| Line 23: |
Line 23: |
| | "even the FDA has acknowledged that off-label use of a drug may be appropriate and rational (see Use of Approved Drugs for Unlabeled Indicators, FDA Drug Bulletin (Public Health Service, Md.) April 1982, vol. 12, No. 1, 4-5)." | | "even the FDA has acknowledged that off-label use of a drug may be appropriate and rational (see Use of Approved Drugs for Unlabeled Indicators, FDA Drug Bulletin (Public Health Service, Md.) April 1982, vol. 12, No. 1, 4-5)." |
| | ''Proctor v. Davis'', 291 Ill. App. 3d 265, 295, 225 Ill. Dec. 126, 146, 682 N.E.2d 1203, 1223 (1997) (dissent). | | ''Proctor v. Davis'', 291 Ill. App. 3d 265, 295, 225 Ill. Dec. 126, 146, 682 N.E.2d 1203, 1223 (1997) (dissent). |
| | + | |
| | + | {{cquote|Despite the increased federal scrutiny of new drugs, important aspects of patient access to drugs are unregulated by the government and appear always to have been unregulated. The "FDA's regulatory authority . . . extends to manufacturers of drugs but not to the physicians who dispense them." 14 Thus, a doctor may -- and approximately 21% of the time does -- prescribe a drug to a patient for a purpose other than that for which the FDA has approved the use of the drug. 15 Such "off-label" use may occur even if the drug is not deemed safe or effective for that use, such as when a drug studied only for adults is prescribed for a child. Further, it appears that the FDA has never prohibited either off-label prescription or off-label use of drugs. 16 In recent years, the FDA has been moving to permit drug manufacturers to promote the use of their drugs for off-label purposes in limited circumstances. 17 See Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296 (codified in scattered sections of 21 U.S.C. §§ 301-81). |
| | + | |
| | + | 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) |
| | | | |
| | == See also == | | == See also == |