I am here today to talk to you about the Federal Freedom of Information Act, or FOIA as it is called by those who use it, and the lessons learned in the United States after 33 years of experience with the law. I will focus on how FOIA has enabled the public to gain information about the safety and effectiveness of drugs and medical devices marketed in the United States, because I know that topic is of particular concern to Yakugai Ombudsperson Medwatcher Japan.

　First, though, I will give you a little background information about Public Citizen and the Freedom of Information Act Clearinghouse.

　　I am an attorney for Public Citizen Litigation Group, a ten-lawyer public interest law firm co-founded by Ralph Nader and Alan Morrison in 1972. The Litigation Group is an arm of Public Citizen, a non-profit consumer advocacy organization with approximately 150,000 members. From its founding, Public Citizen Litigation Group has focused a significant portion of its efforts on fighting government secrecy.

　　Since the adoption of FOIA in 1966, millions of Americans -- including scholars, journalists, and private citizens -- have made use of the law to monitor the government's activities and to hold the government accountable for its actions. By giving the public an enforceable right of access to government information, FOIA has enabled American citizens to be informed of the government's actions and to participate more effectively in the public debate that is vital to a strong and vibrant democracy. No nation that shields the workings of its government from the governed can rightly call itself a democracy.

　　In the thirty-three years since its adoption, FOIA has become interwoven into the fabric of American life. Citizen advocacy groups like mine use FOIA almost daily -- to learn about serious adverse effects of drugs, of the chemicals that are present at hazardous waste sites, and of nuclear power plant accidents and mishaps. Our efforts to organize and lobby on health and safety issues and to serve as a government watchdog fundamentally depend upon our ability to obtain access to government information.

　　FOIA has been particularly instrumental in helping the public obtain information about unsafe and ineffective drugs. Thanks to FOIA, doctors, patients, journalists, and watchdog organizations that wish to learn more about a drug that has been approved for market in the United States have numerous sources of information about that drug. Public Citizen Health Research Group, which is an arm of Public Citizen devoted to monitoring the safety of drugs and medical devices, has used FOIA with great frequency and success to obtain information it needs. 　

　　The first place to look for information on an approved drug is the Food and Drug Administration's (FDA) web site. In 1996, Congress amended FOIA to provide for greater access to government information via the internet. The amendments, which are known as the Electronic FOIA Amendments, or referred to as E-FOIA for short, require that agencies post on their web site, and store in electronic reading rooms, all records that have been requested under FOIA in the past, and that have been, or are likely to be, subject to additional FOIA requests. As a result, the most popular and frequently requested records will be available to the public without the need to submit a FOIA request. For example, because members of the public frequently request information about popular drugs such as Viagra and Prozac, the FDA posts the drug approval packages for those drugs on its web site, where they are available to anyone with access to the internet.

　　Also beneficial is the provision in the Electronic FOIA Amendments that requires agencies to post indexes on their web sites that identify and describe the records possessed by the agency. FOIA requesters can use these indexes to determine which of the records in the agency's possession are likely to contain the answers to their questions. The indexes streamline the process of requesting documents: They allow members of the public to target their requests for documents containing the information they seek, and reduce the time agencies waste searching for and copying unresponsive records. I have brought with me today a copy of the index posted on FDA's web site. As you can see, it lists categories of documents and provides links to product approval of drugs and medical devices.

　　 Unfortunately, not all agencies have complied with the Electronic FOIA Amendments as willingly as FDA. Public Citizen has filed a lawsuit against seven government agencies -- among them the Departments of Justice, State, and Education -- charging them with violating the indexing requirement in E-FOIA. (Public Citizen v. Lew, No. 97-2891 (D.D.C. 1997). Because these agencies have not posted lists of the information they maintain, members of the public do not know to which agency to submit a FOIA request, or even whether the information they seek exists at all. That lawsuit is currently pending before a district court in Washington, D.C. Even though a judgment in the case has yet to be issued, the lawsuit has motivated the government to begin developing current and complete indexes for all of its agency holdings.

