US court grants drug access after phase I trials
Posted: Wed May 03, 2006 7:42 am
Interesting US court decision that could end up with some/all patients being given access to drugs after phase I trials.
FDA Shock
In a stunning decision the DC Circuit Court of Appeals ruled yesterday that dying patients have a due process right to access drugs once they have been through FDA approved safety trials. The FDA's refusal to allow firms to sell and patients to buy these drugs "impinges upon an individual liberty deeply rooted in our Nation's history and tradition of [respecting the right of] self-preservation."
A patient's fundamental right could be rebutted if the FDA can show that its policy of barring access to these drugs is "narrowly tailored to serve a compelling governmental interest." (This issue will be decided on remand). But the opinion, by Clinton appointee Judge Judith Rogers and backed by Chief Judge (and GMU faculty member) Douglas Ginsburg, is strongly worded.
The court writes:
A right of control over one’s body has deep roots in the common law. The venerable commentator on the common law William Blackstone wrote that the right to “personal security” includes “a person’s legal and uninterrupted enjoyment of his life, his limbs, his body, [and] his health,”...barring a terminally ill patient from use of a potentially life-saving treatment impinges on this right of self-preservation.
In perhaps the most shocking statement the court says the FDA is like someone who interferes with another person trying to aid a third. The court cites the Restatement (First) of Torts:
[someone who] intentionally prevents a third person from giving to another aid necessary to his bodily security, is liable for bodily harm caused to the other by the absence of aid which he has prevented the third person from giving.
To read the rest of the blog:
http://www.marginalrevolution.com/margi ... shock.html
FDA Shock
In a stunning decision the DC Circuit Court of Appeals ruled yesterday that dying patients have a due process right to access drugs once they have been through FDA approved safety trials. The FDA's refusal to allow firms to sell and patients to buy these drugs "impinges upon an individual liberty deeply rooted in our Nation's history and tradition of [respecting the right of] self-preservation."
A patient's fundamental right could be rebutted if the FDA can show that its policy of barring access to these drugs is "narrowly tailored to serve a compelling governmental interest." (This issue will be decided on remand). But the opinion, by Clinton appointee Judge Judith Rogers and backed by Chief Judge (and GMU faculty member) Douglas Ginsburg, is strongly worded.
The court writes:
A right of control over one’s body has deep roots in the common law. The venerable commentator on the common law William Blackstone wrote that the right to “personal security” includes “a person’s legal and uninterrupted enjoyment of his life, his limbs, his body, [and] his health,”...barring a terminally ill patient from use of a potentially life-saving treatment impinges on this right of self-preservation.
In perhaps the most shocking statement the court says the FDA is like someone who interferes with another person trying to aid a third. The court cites the Restatement (First) of Torts:
[someone who] intentionally prevents a third person from giving to another aid necessary to his bodily security, is liable for bodily harm caused to the other by the absence of aid which he has prevented the third person from giving.
To read the rest of the blog:
http://www.marginalrevolution.com/margi ... shock.html