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(4) are not sold or offered for sale in domestic commerce; and

(5) if the Secretary of DHHS determines that their export would

not be contrary to the public health and safety; and

(6) that their export has the approval of the country to which

they are intended to export.

The most important public health safeguards in the medical device

provision are the last two I mentioned, namely, concern over public

health and safety and the approval of the importing country.

Unt imately, however, we believe that the governments of other nations

are the proper authorities to assess their own health needs, the

diseases and health-related characteristics of their populations, the nature of their health care delivery systems, the availability of

treatment alternatives, and all of the many other factors that go into

risk/benefit decisions. We support, and would continue to support,

international efforts to assure that all nations have access to

information to assist in those risk/benefit determinations.

In this regard, the Adminstration supports international efforts to share information and to improve the ability of all nations to make their own risk/benefit decisions regarding drugs. FDA shares with

other countries information regarding drug approvals and withdrawals,

as well as concerns we may have with respect to specific drugs. The United States has actively participated in the World Health Organization's (WHO) Certification Scheme for Pharmaceuticals Moving in

International Commerce. This system, adopted by WHO in 1975 and

currently agreed to by over 80 countries, permits an importing country

to obtain from the government of an exporting country current

information on the quality and approval status of a drug in the country

of export.

The United States is also involved in other international activities

for ensuring the flow of information on the safety and efficacy of pharmaceutical products. These activities include regular submissions

of information as well as notifications of significant regulatory

actions on drugs to the WHO for subsequent dissemination in WHO's Drug

Information Circular and the WHO Drug Information Bulletin. The United

States also serves as a National Collaborating Center for the WHO

International Drug Monitoring Scheme.

In addition, the United States

participates in the biennial International Conferences of Drug Regulatory Authorities, which provides a forum for the exchange of drug

information and discussions of regulatory actions. The first such conference was hosted by the United States in Annapolis, Maryland in

1980 and the second conference was held in Rome, Italy in 1982. The third has just been held in Sweden.

Thus, we believe that the safeguards described above relating to medical devices, together with WHO's information dissemination efforts, in which we actively cooperate, would provide an appropriate measure of control over the export of unapproved new drugs and unlicensed biologicals, while at the same time permitting the governments of other nations to exercise their om risk/benef it decisions with respect to the pharmaceuticals they believe are suitable for use in their countries.

Now let me turn to the draft legislative proposal at hand. We support its intent, and we especially support the reliance placed on requiring assurance that the drug may be lawfully offered for use in that country. As noted above, this has proven to be quite workable in

the export of un approved medical devices. There are some aspects of

the draft bill that do cause us some concern, however. Let me outline

them for you briefly.

1. Development of the list of Countries Eligible to Receive Drug

Products Not Approved in the United States.

We understand the objectives of the draft's requirement that we establish a list of foreign countries with adequate regulatory systems in place to approve drugs. While such a list could be developed, we believe that for us to sit in judgment of our sister regulatory agencies around the world would place us in the very difficult diplomatic position of publicly assessing the suitability of public health safeguards in other countries. We believe the governments of other nations are in the best position to assess their own health needs.

Mr. Chairman, the system devised by the Congress to authorize the export of un approved medical devices, the key elements of which I described earlier, is sound and efficient, and deserves the Committee's

consideration.

2. Labeling Provisions

A more technical point is that the provision for foreign language Tabeling is not feasible from an administrative standpoint. The draft would allow the pre-export notification to FDA for a drug not approved in the United States to contain non-English labeling from a listed country and a non-English translation of that labeling for an unlisted country. The Agency would, therefore, be required to check the adequacy of the labeling in multiple languages. This provision should be changed to require that the pre-export notification to FDA contains certified English translations of all labels submitted.

3. Definition of "Banned" Drugs

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One of the conditions to be met in order for a product to be exported to listed or unlisted countries raises the concept of a drug that is "banned" in the United States, a concept which has not been defined in either the draft or existing law for drugs. The current statutory scheme for drugs and biologics in the United States results in essentially two categories: those that are approved or licensed and those that are not. For a relatively small number of those that are not approved or licensed, the FDA has refused approval or has withdrawn approval. If the concept of a "banned" drug is to be retained, it should probably include, at a minimum, products for which FDA has formally withdrawn approval or suspended licensure under the normal statutory procedures for withdrawing approval of such application as well as under the "imminent hazard" provision of the FDC Act.

4. Dissemination of Significant Information on Drugs

As I discussed earlier, we already have mechanisms in place to provide important regulatory information to foreign governments and

WHO. Specific legislation to do so is, therefore, unnecessary. To

expand this effort as described in the draft to include information on all drug approvals and all labeling revisions, and sending this regularly to over 160 member countries of WHO, would be extremely burdensom. I also do not believe that even WHO would have the

resources to perform such a function.

In closing, Mr. Chairman, I can only emphasize that, with the few technical amendments that I have discussed with you today, the Department supports S. 2748. We will also work with the Committee to: help develop legislation regarding the export of unapproved drug

products.

That concludes my prepared statement, Mr. Chairman. I will be glad

to answer any questions you may have.

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