　　Although FDA's web site is a useful source of information about drugs approved for market, it is incomplete. Significant amounts of information in New Drug Applications and in FDA reviews of new drugs are either redacted from the material on FDA's web site, or are not posted on the web site at all. For example, I have brought with me an overhead of graphs concerning testing of the drug Viagra. Although the FDA posted these graphs, and other information about Viagra, on its web site, as you can see, it has redacted the results of the clinical tests on the drug. Public Citizen Health Research Group is concerned that Viagra may cause adverse reactions in some users, and it is seeking the results of these tests under FOIA.

　　If information is not on the FDA's web site, it is necessary to submit a FOIA request to the agency. The FOIA request must specifically identify the material sought. The FDA then has 20 business days to respond to the request. If the FDA fails to respond, the requester can file suit. If, instead, the FDA denies the request, the requester must appeal the denial, and wait another 20 business days, before he or she can filed suit. This process ensures that the agency has had an opportunity to consider whether to grant or deny the request before the courts become involved.

　　If the FDA denies a request for information about a drug -- for example, the information about Viagra that was redacted from the graphs I just showed you on the overhead projector -- the usual ground is that the information qualifies for the fourth Exemption to FOIA, which bars public access to "trade secrets and confidential commercial information." "Trade secret" is narrowly defined as "a secret, commercially valuable plan, formula, process, or device" that is used to make a trade commodity and that is "the product of either innovation or substantial effort." (Public Citizen Health Research Group v. FDA, 704 F.2d 1280, 1288 (D.C. Cir. 1983)) "Confidential commercial information" is defined as information that, if disclosed "is likely to cause substantial competitive harm" to the submitter of the information. (National Parks & Conservation Ass'n v. Morton, 498 F.2d 765 (D.C. Cir. 1974)). In determining whether any of the requested information qualifies for Exemption 4, the FDA will ask the drug sponsor if the release of information that the sponsor submitted to the FDA in its New Drug Application would cause it substantial competitive harm. Not surprisingly, drug sponsors usually argue that a large amount of information in the New Drug Application constitutes "confidential commercial information" that cannot be disclosed. If the FOIA requester files a lawsuit against the FDA in an attempt to obtain the information, the drug company will almost always intervene to argue against disclosure. Indeed, if the drug company does not intervene and litigate the case on its own behalf, the FDA will deem the Exemption 4 claim waived by the drug sponsor, and will disclose the requested information.

　　Although it is clear that "trade secret" covers no more than a drug's formula, there is still much disagreement over what constitutes "confidential commercial information." Drug companies and the FDA claim that a great deal of information in New Drug Applications, including safety and efficacy data, qualifies as "confidential commercial information." Public Citizen strongly disagrees, and has litigated a number of cases arguing that data relating to a drug's safety and efficacy does not qualify for withholding under Exemption 4.

　　For example, Public Citizen is currently litigating a case against Searle Pharmaceuticals, in which Searle seeks to withhold test results on Celebrex (a recently approved drug), the names of all the researchers who conducted clinical tests on Celebrex, and titles of unpublished articles about the drug. Searle claims that its competitors could hire away its clinical investigators and gain a head start in developing competing drugs if the information were disclosed. In response, Public Citizen argues that clinical investigators names are not normally confidential -- in fact, the clinical investigators frequently publish articles in which they discuss their work for Searle -- and so the names do not qualify as "confidential commercial information." In addition, Public Citizen argued that the test results it seeks would not be applicable to a drug with a different formulation from Celebrex, and thus would have not be of value to a competitor.

　　Another example is a case decided a few years ago, in which Public Citizen sought the clinical protocols used to test the drug Metformin, which the FDA and Bristol-Meyers Squib (the drug's manufacturer) both claimed were nondisclosable as confidential commercial information. They argued that, if disclosed, the protocols could be used by Bristol-Meyers Squib's competitors to develop their own drugs. Public Citizen disputed that assertion, pointing out that the protocols were not at all unique or unusual, and thus would not benefit a competitor, and the court eventually agreed with us.

