost.corn) Page 
Danco said statement from its New York offices that the site was 
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inspected the FDA make sure met the agency's requirements but 
that could not identify the plant comment its location because confidentiality agreement. 
The fact that state-owned company China will producing RU486, mifepristone, for U.S. consumers could become part debate 
over the drug the United States. Told the Chinese factory's role, 
U.S. antiabortion activists said they intend question the safety and purity Chinese pharmaceuticals and tie the drug China's controversial one-child policy and human rights record. 
Douglas Johnson, legislative director the National Right Life Committee, said his group found the news "very disturbing." also criticized the FDA for its refusal reveal that the manufacturer was China, saying the agency's rationale was "highly implausible." 
"They said they wanted protect the company from violence protests, but it's ludicrous say that issue China, where demonstrations aren't permitted," added. "It's public relations problem they want avoid--they don't want the association with Chinese coercive abortion practices." 

RU-486 has been key ingredient China's population control strategy for years. the estimated million abortions performed annually China, about half are carried out with RU-486, said Gao Ersheng, director the Shanghai Institute Planned Parenthood Research. 
Hua Lian has been making RU-486 for least nine years, one three companies China that manufacture the drug. Established 1939 and nationalized after the 1949 Communist revolution, one the largest pharmaceutical firms Cliina, according its Web site. 
With the help the Rockefeller Foundation and the Bangkok-based Concept Foundation, the company has been working for three years upgrade its equipment and retrain its staff meet international standards order permitted export the drug. 
The Concept Foundation was established the World Health Organization and World Bank 1989 assist factories developing countries make medical products low cost for Third World health agencies. The Rockefeller Foundation gave million the group 1997 help Hua Lian and China's state family planning agency upgrade the factory. 

Joachim Oehler, who heads the Concept Foundation, said the goal was enable Hua Lian produce export-quality RU-486 used China and elsewhere emergency contraceptive. said the foundations knew that would also allow Hua Lian export the drug used for inducing abortions, but that that was not their goal. 
htto ://www.washingtonpost.com/wp-dyn/articles/ A5393 8-20000ctl .html 
10/13/00 Chinese Make RU-486  TT.S. (washingtonpost.com) Page 3of4 
10/13/00 
Oehler said FDA inspectors spent week the factory July and agreed allow Hua Lian produce RU-486 bulk amounts for export the United States. The factory not certified export RU-486 pill form, but Oehler said expects meet those standards three five months. the meantime, said, Hua Lian will send RU-486 amounts about 100 pounds another factory that will make into pills. said does not know the location the other factory but assumes the United States and does not know other factories elsewhere might manufacture the drug for U.S. use. 
"If you compare with other manufacturers China, they are among the tops terms their production standards," Oehler said Hua Lian. "The factory very good shape. would not have survived the FDA inspection otherwise." 
The Hua Lian Pharmaceutical Co. denied multiple requests for interviews tour the factory, did its corporate parent, the Shanghai Pharmaceutical Group Corp. But Gao and three Hua Lian officials said the factory will making RU-486 for export the United States. 
Oehler said unclear how much RU-486 the factory will produce 
annually, but said can manufacture least half ton year, 
enough meet the entire world demand. 

Neither abortion nor RU-486 subject moral debate China the way the United States. 
During the first decades Communist rule, government authorization was required obtain abortion, and was often difficult obtain, especially for unmarried women. result, women often sought abortions from illegal providers, who often prescribed various forms folk medicine. the 1970s, though, China began adopt population control measures and the government changed its policy, allowing women obtain abortions without government approval. 
China began experimenting with RU-486 early 1983, participating clinical trials with the World Health Organization. 198 along with France, became one the first countries approve the drug. the mid-1990s, the drug had become popular for women seeking alternative surgical abortion. 
Gao, the director the research institute, attributed the popularity the drug part the fact that most surgical abortions China are performed without anesthesia and are thus extremely painful. addition, many Chinese women choose RU-486 because they fear that complications during surgical abortions might harm their ability have 
httn//www.washin2:tonoost.com/wu-dvn/articles/A53938-20000ctll.html Chinese JYlake RU-486 .,.... T.S. (washingtonpost.com) Page 
 
children later, other experts said. 
"RU-486 has given women more choices, and it's been beneficial women's health. has also helped limit the growth the population," Gao said. also said was not surprised the debate the United States. "My feeling that isn't should opposed. But you oppose abortion, understand. But you shouldn't oppose just because it's made China. That shouldn't matter all. 
Staff writer Marc Kaufman Washington contributed this rep01t. 
 2000 The Washington Post Company 
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