Academic journal article Journal of Law and Health

Restricting Access to Unapproved Drugs: A Compelling Government Interest?

Academic journal article Journal of Law and Health

Restricting Access to Unapproved Drugs: A Compelling Government Interest?

Article excerpt

  I. INTRODUCTION
 II. FDA DRUG APPROVAL PROCESS
     A. History
     B. The Clinical Trial System
     C. Expanded Access Programs
        1. Treatment IND
        2. Group C Treatment IND
        3. Emergency Use IND
        4. Parallel Track
III. BALANCING INDIVIDUAL RIGHTS WITH STATE
     PROMOTION OF PUBLIC HEALTH
     A. The Limits of Paternalistic Regulation
     B. Safeguarding the Clinical Trial System
        1. Scope of the Constitutional Right of Access
        2. Research Subject Motivation
        3. Will a Market Exist?
 IV. CONCLUSION

I. INTRODUCTION

The prospective review and approval of drugs is central to the public health mission of the United States Food and Drug Administration (FDA). Requiring pharmaceutical manufacturers to generate information about their products' safety and efficacy enables the agency to evaluate the risks and benefits associated with their use, thereby preventing overly harmful products from reaching the market. The majority of consumers benefit from this intervention by gaining access to an array of drugs that are proven to be safe and effective. Thus, governmental regulation in this area is arguably justified because the aggregate social welfare is substantially improved.

However, this majoritarian view overlooks the concentrated costs that the drug approval process imposes upon minority groups within society. Drug testing is both resource intensive and time consuming, with an average of eight years required for human clinical testing alone. (1) For individuals suffering from terminal illness who have exhausted conventional therapies, this delay in access can be fatal. Many terminally ill patients are therefore willing to tolerate vastly greater therapeutic risks in an effort to find a cure. Under the current regulatory structure, however, willingness to tolerate, risk does not necessarily translate into access to unapproved drugs.

The tension between drug safety and access to developing experimental drugs most recently came to the forefront in 2003, when the Abigail Alliance for Better Access to Developmental Drugs [hereinafter Abigail Alliance] (2) brought suit to enjoin the FDA from enforcing its current policy banning the use of post-Phase I investigational drugs by terminally ill patients excluded from Phase II clinical trials. (3) The Court of Appeals for the D.C. Circuit recognized a constitutional substantive due process right "to access potentially life-sustaining medication where there are no alternative government-approved treatment options." (4) After concluding that the right asserted by Abigail Alliance merits due process protection, the court remanded the case to the district court to determine whether the FDA's current policy withstands the application of the rigorous strict scrutiny review, essentially, to determine whether the policy is narrowly tailored to serve a compelling governmental interest. (5)

This article analyzes whether the government has a compelling interest in preventing mentally competent, terminally ill patients from accessing post-Phase I drugs. Part II reviews the history of FDA drug regulation and summarizes current law pertaining to the drug approval process. Part III considers whether, in light of the constitutional right recognized by the D.C. Circuit, the government's interest in public health can validate restrictions on drug access for terminally ill patients. More specifically, Part III examines whether such restrictions can be justified either by the benefits they confer upon terminally ill patients themselves, or by the benefits they confer upon society at large. Finally, Part IV concludes by finding that both of these justifications fail, thereby undermining the government's claim to a compelling interest in restricted drug access for this population.

II. FDA DRUG APPROVAL PROCESS

A. History

Federal regulation of drugs began with the Pure Food and Drug Act [hereinafter PFDA]. …

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