| Line 44: |
Line 44: |
| | ''Klein v. Biscup'', 109 Ohio App. 3d 855, 863-64, 673 N.E.2d 225, 231 (1996) | | ''Klein v. Biscup'', 109 Ohio App. 3d 855, 863-64, 673 N.E.2d 225, 231 (1996) |
| | | | |
| | + | <blockquote>However, physicians may exercise their independent medical judgment to prescribe FDA-approved drugs to treat conditions other than those for which the drug is approved, if appropriate for the particular patient.25 |
| | + | |
| | + | Absent state regulation, once a drug has been approved by FDA, doctors may prescribe it for indications and in dosages other than those expressly approved by the FDA. This is a widely employed practice known as "off-label" use. Off-label use does not violate federal law or FDA regulations because the FDA regulates the marketing and distributing of drugs in the United States, not the practice of medicine, which is the exclusive realm of the individual states.</blockquote> |
| | + | |
| | + | ''Goico v. United States FDA'', No. 20-1248-JAR-KGG, 2020 U.S. Dist. LEXIS 226868, at *8-9 (D. Kan. Dec. 3, 2020). |
| | ===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> |
| Line 54: |
Line 59: |
| | ''Blazoski v. Cook'', 346 N.J. Super. 256, 272, 787 A.2d 910, 919-20 (Super. Ct. App. Div. 2002) | | ''Blazoski v. Cook'', 346 N.J. Super. 256, 272, 787 A.2d 910, 919-20 (Super. Ct. App. Div. 2002) |
| | | | |
| − | <blockquote>However, physicians may exercise their independent medical judgment to prescribe FDA-approved drugs to treat conditions other than those for which the drug is approved, if appropriate for the particular patient.25
| |
| − |
| |
| − | Absent state regulation, once a drug has been approved by FDA, doctors may prescribe it for indications and in dosages other than those expressly approved by the FDA. This is a widely employed practice known as "off-label" use. Off-label use does not violate federal law or FDA regulations because the FDA regulates the marketing and distributing of drugs in the United States, not the practice of medicine, which is the exclusive realm of the individual states.</blockquote>
| |
| − |
| |
| − | ''Goico v. United States FDA'', No. 20-1248-JAR-KGG, 2020 U.S. Dist. LEXIS 226868, at *8-9 (D. Kan. Dec. 3, 2020).
| |
| | <blockquote>(not a quote) lack of FDA approval does not prohibit a physician from "off label" use</blockquote> | | <blockquote>(not a quote) lack of FDA approval does not prohibit a physician from "off label" use</blockquote> |
| | Kirkman v. Sofamor, S.N.C., 1998 U.S. Dist. LEXIS 13357, 1998 WL 666706 at *4 (W.D. N.C. July 21, 1998) | | Kirkman v. Sofamor, S.N.C., 1998 U.S. Dist. LEXIS 13357, 1998 WL 666706 at *4 (W.D. N.C. July 21, 1998) |