Effective 5/12/2020
58-1-501.7. Standards of conduct for prescription drug education — Academic and commercial detailing.
58-1-501.7. Standards of conduct for prescription drug education — Academic and commercial detailing.
- (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.
- (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:
- (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”:
- (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.
- (i) the actions of the person engaged in academic detailing, that are a violation of this section, are:
- (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) a Medicare plan; or
- (D) 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:
- (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”:
Amended by Chapter 354, 2020 General Session