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Effects on IOL Producers Arising from
Release of Misleading Information to
Physicians and the General Public .......


E., Windfall Benefits to New Market Entrants

and Foreign Producers


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Value of the Present System of Confidential
Investigational Process
1. Unique Ability of Practitioners

Effectively to interpret preliminary


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Mr. RADER. Mr. Braverman.



Last week, in testifying before the House in similar hearings, I characterized my testimony as a confession. It was a confession of advice which I am now compelled to give my clients and advice which my clients are now compelled to follow.

It is advice that I do not want to give. It is advice that they do not want to follow, but it has become necessary.

The substance of the advice is: Do not cooperate with the Government. Do not give information to Government agencies when requested, and make it more difficult for Government agencies to get this information even when it is required to be submitted.

The reason for this advice is quite simple. Over the past 7 or 8 years, the courts have eroded the protection that exemption 4 of the Freedom of Information Act was intended to provide and which it is able to provide.

Three factors have contributed to this condition. First, the standard of confidentiality under the exemption has in essence been redefined by the courts-redefined from that which Congress originally intended. The customarily withheld standard which Senator Hatch mentioned in his introductory remarks has been eliminated from the act judicially.

Second, agencies have been given total and virtually unrestrained authority and discretion to disclose information, even though it is found to fall within the fourth exemption of the Freedom of Information Act and even though that might injure legitimate commercial interests.

Finally, the commercial interests at stake here have been deprived of their rights to obtain de novo review of an agency decision to disclose their valuable information.

These factors have created a perception on the part of industry that the Federal Government is either unwilling or unable to pro tect valuable intellectual property-information that is being submitted to Federal agencies—and that industry can no longer rely upon those agencies to protect that information.

Consequently, in response to my advice, my clients have now begun to follow a number of practices designed to make it more difficult for agencies to get this information. For example; some companies simply will not submit it to the agencies. Others now require the Federal representatives to come to their sites to examine the information, but do not allow them to take it back for further use. Still other companies must now make agencies subpena the information and to court for enforcement of the sub pena in a proceeding in which the company can secure protective provisions designed to prevent subsequent disclosure under the Freedom of Information Act of information furnished to the agencies.

All of these strategies are designed to make it more difficult for the Federal Government to get this information. Why? Because the Government under the present state of the law, is no longer able to protect this information as Congress intended it would do so when the Freedom of Information Act was initially enacted and when exemption 4 was included within the act.

There is a solution-S. 1247. S. 1247 would fill the substantive void which has been created in terms of protection of commercial information by the court decision. S. 1247 would cure the procedural problems which are plaguing agencies and submitters alike. For example, the act does not require notification to a submitter; nor does it require that a submitter be granted a right to object. S. 1247 would provide these essential, basic rights.

Most importantly, S. 1247 would cure the perception that Federal agencies are either unwilling or unable to protect confidential business information.

You have heard critics say that this is an attack on openness and an attack on the Freedom of Information Act. It is none of those. What it is is an attempt to restore a balance that Congress intended when the Freedom of Information Act was originally enacted-a balance between openness on the one hand and a legitimate expectation that confidential business information submitted to the Government would be protected.

We would urge that S. 1247 be enacted to restore this balance.
Thank you.
Mr. RADER. Thank you, Mr. Braverman.
[The prepared statement of Mr. Braverman follows:


I am Burt A. Braverman, an attorney and member of

the firm Cole, Raywid & Braverman.

I am appearing before

the Subcommittee to testify concerning Exemption 4 of the

Freedom of Information Act ("FOIA"), 5 u.s.c. $552 (b) (4), and

"reverse FOIA" law suits.



My testimony today deals with the widespread misuse

of the Freedom of Information Act as a means of obtaining confidential business information, the adverse impact which

that practice has had both on the businesses which submit

such information to the Government and on cooperation by such businesses with federal agencies, and the need to remedy this condition by amending Exemption 4 of the FOIA.

This testimony is based on the experience and knowledge which I have gained in representing businesses in a number of reverse FOIA actions which they have commenced in order to enjoin federal government agencies from publicly disclosing private documents which are confidential and commercial in nature,

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