58-1-501.7. Standards of conduct for prescription drug education — Academic and commercial detailing.
(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 :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
(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 |
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(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. |
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(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. |
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(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. |
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(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 |
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(ii) |
the damages to the person are reasonable, foreseeable, and proximately caused by the violations of this section. |
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(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. |
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(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 26B-3-902; |
(D) |
a Medicare supplement plan; |
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(ii) |
a hospital as defined in Section 26B-2-201; |
(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 |
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(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. |
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Amended by Chapter 328, 2023 General Session