The stated purpose of the Food and Drug Administration ("FDA" or "Agency") is "to promote and protect the public health."1 In furtherance of this end, the FDA has created a regulatory framework to ensure that drugs marketed to the general public are both safe and effective.2 However, critics insist that the FDA's paternalistic drug approval process does little to achieve its goal.3
At the onset of the AIDS epidemic in the 1980s, criticism of the FDA intensified, as the FDA's lengthy and expensive drug approval process hindered terminally ill AIDS patients' access to potentially lifesaving treatment.4 Advocates for these patients clamored for increased and expedited access to experimental drugs.5 In response, the FDA liberalized its experimental drug policies. This response was not enough, however, to save Abigail Burroughs. Abigail, a twenty-one year-old honors student at the University of Virginia, died in 2001 after exhausting all FDA-approved treatments for her cancer. Prior to her death, Abigail unsuccessfully attempted to gain access through clinical trials to the experimental cancer drugs Iressa and Erbitux (since approved by the FDA).6
In Abigail Alliance v. Von Eschenbach, a lawsuit filed by the foundation named in Abigail's honor, a three-judge panel of the Court of Appeals for the District of Columbia Circuit ruled in May 2006 that terminally ill patients have a due process right of access to such experimental drugs.7 However, the D.C. Circuit reheard the case en bane and reversed the decision 8-2 in August 2007.8 The Supreme Court denied the Abigail Alliance for Better Access to Developmental Drugs's ("Abigail Alliance's" or "Alliance's") petition for a writ of certiorari in January.9 Even if the Court had taken the case, however, it likely would have followed precedent and deferred to Congress and the FDA on the question of drug regulation.10 Despite the Court's denial of Abigail Alliance's petition-and despite the likely disposition had the Court granted cert-it is time to reform the FDA framework so that it no longer impedes the access of terminally ill patients to experimental drugs.
This Note concludes that the greatest prospect for successful reform lies in the legislative process. Reform of the FDA framework through the courts or through the administrative process is likely to prove unavailing. To show why, this Note first reviews the history of FDA regulation, both generally and as applied to terminally ill patients. The Note then demonstrates that the courts cannot bring about successful reform. Proponents of greater access to experimental drugs have no statutory argument and only weak constitutional arguments. Thus, courts should exercise restraint and defer to the judgment of Congress and the FDA on the question of drug regulation-a question of science and medicine. Once the need for some government regulation of scientific and medical questions is acknowledged, Congress and executive agencies-the political branches, rather than the judicial branch-are best equipped to fine tune regulatory policy.
Because recently proposed regulatory reforms are unlikely to succeed, this Note concludes that Congress must step in. The recently proposed Access, Compassion, Care, and Ethics for Seriously Ill Patients Act ("ACCESS Act") provides a model for legislative reform of the FDA framework.11 The Note endorses the Act, along with several suggested modifications to improve the legislation and its chance of enactment. In conclusion, the Note recognizes the implications of its analysis on other questions of science and medicine-from abortion to medical marijuana to physician-assisted suicide-which are traditionally addressed by the judiciary.
II. THE FDA REGULATORY SCHEME
A. The Gold Standard: A History of FDA Regulation
In 1906, President Theodore Roosevelt signed the Food and Drugs Act ("1906 Act"), delegating its implementation to the Bureau of Chemistry in the Department of Agriculture. …