The Congressional Record is a unique source of public documentation. It started in 1873, documenting nearly all the major and minor policies being discussed and debated.
“REFORM OF THE FEDERAL FOOD AND DRUG ADMINISTRATION” mentioning the U.S. Dept. of Commerce was published in the Senate section on pages S12020-S12021 on Sept. 30, 1996.
The publication is reproduced in full below:
REFORM OF THE FEDERAL FOOD AND DRUG ADMINISTRATION
Mr. GREGG. Mr. President, I would like to take one last opportunity in this Congress to discuss on the floor of the Senate a matter that is of high priority to me: reform of the Federal Food and Drug Administration. As I have stated many times, FDA reform is critical if the United States is going to continue to be the world leader in the field of medical technology, and I, for one, plan to pick up the mantle that was dropped in relation to this legislation this year.
And I believe the amendments that I offered that were adopted during consideration of Senator Kassebaum's bill by the Labor Committee represent some important principles on which we will need to build a new reform bill in the 105th Congress. One of these amendments dealt with the dissemination of new information relating to health discoveries uncovered by other authoritative Government agencies, such as the National Institutes of Health or the National Academy of Sciences. I believe the American public has the right to be as informed as possible about the nutritional value--or even the scientific potential value--of the food they eat.
Another amendment adopted would allow a system of national uniformity for the regulation, labeling, and marketing of nonprescription drugs. This is an important, pro-consumer provision. It would put an end to the confusing requirements that various States and localities choose to impose on these common products, ensure more efficient interstate commerce of these products, and will not force manufacturers to bear the cost of such mandates which are generally passed on to purchasers. This amendment also contributes to a higher standard of safety by exempting compelling State or local requirements, and creating a mechanism to make truly worthy requirements national.
Mr. President, I was especially pleased to see report language included by the committee acknowledging that other FDA-regulated products, ``may also lend themselves to such a comprehensive system.'' I would hope that the starting point of this provision next year will include cosmetics, prescription drugs, and biologics along with nonprescription products. The value of governing these products by a single, nationwide system is potentially vast. And, Mr. President, I think that discussion of such a comprehensive system for the regulation of food and food additives should be part of the debate.
This provision also dovetails nicely with another amendment that was accepted by the Labor Committee. For example, there is a global trend of international harmonization for products such as cosmetics: The countries in the European Union, Latin American, and various Asian countries are working toward regulatory cooperation. The Labor Committee, recognizing the significance of mutual recognition agreements [MRA] and the on-going negotiations the U.S. Commerce Department and others are involved in, accepted my amendment urging the continuation and completion of such MRA's.
I am concerned by reports that many times, when the folks negotiating these agreements are very close, it is the FDA that throws a wrench into the works. I hope that the agency will take the instruction passed as part of the Labor Committee bill seriously in regard to these international agreements. We need to see them demonstrate a greater willingness to recognize the standards used in other countries. As I have stated many times, the Food and Drug Administration in this country does not have a corner on the ability to regulate well.
These are the sort of FDA reforms that I believe will promote a more efficient, higher quality regulatory process at the Food and Drug Administration. I look forward to revisiting these issues, and all of the other aspects of FDA reform, early in the 105th Congress.
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