Feature Article

The FDA and HCFA (Part I): Unconstitutional Regulatory Agencies

James A. Albright, MD

The accumulation of all powers, legislative, executive and judiciary, in the same hands whether of one, a few or many,
and whether hereditary, self-appointed or elective, may justly be pronounced the very definition of tyranny.

James Madison, 1787
Federalist Papers #47


Executive Agencies with the Power of Legislation


Many of the current problems in this country can be traced to the growth of the regulatory agencies, some of which have become independent fiefdoms with legislative as well as executive and judicial powers. This has indirectly led to disaffection of the population, which in general believes that the government no longer represents their interests. It is a justifiable conclusion, because a high percent of our "laws" are now written by the regulatory agencies in the form of "regulations." The bureaucrats of the regulatory agencies do not answer to the people, as do the congressional legislators. However, the legislators are willing to approve such a system because it serves their interests. It allows them to write general, benevolent sounding laws without taking responsibility for the "nasty" details because these are written by the regulatory agencies. There is little question that the laws would have a different bent if legislators were responsible for the details. Yet, there is a light at the end of the tunnel: Regulations written by the regulatory agencies are unconstitutional, other than those which are procedural recommendations, not binding extensions of the law itself.

The U.S. Constitution

One of the settled maxims in constitutional law is, that the power conferred upon the legislature to make laws cannot be delegated by that department to any other body or authority. Where the sovereign power of the State has located the authority,
there it must remain...until the Constitution itself is changed.

Thomas M. Cooley, 1883(1)


Article I, Section 1, of the Constitution states: "All legislative Powers herein granted shall be vested in a Congress..." But does this statement mean what it says? In actuality, the evidence that it does is overwhelming, beginning with the intent of the Founding Fathers, as well as comments and arguments in speeches and publications during ratification, plus actions of the court, particularly those decisions closer in time to the constitutional period.

The individual whose ideas had the greatest influence on the Founding Fathers was Baron Charles Louis de Montesquieu (1689-1755) from France. He was the first modern writer during the constitutional period to promote the concept of three separate, but equal, powers: Executive, Legislative, and Judicial. The contribution of Montesquieu to our system of government cannot be overemphasized, a fact that has often been overlooked in the past. In 1940, P.M. Spurlin recognized the critical role of Montesquieu, and he quoted numerous authorities who emphasized his importance.(2) This conclusion was documented in a recent study of citations between 1760 and 1805.(3) This study found that, "If there was one man read and reacted to by American political writers of all factions during all stages of the founding era, it was probably not Locke but Montesquieu." Even so, John Locke's (1632-1704) views supported similar concepts, as indicated by his statement in 1690: "The legislature neither must nor can transfer the power of making law to anybody else, or place it anywhere but where the people have."(4)

Montesquieu's concepts captured the imagination of the Founding Fathers who immediately recognized the wisdom of his warning that freedom is abolished and totalitarian powers prevail whenever any individual or group controls any two of the three powers. Montesquieu's, as well as Locke's, influence on James Madison (1751-1836) is evident in Federalist Paper #47 which states that the lack of the separation of powers is "the very definition of tyranny."(5) The wide circulation of Montesquieu's concepts in this country can be appreciated by Spurlin's statement that if Montesquieu's book The Spirit of Laws(6) were suddenly blotted out of existence, a goodly portion of it, certainly the important parts, could be reconstructed accurately from American newspapers of the 18th century. In fact, Madison himself gives Montesquieu full credit.

John Marshall (1755-1835), the 4th Chief Justice of the Supreme Court (January 27, 1801-July 6, 1835), recognized the importance of Montesquieu's writings.(7) Marshall has been called the definer of our nation, the expounder of the Constitution, and the greatest jurist in our history. After ratification of the Constitution, the role of the court was ill-defined. In fact, when the government moved from Philadelphia to Washington, D.C., in 1800, no provision was made to fund or house the court, and for many years it convened in one room in the Capital. At that time, it was questioned whether the court had a significant role to play. Yet, by the end of Marshall's tenure the court had assumed the role it has today: It is a critical pillar supporting our tripartite system of governance.

