Government Overreach Threatens Lives

Tuesday, October 1, 2013

Throughout its long history, the Federal Food and Drug Administration has insisted that its mission is “protecting and promoting your health.” Take that your seriously. In area after area, the record suggests that the paternalist FDA fails you in its announced purpose. Far from protecting “your health,” the FDA prevents you from making the informed decisions to preserve and promote your own health. All too often, the FDA lacks both the judgment and technical expertise to decide which treatments ordinary people may choose to undergo and which they must turn aside.

To take one example, the FDA’s critics have bemoaned its ignorance on such cutting-edge technologies as mobile health apps. Uncertain of its own footing, the FDA’s habitual regulatory caution drives away private investment from venture capital firms that know that millions of dollars in equity can disappear the instant the FDA issues a single adverse notice, which in practice can never be reversed by anyone else.

Illustration by Barbara Kelley

The FDA misfires at the outset by insisting that on matters of human health the correct approach is “better safe than sorry.” Like all rules of thumb, this one is at best a crude proxy for choosing your optimal risk bearing strategy. All too often, errors from delay can dwarf those from the hasty deployment of chancy technologies. Without any detailed knowledge of your relevant situation, the FDA has no idea whether you face a greater risk from going too fast or too slow.

Yet the FDA boldly exercises its premarket approval power early on in the risk cycle, when it typically acts in total ignorance of the individual elements of your cost-benefit decision. If it lets a risky product on the market, you need not deploy it if its risks are too high in your case. But if the FDA keeps a drug or device off the market, no matter how well informed or advised, you no longer have it within your power to make any downstream correction of the FDA’s initial error.

Stem-cell treatment.

In light of all these difficulties, it is absolutely critical that the FDA should not be allowed to extend its power over new drugs and devices to regulate the practice of medicine, where it is singularly ill-equipped to intervene. Unfortunately, the FDA has sought with some success to insert itself into the regulation of medical practice in the highly promising area of stem-cell technology.

In the 2012 watershed decision Regenerative Sciences LLC v. United States, Judge Rosemary Collyer sustained the FDA’s asserted control of this entire area. Now that her decision is on appeal, I have attacked her opinion at length in my essay for the Manhattan Institute, “The FDA’s Misguided Regulation of Stem-Cell Procedures: How Administrative Overreach Blocks Medical Innovation.”

It is widely recognized that stem-cell therapies hold the key to the next generation of medical advances in connection with such devastating conditions such as leukemia and Parkinson’s diseases. It is also common ground in the medical profession that so-called “allogenic” treatments, whereby stem-cells from one person are ultimately transferred into the body of another, run the risk of immunological rejection by the recipient. The preferred road to medical advance lies therefore through “autologous” transfers that remove your own cells, which are then manipulated under laboratory conditions to grow new tissue forms that can then be reinjected into your body to restore its lost function.

Regenerative Sciences uses its “Cultured Regenexx Procedure” for treating patients suffering from certain musculoskeletal damage, including those arising from athletic injuries, like those suffered by professional athletes, who have every incentive to select the right treatment. Like all stem-cell treatments, the Regenerative Science protocol required the standard autologous treatment that requires your cells to be grown and concentrated before being reinjected into the body at the site of damaged joints.

Regenerative Sciences’ track record of successes led large numbers of patients to beat a path to its door. But that same success also attracted FDA attention in 2008 when Mary A. Malarkey, director of the Office of Compliance and Biologics Quality at the Center for Biologics Evaluation and Research at the FDA, delivered a a letter to the firm, which shut its activities down:

Please be advised that in order to introduce or deliver for introduction a drug that is also a biological product into interstate commerce, a valid biologics license must be in effect. Such licenses are issued only after a showing of safety and efficacy for the product’s intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application in effect as specified by FDA regulations.

A small medical practice like Regenerative Science cannot hope to recover through its medical practice the huge-front end costs that often prove too much to bear from large well-capitalized pharmaceutical companies. But rather than fold its tent, Regenerative Sciences challenged the FDA in court in ways that put the agency’s powers and wisdom in the spotlight. Let us take these matters up in order.

The FDA’s Power

Ms. Malarkey’s letter bases the FDA’s power on the fact that the new technology affects “interstate commerce.” As a matter of plain English, her approach is surely wrong-headed because every stage of Regenerative Sciences treatment took place within the state of Colorado.

