61 Pages Posted: 21 Mar 2004
Pharmaceutical innovation has created medications which hold out the promise of enhancing both the quality and quantity of people's lives, but at a high cost. Expenditures on prescription medications are exploding and many Americans are unable to afford needed medications. Although Congress has recently enacted the Medicare Prescription Drug Modernization Act, the law is highly controversial and will not fully remedy the access problem. Americans are continuing to turn to Internet pharmacies to obtain necessary prescription drugs at a reasonable cost, but there are significant health risks involved.
This article uses the lens of federalism to analyze the impact of Internet pharmacies on American healthcare policy. Through a comprehensive examination of the flourishing phenomenon of Internet pharmacies, the article demonstrates that the present pharmaceutical regulatory structure, established more than fifty years ago, can no longer ensure individual and public health. Although in theory patients are protected through the bifurcated allocation of authority between the states and the federal government - that is, with the federal government overseeing the big picture - drug safety, efficacy, labeling, and advertising - and the states licensing and disciplining health care professionals who prescribe and dispense medications, in practice it is easy to circumvent this regulatory regime.
Internet pharmacies have opened a giant loophole in the current regulatory safety net, which must be rewoven, not simply mended. While federal agencies have made some efforts to protect the public under the existing statutory framework they have largely deferred to the states, leaving a haphazard patchwork of state initiatives (prosecutorial, legislative, and regulatory) aimed at shielding their citizens from unscrupulous Internet pharmacies.
However, states lack both the clear legal authority and the financial resources to do this. This article explores the significant jurisdictional, constitutional, and practical obstacles to successful state law responses to Internet pharmacies. It demonstrates why only a comprehensive federal regulatory approach will ensure that patients receive safe, effective, and medically necessary drug treatment, while also safeguarding public health. The article makes concrete recommendations for change in current law to achieve the three-fold goal of expanding health care access, assuring heath care quality, and delivering health care in a cost-effective manner.
Keywords: internet pharmacy, Medicare, Food and Drug Administration, jurisdiction, dormant commerce clause
JEL Classification: I10, I18, K13, K14, K23, K32, K42
Suggested Citation: Suggested Citation
Fentiman, Linda Christine, Internet Pharmacies and the Need for a New Federalism: Protecting Consumers While Increasing Access to Prescription Drugs. Rutgers Law Review, Vol. 56, No. 1, pp. 119-179, 2003. Available at SSRN: https://ssrn.com/abstract=507602