　　FOIA creates a presumption in favor of disclosure. Thus, the burden is on the FDA and the drug manufacturer to justify withholding information under an exemption to FOIA. The FDA and the drug sponsor cannot rely on generalized and conclusory allegations of competitive harm; they must be specific when explaining why they think disclosure of the information will put them at a competitive disadvantage. The FDA and drug sponsors usually provide affidavits from employees who give further explanation for withholdings. In the vast majority of these cases, the agency or drug sponsor must prepare a Vaughn index, which provides a summary of the information withheld and the government's rationale for nondisclosure. I have brought with me a page from a Vaughn index prepared by Searle Pharmaceuticals to defend withholding information about Celebrex, which I have had translated into Japanese. As you can see, the contents of each withheld document is described with a fair degree of detail, and Searle has listed its justification for withholding each piece of information.

　　Although FOIA itself does not require each agency or interested party to prepare such an index, agencies have been required to produce such indexes ever since 1974, when Public Citizen argued for, and won the right to, such an index, in the case Vaughn v. Rosen. Without these indexes describing the information withheld and the reasons for withholding, it would be very difficult for litigants to contest an agency's reliance on a FOIA exemption, or judges to determine if withholdings were justified.

　　FOIA requesters such as Public Citizen Health Research group then have an opportunity to contest the drug manufacturers' claim that it will suffer harm from disclosure. Again, using the FOIA case involving Searle Pharmaceuticals and Celebrex as an example, Public Citizen Health Research Group responded to Searle's claim that it would suffer harm from release of clinical test results by submitting an affidavit from a former FDA employee explaining that Searle's data could not be submitted to support another drug company's new drug because it would not be applicable to a drug with a different formulation. Public Citizen also argued that the data is only useful to show whether Celebrex is safe and effective for its intended use.

　　Courts often have difficulty deciding Exemption 4 cases, because they do not have the scientific background to determine whether disclosure would harm the competitive position of the drug's sponsor. Some judges rely on independent experts to help them make the determination. In such cases, the judge will ask the FOIA requester and the drug manufacturer to choose an expert that is acceptable to both sides, and then have the expert prepare a report for the judge explaining why disclosure is, or is not, likely to cause the drug sponsor substantial competitive harm. Public Citizen has been involved in one such case, which I briefly described above, where the drug company Bristol-Meyers Squib claimed that it would suffer harm from release of a clinical protocol used in testing the drug Metformin. The expert approved by both Public Citizen and Bristol-Meyers Squib concluded that release of the information would not harm the competitive position of Bristol-Meyers Squib. As a result, the judge ordered that the information be disclosed.

　　One of the major benefits of FOIA is that it requires agencies to release all information that does not qualify for an exemption. Therefore, even if some information in a New Drug Application qualifies for an exemption from FOIA, the rest must be disclosed. As I have already explained, the agency cannot simply assert an exemption to avoid disclosing many pages of information. Instead, it must submit a Vaughn index that explains each deletion. Often, agencies make the mistake of redacting non-exempt information that is in the same document as exempt information. If a judge feels that an agency has failed to segregate and disclose non-exempt information, the judge will order the agency review the documents and release the improperly withheld information. These segregability determinations are a vital aspect of FOIA, since they allow a great deal of useful information to be released even when it is intertwined with exempt information. I have brought with me today a copy of a document redacted by an agency before segregation, and the document after the exempt information has been segregated and disclosed. You can see for yourself that a significant amount of information was released that had previously been withheld.

　　Thus far, I have explained how interested persons can obtain information about drugs that have already been approved for market by the FDA. It has proven far more difficult to gather information about drugs that are currently being tested, but have not yet been approved for sale in the United States. Watchdog groups, such as Public Citizen Health Research Group, seek access to information about drugs before they are approved, so that they can lobby against approval if they think that a particular drug is unsafe or ineffective. The Health Research Group is also interested in obtaining information about the safety of drugs that are in clinical trials to ensure that FDA is protecting the human trial participants on whom the drug is being tested.

