Right to Experimental Treatment: FDA New Drug Approval, Constitutional Rights, and the Public's Health

Abstract

On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.

Biosociality, biocitizenship and the new regime of hope and despair: interpreting “Portraits of Hope” and the “Mehmet Case”

“…This situation may establish a specific subjective relation to medical research. Individuals may not only volunteer, but even claim a "right" to be premature research objects because the severity of the disease leaves them with no other hope (Leonard 2009). There is a strong desire to try anything: I had a car wreck when I was 16 that left me paralyzed from the chest down (c/7 quad).…”

Ethical Issues in Brain–Computer Interface Research, Development, and Dissemination

“…Moreover, the balance between individual and public welfare may be skewed if pressure is put on access to experimental assistive technology by users who face the prospect of communication impairments or physical disabilities. A similar pressure was observed regarding experimental medication for acquired immunodeficiency syndrome, which led to public debate and lawsuits concerning the public right to experimental treatment (see, for example, Richman 34 and Leonard 35 ).…”

Access to investigational medicinal products for minors in Europe: ethical and regulatory issues in negotiating children's access to investigational medicines

“…Shire, the British firm that had acquired Metazym by the time funds were raised, stated that they were unable to provide the family with Metazym, due to supply constraints 8. Even when production restrictions are not applicable, litigation fears and public relations concerns may constitute a hurdle to the provision of an IMP at the request of an individual patient 1 2…”

“…The conduct of clinical studies in a sufficient number of eligible research subjects is indispensible to develop safe and efficacious drugs 2 13. However, opportunities to access IMP outside of clinical trials are likely to interfere gravely with the already difficult recruitment of minor research subjects 1 15.…”

“…For many, awaiting the uncertain and time-consuming process of converting an IMP into an approved drug may not appear a realistic option, as prognoses may be grim and a dramatic outcome may seem hard to avert. Therefore, patients have been actively seeking access to IMP ever since the AIDS crisis in the 1980s 2. Gaining access to an IMP, however, often proves to be a difficult enterprise with a highly uncertain outcome.…”