Changes

''Bailey v. Wyeth, Inc.'', 2008 N.J. Super. Unpub. LEXIS 3004, *17-19.

''Bailey v. Wyeth, Inc.'', 2008 N.J. Super. Unpub. LEXIS 3004, *17-19.

"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)."  

<blockquote>"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)."</blockquote>

''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).

{{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).

''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)

''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)

===Devices===

===Devices===

<blockquote>Moreover, the FDA's "approval process generally contemplates that approved [devices] will be used in off-label ways," United States v. Caronia, 703 F.3d 149, 166 (2d Cir. 2012); see also Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206, 1218 n.3 (W.D. Okla. 2013) (noting that off-label use is not illegal or disfavored but an accepted and valuable part of the practice of medicine). Off-label use may even be a recognized standard of care. Caronia, 703 F.3d at 153. And congress has prohibited the FDA from "limit[ing] or interfer[ing] with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease." 21 U.S.C. § 396 (2014). Although the Infuse Device was approved as a system, the statutory definition supports our conclusion that each component is a "device" under the FDA that must follow specific federal requirements. See Riley v. Cordis Corp., 625 F. Supp. 2d 769, 780 (D. Minn. 2009) ("It makes no sense—indeed, it would probably be impossible—to pick apart the components of a medical device and apply different preemption analyses to different components."). Consequently, we conclude that the FDA established specific federal requirements for the Infuse Device, even when the Infuse Protein is used alone.</blockquote>

<blockquote>Moreover, the FDA's "approval process generally contemplates that approved [devices] will be used in off-label ways," United States v. Caronia, 703 F.3d 149, 166 (2d Cir. 2012); see also Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206, 1218 n.3 (W.D. Okla. 2013) (noting that off-label use is not illegal or disfavored but an accepted and valuable part of the practice of medicine). Off-label use may even be a recognized standard of care. Caronia, 703 F.3d at 153. And congress has prohibited the FDA from "limit[ing] or interfer[ing] with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease." 21 U.S.C. § 396 (2014). Although the Infuse Device was approved as a system, the statutory definition supports our conclusion that each component is a "device" under the FDA that must follow specific federal requirements. See Riley v. Cordis Corp., 625 F. Supp. 2d 769, 780 (D. Minn. 2009) ("It makes no sense—indeed, it would probably be impossible—to pick apart the components of a medical device and apply different preemption analyses to different components."). Consequently, we conclude that the FDA established specific federal requirements for the Infuse Device, even when the Infuse Protein is used alone.</blockquote>