Abstract

http://ssrn.com/abstract=2173770
 
 

Footnotes (68)



 


 



Doctors, Patients, and Pills - A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription to Make Drug Approval More Meaningful in the Delivery of Health Care


Michael J. Malinowski


Louisiana State University, Baton Rouge - Paul M. Hebert Law Center

February 1, 2012

Cardozo Law Review, Vol. 33:3, No. 102, 2012

Abstract:     
This Article challenges the scope of physician discretion to engage in off-label use of prescription drugs. The discretion to prescribe dimensions beyond the clinical research that puts new drugs on pharmacy shelves has been shaped by two historic influences: a legacy of physician paternalism, solidarity, autonomy, and self-determination that predates the contemporary commercialization of medicine by more than half a century; and regulatory necessity due to the limits of science and the innate crudeness of pharmaceuticals prior to the genomics revolution (drug development and delivery based on genetic expression). Although both factors have changed immensely, the standard for drug approval has lingered. This Article proposes that doctor discretion to prescribe off-label must be modified and the regulatory standard for new drug approvals raised, given the proliferation of adverse events, drug ineffectiveness, the need to make choices among treatment options under time pressures, the increasing complexity of biopharmaceuticals, health-care-cost pressures, and the vulnerability of patients - seekers of health care, not research subjects protected under the scrutiny of regulations to protect human subjects. The Article concludes that although some physician discretion to prescribe off-label still is necessary, law-policy reforms to shift more of the drug-discovery process from the clinical care of patients to clinical research in drug development are long overdue. Proposals to accomplish this, drawn from recent legislation and ongoing health care reform, include heightening the regulatory standards for new drug approvals and drug reimbursement.

Number of Pages in PDF File: 47

Accepted Paper Series


Download This Paper

Date posted: November 12, 2012  

Suggested Citation

Malinowski, Michael J., Doctors, Patients, and Pills - A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription to Make Drug Approval More Meaningful in the Delivery of Health Care (February 1, 2012). Cardozo Law Review, Vol. 33:3, No. 102, 2012. Available at SSRN: http://ssrn.com/abstract=2173770

Contact Information

Michael J. Malinowski (Contact Author)
Louisiana State University, Baton Rouge - Paul M. Hebert Law Center ( email )
440 Law Center Building
Baton Rouge, LA 70803
United States
225-578-8716 (Phone)
Feedback to SSRN


Paper statistics
Abstract Views: 134
Downloads: 20
Footnotes:  68

© 2014 Social Science Electronic Publishing, Inc. All Rights Reserved.  FAQ   Terms of Use   Privacy Policy   Copyright   Contact Us
This page was processed by apollo8 in 0.312 seconds