August 30, 2010
You learn a lot about members of Congress from the bills they introduce. The FDA Food Safety Modernization Act (S. 510) tells us a lot about Illinois Senator Richard Durbin. Durbin loves big government. Quick to condemn entire sectors of the American economy based on a few rotten apples, he rarely criticizes big government for doing too much regulating because he believes to his core that government is doing too little of it. You will not hear Durbin complaining that government power must be carefully checked to prevent abuse and to stem violations of civil or economic liberties. Indeed, if he believes in economic liberty at all, it is a well kept secret.
The FDA Food Safety Modernization Act adds power to FDA precisely at a time when the agency is discredited by Inspector General reports, by private assessments of its performance, and by judicial decisions against the agency. Its abuses are legion, including approval of unsafe drugs against its own medical reviewers’ objections; failure to remove unsafe drugs from the market for decades, if at all; failure to abide by federal court orders; censorship of nutrient-disease information that could save lives, and on and on. Before you would ever want to give a government agency so abusive of the public trust more power, you would want to be sure that you gutted it of the power it so abusively wields and put in place safeguards against future abuses of power.
Although Durbin knows of these abuses, he does nothing to end them. Instead, he just keeps on giving FDA more and more power—a bit like the best friend of a drunken sailor.
Although the FDA Food Safety Modernization Act calls for the Food and Drug Administration to perform many more food inspections, it includes no provision to protect against abuses arising from inspections. It includes no provision to require that inspectors possess requisite education, training, or skill necessary to discern the existence of adulteration. It does not even limit food safety inspections to inspections for adulteration. Rather, it is an open invitation for FDA to inspect without any limitation on the scope of that inspection power.
Imagine that a policeman was permanently stationed in front of your house. Imagine further that he could inspect your house whenever he chose to do so without any advance notice. Imagine also that during the inspection, he could ask you to produce anything in the house he desired to examine and could ask you any question he cared to, whether germane to a specific law violation or not. At last, imagine that he could stay for as long as he wanted; or, that if you wanted him to leave, he could then go get a subpoena without your knowledge and compel you to turn over everything in your house (the family cat included). You might well declare that your privacy had been taken from you, that you lived under the thumb of rapacious government, and that you appeared to have no presumption of innocence or Fourth Amendment right against unreasonable search and seizure. You would be correct, of course, but this is precisely the kind of reign of terror members of Congress like Richard Durbin (and ally Henry Waxman) seek to create for select American businesses they detest.
Adding to the horrors of S. 510, the law follows a legislative pattern popular with those in power that requires the companies inspected to pay the full cost of inspections. In a weak attempt to placate those who rightfully condemned the law for creating an incentive to use inspections to bleed companies dry, Durbin’s bill will only be imposed for “re-inspections” that follow findings of food safety violations. It does not, however, constrain “re-inspection” to instances in which FDA can prove a product harmful to the public from a first inspection. Rather, even a record keeping error can be enough to justify a reinspection. Reinspection occurs essentially whenever FDA wants, because a finding of a record keeping error is simple under GMP regulations that give FDA inspectors liberal discretion to determine what constitutes a failure of record-keeping. Indeed, under the GMP rules a record keeping violation is unlawful and “adulteration” by operation of law even if the products sold are entirely safe. The reinspection provision is thus an illusory protection, doing nothing material to arrest FDA’s abusive use of its power for which it has become infamous.
I know of no administrative agency that chooses not to take advantage of new revenue raising provisions. All the FDA Commissioner need do is authorize reinspections to bring in cash. It’s a no brainer for her. There are no limits to the number of times re-inspections may occur. To use an Illinois metaphor Durbin should appreciate, the corn is ripe and the combine is filled with gas; it’s time to harvest.
Many FDA Commissioners harbor a bias against particular kinds of dietary supplements, some well-founded, most not. FDA Commissioners, other political appointees in the agency, and FDA district office directors sometimes become upset when a regulated company dares disagree with an agency position or sues the agency to protect itself against abuses of FDA power. There is nothing in this bill to prevent those officials from retaliating against disfavored regulatees by authorizing reinspections simply to impose costs on disfavored companies.
I find it hard to believe that Durbin sees no perverse incentive or conflict of interest in having an agency that enjoys virtually unlimited inspection powers be able to earn revenue simply by calling for inspections. Indeed, if he failed to perceive those problems, why did he authorize payment only for “reinspections.” The real reason is that in this bill, as in other costly, burdensome, and largely incompetent measures that he has favored (like his poorly crafted adverse event reporting bill making the very industry accused of injury responsible for reporting it), this latest bill gives a government agency already possessed of several weighty clubs to pummel industry into submission yet another one.
It is not that Durbin is unaware of instances of FDA abuse of power, he just does not care about them. Durbin’s philosophy might well be summed up as follows: Let government crush a thousand companies or more and let the people employed therein lose their jobs because the government can always step in and provide, AND IT SHOULD. This Durbin bill true to his form places blind faith in a corrupt and abusive agency of the federal government, blind faith in an agency long known to be a captive of the pharmaceutical industry and an enemy of dietary supplements. More power not to the people, more power to a leviathan agency that effectively controls over a quarter of the American economy.
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Durbin, Waxman, and a host of others who view with fondness nearly every measure that gives government more power to wield would do well to consider words of wisdom from none other than Thomas Jefferson: “When the people fear their government, there is tyranny; when the government fears the people, there is liberty.” It is high time the people put the fear of liberty back into members of Congress like Durbin and Waxman by voting those rascals out of office.
© 2010 Jonathan W. Emord – All Rights Reserved
Jonathan W. Emord is an attorney who practices constitutional and administrative law before the federal courts and agencies. Congressman Ron Paul calls Jonathan “a hero of the health freedom revolution” and says “all freedom-loving Americans are in [his] debt . . . for his courtroom [victories] on behalf of health freedom.” He has defeated the FDA in federal court a remarkable seven times, six on First Amendment grounds, and is the author of Amazon bestsellers The Rise of Tyranny, and Global Censorship of Health Information. For more info visit Emord.com.