Marshall's most famous case, Marbury vs Madison, firmly established the power of the court to rule on the constitutionality of legislative acts by Congress. Marshall had purchased Montesquieu's book, The Spirit of Laws, which focuses on the necessity of a tripartite system if liberty is to be protected. This was clearly expressed in the Majority decision written by Marshall: "It is a proposition too plain to be contested that the Constitution controls any legislative act repugnant to it." Moreover, "courts as well as other departments are bound by that instrument."(8)

In 1975, Sotirios Barber stated: "From the early years of the Republic the courts have found implicit in the Constitution a rule restricting the degree to which Congress may delegate its powers to others."(9) Barber called this principle: "The rule of nondelegation."(10) This rule defines a crucial principle for the effective function of a tripartite system (i.e., Executive, Legislative, and Judicial), where each body has specified powers. However, since the 1930s, the Supreme Court has permitted the regulatory agencies to write laws. Technically, these laws are called regulations, but in reality, they are treated as laws by the government, including all three branches, even the judiciary. Anyone who argues that regulations are not laws can easily test this supposition by purposely creating an infraction of a "regulation." The response thereby engendered will be more than that stimulated by a "recommendation"; it will be indistinguishable from a "law."(11) This creates two fascinating constitutional issues: 1) The Constitution gives Congress, and only Congress, the power to write laws; 2) Only the Legislative branch is authorized to write laws; yet, the regulatory agencies are part of the Executive branch which is authorized to enforce the law, not to make law.

Furthermore, the power of the regulatory agencies extends beyond the creation of laws de novo. Their actions can turn a constitutionally enacted law by Congress on its head --- i.e., the law is reinterpreted to serve the interests of the bureaucrats.(12)

Clearly, it is destructive to constitutional government when an executive agency promulgates its own rules, and then interprets and executes those rules, prosecutes alleged violations, imposes penalties, and even adjudicates challenges to its authority. Congressional delegation of legislative powers can also be, and has been, challenged because it encroaches on the civil liberties of citizens without due process of law."(13) It also encroaches on First Amendment rights.

In short, the Supreme Court has avoided the constitutional issue itself, indicating it is aware of the underlying problem but refuses to address it. Even more startling is the fact that under our current system the courts can overturn the decisions of Congress and of the president, but decisions by the FDA and HCFA seem not to be subject to any higher authority.(14) It is not possible for the non-legal mind to grasp the reasons for this bizarre twist of logic. It is a situation where the Judiciary, that branch of government most responsible for upholding citizens' rights, has been inactivated by what appear to be self-imposed restrictions.(15)

This stance of the court presumably stems from a doctrine known as stare decisis which honors precedent as determined by previous court decisions. In a legal sense this may hold true for laws, but it cannot be applied to constitutional principles which do not change except by Amendment. Schoenbrod states that the doctrine of stare decisis has three major purposes:

1. To appraise accurately the intention of those who wrote the text being interpreted. The Supreme Court did not depart from this interpretation until the end of the 19th century.

2. To maintain public faith in the judiciary as a source of impersonal and reasoned judgments.

3. To protect expectations based on precedent so that people can rely on prior judicial decisions.(16)

This doctrine, therefore, requires judges to examine the Constitution itself, together with the framers' opinion of the Constitution, as well as that of judges who lived closest in time to the Founding Fathers who wrote the constitutional provision in question. Nevertheless, there is considerable disagreement on this issue. Some believe that supporting evidence is crucial, and some believe that the words themselves take precedence. Fortunately, on the question of delegation there is no conflict. The intent of the Founders, and the opinion of the courts during the first two-thirds of the country's existence, are synonymous with the words themselves, which even a layman can understand: "All legislative Powers herein granted shall be vested in a Congress...."

Marshall's stance was that of professional objectivity. He was determined that the Court not be made an instrument of partisan politics. He believed that political issues were within the purview of the Executive, and legal issues were within the jurisdiction of the court, i.e., checks and balances rather than reliance on official and citizen virtue as the primary method for maintaining constitutional order.

Debate at the Constitutional Convention proceeded on the premise that Congress could not delegate its legislative powers to the Executive. Furthermore, the framers' claim that Article I of the U.S. Constitution protects the people from elected officials would have been inconsistent with delegated authority that permitted officers to make law outside of the Article I process.(17,18)

A basic premise of the delegates was that a written constitution to establish specific guidelines was essential in order to prevent gradual corruption. Therefore, they felt a sense of accomplishment, even exhilaration after completing what they claimed to be the world's first written constitution.

In short, abundant evidence from the constitutional period indicates that the words in the constitutional text mean exactly what they say.

In Part II of this essay, we will explore, explain, and provide evidence that the FDA and HCFA have abused their regulatory power to interfere in the practice of medicine in America.



