Utah Code 58-1-501.7. Standards of conduct for prescription drug education — Academic and commercial detailing
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(1) For purposes of this section:
Terms Used In Utah Code 58-1-501.7
- Administrator: includes "executor" when the subject matter justifies the use. See Utah Code 68-3-12.5
- Damages: Money paid by defendants to successful plaintiffs in civil cases to compensate the plaintiffs for their injuries.
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
- Person: means :(24)(a) an individual;(24)(b) an association;(24)(c) an institution;(24)(d) a corporation;(24)(e) a company;(24)(f) a trust;(24)(g) a limited liability company;(24)(h) a partnership;(24)(i) a political subdivision;(24)(j) a government office, department, division, bureau, or other body of government; and(24)(k) any other organization or entity. See Utah Code 68-3-12.5
- State: when applied to the different parts of the United States, includes a state, district, or territory of the United States. See Utah Code 68-3-12.5
(1)(a) “Academic detailing”:(1)(a)(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:(1)(a)(i)(A) for the purpose of countering information provided in commercial detailing; and(1)(a)(i)(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(1)(a)(ii) does not include a health care provider who:(1)(a)(ii)(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;(1)(a)(ii)(B) is disseminating educational information about a prescription drug to a patient or a patient’s representative; or(1)(a)(ii)(C) is acting within the scope of practice for the health care provider regarding the prescribing or dispensing of a prescription drug.(1)(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.(1)(c) “Manufacture” is as defined in Section 58-37-2.(1)(d) “Pharmaceutical manufacturer” is a person who manufactures a prescription drug.
(2)
(2)(a) Except as provided in Subsection (3), the provisions of this section apply to an academic detailer beginning July 1, 2013.
(2)(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:
(2)(b)(i) false and misleading advertising in 21 C.F.R., Part 201 (2007);
(2)(b)(ii) prescription drug advertising in 21 C.F.R., Part 202 (2007); and
(2)(b)(iii) the federal Office of the Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers issued in April 2003, as amended.
(2)(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:
(2)(c)(i) the actions of the person engaged in academic detailing, that are a violation of this section, are:
(2)(c)(i)(A) the result of gross negligence by the person; or
(2)(c)(i)(B) willful and wanton behavior by the person; and
(2)(c)(ii) the damages to the person are reasonable, foreseeable, and proximately caused by the violations of this section.
(3)
(3)(a) For purposes of this Subsection, “accident and health insurance”:
(3)(a)(i) means the same as that term is defined in Section 31A-1-301; and
(3)(a)(ii) includes a self-funded health benefit plan and an administrator for a self-funded health benefit plan.
(3)(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:
(3)(b)(i) a person who provides accident and health insurance, including when the person who provides accident and health insurance contracts with or offers:
(3)(b)(i)(A) the state Medicaid program, including the Primary Care Network within the state’s Medicaid program;
(3)(b)(i)(B) the Children’s Health Insurance Program created in Section 26B-3-902;
(3)(b)(i)(C) a Medicare plan; or
(3)(b)(i)(D) a Medicare supplement plan;
(3)(b)(ii) a hospital as defined in Section 26B-2-201;
(3)(b)(iii) any class of pharmacy as defined in Section 58-17b-102, including any affiliated pharmacies;
(3)(b)(iv) an integrated health system as defined in Section 13-5b-102; or
(3)(b)(v) a medical clinic.
(3)(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 26B-2-201, or a medical clinic.