The Book of Ron Paul
1997 Ron Paul Chapter 91

Food And Drug Administration Regulatory Modernization Act Of 1997

7 October 1997

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Congressional Record (Page H8480)   Cached

1997 Ron Paul 91:1
Mr. PAUL. Mr. Speaker, today, out of nowhere, comes the stealth Prescription Drug User Fee Re-authorization and Drug Regulatory Modernization Act of 1997. Regrettably, but unlike certain militarily procured aircraft, a little rain will not make this bill disintegrate.

1997 Ron Paul 91:2
According to its proponents, this FDA-strengthening bill was more than 3 years in the making—a so-called compromise between industry and the administration, we are told. Yet, despite the 177 pages attempting to reform an administrative agency and its rule-making direction, the leadership did not see fit to announce floor consideration of this bill in the Weekly Whip Notice, yesterday’s Shipping Post’s “Tuesday’s Forecast” section or any other commonly accepted medium as near as I can discern. More curiously, in my attempts to draw some attention to the broadsweeping nature of the bill on the House floor and the process by which it had come up for consideration, I am told by the bill’s proponents that “there is no time available to speak regarding the bill.” Instead, C-SPAN viewers will be treated to a love-in during which each of the bill’s drafters and advocates commend one another for the fine job of corporatism and internationalism they are about to bestow upon the American citizenry and in such a critical aspect of their lives; that is, their health.

1997 Ron Paul 91:3
When a 177-page bill comes to the floor under suspension with practically nothing more than an hours notice, one must always question what freedom-depriving regulation is about to be forced upon the citizens. Below is a sneak preview of the latest regulatory loss of individual liberty and State sovereignty.

1997 Ron Paul 91:4
So-called harmonization language contained in the bill requires the Secretary, through bilateral and multilateral agreements, to “harmonize regulation * * * and seek appropriate reciprocal arrangements” with foreign regulatory agencies. Vocal opponents of this harmonization language convincingly argue this internationalizing of what is already an unconstitutional usurpation of States rights, is very likely to greatly limit the availability of food supplements by requiring prescriptions for dispensation as is the case in certain parts of Europe. Perhaps with such harmonization, we will not only have a Federal war on drugs, but a Federal war on riboflavin, folic acid, and bee pollen. At last, an American alfalfa czar.

1997 Ron Paul 91:5
Food supplement availability may be the least of concerns amongst those who still revere states’ rights and acknowledge the continued existence of the tenth amendment. Section 28 of H.R. 1411, as available on the Internet, entitled “National Uniformity,” “prohibits states and subdivisions from regulating food, drugs, or cosmetics * * *” The bill permits the FDA to set national standards for cosmetics but permits States to issue warning labels and take defective products off the shelves.

1997 Ron Paul 91:6
To the dismay of medical privacy advocates, the bill authorizes the FDA to mandate the tracking of medical patients who use certain medical devices for up to 36 months as well as conduct post-market surveillance of these patients.

1997 Ron Paul 91:7
The bill limits the speech of manufacturers who would claim health benefits on their product labels without the approval of a scientific agency of the Federal Government. The bill responsibly makes provisions for such Scientific Advisory Panels in section 6. According to the bill, these panels are to be made up of “persons who are qualified by training and experience * * * and who, to the extent feasible, possess skill in the use of, or experience in, the development, manufacture, or utilization of * * * drugs or biological products.” Here we have yet another chapter in the book of corporatism detailing the means by which one politically connected private concern gains a competitive advantage or Government privilege at the expense of some less-politically-connected entity or the consumer via some Federal Government, regulatory framework.

1997 Ron Paul 91:8
A bill effecting a major reformation of the Food and Drug Administration with such serious implications for individual liberties and for States’ ability to effectuate their constitutionally-ordained police powers, warrants something more than the “stealth” procedure by which this regulatory “bomb” has been brought to the house floor. This bill apparently will be passed without a real opportunity for responsible debate or even a recorded vote. At a minimum, an opportunity to speak or inquire regarding the bill’s provisions on the house floor and/or the opportunity to amend the bill to improve or remove offensive language, should have been provided within the legislative process. Unfortunately, this was not the case. For these reasons, I oppose H.R. 1411.


1997 Ron Paul Chapter 91
The text of this chapter was inserted in Congressional Record as an extension of remarks, and was not spoken on the House floor.

1997 Ron Paul 91:7
less-politically-connected probably should be unhyphenated: less politically connected.

1997 Ron Paul 91:8
constitutionally-ordained probably should be unhyphenated: constitutionally ordained.

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