1. Cooley TM. A Treatise on the Constitutional Limitations which Rest Upon the Legislative Power of the United States of the American Union. 5th Edition, Little, Brown & Co., Boston, 1883.
2. Spurlin PM. Montesquieu in America: 1760-1801. Baton Rouge, LSU Press, 1940.
3. Lutz DS. The Relative Influence of European Writers on late Eighteenth-Century American Political Thought. Am Political Sci Review, March 1984, pp. 189-197.
4. Locke J. Second Treatise of Government. 1690. Reprinted 1980. Hackett Publishing Co, Inc., Indianapolis, Cambridge, 141, pp. 74-75. "The legislature cannot transfer the power of making laws to any other hands: for it being but a delegated power from the people, they who have it cannot pass it over to others...and when the people have said, We will submit to rules, and be governed by laws made by such men, and in such forms, no body else can say other men shall make laws for them; nor can the people be bound by any laws, but such as are enacted by those whom they have chosen, and authorized to make laws for them. The power of the legislative being derived from the people by a positive voluntary grant and institution, can be no other than what that positive grant conveyed, which being only to make laws, and not to make legislators, the legislative can have no power to transfer their authority of making laws, and place it in other hands."
5. Madison J. Federalist Paper #47.
6. Montesquieu Baron Charles Louis de. The Spirit of Laws. Thomas Nugent's translation (London, Nourse, 1750). Reprinted 1977, David Wallace Carruthers (ed.). University of California Press, Berkeley, Los Angeles, London. Book XI, Chapter 6, p. 201.
7. Smith JE. John Marshall: Definer of a Nation. Henry Holt & Co, NY, 1996.
8. Marbury vs Madison. 5 U.S. (I cranch) 137,2 L.Ed. (1803).
9. Barber SA. The Constitution and the Delegation of Congressional Power. University of Chicago Press, Chicago, 1975, p. 1.
10. Ibid., p. 11. Barber also stated that the "Rule of Nondelegation" has been called an import into constitutional law from the common law of agency where an ancient maxim prohibits the redelegation of delegated power (delegata potestas non potest delegari).
11. Crews CW. Kerrigan K. Here's a winning issue. Wall Street Journal, March 7, 1996.
12. DiIulio JJ. How bureaucrats rewrite laws. Wall Street Journal, October 2, 1996.
13. Barber, op. cit., pp. 31-34.
14. Driscoll JA. Cure for FDA-induced pain. Wall Street Journal, February 2, 1996. Regulatory gridlock should not be compared with the much ballyhooed "government gridlock" which is actually the system of checks and balances the framers created to prevent runaway government.
15. Murphy WE, Fleming JE, Barber SA. American Constitutional Interpretation, 2nd Ed. The Donation Press, Inc., Westbury, NY, 1995, p. 427. Prior to the New Deal, the court had ruled that the president did not have to seek the Senate's approval to remove a postmaster from office (Myers vs U.S., 1926). That case suggested that Congress could place no limitations on the president's removal power. However, later on the court decided that Congress could insulate some administrators from presidential control, specifically commissioners of the independent regulatory agencies, such as the Interstate Commerce Commission, the Federal Trade Commission, and the Federal Power Commission. These individuals could serve for specific terms, rather than at the pleasure of the president. In effect, the court established independent fiefdoms, which in actuality constitute a fourth branch of government controlled by unelected officials who wield power equal to the other three branches. This action not only fits, it exceeds, James Madison's definition of tyranny.
16. Schoenbrod D. Power Without Responsibility: How Congress Abuses the People Through Regulation. Yale University Press, New Haven, 1993.
17. Madison J. Notes of Debates in the Federal Convention of 1787. W.W. Norton and Co., New York, 1966, pp. 326-327. Mr. Madison: "If it be a fundamental principle of free government that the Legislative, Executive and Judiciary powers should be separately exercised, it is equally so that they be independently exercised. There is the same and perhaps greater reason why the Executive should be independent of the Legislature, than why the Judiciary should: A coalition of the two former powers would be more immediately and certainly dangerous to public liberty."
18. Ibid., p. 339. Mr. Gov Morris: "...expositors of laws ought to have no hand in making them.

Dr. Albright is Professor and Chairman of the Department of Orthopedic Surgery at Louisiana State University Medical Center in Shreveport, Louisiana. His e-mail is jalbri@ortho.lsumc.edu.

Originally published in the Medical Sentinel 2000;5(5):169-171. Copyright © 2000 Association of American Physicians and Surgeons (AAPS).