Section 501.7 - Standards of conduct for prescription drug education -- Academic and commercial detailing.

UT Code § 58-1-501.7 (2019) (N/A)
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(1) For purposes of this section: (a) "Academic detailing": (i) means a health care provider who is licensed under this title to prescribe or dispense a prescription drug and employed by someone other than a pharmaceutical manufacturer: (A) for the purpose of countering information provided in commercial detailing; and (B) to disseminate educational information about prescription drugs to other health care providers in an effort to better align clinical practice with scientific research; and (ii) does not include a health care provider who: (A) is disseminating educational information about a prescription drug as part of teaching or supervising students or graduate medical education students at an institution of higher education or through a medical residency program; (B) is disseminating educational information about a prescription drug to a patient or a patient's representative; or (C) is acting within the scope of practice for the health care provider regarding the prescribing or dispensing of a prescription drug. (b) "Commercial detailing" means an educational practice employed by a pharmaceutical manufacturer in which clinical information and evidence about a prescription drug is shared with health care professionals. (c) "Manufacture" is as defined in Section 58-37-2. (d) "Pharmaceutical manufacturer" is a person who manufactures a prescription drug.

(a) "Academic detailing": (i) means a health care provider who is licensed under this title to prescribe or dispense a prescription drug and employed by someone other than a pharmaceutical manufacturer: (A) for the purpose of countering information provided in commercial detailing; and (B) to disseminate educational information about prescription drugs to other health care providers in an effort to better align clinical practice with scientific research; and (ii) does not include a health care provider who: (A) is disseminating educational information about a prescription drug as part of teaching or supervising students or graduate medical education students at an institution of higher education or through a medical residency program; (B) is disseminating educational information about a prescription drug to a patient or a patient's representative; or (C) is acting within the scope of practice for the health care provider regarding the prescribing or dispensing of a prescription drug.

(i) means a health care provider who is licensed under this title to prescribe or dispense a prescription drug and employed by someone other than a pharmaceutical manufacturer: (A) for the purpose of countering information provided in commercial detailing; and (B) to disseminate educational information about prescription drugs to other health care providers in an effort to better align clinical practice with scientific research; and

(A) for the purpose of countering information provided in commercial detailing; and

(B) to disseminate educational information about prescription drugs to other health care providers in an effort to better align clinical practice with scientific research; and

(ii) does not include a health care provider who: (A) is disseminating educational information about a prescription drug as part of teaching or supervising students or graduate medical education students at an institution of higher education or through a medical residency program; (B) is disseminating educational information about a prescription drug to a patient or a patient's representative; or (C) is acting within the scope of practice for the health care provider regarding the prescribing or dispensing of a prescription drug.

(A) is disseminating educational information about a prescription drug as part of teaching or supervising students or graduate medical education students at an institution of higher education or through a medical residency program;

(B) is disseminating educational information about a prescription drug to a patient or a patient's representative; or

(C) is acting within the scope of practice for the health care provider regarding the prescribing or dispensing of a prescription drug.

(b) "Commercial detailing" means an educational practice employed by a pharmaceutical manufacturer in which clinical information and evidence about a prescription drug is shared with health care professionals.

(c) "Manufacture" is as defined in Section 58-37-2.

(d) "Pharmaceutical manufacturer" is a person who manufactures a prescription drug.

(2) (a) Except as provided in Subsection (3), the provisions of this section apply to an academic detailer beginning July 1, 2013. (b) An academic detailer and a commercial detailer who educate another health care provider about prescription drugs through written or oral educational material is subject to federal regulations regarding: (i) false and misleading advertising in 21 C.F.R., Part 201 (2007); (ii) prescription drug advertising in 21 C.F.R., Part 202 (2007); and (iii) the federal Office of the Inspector General's Compliance Program Guidance for Pharmaceutical Manufacturers issued in April 2003, as amended. (c) A person who is injured by a violation of this section has a private right of action against a person engaged in academic detailing, if: (i) the actions of the person engaged in academic detailing, that are a violation of this section, are: (A) the result of gross negligence by the person; or (B) willful and wanton behavior by the person; and (ii) the damages to the person are reasonable, foreseeable, and proximately caused by the violations of this section.

(a) Except as provided in Subsection (3), the provisions of this section apply to an academic detailer beginning July 1, 2013.

