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.
I. 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. …