Technology unbound: will funded libertarianism dominate the future?

• Author: Goldberg, Steven

On May 2, 2006, a liberal and a conservative on the U.S. Court of Appeals for the District of Columbia Circuit joined forces and held that terminally ill patients have a constitutional right to use certain medicines that have not received Food and Drug Administration (FDA) approval. (1) The panel decision in the Abigail Alliance case may or may not survive further review, (2) but the important point has already been established. The FDA has expressed sympathy with the plaintiffs' desire for increased access to non-approved drugs. (3) The increasing reduction of FDA oversight in recent decades (4) has taken another dramatic step.

Access to pharmaceuticals does not stand alone. In vitro fertilization (IVF) is a modern medical procedure that raises a variety of ethical and consumer protection issues. (5) Yet in the United States, it takes place in an unregulated environment reminiscent of the Wild West. State and federal regulators have almost no role, leaving the field to modest and non-binding self-regulation. (6) Just one year before the Abigail Alliance decision, President Bush decried the creation of "spare embryos," a central consequence of IVF, (7) yet his words have led to no restrictions on the widespread availability of this procedure.

These developments do not represent a victory for those who would let the market decide what drugs and medical procedures should be produced and consumed. The plaintiffs in Abigail Alliance have joined forces with groups lobbying for increased federal spending on medical research. (8) The IVF community has a similar record of pushing for government-funded research on enhancing fertility. (9) These groups support what might be called funded libertarianism: the government should use taxpayers' money to support research, but the products and procedures that result should be available on a caveat emptor basis. The maturation of the Internet provides a rough but helpful analogy. Developed initially with substantial government funding, the Internet now operates in a largely unregulated fashion, despite calls for government action against pornography and other social ills. (10)

This new pressure for unfettered access to drugs and medical procedures turns the received wisdom about government regulation of new technology on its head. It has long been noted that novel technologies receive far more regulatory scrutiny than old-fashioned ones. (11) As Cass Sunstein observed in 1997, "people are especially hostile to new risks." (12) Coal mining may be particularly hazardous for workers and emissions from coal plants may substantially endanger the public, but coal mining, an old industry, will never be subject to the level of regulatory oversight that governs the newer nuclear power industry. (13) Yet proponents of access to new pharmaceuticals and to IVF actually seek less regulation than is typical for older drugs and procedures.

We will look first at the Abigail Alliance litigation and what it can tell us about drug regulation and deregulation. We will then turn to the remarkable status of IVF procedures, which have eluded regulation despite (or perhaps because of) obvious links to disputes over the legal status of the embryo. We will then look at the future of funded libertarianism. Although the matter is not free from doubt, it seems unlikely that this approach can serve as a new template for technological progress.

1. ABIGAIL ALLIANCE AND DRUG DEREGULATION

   Under the federal Food, Drug, and Cosmetic Act, (14) a new drug cannot be marketed until the FDA determines it is safe and effective. The FDA makes this determination by subjecting investigational new drugs (INDs) to three phases of testing. (15) In order to understand the holding of the Abigail Alliance court, it is necessary to describe these phases.

   Phase I testing, which takes about one year, involves administering the drug to a small number of human subjects to determine if it is dangerous. (16) The subjects are often healthy, although Phase I can also involve ill patients. According to the FDA, drugs that make it through Phase I are "sufficiently safe for substantial human testing," but they have not yet been shown to be safe and effective enough to be commercially sold. (17)

   If an IND survives Phase I, it moves to Phase II, where it is subjected to a large controlled clinical study involving hundreds of human subjects who have the disease for which the drug is designed. The participants are randomly divided into two groups, one receiving the drug and the other a placebo. Neither the subjects nor those administering the drugs know which group a patient is in. Phase II provides evidence on the effectiveness of the IND as well as additional evidence on its safety. If a drug makes it through Phase II, it moves on to Phase III, which is an expanded controlled study that might involve thousands of human subjects. Those INDs that successfully complete Phase III are eligible to be marketed commercially.

   This FDA process can take years. An individual who might benefit from a drug under study might not be chosen for the clinical trials and, in any event, might receive a placebo in those trials. The FDA has the authority to grant "compassionate use" exemptions for patients who are not receiving a drug under study, but it typically does so only when a drug has at least entered Phase II and there is some evidence of the drug's effectiveness.

   The Abigail Alliance for Better Access to Developmental Drugs (Abigail Alliance) is a lobbying group that was founded by Frank Burroughs after his twenty-one-year-old daughter Abigail died in 2001 of cancer. (18) Abigail was unable to obtain promising drugs that were working their way through the FDA process while she was dying. (19)

   On June 11, 2003, the Abigail Alliance and the Washington Legal Foundation petitioned the FDA to allow terminally ill patients to have access to drugs that had made it through Phase I of the FDA process. (20) After the petition was denied, they brought suit. (21) The District Court dismissed their case, but the District of Columbia Circuit reversed. (22)

   Written by Judge Judith Rogers, a Clinton appointee associated with the court's liberal wing, and joined by Chief Judge Douglas Ginsburg, a conservative Reagan appointee, Abigail Alliance found that terminally ill patients have a substantive due process right to use "potentially life-saving new drugs that the FDA has yet to approve for commercial marketing but that the FDA has determined, after Phase I clinical human trials, are safe enough for further testing on a substantial number of human beings." (23) By carefully defining their claim in this fashion, the plaintiffs persuaded the court that they had satisfied the Supreme Court's requirement that the Due Process Clause not be used to "multiply rights without principled boundaries." (24)

   Moreover, by limiting their claim to drugs that have made it through Phase I, the plaintiffs avoided the question of whether individuals have a right to unsafe medications, and thus avoided a precedent from 1980 upholding the FDA's refusal to approve the use of Laetrile for cancer. (25) As Judge Rogers said, Laetrile might have been "a poison," while Phase I approval assures that drugs have passed somewhat of a threshold. (26)

   The panel's substantive due process analysis found that terminally ill patients had a fundamental right to use potentially life-saving drugs by applying the Supreme Court's Glucksberg (27) approach. (28) Under this test, the court asks whether the asserted fundamental right is "objectively, 'deeply rooted in this Nation's history and tradition'" and whether it is "implicit in the concept of ordered liberty, such that neither liberty nor justice would exist if [it] were sacrificed." (29)

   On the historical point, the court, citing cases beginning in 1609, argued that control over one's body has been traditionally protected at common law for centuries. (30) Government regulation, on the other hand, began in 1906, and only in 1962 did Congress require that drugs be effective as well as safe. (31)

   This approach, of course, turns entirely on the...