(b) An academic detailer and a commercial detailer who educate another health care provider about prescription drugs through written or oral educational material is subject to federal regulations regarding: (i) false and misleading advertising in 21 C.F.R., Part 201 (2007); (ii) prescription drug advertising in 21 C.F.R., Part 202 (2007); and (iii) the federal Office of the Inspector General's Compliance Program Guidance for Pharmaceutical Manufacturers issued in April 2003, as amended.

(i) false and misleading advertising in 21 C.F.R., Part 201 (2007);

(ii) prescription drug advertising in 21 C.F.R., Part 202 (2007); and

(iii) the federal Office of the Inspector General's Compliance Program Guidance for Pharmaceutical Manufacturers issued in April 2003, as amended.

(c) A person who is injured by a violation of this section has a private right of action against a person engaged in academic detailing, if: (i) the actions of the person engaged in academic detailing, that are a violation of this section, are: (A) the result of gross negligence by the person; or (B) willful and wanton behavior by the person; and (ii) the damages to the person are reasonable, foreseeable, and proximately caused by the violations of this section.

(i) the actions of the person engaged in academic detailing, that are a violation of this section, are: (A) the result of gross negligence by the person; or (B) willful and wanton behavior by the person; and

(A) the result of gross negligence by the person; or

(B) willful and wanton behavior by the person; and

(ii) the damages to the person are reasonable, foreseeable, and proximately caused by the violations of this section.

(3) (a) For purposes of this Subsection, "accident and health insurance": (i) means the same as that term is defined in Section 31A-1-301; and (ii) includes a self-funded health benefit plan and an administrator for a self-funded health benefit plan. (b) This section does not apply to a person who engages in academic detailing if that person is engaged in academic detailing on behalf of: (i) a person who provides accident and health insurance, including when the person who provides accident and health insurance contracts with or offers: (A) the state Medicaid program, including the Primary Care Network within the state's Medicaid program; (B) the Children's Health Insurance Program created in Section 26-40-103; (C) the state's high risk insurance program created in Section 31A-29-104; (D) a Medicare plan; or (E) a Medicare supplement plan; (ii) a hospital as defined in Section 26-21-2; (iii) any class of pharmacy as defined in Section 58-17b-102, including any affiliated pharmacies; (iv) an integrated health system as defined in Section 13-5b-102; or (v) a medical clinic. (c) This section does not apply to communicating or disseminating information about a prescription drug for the purpose of conducting research using prescription drugs at a health care facility as defined in Section 26-21-2, or a medical clinic.

(a) For purposes of this Subsection, "accident and health insurance": (i) means the same as that term is defined in Section 31A-1-301; and (ii) includes a self-funded health benefit plan and an administrator for a self-funded health benefit plan.

(i) means the same as that term is defined in Section 31A-1-301; and

(ii) includes a self-funded health benefit plan and an administrator for a self-funded health benefit plan.

(b) This section does not apply to a person who engages in academic detailing if that person is engaged in academic detailing on behalf of: (i) a person who provides accident and health insurance, including when the person who provides accident and health insurance contracts with or offers: (A) the state Medicaid program, including the Primary Care Network within the state's Medicaid program; (B) the Children's Health Insurance Program created in Section 26-40-103; (C) the state's high risk insurance program created in Section 31A-29-104; (D) a Medicare plan; or (E) a Medicare supplement plan; (ii) a hospital as defined in Section 26-21-2; (iii) any class of pharmacy as defined in Section 58-17b-102, including any affiliated pharmacies; (iv) an integrated health system as defined in Section 13-5b-102; or (v) a medical clinic.

(i) a person who provides accident and health insurance, including when the person who provides accident and health insurance contracts with or offers: (A) the state Medicaid program, including the Primary Care Network within the state's Medicaid program; (B) the Children's Health Insurance Program created in Section 26-40-103; (C) the state's high risk insurance program created in Section 31A-29-104; (D) a Medicare plan; or (E) a Medicare supplement plan;

(A) the state Medicaid program, including the Primary Care Network within the state's Medicaid program;

(B) the Children's Health Insurance Program created in Section 26-40-103;

(C) the state's high risk insurance program created in Section 31A-29-104;

(D) a Medicare plan; or

(E) a Medicare supplement plan;

(ii) a hospital as defined in Section 26-21-2;

(iii) any class of pharmacy as defined in Section 58-17b-102, including any affiliated pharmacies;

(iv) an integrated health system as defined in Section 13-5b-102; or

(v) a medical clinic.

(c) This section does not apply to communicating or disseminating information about a prescription drug for the purpose of conducting research using prescription drugs at a health care facility as defined in Section 26-21-2, or a medical clinic.