SirBlazinBowl
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The D.C. Circuit Court of Appeal's ringing endorsement of the right of terminal patients' to sue FDA for access to potentially lifesaving investigational drugs is a long-overdue triumph for Americans right to medicine .(Abigail Alliance v Eschenbach) text of decision at The ruling is especially timely at this moment when the nation approaches the 100th anniversary of federal drug regulation and the Pure Food & Drugs Act (enacted June 30, 1906) For more on this anniversary, see, "Centennial of an Unnatural Disaster," in the current June, 2006 edition of Liberty In its brief, the government tried to advance the historical argument that "The FDA has had statutory authority to regulate drugs for almost a century, and that authority is now firmly ingrained in our understanding of the appropriate role of government."
The court rightly rejected this notion, ruling that the "right of control over one's body has deep roots in the common law," whereas FDA regulation is of recent origin."Prior to 1906, there was essentially no drug regulation in the United States," the court observed, adding that it wasn't until 1962 that FDA gained power to regulate access to investigational drugs under the Kefauver Amendment to the Food, Drug and Cosmetics Act (FDCA)."For over half of our Nation's history, then...a person could obtain access to anynew drug without any government interference whatso ever.Even after enactment of the FDCA in 1938, Congress imposed no limitation on the commercial marketing of new drugs based upon the drugs' effectiveness. Rather, at that time, the FDA could only interrupt the sale of new drugs based on its determination that a new drug was unsafe. Government regulation of drugs premised on concern over a new drug's efficacy, as opposed to its safety, is of recent origin. And even today, a patient may use a drug for unapproved purposes even where the drug may be unsafe or ineffective for the off-label purpose. Despite the FDA's claims to the contrary, therefore, it cannot be said that government control of access to potentially life-saving medication "is now firmly ingrained in our understanding of the appropriate role of government."The court's majority concluded The prerogative asserted by the FDA - to prevent a terminally ill patient from using potentially life-saving medication to which those in Phase II clinical trials have access - thus impinges upon an individual liberty deeply rooted in our Nation's history and tradition of self-preservation.
The DC Circuit is to be applauded for this glorious ruling for patients' right to choice in medicine. Americans never intended to sacrifice their right of access to life-saving drugs; rather, this right was usurped by federal drug bureaucrats, who arrogated to themselves increasingly sweeping and dictatorial powers over therapeutic drug decisions. By their very nature, government drug bureaucrats are incapable of taking into account differences in individual values, risk preferences, and medical circumstances when they dictate societal-wide decisions about access to drugs. This decision is especially heartening coming from the DC circuit, in the heart of the beltway, rather than from the left-coast liberal 9th Circuit. Let us pray that this decision stands as a precedent for a new jurisprudence leading us out of a century of pharmaceutical bondage to government bureaucrats!
Kudos to the Abigail Alliance & its attorneys for bringing this issue to the courts.
Newshawk: SirBlazinBowl - 420 Magazine
Source: Drug Policy Forum of California
Copyright: 2006 Drug Policy Forum of California
Contact: N/A
Website:N/A
Author: D. Gieringer
The court rightly rejected this notion, ruling that the "right of control over one's body has deep roots in the common law," whereas FDA regulation is of recent origin."Prior to 1906, there was essentially no drug regulation in the United States," the court observed, adding that it wasn't until 1962 that FDA gained power to regulate access to investigational drugs under the Kefauver Amendment to the Food, Drug and Cosmetics Act (FDCA)."For over half of our Nation's history, then...a person could obtain access to anynew drug without any government interference whatso ever.Even after enactment of the FDCA in 1938, Congress imposed no limitation on the commercial marketing of new drugs based upon the drugs' effectiveness. Rather, at that time, the FDA could only interrupt the sale of new drugs based on its determination that a new drug was unsafe. Government regulation of drugs premised on concern over a new drug's efficacy, as opposed to its safety, is of recent origin. And even today, a patient may use a drug for unapproved purposes even where the drug may be unsafe or ineffective for the off-label purpose. Despite the FDA's claims to the contrary, therefore, it cannot be said that government control of access to potentially life-saving medication "is now firmly ingrained in our understanding of the appropriate role of government."The court's majority concluded The prerogative asserted by the FDA - to prevent a terminally ill patient from using potentially life-saving medication to which those in Phase II clinical trials have access - thus impinges upon an individual liberty deeply rooted in our Nation's history and tradition of self-preservation.
The DC Circuit is to be applauded for this glorious ruling for patients' right to choice in medicine. Americans never intended to sacrifice their right of access to life-saving drugs; rather, this right was usurped by federal drug bureaucrats, who arrogated to themselves increasingly sweeping and dictatorial powers over therapeutic drug decisions. By their very nature, government drug bureaucrats are incapable of taking into account differences in individual values, risk preferences, and medical circumstances when they dictate societal-wide decisions about access to drugs. This decision is especially heartening coming from the DC circuit, in the heart of the beltway, rather than from the left-coast liberal 9th Circuit. Let us pray that this decision stands as a precedent for a new jurisprudence leading us out of a century of pharmaceutical bondage to government bureaucrats!
Kudos to the Abigail Alliance & its attorneys for bringing this issue to the courts.
Newshawk: SirBlazinBowl - 420 Magazine
Source: Drug Policy Forum of California
Copyright: 2006 Drug Policy Forum of California
Contact: N/A
Website:N/A
Author: D. Gieringer