Judge Collyer’s answer to that interpretive issue lies in the modern jurisprudence of Article I the Commerce Clause—“Congress shall have the power to regulate commerce with foreign nations, among the several states and with the Indian tribes.” That Clause received an indefensibly broad reading in the key New Deal decision Wickard v. Filburn, where the Supreme Court allowed Congress to regulate purely local activities within a given state that, when aggregated, influenced the total level of national economic activity—which is surely the case with respect to stem-cell research.

Yet by running first to the Constitution, Judge Collyer never addressed the key statutory provisions, which tell a different tale. Under the Federal Food Drug and Cosmetic Act, “The term ‘interstate commerce’ means (1) commerce between any State or Territory and any place outside therefore, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.” Similarly, the Public Health Service Act authorizes the FDA to make rules and regulations “to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.”

These key definitions of commerce and communicable diseases were not chosen at random. Historically, they reflect the pre-New Deal vision that the FDA’s jurisdiction only reaches those drugs that actually move in interstate commerce, where they present a risk of communicable diseases. The statutory language consciously reflects the 1903 Supreme Court decision in Champion v. Ames, where the Supreme Court by a five-to-four vote found that Congress had—under the Commerce Clause—the power to prohibit the movement of lottery tickets in interstate commerce.

The decision was notable for two reasons. First, it was consistent with the then well-established rule that Congress could not regulate the manufacture of lottery tickets or indeed anything else. Second, it was a limited power insofar as it left it unclear whether Congress could prohibit the sale of any good in interstate commerce, a position that was widely rejected prior to the Civil War.

Champion exerted a powerful influence over the shape of the 1906 Pure Food and Drug Act, which gave Congress the power to regulate the manufacture of drugs within the territories while denying it the power to regulate the manufacture of drugs within the states. At the same time, it seized on Champion to allow Congress to prohibit, if need be, the shipment of drugs in interstate commerce.

Those limitations were carried forward into the 1938 Food Drug and Cosmetic Act, where they functioned just as they did in the earlier statute. It takes therefore an extraordinary level of judicial imagination to take a statute intended to prevent the shipment of some dangerous substances in interstate commerce and use it to regulate the growth of new substances that pose no threat of a communicable disease within the state.

Under the statute, however, it is not enough that some product used in the course of this stem cell procedure had moved in interstate commerce, even if it did pose any threat of a communicable disease. To be sure, these products could, if improperly prepared, result in the spread of some communicable disease.

But so too could standard surgeries which present that risk whenever physicians fail to wash their hands during a routine procedure—a topic that has been vividly illustrated in Atul Gawande’s 2007 New Yorker masterpiece The Check List. But that point proves too much: by its logic, it would allow the FDA to regulate the entire practice of medicine so long as the doctors used products brought in from out of state—which doctors always do.

In its 1997 report on Proposed Approach to Regulation of Cellular and Tissue-Based Products, the FDA sought, at least for the moment, to limit the potential scope of its power by insisting that it only sought to exert control over “the cells or tissues [that] are…more-than-minimally, manipulated,” which covers all autologous stem cell procedures. But that “more than minimally” language bears no relationship to any portion of the relevant statutory text. Nor does the use of that phrase explain why this stem-cell procedure is not a text-book instance of the practice of medicine.

Bad Policy

In addition to being bad law, the FDA decision represents bad policy. The stem-cell practice may well pose some patient dangers, but that is far more true of other forms of surgery that have life-threatening implications. Yet the FDA has not regulated other forms of surgery that have shown staggering advances at every level without its intervention. It is today bad enough that the FDA regulates medical devices, but it would be a serious setback to medical innovation if each stem-cell procedure had to go through the FDA gauntlet.

Surgery is half science and half art. The procedures that are used at any time will be modified countless times within very short periods. Right now, it is only a combination of hunch, experience, and collaboration that indicate which new techniques are applied and which older ones are rejected. And this is how it should be. The business would come to a screeching halt if the FDA took it upon itself to insist that each and every one of these changes could only be done with its imprimatur.

And it is all so unnecessary. At the time Ms. Malarkey wrote her letter, Regenerative Sciences had already built up a track record of performance that the FDA could have investigated before dropping its regulatory bomb on the company. But information like that is irrelevant to the FDA, which only thinks in terms of its powers, without bothering to ask whether there is actually a problem to fix.

A far better approach is for the FDA to stay its hand in all cases until there is some evidence of mishap that calls for its intervention. It is the same story all over again. The FDA is keenly cognizant of its own powers, but largely oblivious to its own institutional weaknesses. In dealing with drugs and medical devices it may take a revitalized Congress to rein it in. But the courts are well within their power in striking down the FDA’s unwise venture into the regulation of medical practice in stem cell cases.