Changes

For more than half of this Nation's history, then, until the enactment of the 1906 Act, a person could obtain access to any new drug without any government interference whatsoever. Even after enactment of the FDCA in 1938, Congress imposed no limitation on the commercial marketing of new drugs based upon the drugs' efficacy. Rather, at that time, the FDA could interrupt the sale of new drugs only if it determined that the new drug was unsafe. Government regulation of such drugs premised on concern over a new drug's efficacy, as opposed to its safety, is of very recent origin. Even today, a patient may use a drug for unapproved purposes where the drug may be unsafe or ineffective for the off-label purpose. In short, encumbrances on the treatment decisions of a patient and her physician lack the historical pedigree of the rights that the Alliance seeks to vindicate.}}

For more than half of this Nation's history, then, until the enactment of the 1906 Act, a person could obtain access to any new drug without any government interference whatsoever. Even after enactment of the FDCA in 1938, Congress imposed no limitation on the commercial marketing of new drugs based upon the drugs' efficacy. Rather, at that time, the FDA could interrupt the sale of new drugs only if it determined that the new drug was unsafe. Government regulation of such drugs premised on concern over a new drug's efficacy, as opposed to its safety, is of very recent origin. Even today, a patient may use a drug for unapproved purposes where the drug may be unsafe or ineffective for the off-label purpose. In short, encumbrances on the treatment decisions of a patient and her physician lack the historical pedigree of the rights that the Alliance seeks to vindicate.}}

''Abigail All. for Better Access to Developmental Drugs v. Von Eschenbach'', 378 U.S. App. D.C. 33, 63-64, 495 F.3d 695, 725-26 (2007)

''Abigail All. for Better Access to Developmental Drugs v. Von Eschenbach'', 378 U.S. App. D.C. 33, 63-64, 495 F.3d 695, 725-26 (2007) (Rogers, J., dissenting)

== See also ==

== See also ==