　　Obtaining information about drugs that have not yet been approved by the FDA is difficult, even under the broad, pro-access provisions of FOIA, because the FDA has promulgated regulations denying public access to information in New Drug Applications prior to a drug's approval. Indeed, FDA regulations requires that the very fact that a New Drug Application has been filed be kept a secret. However, the FDA's regulations conflict with FOIA, which mandates disclosure unless information qualifies for one of FOIA's nine narrow exemptions. In theory, agency regulations are trumped by a conflicting statute, so FDA's regulations denying access must give way to FOIA. Nonetheless, it is difficult to obtain information about a yet-to-be-approved drug from the FDA when its official policy is to keep all the information about that drug secret.

　　Public Citizen has recently made great strides in gaining access to information about drugs pending FDA approval. This past January, Public Citizen brought suit against the FDA under the Federal Advisory Committee Act, or FACA as it is called for short. Under FACA, FDA holds advisory committee meetings, in which a panel of independent medical experts evaluate the safety and efficacy of a proposed new drug, and then recommend whether or not the drug should be approved. These meetings are open to the public, and the public is given an opportunity to participate in the discussion. Members of advisory committees are provided selections from the New Drug Application submitted by the sponsor and from the FDA's evaluation and review of the drug -- information which assists the panel in discussing the safety and efficacy of the drug and in making their determination whether to recommend the drug be approved for market. Although FACA requires that materials provided to advisory committee members also be given to the public, the FDA's practice had been to deny public access to advisory committee materials. After we filed suit, the FDA agreed to provide to the public the materials given to advisory committee members at or before the meeting. Although this agreement will not go into effect until January 2000, we expect that the newly available information will prove to be enormously beneficial to all individuals who wish to participate in advisory committee meetings.

　　In the United States, administrative agencies oversee an ever-increasing number of laws, and they promulgate regulations that effect every area of public life. Unlike Congress and the President, agency officials are not elected by the public. As a result, agencies can sometimes lose sight of the public interest, particularly when the entities they regulate have gained influence over agency policymakers. FOIA serves the important purpose of ensuring that agencies remain accountable to the public. I believe that agencies such as FDA improve their performance simply because they know that the public can use FOIA, and other open government laws, to monitor how well the agency is doing its job.

　　Public Citizen Health Research Group has often used FOIA as a means of monitoring the FDA's activities. For instance, in 1993, the Health Research Group became alarmed with FDA's monitoring of pre-clinical and clinical studies after a number of individuals who took the drug fiafluridine as part of a clinical trial developed irreversible liver damage, resulting in five deaths. This tragedy inspired Public Citizen Health Research Group to review the FDA's methods of ensuring the safety of drug trial participants. The Health Research Group discovered that a drug need only be tested on animals for 2 weeks before the FDA will give its approval to have the drug tested on human volunteers. Public Citizen then submitted a FOIA request asking for all safety and efficacy information concerning drugs that were tested on humans but were later abandoned for health and safety concerns. Using the information gained from this FOIA request, Public Citizen has successfully lobbied for greater FDA oversight of clinical testing.

V. FOIA's Weaknesses

　　At the same time that FOIA has been an overall success in expanding public access to government information, the Act has certain weaknesses. First and foremost is the problem of delays. Under FOIA, agencies are required to respond to requests within 20 business days. Unfortunately, these limits are more often honored in the breach, so that for example, the worst offender -- the Federal Bureau of Investigation -- routinely takes two to ten years to process a FOIA request. The most frequent complaint I hear from requesters is the delay in receiving a response. However, the E-FOIA amendments provide that, if the requester shows a compelling need for the information, such as to protect human life, the agency should expedite the disclosure process. I am hopeful that the Electronic FOIA amendments and continued Congressional oversight will speed up the FOIA process and significantly reduce delays in the future.

　　A second problem area -- and one not addressed by Congress in the 1996 amendments -- is that agencies have used broad or vague terms in an exemption to expand secrecy beyond the purpose the exemption is meant to serve. Unfortunately, at times, the courts have upheld the government's broad interpretations and withholding decisions. For example, a significant loss for our office and for those who support broad access to government information was the Critical Mass Energy Project v. NRC decision in 1992. In Critical Mass, we sought access to analytical safety reports about nuclear power plants submitted to the Nuclear Regulatory Commission (NRC) by a non-profit organization created by the nuclear industry after the accident at Three Mile Island. Although the reports were circulated widely within the industry, they were not available to the public, and the industry argued that the reports constituted "confidential commercial information" that qualified for Exemption 4 of FOIA.

