Consent to FDA Regulation: The Political Picture

In five preceding articles in this series, I’ve predicted that We the People will rise-up and withdraw our consent for FDA governing our medicine.  (I take for granted that the reader knows the arguments from recent history which might justify revolt.)  I have boldly proposed that FDA and other Federal agencies’ power to govern medicine be re-thought from the ground-up.  

I’ve based my cry for revolt in medicine regulation by questioning the fundamental pillars for Federal legislation.  The pre-textual presuppositions are ill-defined; indeed, they are intrinsically undefinable.  The key terms are Effectiveness; Safety; Cost/Benefit; Abuse; Addiction; and potential for Acceptable Medical Use.  I hold that We the People of the US have no common definition for each of these terms!  Therefore, the Commissioner of Food and Drugs, the Administrator of the DEA, et al. can’t possibly be carrying out the will of the people in applying their personal whimsical definitions of these terms.

I’ve further suggested that if our medicine is to be governed at all, and by our consent, that it can only be governed by the legislatures of the several states.  Here, and now, it is time for me to articulate my rationale for surveying the states as the path to liberty.

My conservative friends will protest that we can’t, and shouldn’t, trust the states to carry out such an important a task as regulating the medicine consumed by ignorant and naive American citizens (the unwashed masses).  The People must necessarily be governed by Congress.  The evil that bureaucrats do can all be cured by beheading these agencies and replacing them with more wise, ethical and fitting [wo]men.  Allegations of corruption by industry capture and pecuniary greed are intrinsically curable by Congressional “reforms”.  

My simple response is to quote James Madison, the architect of our Constitution:

“If Men were angels, no government would be necessary. If angels were to govern men, neither external nor internal controls on government would be necessary. In framing a government which is to be administered by men over men, the great difficulty lies in this: you must first enable the government to control the governed; and the next place, oblige it to control itself.”

It is impossible to oblige the FDA et al. to control itself.  Nor is it possible to oblige industrialists to control their greed on behalf of shareholders.  Still the key flaw in conservatives’ view is that there is anything we Americans agree upon which is to be governed.  There is no commonly accepted meaning of: Effectiveness; Safety; Cost/Benefit; Abuse; Addiction; and potential for Acceptable Medical Use.  The principal pillars that support FDA, DEA, etc. are all a mirage; a fantasy.  We need only debate among ourselves to recognize that we share no common definition of any of these terms.  And, therefore, we cannot delegate their governance to any official whatsoever.

Each of these 6 terms are quite unlike others such as: Murder; . . .; or Grand Theft Auto.  We Americans are in general agreement as to the essential elements of murder and car-jacking.  Even so, we delegate power to regulate these deleterious activities to the state government; not the Feds.  Why?  Because the 10th Amendment reserves to the States, or to the People themselves, the sole police power to legislate for public safety, health and morals.  If — in our system – both murder and mail-practice are governed by the states, then so too should the states govern our medicine.

My libertarian friends will protest my principled flaw in submitting to any government at all.  I consent to submit to the Power of Harrisburg by living in the Commonwealth of Pennsylvania.  I do so not because I lack faith in the intrinsic angelic nature of my fellow Penciltuckians.  I do not have faith in them.  I have still less faith in our representatives in Harrisburg.  They are all scalawags and thieves, nearly to a man.  

I consent to be governed as to murder and malpractice by Harrisburg; and, so, I am willing to be governed as to medicine by Harrisburg as well.  This is our system of government, as designed by Madison in the original articles of the Constitution and by the residents of the several states in ratifying their respective states’ constitutions.  If there is just a single thing upon which we Americans ought to agree, it is this division of power between the Feds and the states.  The Feds govern military, international and interstate commerce affairs.  The states govern public safety, health and morals.  

If we intend to succeed in retracting our consent to be covered  by the FDA, then we must base our revolt upon the principles of the one thing upon which we have the greatest agreement: our Constitutional structure.  If the states are the proper regulators of our doctors, then they are also the proper custodians of the responsibility to regulate our medicine.

We are all too habituated to our long pattern and practice of believing that there is no other way to do things than in how they have “always” been done.  

“Prudence, indeed, will dictate that Governments long established should not be changed for light and transient causes; and accordingly, all experience hath shewn, that mankind are more disposed to suffer, while evils are sufferable, than to right themselves by abolishing the forms to which they are accustomed. But when a long train of abuses and usurpations, pursuing invariably the same Object evinces a design to reduce them under absolute Despotism, it is their right, it is their duty, to throw off such Government, and to provide new Guards for their future security.-“

As for national governments, so be it for bureaucracies.  Sic semper tyrannis!  This is politics; but not yet “politics by other means.”  If we are to succeed in this revolt with fewer deaths than suffered these past two years — perhaps these last two generations — then we will do so by the art of the possible.  It is possible for residents in each state to withdraw their consent from the FDA and turn to their respective legislatures for whatever government may provide new guards for their future security.

Initiative at the state, and even local, level is succeeding with respect to immigration; marijuana; psilocybin; and the right to arms.  Congress and the executive branches have enormous power; but only to the extent that they are supported by state and local governments.  Some things the Feds can’t do at all without local police acting on their behalf.  Other things they can do only with great difficulty without local police cooperation.  It is sufficient for the people – if but those in a single municipality – to withdraw police support to render moot Federal enforcement.  If an entire state withdraws police support, Federal enforcement is rendered feeble. If the Feds can’t do much in a certain line of enforcement, they won’t do much.  And, eventually, the will of the peoples of the several states will supersede the will of Congress to continue to tyrannize us.  I invite the critical reader to study the foregoing with a view to discovering the error in my reasoning.  

Are all the 6 key terms in FDA regulation of medicine so well defined that we the whole People of the US agree on their meaning?  Bear in mind, each of these terms must be shown to be well defined; else, the principles by which FDA, DEA, et al. govern us are reduced to whim.  If just one is weak, the scheme is on unstable ground.  If two or more are weak, then the entire edifice crumbles.  We have to just look and think for ourselves.  Do we think everyone agrees to common definitions?

Are the bureaucrats in the FDA angels?  Can they control themselves?  Are the managers of great industrial enterprises angels?  Can they control themselves?  Could Congress ever control either body of sinful men?  No better than our state legislators are angels or could control chemists, dealers and consumers within their respective jurisdictions.  Yet, it is up to the residents of each state to decide if, and to what extent, chemists, dealers and consumers are to be governed.  As to their behaviors in murder; malpractice; or medicine.

What might we expect to realize as the realization of the government of medicine by states?  What are the consequences of such a plan?  I do not propose that we gather with tar and feathers at our local pharmacies without meditating on what might become of a system of state regulation.