　　In Critical Mass, the court distinguished between information that is voluntarily submitted to the government and information that must be submitted to the government either because of regulatory requirements or as a condition for a government benefit. If submission of information is mandatory, that information will be disclosed to the public unless the disclosure would cause substantial competitive harm to the company. However, Critical Mass allows the government to withhold information that was voluntarily submitted so long as the submitter can show that it does not customarily release the information to the public. In practice, this allows a company that submits information voluntarily to prevent any of its information from being disclosed to the public. After all, a company is not likely to customarily release information that reflects badly on its products or that is embarrassing, even if the release would not cause it competitive harm. Indeed, these were exactly the type of documents at issue in the Critical Mass case. The nuclear power industry had access to all of the information at issue in Critical Mass. Therefore, none of the companies could argue that disclosure would cause them competitive harm, since their competitors already had seen the information. The industry was fighting disclosure because it feared the bad publicity that would follow if the public reviewed reports detailing problems that arose during the operation of nuclear power plants.

　　The Critical Mass decision has the potential to be quite expansive in its impact because it could lead to government agencies and industry conspiring to keep information from the public by agreeing to the voluntary submission of information that the agency has the power to compel. This is of particular concern whenever the public is interested in industry information submitted to any law enforcement agency with subpoena power.

　　The research and advocacy efforts of my own organization have not been impacted by the Critical Mass standard as much as we feared because much of the industry-submitted information we seek is "required" to be submitted to the agency and therefore does not qualify for the broader protection afforded to "voluntary" submissions. For example, our organization often uses the FOIA to seek safety and effectiveness data submitted to the FDA for drugs and medical devices, or to obtain information submitted by the auto industry to the National Highway Traffic Safety Administration. This data is required to be submitted under our country's extensive regulatory reporting scheme, and so falls outside of the Critical Mass decision and may be released unless the company shows substantial competitive harm. Thus, the harmful impacts of Critical Mass on public access are somewhat minimized by virtue of the significant reporting requirements established by Congress and by the regulations of our nation's health and safety agencies. The Critical Mass standard would be much more dangerous in a society with a less-developed regulatory structure.

　　Another problem with FOIA has been the tendency by agencies to drag their feet and avoid complying with FOIA's mandate. The FDA has not always made it as easy as it should be to gain information about drugs and medical devices. For one, when it comes to FOIA, the FDA tends to follow the lead of the companies it regulates. If a company that submitted a new drug application or a medical device application believes the information qualifies for FOIA Exemption 4, the FDA will almost always support the drug sponsors position by submitting briefs arguing that the information should be withheld, even though the company itself has intervened and is defending against disclosure as well. FOIA certainly does not require FDA to take the drug companies' side in these disputes, and the FDA is free to take at least a neutral stance and simply let the drug company litigate the case against disclosure. Although judges are not supposed to defer to the FDA in FOIA cases, the agency's participation often influences the judge to find that the information is nondisclosable. This is particularly true in Exemption 4 cases, when judges sometimes feel that they do not have the necessary familiarity with the drug testing and approval process to determine whether disclosure is likely to cause substantial competitive harm. As previously discussed, some judges are beginning to rely on the advice of independent experts to help make the Exemption 4 determination. Public Citizen Health Research Group supports this practice, since it serves to ensure that the public gets the information it needs without jeopardizing the financial health of drug manufacturers.　

　　In conclusion, the Freedom of Information Act has revolutionized public access to 　　information in the United States. At the same time, however, more must be done in our country to improve the FOIA process, make government records more accessible to the public, and to reduce government secrecy. I hope that here in Japan you will be able to learn from our experiences -- to adopt what has been successful and to improve upon the weaknesses in our law. I congratulate you on your efforts to open up government action to public scrutiny and wish you the best.

_ Thank you.